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Surgin's Prizm Blades are designed as replacement blades for the Nidek Model MK2000 keratome.

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This document, a 510(k) clearance letter from the FDA for the Prizm Keratome Blade, does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976 ... You may, therefore, market the device, subject to the general controls provisions of the Act."

The 510(k) pathway for medical device clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove performance against specific acceptance criteria.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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