(208 days)
The Model 700700 M2 Compatible Microkeratome Blade is intended to be used as a replacement blade for the Moria M2 non-disposable Microkeratome K002191
The MICROspecialties, Inc. disposable M2 compatible Microkeratome blade is a replacement stainless steel blade for the Moria M2 Microkeratome blade. Both blades are made of 400 series stainless steel and they are packaged and shipped using the same methods. Both blades are single-use, sterile, and disposable blades.
The provided document describes the MICROspecialties, Inc. Disposable M2 Compatible Microkeratome Blades and its substantial equivalence to the predicate device, the Moria M2 Microkeratome blade (K002191). The study aims to demonstrate that the new device performs comparably to the predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating comparability to the predicate device.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (MICROspecialties M2 Compatible Blade) |
|---|---|---|
| Intended Use | Same as predicate device (Moria M2 Microkeratome blade) | As indicated (Same as predicate) |
| Target Population | Same as predicate device | As indicated (Same as predicate) |
| Performance (General) | Comparable to the M2 Blade (predicate) | Comparable to the M2 Blade (predicate) |
| Blade Material | Low carbon stainless steel (same as predicate) | Low carbon stainless steel (Same as predicate) |
| Blade Dimensions | Comparable to the M2 blade (predicate) | Comparable to the M2 blade (Same as predicate) |
| Physical Measurements | Same as the predicate device | Same as the predicate device |
| Sharpness | Comparable to the predicate blade | Comparable to the predicate blade |
| Fit | Same as the predicate blade | Same as the predicate blade |
| Corneal Resections | Similar accuracy and variability to predicate device | Similar accuracy and variability (demonstrated on porcine eyes) |
| Sterilization | Sterilized to SAL of 10-6 with validated process to EN 552 | Sterilized by exposure to gamma radiation to an SAL of 10-6 with a validated process to EN 552 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly mentions "Non-clinical testing on porcine eves". However, the exact number of porcine eyes used in this testing is not specified in the provided text.
- Data Provenance: The testing was "non-clinical" and likely conducted in a laboratory setting. There is no mention of country of origin for this specific testing or if it was retrospective or prospective. It is implied to be prospective testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- The document does not mention the use of human experts or an expert panel to establish ground truth for the non-clinical testing on porcine eyes. The assessment of "corneal resections that had similar accuracy and variability" would likely be performed by technicians or researchers, but their qualifications are not specified.
4. Adjudication Method for the Test Set
- Since there's no mention of human experts establishing ground truth or a multi-reader setup, there is no adjudication method described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. The study focuses on the physical and performance characteristics of the device itself (blade material, sharpness, fit, and corneal resection quality on animal models), not on human reader performance with or without AI assistance. This device is a surgical blade, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable. This device is a microkeratome blade, a physical surgical instrument, not an algorithm or AI system. Therefore, standalone algorithm-only performance testing is not relevant.
7. Type of Ground Truth Used
- The ground truth for the performance testing (specifically for corneal resections) appears to be based on objective measurements and observations of the quality and consistency of corneal flaps created on porcine eyes. This is a form of experimental or laboratory ground truth, comparing new device outcomes to those known to be produced by the predicate device.
8. Sample Size for the Training Set
- There is no mention of a training set in this document. As the device is a physical surgical blade and not an AI or machine learning model, a training set as typically understood in AI/ML development is not applicable. The device's design and manufacturing are based on established engineering principles and material science, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a training set is not mentioned and is not relevant for this type of device, the method for establishing its ground truth is also 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.