The Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190.

The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Device Description

The Amadeus II Epikeratome is a modification of the ACCM/Amadeus Microkeratome, which is firmly established in the market for several years. In the course of a product update, the designs of blade and blade holder have been modified to provide surgeons with the option to perform Epi-LASIK.

The surgical principles of the Amadeus II Epikeratome and its predicate device are essentially identical. To perform a lamellar corneal resection, the cornea is held in position by means of a suction ring, and vacuum is applied to increase intraccular pressure to a level allowing the epikeratorne blade to move across the cornes in a mode similar to that of a carpenter's plane. The corneal flap is made by the same open ating principle as in the predicate device, i.e., a blade is advancing and simultane opelva oscillating horizontally and perpendicular to the advancement direction. A Control Unit provides power and a controlled vacuum for fixing the eye.

The comeal flap created by the epikeratorne consists of the entire epithelium, while in the predicate device it consists of the entire epithelium plus parts of the stroma. This difference in flap structure is obtained by modifications of the blade and thre hlade holder.

Like its predicate device, the Amadeus II Epikeratome comprises three major groups of components:

a) A Handpiece, incorporating the Suction Unit, the Blade Holder, the Epikeratome Epi-A handpiece, IntoSperating theit. The Handpiece offers several safety features designed to prevent product malfunction or incorrect use, and allows the surgeon to handle the Epikeratome with only one hand.
b) A Control Unit with touch-screen interface, managing the epikeratome's cutting A Gontrol Only With toutic documentation of the chosen cutting parameters and user interface dialogs.
c) Two footswitches that serve to actuate and discontinue the epikeratome cutting r wo rocedure. The standard actuation footswitch serves to initiate suction and the epikeratome cutting action.

Disposable components of the Amadeus II Epikeratome system are 1) a sterile plastic epikeratome blade and 2) a sterile vacuum tubing kit. Additionally, an autoclavable instrument tray is provided for sterilization.

AI/ML Overview

This device is an Amadeus II Epikeratome, a surgical tool used to separate the epithelium from the cornea. The device is a modification of a predicate device, the Amadeus Microkeratome (K993190), and is used for lamellar corneal resections.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., flap thickness, precision, consistency, failure rates) for the Amadeus II Epikeratome.

Instead, the submission focuses on demonstrating substantial equivalence to its predicate device. The rationale for substantial equivalence is based on:

Acceptance Criteria (Implied by Substantial Equivalence to K993190)	Reported Device Performance (as stated in 510(k) Summary)
Intended Use: Same as predicate device (Amadeus Microkeratome, K993190).	Intended Use Met: "The Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190." "The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea."
Operating Principle: Very similar to predicate device, based on same cutting kinematics.	Operating Principle Met: "The surgical principles of the Amadeus II Epikeratome and its predicate device are essentially identical." "To perform a lamellar corneal resection, the cornea is held in position by means of a suction ring, and vacuum is applied to increase intraocular pressure to a level allowing the epikeratome blade to move across the cornea in a mode similar to that of a carpenter's plane. The corneal flap is made by the same operating principle as in the predicate device..."
Safety Features: Same as those offered by the predicate device.	Safety Features Met: "The safety features of the Amadeus II Epikeratorne are the same as those offered by the predicate device." The Handpiece offers "several safety features designed to prevent product malfunction or incorrect use."
Design Controls: Ensure safety and effectiveness of changes.	Design Controls Met: "Design controls (e.g., risk assessment, design verification and design validation), as well [as a] non-clinical study, were used to demonstrate that the changes made to the device are safe and effective." (No specific results from these controls are detailed in this summary).
Flap Structure: Creation of an epithelial flap (new feature).	Flap Structure Achieved: "The comeal flap created by the epikeratorne consists of the entire epithelium, while in the predicate device it consists of the entire epithelium plus parts of the stroma. This difference in flap structure is obtained by modifications of the blade and the blade holder."

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

The document mentions "Design controls (e.g., risk assessment, design verification and design validation), as well [as a] non-clinical study, were used to demonstrate that the changes made to the device are safe and effective."

However, no specific sample size for a test set is provided within this 510(k) summary. The details of this "non-clinical study" (e.g., lab testing, animal models, cadaver eyes) and data provenance are not elaborated upon. The context strongly suggests this was not a clinical study involving human patients.

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

Given that the document refers to a "non-clinical study" and focuses on substantial equivalence based on engineering and design similarities, there is no mention of experts being used to establish ground truth for a test set in the way one would for diagnostic AI.

For a surgical device like an epikeratome, "ground truth" would likely relate to objective measurements of flap quality, thickness, smoothness, consistency, and epithelial integrity, possibly performed by engineers or specialized technicians during laboratory testing, rather than human experts evaluating subjective outcomes.

4. Adjudication Method for the Test Set

As no specific test set involving human interpretation of data is described, there is no mention of an adjudication method.

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

No, an MRMC comparative effectiveness study was not conducted or reported for this device. This is a surgical instrument, not an AI diagnostic system where human readers would interpret results.

6. Standalone Performance Study (Algorithm Only)

No, a standalone performance study in the context of an algorithm's performance (without human-in-the-loop) was not conducted or reported. This device is a mechanical surgical tool.

7. Type of Ground Truth Used

Based on the documentation, the "ground truth" likely refers to:

Engineering specifications and design requirements: Ensuring the modified blade and blade holder achieve the desired epithelial flap while maintaining the core operating principle.
Performance metrics in non-clinical testing: This would involve objective measurements (e.g., using imaging, microscopy, or physical gauges on excised tissue or models) to confirm flap characteristics, cutting precision, and consistency.
Compliance with safety standards: Verification that the device's safety features function as intended.

The document does not mention pathology, outcomes data from human patients, or expert consensus in relation to a specific test set.

8. Sample Size for the Training Set

Since this is a mechanical surgical device and not an AI/machine learning system, the concept of a "training set" for an algorithm does not apply.

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

As there is no training set mentioned, this question is not applicable.

Summary

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AN 3 1 2005

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510(k) Summary for the Amadeus II Epikeratome

Name and Address of Sponsor

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: 0041 32 332 70 70 Fax: 0041 32 332 70 71 Email: frank.ziemer@sisItd.ch

Name and Address of Manufacturer

SIS Surgical Instrument Systems Ltd. Registration Number: 9614468 Allmendstrasse 11 2502 Port Switzerland Phone: 0041 32 332 70 70 Fax: 0041 32 332 70 71 Email: frank.ziemer@sisItd.ch

Name and Address of Official Correspondent

Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, Colorado 80127 Phone: 720-962-5412 Fax: 720-962-5413 Email: kevin@reginsight.com

Device Name

Device trade name: Amadeus II Epikeratome Common/Classification name: Keratome

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Classification, Panel and Product Code

Device Classification: Reviewing Panel:

Class I (reserved), HNO Ophthalmic Devices

Intended Use

The Amadeus II Epikeratome is intended for use in performing lamellar corneal resections. This is the same intended use as previously cleared for the Amadelis microkeratome, K993190.

Indications for Use

The Amadeus II Epikeratome is intended for use in the separation of epithelium from the comea in preparation for subsequent surgical procedures on the denuded comea.

Substantial Equivalence

The Amadeus II Epikeratorne is substantially equivalent to the Amadeus Microkeratorne, K993190. 02/10/2000.

Device Description

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Like its predicate device, the Amadeus II Epikeratome comprises three major groups of components:

a) A Handpiece, incorporating the Suction Unit, the Blade Holder, the Epikeratome Epi-A handpiece, IntoSperating theit. The Handpiece offers several safety features designed to prevent product malfunction or incorrect use, and allows the surgeon to handle the Epikeratome with only one hand.
b) A Control Unit with touch-screen interface, managing the epikeratome's cutting A Gontrol Only With toutic documentation of the chosen cutting parameters and user interface dialogs.
c) Two footswitches that serve to actuate and discontinue the epikeratome cutting r wo rocedure. The standard actuation footswitch serves to initiate suction and the epikeratome cutting action.

Performance Data:

Design controls (e.g., risk assessment, design verification and design validation), as well Design controls (c.g., nonimal study, were used to demonstrate that the changes made to the device are safe and effective.

Rationale for Substantial Equivalence

Intended use of the Amadeus II Epikeratome is the same as that of the predicate . device.
The operating principle of the Amadeus II Epikeratome is very similar to the one of . the predicate device and based on the same cutting kinematics.
The safety features of the Amadeus II Epikeratorne are the same as those offered by . the predicate device.

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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 is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 31 2002

SIS Surgical Instrument Systems Ltd. c/o Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 13 Red Fox Lane Littleton, CO 80127

Re: K043150

Trade/Device Name: Amadeus II Epikeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: January 11, 2005 Received: January 12, 2005

Dear Mr. Walls:

We have reviewed your Scction 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 Cosinctic 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 fisting (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 - Kevin Walls, RAC

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,

A. Ralph 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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Indications for Use Statement

510(k) Number (if known):

Device Name: Amadeus II Epikeratome

Indications For Use: The Amadeus II Epikeratome is intended for use in the separation of epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

i/c/w/e X. Juhki huchita
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

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510(k) Number_[) (id jij je C

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.