(56 days)
The M2 SINGLE USE microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
List of components
a) Power unit
b) Motor
c) Suction rings
d) Applanator lenses
e) Footswitches
f) Keratome head with pre-inserted Keratome blade
The M2 SINGLE USE microkeratome is intended for use in creating a corneal flap for LASIK surgery or other treatments requiring initial lamellar resection of the cornea.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for the M2 SINGLE USE microkeratome. Instead, it relies on demonstrating equivalence to predicate devices and qualitative performance. The reported performance is based on in-vivo and in-vitro studies:
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| In-vitro: | |
| Flap thickness consistency | Demonstrated in in-vitro studies on porcine eyes. |
| Safety of corneal resections | Demonstrated in in-vitro studies on porcine eyes. |
| Good quality of corneal resections | Demonstrated in in-vitro studies on porcine eyes. |
| In-vivo: | |
| Safety in human eyes | "M2 SINGLE USE microkeratome is a safe Keratome" (based on in-vivo studies on 72 human eyes). |
| Ability to create circular lamellar resection | "able to create... circular lamellar resection" (based on in-vivo studies on 72 human eyes). |
| Ability to create resection of predetermined diameter | "able to create... of a predetermined diameter" (based on in-vivo studies on 72 human eyes). |
| Ability to create resection of predetermined thickness | "able to create... of a predetermined... thickness" (based on in-vivo studies on 72 human eyes). |
| Bed smoothness | "and bed smoothness" (based on in-vivo studies on 72 human eyes). |
| Equivalence to predicate device (CARRIAZO BARRAQUER products) | "able to create, equivalently to the predicate device, circular lamellar resection of a predetermined diameter and thickness and bed smoothness." (based on in-vivo studies on 72 human eyes compared to the predicate device CARRIAZO BARRAQUER SINGLE USE Microkeratome (K003594) and CARRIAZO BARRAQUER II Microkeratome (K002191)). (The document implies this equivalence is for all listed in-vivo performance metrics). |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- In-vitro: Not specified, but stated as "in-vitro studies on porcine eyes."
- In-vivo: 72 human eyes.
- Data Provenance: The document does not explicitly state the country of origin. Given the submitter's location (MORIA S.A. in France), it is plausible the studies were conducted in Europe, but this is not confirmed. The studies are implicitly prospective for the M2 SINGLE USE microkeratome as they are conducted to demonstrate its performance.
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts or their qualifications used to establish ground truth for either the in-vitro or in-vivo studies. The "Discussion of tests and results" section simply states what was "demonstrated" by the studies.
4. Adjudication Method
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study compares the M2 SINGLE USE microkeratome to predicate devices, but there is no indication of human readers improving with or without AI assistance, as AI is not a component of this device.
6. Standalone Performance
Yes, the studies described are for the standalone performance of the M2 SINGLE USE microkeratome, as it is a physical device and not an AI algorithm requiring human-in-the-loop interaction. The performance metrics listed describe the device's inherent ability to create corneal flaps.
7. Type of Ground Truth Used
- In-vitro studies (porcine eyes): The ground truth for flap thickness consistency, safety, and quality of corneal resections would likely be based on direct measurements, microscopic examination, and qualitative assessment by trained surgical or pathology personnel.
- In-vivo studies (human eyes): The ground truth for safety, ability to create circular lamellar resection, predetermined diameter and thickness, and bed smoothness would be assessed directly by the operating surgeon and through post-operative clinical evaluations, possibly including imaging techniques for flap dimensions and quality. This primarily relies on expert assessment/clinical observation.
8. Sample Size for the Training Set
This information is not applicable as the M2 SINGLE USE microkeratome is a mechanical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reason stated above (it's not an AI/machine learning device).
§ 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.