Important Safety Information
The device output is not a clinical diagnosis. The probability distributions, severity scores, and clinical sign quantifications produced by the device are clinical decision support information that must be interpreted by a qualified healthcare professional in the context of the patient's complete clinical picture.
Como tirar fotos
Princípios básicos
Benefícios Clínicos e Declarações de Desempenho
Esta seção descreve os benefícios clínicos pretendidos do dispositivo e as declarações de desempenho que fundamentam cada benefício. Cada benefício clínico é apoiado por métricas de desempenho específicas validadas através de estudos clínicos.
Clinical Validation Studies
This section provides full bibliographic references for the clinical validation studies cited in the Clinical Benefits and Performance Claims section. Each study code that appears alongside a performance metric is defined below with its complete study metadata.
Contraindicações
Recomendamos ao usuário não utilizar o dispositivo se:
Precauções
Após analisar os riscos associados ao uso do dispositivo, identificamos alguns riscos residuais.
Feedback questionnaires
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Testing the performance
For many reasons, you may be interested in measuring the performance of our technology with your own testing dataset. We encourage this practice, although when conducting such a test, you must understand what is the right way of testing the performance of a computer vision model, and which are appropriate methods to test the performance of the device.