(88 days)
The Hansatome™ microkeratome is a precision-manufactured instrument indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
The Hansatome™ microkeratome is a precision-manufactured instrument designed for cutting a precise corneal disc of preselected thickness and diameter. The device is intended for use in performing lamellar corneal resections. The Hansatome™ Microkeratome materials are similar to those used in the predicate device.
This submission for the Hansatome™ Microkeratome is a 510(k) premarket notification, claiming substantial equivalence to a predicate device (Automatic Corneal Shaper, K913697). As such, it focuses on demonstrating that the new device is as safe and effective as the predicate, rather than providing extensive de novo clinical study data to meet specific acceptance criteria for performance. The summary explicitly states that the technological changes "do not raise any new issues of safety, effectiveness or performance of the product," relying on the predicate's established performance.
Therefore, the "acceptance criteria" here are primarily about demonstrating equivalence in performance to the predicate device in non-clinical tests.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent intended use | Same |
| Equivalent operating principle | Same |
| Equivalent patient contact portion | Same |
| Equivalent materials | Same |
| Equivalent ability to create corneal resections | "found to perform equivalently to the predicate device, Automatic Corneal Shaper (ACS) with respect to the creation of corneal resections." |
| No new safety, effectiveness, or performance issues | "the technological changes... do not raise any new issues of safety, effectiveness or performance of the product." |
Study Proving Device Meets Acceptance Criteria:
The study described is a non-clinical comparative test.
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Sample size used for the test set and the data provenance: Not specified. The document states "will be tested" and "was found to perform equivalently," implying non-clinical testing was conducted, but details on sample size or data provenance (e.g., in-vitro tests on cadaver eyes, animal models) are not provided. It is considered retrospective as per the K913697.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was a non-clinical comparison focusing on mechanical performance (creation of corneal resections) and material equivalence, not expert-adjudicated clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human adjudication of clinical data is described.
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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. This is a mechanical surgical device, not an AI-assisted diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical surgical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly refers to the established performance characteristics and specifications of the predicate device. The performance of the new device was compared against these. For the "creation of corneal resections," the ground truth would likely be quantitative measurements of the consistency, thickness, and diameter of resections performed by the device on an appropriate test medium (e.g., cadaveric eyes, synthetic cornea models).
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The sample size for the training set: Not applicable. As a non-AI mechanical device, there is no "training set."
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How the ground truth for the training set was established: Not applicable.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.