(53 days)
The Bausch & Lomb Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
The Zyoptix™ XP Microkeratome is an automated pivoting keratome that is connected to, and driven by the translational drive mechanism to create a corneal flap of a predetermined diameter and thickness. The same options are available as with the Hansatome® Excellus™ Microkeratome including flap depths of 160, 180 and 200 microns, 8.5 mm or 9.5 mm flap diameter, and two sizes of suction rings, a 19 mm and 20 mm suction ring. The device is designed to provide the same suction ring-to-eye interface geometry as the Hansatome® Excellus™ Microkeratome.
The translation drive has been changed from a rack and pinion gear drive to a two-link pivot mechanism that provides an identical motion. Corresponding modifications have been made to cutting head and suction ring that supports the two-link offset. The new cutting head is also easier for the operator to handle and the component parts were designed for ease of manufacture, assembly, interchangeability, and improved reliability.
The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. This manufacturing process reduces the tolerance of blade extension variation. An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average thickness of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent.
The provided text in the 510(k) summary for the Zyoptix™ XP Microkeratome does not describe a study with acceptance criteria and device performance results in the typical sense of a clinical trial or performance study for a new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (the Hansatome® Excellus™ Microkeratome).
Therefore, the "acceptance criteria" and "device performance" are primarily framed around proving that the new device is as safe and effective as the predicate device, despite some mechanical design changes.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to the concept of substantial equivalence, meaning the Zyoptix™ XP Microkeratome should perform equivalently to the Hansatome® Excellus™ Microkeratome in creating corneal flaps.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance/Evidence |
|---|---|
| 1. Equivalent Corneal Flap Quality (Diameter and Thickness): The device should produce corneal flaps with dimensions (diameter and thickness) equivalent to those produced by the predicate device (Hansatome® Excellus™ Microkeratome). This is the core functional output of the device. | "An analysis of the dimensional specifications based on 3-D CAD Modeling (3 dimensional computer aided design) established that the average dimensions of the corneal flap produced by the Zyoptix™ XP Microkeratome and the Hansatome® Excellus™ Microkeratome are equivalent." |
| 2. Equivalent Indications for Use: The device should be safely and effectively used for the same clinical application as the predicate device. | "The Zyoptix™ XP Microkeratome is a precision-manufactured instrument indicated for creating a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea." This is identical to the predicate device's stated indications. |
| 3. Equivalent Operating Principle: The fundamental mechanism of action should remain the same. | "Electrically driven oscillating blade housed in a head, which guides the blade across the cornea within controlled parameters." (Identical to predicate) |
| 4. Equivalent Patient Contact Portions and Materials: The parts of the device that contact the patient should be the same, with comparable biocompatibility. | "Suction Ring Microkeratome Head Blade" (Identical). Materials: "Stainless Steel Stainless Steel Low Carbon Stainless steel" (Identical). |
| 5. Safety and Risk Profile is Acceptable: Any changes introduced should not introduce new, unacceptable risks, and the overall safety profile should be comparable to the predicate. | "The Medical Devices Risk Analysis applies to the changes made from the existing Hansatome® Excellus™ Microkeratome to the proposed Zyoptix™ XP Microkeratome. The analysis concluded there are no unacceptable risks known." |
| 6. Manufacturing Precision (specifically blade extension variation): Improvements in manufacturing should reduce variability impacting performance. This isn't a direct "acceptance criterion" in the same way as flap dimensions, but it's a supportive claim for equivalence or improvement. | "The Zyoptix™ XP Blade is produced by a more exacting manufacturing process and is designed to be used exclusively with the Zyoptix™ XP Microkeratome. This manufacturing process reduces the tolerance of blade extension variation." |
Study Details (Based on the provided information)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of a prospective clinical study involving patient samples. The primary evidence for flap dimensions was based on "dimensional specifications" and "3-D CAD Modeling." This suggests a computational analysis rather than a physical test set on biological samples for the primary equivalence claim.
- Data Provenance: The data related to flap dimensions came from "3-D CAD Modeling" (computer-aided design). This is a retrospective analysis of design specifications and theoretical performance, not a prospective study on patient data. No country of origin for this "data" is specified beyond the company's location (Rochester, NY, USA).
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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. The ground truth for the flap dimension equivalence was established through engineering analysis (3-D CAD Modeling), not through expert review of physical outcomes or images.
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Adjudication method for the test set:
- Not applicable. There was no test set in the sense of a collection of cases requiring adjudication by experts.
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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:
- No. This is a mechanical device (microkeratome), not an AI diagnostic tool. Therefore, an MRMC study is not relevant to this submission.
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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 device, not an algorithm. The 3-D CAD modeling could be considered a "standalone" computational analysis of the device's theoretical mechanical output.
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The type of ground truth used:
- The primary ground truth for the equivalence of flap dimensions was derived from engineering specifications and theoretical calculations via 3-D CAD modeling. This is a design-based ground truth or computational ground truth as opposed to a clinical or pathological ground truth from actual surgical outcomes.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.