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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:

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).

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Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.

Millenium Microkeratome is electrically powered manual mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eve. Microkeratome includes Fixation Ring, cutting Head and operates by Control Unit. The Fixation Ring is placed against the eye. Cutting blade oscillate inside special Insert placed in to the Head. Electric Motor is used to drive the blade. Forward manual movement of the Head against Fixation Ring creates resection of cornea tissue. Different Fixation Rings and Inserts determinate diameter and thickness of resection. Control Unit - power independent with built-in rechargeable battery provide vacuum to hold Fixation Rind on the eye and electric power to control Electric Motor.

The Millenium Microkeratome is an electrically powered mechanical cutting instrument for severing a thin layer of corneal tissue (flap) from the surface of the eye. Its intended use is in refractive surgery or other treatments requiring initial lamellar resection of the cornea, circular and of predetermined diameter and thickness.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." The study was conducted on "porcine eyes." The number of porcine eyes is not specified.
   • Data Provenance: The study was non-clinical and conducted on porcine eyes. There is no mention of country of origin, as it's an animal model study. It is a prospective study in the sense that the device was used on these eyes for testing.

2. Number of Experts and Qualifications:

   • No information provided regarding the number or qualifications of experts used to establish ground truth.

3. Adjudication Method:

   • No information provided on an adjudication method. The assessment appears to be a direct comparison of the corneal lamellar resection to that achieved by predicate devices.

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

   • No MRMC comparative effectiveness study was done. This study is for a medical device (a microkeratome) that performs a surgical procedure, not an imaging or diagnostic device that requires human interpretation.

5. Standalone Performance Study:

   • Yes, a standalone study was performed. The device was tested directly on porcine eyes to evaluate its ability to perform corneal lamellar resection. The results were then compared to the performance of predicate devices.

6. Type of Ground Truth Used:

   • The ground truth was established by comparing the corneal lamellar resection produced by the Millenium Microkeratome to that produced by "predicated devices." The equivalence was determined based on the physical characteristics of the resected tissue. This implicitly refers to device performance characteristics rather than a clinical ground truth like pathology or patient outcomes.

7. Training Set Sample Size:

   • Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

8. How Ground Truth for Training Set was Established:

   • Not applicable/not provided. This is a non-clinical device performance study, not a machine learning model.

Summary of the Study:

The study was a non-clinical test on porcine eyes to demonstrate that the Millenium Microkeratome could achieve corneal lamellar resection equivalent to that produced by predicate devices (Plancon microlamellar keratome and Evolution power unit). The fundamental conclusion was that the technological differences (primarily electric motor vs. gas turbine) did "not raise any new issues of safety, effectiveness, or performance of the product." The focus was on establishing functional equivalence for the intended use rather than clinical efficacy or human-in-the-loop performance.

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