(13 days)
The Zyoptix XP Epi Separator System is indicated for the partial or complete delamination of the corneal epithelium in preparation for subsequent surgical procedures on the denuded cornea.
The Epi Separator System is designed exclusively for use with the Zyoptix XP Microkeratome. The Zyoptix XP Separator System, which consists of the Epi Head and single use Epi separator, are optional accessories for the Zyoptix XP microkeratome.
This document is a 510(k) Premarket Notification for the Zyoptix XP Epi Separator System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional study with acceptance criteria and performance metrics for a novel medical device. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert adjudication as one might see for an AI/algorithm-based device is not present.
However, based on the provided text, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy) is not explicitly defined because this submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel performance. The "performance" is implicitly tied to the device's ability to safely and effectively perform its intended use as compared to its predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Substantial Equivalence and Safety/Effectiveness Sections) | Reported Device Performance and How it Meets Criteria (Inferred) |
|---|---|---|
| Safety | No additional unacceptable known risks compared to the predicate device. | "The Medical Device Risk Analysis was performed comparing the changes made to the Zyoptix XP Microkeratome. The analysis concluded there are no additional unacceptable known risks." (Section 6 & 8 - Safety) |
| Effectiveness/Functionality | Compliance to design requirements and specifications for its intended use (partial or complete delamination of the corneal epithelium). | "Design verification was conducted to demonstrate compliance to design requirements and specifications for the Zyoptix XP Epi Separator System. Sufficient objective evidence was collected to conclude that the design met the requirements outlined in the product requirements and technical specifications." (Section 8 - Effectiveness) |
| Material Equivalence | Use of same or substantially equivalent materials as the predicate device. | Materials (Stainless Steel, Low Carbon Stainless Steel) are identical to the predicate device. (Section "Substantial Equivalence Summary Table") |
| Operating Principle | Same operating principle (electrically driven oscillating blade across the cornea within controlled parameters) as the predicate. | Operating Principle is identical to the predicate device. (Section "Substantial Equivalence Summary Table") |
| Sterilization | Same sterilization method (EtO) as the predicate device. | Sterilization (EtO) is identical to the predicate device. (Section "Substantial Equivalence Summary Table") |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a 510(k) submission for a physical medical device, not an AI/algorithm. The evaluation is based on design verification, risk analysis, and comparison to a predicate, not clinical trials with "test sets" in the AI sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" established by experts in the context of clinical data for this type of submission. The evaluation is engineering-focused on design and safety, and comparison to an existing device.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" and thus no adjudication method as understood in AI/clinical studies.
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. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
Not applicable in the traditional sense of clinical outcome data or expert consensus on images. The "ground truth" here is compliance with engineering design specifications and safety standards, and functional equivalence to the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an AI/algorithm device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set.
§ 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.