The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

Device Description

List of components

Power unit and footswitch .
Handpiece / submitted device motor .
Head and blade separator .
Suction rings .

a) Power unit and footswitch
The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) 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.
The front panel includes several displays and features:

. Vacuum pressure gauge, Battery level indicator,
. Battery charge indicator,
Connector for the motorized handpiece of the submitted device .
Vacuum outlet connector .
The back panel includes connectors for footswitches and battery charger

b) Handpiece / submitted device motor
The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).

c) Head and blade separator
The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:

The metal part in low carbon steel, and
The plastic holder of the blade separator, which is not in contact with the patient's eye.

d) Suction rings
The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:

Reusable
Disposable

AI/ML Overview

The provided document is a 510(k) summary for the Moria Epi-K™ device, an epikeratome used for separating the epithelium from the cornea. It details the device, its intended use, and claims substantial equivalence to predicate devices, but does not specify numerical acceptance criteria or a dedicated study proving performance against acceptance criteria in the typical sense of a clinical trial with pre-defined endpoints and statistical analysis.

Instead, the submission relies on the concept of substantial equivalence to predicate devices that are already legally marketed. The "tests and results" section describes in-vitro and in-vivo studies to support the device's safety and efficacy, framing them in terms of their ability to perform the intended function similarly to established devices.

Here's an attempt to extract and frame the information requested, with necessary caveats due to the nature of the document:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

As explicit numerical acceptance criteria are not stated in this 510(k) summary, the "acceptance criteria" are inferred from the claims made about the predicate devices (which are legally marketed) and the stated purpose of the Epi-K™. The reported device performance is taken directly from the "Discussion of tests and results" section.

Acceptance Criterion (Inferred from Predicate Devices & Intended Use)	Reported Device Performance (Epi-K™)
Ability to create an epithelial flap safely and effectively.	In-vitro studies on porcine eyes demonstrated: The safety and efficacy of the submitted device for creating an epithelial flap. The quality of the epithelium separation.
Ability to create a hinged circular epithelial flap of predetermined dimensions safely.	In-vivo studies on 77 human eyes showed: Epi-K™ is a safe device able to create a hinged circular epithelial flap of predetermined dimensions.

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

Sample Size for In-vitro Test Set: Not explicitly stated, but "porcine eyes" are mentioned.
Sample Size for In-vivo Test Set: 77 human eyes.
Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The context suggests these were conducted by Moria S.A., a French company. The studies are described as "In-vitro" and "In-vivo," which implies prospective data collection for the purpose of this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies described are performance tests of the device itself rather than assessments requiring expert-established ground truth in the context of diagnostic accuracy. For the "quality of epithelium separation" or "safety" assessment, it's implied that trained professionals (e.g., ophthalmologists, pathologists) would have evaluated the outcomes, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the studies (device performance in creating a flap), a formal adjudication method for ground truth establishment (like 2+1 consensus) is less directly applicable than for diagnostic studies. Evaluations would likely involve direct observation and measurement by investigators.

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

No, an MRMC comparative effectiveness study was not mentioned. This type of study typically compares human readers' diagnostic performance with and without AI assistance. The Epi-K™ is a surgical device, not a diagnostic AI system, so this type of study would not be applicable.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. The Epi-K™ is a mechanical surgical device with a motor, handpiece, and blade. It is not an algorithm or AI system, so a standalone algorithm-only performance study is irrelevant. The "performance" here refers to the device's ability to physically perform its intended function.

7. Type of Ground Truth Used

For the in-vitro porcine eye studies, the "ground truth" would be the direct observation and measurement of the "safety and efficacy" of flap creation and the "quality of epithelium separation" by qualified personnel.

For the in-vivo human eye studies, the "ground truth" for safety and ability to create a "hinged circular epithelial flap of predetermined dimensions" would be direct clinical observation and measurement during and after the procedure by the operating surgeon and clinical team. This could involve histological examination of the removed tissue, but specific details are not provided. Essentially, the "ground truth" is the observed physical outcome of the surgical procedure as performed by the device.

8. Sample Size for the Training Set

Not Applicable. The Epi-K™ is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant to the Epi-K™ device.

Summary

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Image /page/0/Picture/1 description: The image shows the word "Moria" in a stylized font. The "o" in "Moria" is replaced with a solid black circle with a thin vertical line extending upwards from its center. Below the word "Moria" is the text "Section 4 page 1".

MAR 2 5 2005

510(k) SUMMARY

Submitter's identification 1.

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

Mélanie RENAUD-SAMIRI QA & Regulatory Affairs Manager E mail: mrenaud@moria-int. com Or Alain DUPRAT Chief Executive Officer and President

E mail: aduprat@moria-int. com

November 15, 2004

c. Date Summary Prepared:

Device name

Epi-K™M Trade Name:

3. Classification name

Keratome (per 21CFR section 886.4370)

4. Substantial equivalence

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

Trade or Proprietary or Model Name:	OneUse - Plus Microkeratom
Manufacturer:	MORIA S.A.
510(k) number:	K040297

Trade or Proprietary or Model Name: Centurion SESTM Epikeratome Manufacturer: CIBA Vision Corporation 510(k) number: K032978

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Image /page/1/Picture/0 description: The image shows the word "Moria" in a stylized font. The "o" in "Moria" is replaced with a disco ball graphic. The disco ball is hanging from a thin line, suggesting it is suspended in the air. The text is in black and the background is white.

Section 4 page 2

Trade or Proprietary or Model Name: EpiTome SYSTEM Manufacturer: GEBAUER MEDZINTECHNIK GmbH 510(k) number: K041206

న్. Submitted device description

List of components

Power unit and footswitch .
Handpiece / submitted device motor .
Head and blade separator .
Suction rings .

a) Power unit and footswitch

The power unit used for the submitted device Epi-K™ is the same as the power unit used for the predicate devices (OneUse - Plus Microkeratome K040297) 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.

The front panel includes several displays and features:

. Vacuum pressure gauge, Battery level indicator,
. Battery charge indicator,
Connector for the motorized handpiece of the submitted device .
Vacuum outlet connector .

The back panel includes connectors for footswitches and battery charger

b) Handpiece / submitted device motor

The submitted device handpiece has two built-in electrical motors (one motor driving the blade separator oscillation and one motor driving the advance of the handpiece across the cornea).

c) Head and blade separator

The submitted device head is disposable and is supplied with a pre-inserted blade separator The blade separator is made of two parts:

The metal part in low carbon steel, and
The plastic holder of the blade separator, which is not in contact with the patient's eye.

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Image /page/2/Picture/0 description: The image shows the word "Moria" in a stylized font. The "o" in "Moria" is replaced with a disco ball graphic, which is suspended by a thin line from above. The font is bold and black, and the background is white. The image appears to be a logo or a stylized wordmark.

Section 4 page 3

d) Suction rings

The suction rings are used to fixate and pressurize the eye and to provide a base for the head. Different rings are available in order to adjust the diameter of the epithelial flap. The rings are available in two versions:

Reusable
Disposable

Statement of intended use 6.

The submitted device Epi-K is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

7. Discussion of tests and results

Epi-keratome predicate devices are already legally marketed and have been used to cleave the epithelium from the cornea (CIBA Centurion SESTN Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).

In-vitro studies on porcine eyes with the submitted device Epi-K 11" demonstrated:

The safety and efficacy of the submitted device for creating an epithelial flap -
-The quality of the epithelium separation.

In-vivo studies on 77 human eyes showed that the submitted device –Epi-K "" is a safe device able to create a hinged circular epithelial flap of predetermined dimensions.

The intended uses and the operating and separating principles (i.e.; Effectiveness) of the submitted device Epi-K ™ are the same as the predicate devices (CIBA Centurion SEST™ Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).

The operational features of the submitted device Epi-K™ are the same or similar to those offered by the predicate device (MORIA OneUse-Plus Microkeratome K040297).

The safety features of the submitted device Epi-KTM are the same or very similar to those offered by the predicate devices (CIBA Centurion SES 11 Epikeratome K032978 & GEBAUER EpiTome SYSTEM K041206).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, representing health, services, and people. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2005

Moria S.A. c/o Mélanic Renaud-Samiri QA & Regulatory Affairs Manager 15 Rue Georges Besse F 92160 Antony FRANCE

Re: K043183 Trade/Device Name: Epi-KTM Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: March 16, 2005 Received: March 18, 2005

Dear Mrs. Renaud-Samiri:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mélanie Renaud-Samiri

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (301) 827-8910. 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 Manufacturers, International 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/industry/support/index.html.

Sincerely yours.

David M. Whipple

David M. Whipple Acting 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

STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Devicc Name:

Epi-KTM

Indications for use:

The Epi-K 1 is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on denuded cornea.

Marsha L. Burke hi cholova

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

510(k) Number K042183

Prescription Use V (Part 21 CFR 801 Subpart D)

AND / OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.