The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Device Description

The Visitome 20-10 Microkeratome is an AC-powered device that is used for making a flap by incising the cornea at a predetermined thickness and diameter using a high-speed oscillating blade made of stainless steel. The device consists of the following main components and accessories: the control unit, a surgical unit (handpiece with drive assembly, positioning ring assembly, applanator assembly, and a stainless steel blade holder), a foot pedal, and tubing kit with filter and fluid collection container (accessory).

AI/ML Overview

The provided 510(k) summary for the Visitome 20-10 Microkeratome offers limited details regarding formal acceptance criteria or a comprehensive study demonstrating adherence to such criteria in the way modern AI/software as a medical device (SaMD) submissions do. Instead, it focuses on substantial equivalence to predicate devices and performance testing related to basic functionality.

Here's an analysis based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Generalized from text)	Reported Device Performance (Implied/Generalized from text)
Device meets all performance specification requirements for lamellar resection.	Bench testing (on pig eyes) demonstrates the device meets all performance specification requirements.
Device is substantially equivalent to predicate devices regarding safety and effectiveness.	"Bench testing demonstrates that the Visitome 20-10 Microkeratome is equivalent to the predicate devices, and that any differences do not affect safety or effectiveness."
Device is safe and effective for making a corneal flap.	Demonstrated through substantial equivalence to predicate devices.
Device is in accordance with applicable electrical safety standards.	"The Visitome 20-10 Microkeratome has been designed and tested in accordance with applicable electrical safety standards."
New blade size performs adequately.	"The new blade size has undergone performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements."

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

The document states: "The new blade size has undergone performance evaluation testing in pig eyes."

Sample Size for Test Set: Not specified, only that "pig eyes" were used. The number of eyes is not mentioned.
Data Provenance: In vitro (or ex vivo) testing on pig eyes. The country of origin for the data is not mentioned, but the applicant is based in Switzerland, and the testing was likely conducted by or for them. This would be considered prospective data generation for the purpose of this submission, as the testing was performed specifically to evaluate the new blade size and device.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's likely that veterinary ophthalmologists or ocular surgeons were involved in assessing the corneal flaps created on pig eyes, but this is not explicitly stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. The document does not describe any human review or adjudication process for the outcomes of the pig eye testing. Performance was likely assessed based on measurable physical characteristics of the created flaps (e.g., thickness, diameter, smoothness), rather than subjective expert consensus.

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

Was an MRMC study done? No. This device is a surgical instrument, not an AI/SaMD diagnostic or assistive tool where human readers would typically be involved in evaluating performance data. Therefore, an MRMC study and the concept of "improving human readers with AI vs. without AI assistance" are not relevant to this type of device submission.

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

Was a standalone study done? Yes, in a sense. The performance evaluation on pig eyes for the device (a mechanical instrument) without human intervention in the data collection/assessment process beyond operating the device and measuring outcomes. The device itself is standalone in its function of creating a corneal flap. However, this is not an AI algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the pig eye performance testing would have been objective measurements of the corneal flaps created, such as:
- Flap thickness
- Flap diameter
- Quality/smoothness of the cut (e.g., microscopic evaluation of the stromal bed)
- Absence of perforations or irregular cuts.
This is not "expert consensus," "pathology," or "outcomes data" in the typical sense for a diagnostic device. It's based on physical and measurable characteristics of the device's output.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of an AI model. Device "training" would refer to its design, engineering, and iterative improvement processes, not data input for algorithm learning.

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

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI algorithm. The design and validation of mechanical devices like this involve engineering specifications, material testing, prototyping, and bench testing, but not a data-driven training process with ground truth labels for an algorithm.

Summary

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510(k) SUMMARY NOV 1 6 2004 VISITOME 20-10 MICROKERATOME

1. APPLICANT

Company Name:	Biovision AG27 Erlenstrasse2555 Brugg, Switzerland
Official Correspondent:	Dale SadlikProduct DirectorVisitome, Inc.27 Mauchly, Unit 206Irvine, CA 92618Tel: 949-450-0770Fax: 949-450-0990
Date Summary Prepared:	November 3, 2004

2. DEVICE IDENTIFICATION

A.	Classification Name:	Keratome, AC-Powered
B.	Trade/Proprietary Name:	Visitome 20-10 Microkeratome
C.	Classification:	Class I per 886.4370
D.	Product Code:	HNO

DEVICE DESCRIPTION 3.

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4. INTENDED USE

The Visitome 20-10 Microkeratome is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

5. SUBSTANTIAL EQUIVALENCE

The Biovision AG Visitome 20-10 Microkeratome is equivalent to the predicate devices listed below. Each of these devices has a similar indication for use and utilizes suction to the cornea. With respect to corneal resections, the Visitome and device uses a stainless steel blade to cut a corneal flap, while the IntraLase device uses a femtosecond laser for cutting/resection created by micro-photodisruption of the corneal tissue. Bench testing demonstrates that the Visitome 20-10 Microkeratome is equivalent to the predicate devices, and that any differences do not affect safety or effectiveness.

PredicateDevice	Applicant	510(k) No.	Date Cleared
Visitome 20-10Microkeratome	Biovision AG	K014000	March 11, 2002
FS LaserKeratome	IntralaseCorporation	K031960	September 29, 2003

TECHNOLOGICAL CHARACTERISTICS 6.

The Visitome 20-10 Microkeratome contains a positioning ring which allows the cornea to protrude through the ring. The cornea is restrained by an applanation shoe surface, which may be pivoted away. A stainless steel blade is suspended from the end of the positioning ring by a blade support (holder) which is driven by a drive mechanism, so that the blade moves along a forward path between the positioning ring and the applanation shoe while oscillating laterally. Drive control and vacuum for the positioning ring are provided by user command via the control unit and foot pedal.

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7. PERFORMANCE DATA

The Visitome 20-10 Microkeratome has been designed and tested in accordance with applicable electrical safety standards. The new blade size has undergone performance evaluation testing in pig eyes to demonstrate that the device meets all performance specification requirements, and is substantially equivalent to the predicate devices.

CONCLUSIONS 8.

Biovision AG has demonstrated through its evaluation of the Visitome 20-10 Microkeratome that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Biovision AG c/o Mr. Dale Sadlik Visitome, Inc 27 Mauchly, Unit 206 Irvine, CA 92618

Re: K042083 Trade/Device Name: Visitome 20-10 Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: July 19, 2004 Received: August 3, 2004

Dear Mr. Sadlik:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 3 rQth pe is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encrosals) to togally to trgans and the Medical Device Amendments, or to commerce proof to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, devices mar nave been recuire approval of a premarket approval application (PMA). and Cosmetic Treef, market the device, subject to the general controls provisions of the Act. The Tou may, merciole, market the act include requirements for annual registration, listing of general controls provision 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 If your device is classified (500 a00 roy als. Existing major regulations affecting your device can may be subject to satin additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Out of Pource concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that FDF 3 lobants of your device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must of any I cochar statutes and regulated including, but not limited to: registration and listing comply with an the Act 3 requirements, months.go
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Part 607), facemig (21 cegulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Dale Sadlik

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) 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 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/dsma/dsmamain.html

Sincerely yours.

A halyi korenthal

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

510(k) Number:

(To Be Assigned By FDA)

Device Trade Name:

VISITOME 20-10 MICROKERATOME

Indications For Use:

The VISITOME 20-10 MICROKERATOME is intended for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.

Prescription Use X (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)

Doxeylin 11-8-2004

vision Sign-Off Division of Ophthalmic E Nose and Throat Devises

Page 1 of

510(k) Number

November 3, 2004

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.