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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.

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.

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The OneUse - Plus 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 comea.

List of components

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

a) Power unit
The power unit used for the OneUse - Plus Microkeratome is the same as the power unit used for the predicate devices One Up Disposable keratome Head (K981742) & CARRIAZO BARRAQUER II Microkeratome (K002191) already legally marketed in the USA by our company.
The power unit includes pumps for producing vacuum.
The power unit has been designed to operate the Keratome by means of electric motor.
Only one of the above power options can be selected at the time by means of a 2 position switches in the front panel.
The front panel has several displays and features:

• Vacuum pressure gauge,
• Gas pressure gauge,
• Battery level indicator,
• Battery charge indicator,
• Connectors:
  DC motors outlets, Gas turbine outlet Gas outlet, Vacuum outlet
  The back panel has several displays and features:
• Connectors:
  Gas inlet, Foot pedals,
• Battery charger.
  All connectors are of different types for preventing connection mistakes.

b) Keratome motor
The drive system has two built-in electrical motors (one motor for the blade oscillation and one motor for the advance of the microkeratome).

c) Keratome head
In the keratome head, a blade activated by an oscillation motor is inserted.
Different heads are available in order to adjust the thickness of the cut.

d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the microkeratome heads.

e) Applanator lenses
The applanator lenses are made of clear methylmethacrylate with a stainless steel handle.
They are used with the rings to check disk diameter before the cut.
The upper part is convex for magnification.
The base part (contact part) is plane, with an engraved and calibrated reticule diameter.

f) Keratome blade
The blade is made of two parts: the metal part in low carbon steel, and the plastic blade holder, which is not in contact with the patient's eye.
Different blades are available in order to adjust the thickness of the cut.

The provided text describes the MORIA S.A. OneUse - Plus Microkeratome and its intended use, but it does not specify explicit acceptance criteria in a quantitative format. Instead, it mentions general performance characteristics demonstrated through studies.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit quantitative acceptance criteria are not stated, the table below consolidates the qualitative performance mentioned in the "Discussion of tests and results" section.

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

• Sample Size for Test Set:
  • In-vitro studies: Performed on "porcine eyes." The exact number of porcine eyes is not specified.
  • In-vivo studies: 54 human eyes.
• Data Provenance:
  • The document does not explicitly state the country of origin for the data for either the in-vitro or in-vivo studies.
  • The studies were conducted as part of a premarket notification, implying they were prospective safety and performance assessments. However, the exact nature (e.g., fully prospective clinical trial, observational study) is not detailed beyond "in-vivo studies."

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

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for the test set. It mentions "in-vivo studies on 54 human eyes showed..." and "In-vitro studies on porcine eyes demonstrated...", suggesting clinical or laboratory assessments, but details on expert involvement in defining the "truth" for these assessments are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of an effect size regarding human reader improvement with or without AI assistance. The device is a microkeratome, a surgical instrument, not an AI diagnostic tool.

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

This concept is not applicable as the device is a mechanical surgical microkeratome, not an algorithm or AI system. Its performance is inherently tied to its use by a human surgeon.

7. Type of Ground Truth Used

The "ground truth" for the performance claims would be:

• In-vitro studies (porcine eyes): Direct measurements of flap thickness, assessment of corneal resection safety, and quality (bed smoothness) using laboratory techniques.
• In-vivo studies (human eyes): Clinical assessment of the quality of the corneal flap, its thickness, safety, and smoothness in a real-world surgical context. This would likely involve post-operative examinations and clinical measurements. The term "equivallently to the predicate device" suggests a comparative clinical outcome as a "ground truth" for equivalence.

8. Sample Size for the Training Set

No information is provided regarding a separate "training set" or its sample size. This is consistent with a mechanical device where performance is typically evaluated through direct testing rather than training a machine learning model.

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

As no training set is mentioned or applicable in the context of this mechanical device, this information is not provided.

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