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:

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.

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.
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.
Adjudication Method for the Test Set:

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

Summary

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September 10", 2003 Premarket Notification

K032836

Section 4 page 1

510(k) SUMMARY

Submitter's identification 1.

MORIA S.A. a. 15, rue Georges Besse 92160 ANTONY France (33-1) 46 74 46 36 Tel: (33-1) 46 74 46 70 Fax:
Contact person: b.

Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com

Date Summary Prepared: c.
September 10th, 2003

Device name 2.

M3 microkeratome Trade Name:

Classification name 3.

Keratome (per CFR 886.4370)

Substantial equivalence বা

Substantial equivalence is being claimed to the following legally marketed devices:

Device name:	CARRIAZO BARRAQUER II Microkeratome
Company name:	MORIA S.A.
Document control number:	K002191

Device name:	Plancon microlamellar Keratome
Company name:	PLANCON INSTRUMENTS
Document control number:	K970377
Device name:	Automatic Corneal Shaper Surgical Instrument
Company name:	CHIRON VISION CORP.
Document control number:	K941550

JUN 1 8 2004

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September 10", 2003 Premarket Notification

K032836

Section 4 page 2

Device description 5.

List of components

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

a) Power unit

The power unit used for the M3 microkeratome is the same as the power unit used for the The power unit used for the M5 microReratome (K003594) & Plancon
predicate devices CARRIAZO BARRAQUER Microkeratome (KA by our company predicate devices CARRAZO DrineriQ SER

The power unit includes pumps for producing vacuum.

I he power unit incrudes pullips for producting - counting - counting 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.

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ວອຸນາ Premarket Notification

Section 4 page 3

Keratome motor b)

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

Keratome head c)

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.

Suction rings d)

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

Applanator lenses e)

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.

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September 10 , 2003 Premarket Notification

K032@36

Section 4 page 4

Keratome blade f)

The blade is made of two parts: the metal part in low carbon steel, and the plastic blade The blade 15 made in contact with the patient's eye.

Statement of intended use 6.

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

Discussion of tests and results 7.

Keratomes have been used for lamellar keratoplasty for more than 30 years.

In-vitro studies on porcine eyes demonstrated:

The flap thickness consistency, -
The safety of corneal resections, -
The good quality of corneal resections. -

In-vivo studies on 100 human eyes showed that the M3 microkeratome is a safe Keratome able to create, equivalently to the predicate device, circular lamellar resection of a able to - creater, and thickness and bed smoothness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling the eagle. The text is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUN 1 8 2004

Moria S.A. c/o Ms. Melanie Renaud-Samiri Regulatory & Quality Assurance Manager 15 Rue Georges Besse Antony, France 92160

Re: K032836 Trade/Device Name: M3 Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Microkeratome, Keratome Regulatory Class: Class I Product Code: HNO Dated: September 10, 2003 Received: April 28, 2004

Dear Ms. Renaud-Samiri:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 910(x) premier is substantially equivalent (for the indications referenced above and have determined the arrass are devices marketed in interstate for use stated in the encrosule) to regally manation to the Medical Device Amendments, or to commerce prior to May 28, 1770, the encordance with the provisions of the Federal Food, Drug, devices that have been reclassified in accessful of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval of the and Cosmetic Act (Act) that to hot require approvine of the general controls provisions of the Act. The You may, the sible, market the devices, belyer to users for annual registration, listing of general controls provisions of the 110 110 1100 1100 1100 1100 1100 1100 1100 1100 110 adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controller Links. good to 898. In addition, FDA may be found in the Court of Pouchar In Concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dr 3 issualled of a complies with other requirements of the Act
that FDA has made a determination that your device complies with other requirements o that IDA has made a determinations administered by other Federal agencies. You must of ally rederal statures and regaratents, including, but not limited to: registration and listing comply with an the Act 3 requirements, metally, good manufacturing practice requirements as set (21 CFR Fall 807), labornig (21 OFR Part 820); and 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his iciter wif anow you to ought thating of substantial equivalence of your device to a legally premaince notifications "Thesults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at notiation at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other golleral micronational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Paléyi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5 page 1

510(k) Number (if known):

Device Name:

M3 microkeratome

Indications for use:

The M3 microkeratome is intended for use in the making of a corneal flap in patients The M3 microkeratome is intended for use in the manning of the cornea.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF. NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use | (Per 21 CFR 801.109)

Over-The-Counter Use OR (Optional Format 1-2-96)

Dennis L. McCarthy

Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

Ko32836 510(k) Number

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.