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510(k) Data Aggregation
(31 days)
INNOVATIVE OPTICS, INC.
The INNOVATOME™ microkeratome is indicted for the resection of a circular anterior lamellar flap.
The INNOVATOME™ is a microkeratome that rotates at 14,000 rpm and is capable of creating lamella with diameters ranging from 8-10 mm.
This document is a 510(k) summary for the INNOVATOME™ Microkeratome, submitted in 1997. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices, and therefore, no specific acceptance criteria or study demonstrating device performance against such criteria are presented.
The manufacturer explicitly states that "Performance Data: None." and that "Because of this, performance data were not required." The basis for clearance is substantial equivalence, not performance against specific metrics.
Therefore, many of the requested sections below cannot be fulfilled from the provided document as this device falls under a "substantial equivalence" claim where performance data was not required.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No explicit acceptance criteria provided in the document. The submission relies on substantial equivalence to predicate devices regarding specifications and intended use. | No performance data reported as it was not required due to substantial equivalence claim. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No performance data or test set was used for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No performance data or test set was used for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No performance data or test set was used for this 510(k) submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study was conducted. This device is a microkeratome, a surgical instrument, and not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a microkeratome, a surgical instrument, and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No performance data or ground truth was established for this submission.
8. The sample size for the training set
Not applicable. No training set was used for this submission.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth was established for this submission.
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