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Retinal detachment requiring surgical intervention to reattach the retina and preserve/reserve the patient's vision

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I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) clearance letter from the FDA for a device called "Retinal Detachment Implants." This letter confirms that the FDA has reviewed the device and determined it to be substantially equivalent to a legally marketed predicate device.

However, the provided text does not contain any information about:

• Acceptance criteria for the device's performance.
• A study that proves the device meets specific performance criteria.
• Device performance data (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test or training sets.
• Data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

The document is purely an administrative clearance letter, not a technical report detailing performance studies.

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