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A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).

A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea).

This is a 510(k) clearance letter for a medical device (C.S.O. Tonometer) and does not contain detailed information about the acceptance criteria, study design, or performance metrics. Therefore, I cannot extract the requested information from the provided text.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for FDA 510(k) clearance. However, it does not provide the specific performance criteria or the results of a study to demonstrate that the device meets those criteria.

To answer your questions, I would need a detailed study report, a submission summary, or a similar technical document that describes the device's testing and performance.

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An AC-powered slitlamp biomicroscope is intended . for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment

Biomicroscope, Slit Lamp AC Powered

While the provided document is an FDA 510(k) clearance letter for a "Slit Lamp" (Biomicroscope), it does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) clearance process primarily determines substantial equivalence to a predicate device, not necessarily in-depth performance studies against specific clinical acceptance criteria for an AI or advanced medical device. Given the date of the document (1999), it predates the widespread use of AI in medical devices and the level of detail regarding performance studies typically required for AI-powered devices today.

Therefore, I cannot fulfill your request with the provided input. The document

• Does not mention AI assistance.
• Does not provide a table of acceptance criteria or reported device performance.
• Does not detail sample size for test sets, data provenance, expert qualifications, or adjudication methods.
• Does not describe MRMC studies or standalone algorithm performance.
• Does not specify the type of ground truth used or details about training sets.

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