M3 MICROKERATOME

• K Number: K032836
• Device Name: M3 MICROKERATOME
• Manufacturer: MORIA S.A.
• Date Cleared: 2004-06-18 ( 281 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K002191 , K970377 , K941550

Intended Use

The M3 microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.

Device Description

List of components

• Power unit .
• Motor ●
• Suction rings .
• Applanator lenses .
• Footswitches .
• Keratome head 1
• Keratome blade .

AI/ML Overview

This document describes a 510(k) premarket notification for the MORIA M3 microkeratome, a device used to create corneal flaps for LASIK surgery. The submission claims substantial equivalence to previously marketed devices.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state formal "acceptance criteria" with numerical thresholds typically seen in studies for AI/software devices. Instead, it reports on the performance characteristics demonstrated by in-vitro and in-vivo studies in the context of establishing substantial equivalence to predicate devices.

   Performance Characteristic	Reported Device Performance (M3 Microkeratome)
   Flap thickness consistency	Demonstrated in-vitro (on porcine eyes). Implied to be equivalent to predicate devices based on in-vivo human studies.
   Safety of corneal resections	Demonstrated in-vitro (on porcine eyes). Implied to be equivalent to predicate devices based on in-vivo human studies.
   Quality of corneal resections	Demonstrated in-vitro (on porcine eyes). Implied to be equivalent to predicate devices based on in-vivo human studies.
   Circular lamellar resection	Able to create circular lamellar resection (demonstrated in-vivo on human eyes).
   Uniform thickness	Able to create uniform thickness (demonstrated in-vivo on human eyes).
   Bed smoothness	Able to create bed smoothness (demonstrated in-vivo on human eyes).
   Equivalence to predicate device	Shown to be a "safe Keratome able to create, equivalently to the predicate device" in in-vivo human studies.

2. Sample Size Used for the Test Set and Data Provenance:

   • Test Set (In-vivo study): 100 human eyes.
   • Data Provenance: The document does not explicitly state the country of origin. The study was prospective in nature, as it involved performing resections on human eyes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   The document does not provide information on the number or qualifications of experts used to establish a "ground truth" in the traditional sense for these studies. The assessment of performance characteristics such as flap thickness, safety, quality, circularity, uniformity, and bed smoothness would typically be evaluated by ophthalmologists or surgeons using established clinical and imaging techniques, but specific details are not provided.

4. Adjudication Method for the Test Set:

   The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The M3 microkeratome is a surgical device, not an AI/diagnostic imaging tool that would typically involve human readers. The studies focus on the device's physical performance.
   • Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, the studies performed (both in-vitro and in-vivo) represent the standalone performance of the device (microkeratome) itself, without a human-in-the-loop performance component in the context of an AI algorithm. The device performs the corneal resection.
   • However, it's important to clarify that "standalone" in this context refers to the device's function, not an AI algorithm. The device is operated by a human surgeon.

7. Type of Ground Truth Used:

   The "ground truth" for the in-vivo study on human eyes would be based on:

   • Clinical observation and measurement: Assessment of the resected corneal flap characteristics (thickness, circularity, smoothness of the bed) by ophthalmologists using standard clinical methods, likely including pachymetry for thickness and visual inspection/microscopy for quality and smoothness.
   • Safety outcomes: Absence of adverse events attributable to the device.
   • Comparison to predicate device outcomes: Performance was deemed "equivalent" to the predicate device, implying clinical equivalence in measured outcomes.

8. Sample Size for the Training Set:

   This device is a mechanical surgical instrument, not an AI/machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's design and manufacturing process are informed by engineering principles, prior device iterations (like the M5 microkeratome and predicate devices), and the results of the in-vitro and human in-vivo studies.

9. How the Ground Truth for the Training Set Was Established:

   As there is no AI "training set," this question is not applicable. The "ground truth" for the device's development would be established through engineering specifications, performance requirements derived from clinical needs, and iterative design and testing processes informed by mechanical and optical principles relevant to corneal surgery.

Regulation Number and Section

§ 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.