This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

Device Description

The VISULAS YAG III™is a Neodymium : Yttrium : Garnet (Nd: YAG) laser for ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. The device operates at a wavelength of 1064 nm. The beam diameter is 10 um with a pulse length of <4 ns. The maximum energy output per pulse is 10 mJ.

AI/ML Overview

This 510(k) submission for the Carl Zeiss Meditec AG VISULAS YAG III™ is for a medical device (a laser) and not a diagnostic AI/ML device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are geared towards evaluating the performance of AI algorithms, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (VISULAS YAG IIplus™) based on traditional medical device regulatory requirements.

Here's why the requested information cannot be provided from this document:

No AI/ML Component: The VISULAS YAG III™ is a physical laser instrument used for ophthalmic procedures. It does not incorporate any AI or machine learning algorithms for diagnosis, prediction, or image analysis.
Performance Metrics Differ: Acceptance criteria for a laser device typically relate to its physical specifications (e.g., wavelength, pulse duration, energy output, beam diameter, safety features) and its ability to perform its intended physiological functions safely and effectively. These are not reported in terms of diagnostic metrics like sensitivity, specificity, or AUC.
Study Design Differs: The "study" referenced in this 510(k) is an internal comparison to a predicate device, focusing on functional equivalence and safety testing, not clinical performance studies with human readers or ground truth established by experts in an AI context.

Summary of available information as per the prompt's categories (with clarifications on why AI-specific aspects are not present):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for a Laser: These would typically involve engineering specifications (e.g., maximum energy output per pulse, beam diameter, pulse length, wavelength) and safety standards compliance. These are established internally by the manufacturer and are not explicitly listed as "acceptance criteria" in this summary.
- Reported Device Performance: The document states:
  - Wavelength: 1064 nm
  - Beam diameter: 10 um
  - Pulse length: <4 ns
  - Maximum energy output per pulse: 10 mJ
- The overall "performance" is concluded to be "safe and effective for its intended use" based on testing deemed necessary to demonstrate substantial equivalence to the predicate. This is a regulatory conclusion, not a clinical performance metric against a specific threshold.
Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI/ML evaluation. The device undergoes engineering verification and validation testing, which often involves testing units against specifications, but not against a dataset for algorithmic performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth is established by experts for an AI algorithm's performance in this context. The "ground truth" for a laser device is its adherence to design specifications and its ability to perform its intended physical action (e.g., sever tissue) in a controlled manner.
Adjudication method: Not applicable. There is no adjudication of algorithmic outputs.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This type of study is for evaluating human performance, often with and without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm. The device's "standalone" performance refers to its ability to function as designed independently.
The type of ground truth used: Not applicable in the AI/ML sense. For a laser device, "ground truth" would be established by engineering standards, physical measurements, and possibly preclinical (animal) or limited clinical testing to confirm safe and effective operation within its physical parameters.
The sample size for the training set: Not applicable. There is no "training set" for a physical device.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary Carl Zeiss Meditec AG VISULAS YAG III™

K 042139

This 510(k) summary for the VISULAS YAG III is submitted in accordance with the requirements of SMDA 1990 and 21 C.F.R § 807.92.

GENERAL INFORMATION

Manufacturer:	Carl Zeiss Meditec AGCarl-Zeiss-Promenade 1007740 JenaGermanyEst. Reg. No. 9615030
Contact Person:	Michael GiebeManager - Regulatory Affairs
U.S. Agent:	R. Michael CromptonVice President, Regulatory/Clinical Affairs& Quality Assurance5160 Hacienda DriveDublin, California 94568(925) 557-4353 (phone)(925) 557-4481 (fax)

DEVICE DESCRIPTION

Classification:	Class II
Trade Name:	VISULAS YAG III™
Generic/Common Name:	Laser Instrument, Surgical, Powered (21 CFR § 878.4810)

PREDICATE DEVICE

VISULAS YAG IIplusTM (1)

INTENDED USE

This device will be used in ophthalmic applications, including posterior capsulotomy and Filis device will or a so a other is intended for use primarily by physicians and health care perfineral may only be used under the supervision of a physician. This device will not be sold to the general public.

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DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The VISULAS YAG III™ is substantially equivalent to the predicate device identified previously. The VISULAS YAG III™ is substantially equivalent to the predicate device with regard to intended use, operating principle, function, and materials.

CONCLUSION

As described in this 510(k) Summary, all testing deemed necessary was conducted on the VISULAS YAG III™ to ensure that the device is safe and effective for its intended use when used in accordance with its Instructions for Use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2004

Carl Zeiss Meditec AG c/o Mr. R. Michael Crompton Vice President, Regulatory/Clinical Affairs and Quality Assurance Carl Zeiss Meditec, Incorporated 5160 Hacienda Drive Dublin, California 94568-7562

Re: K042139 Trade/Device Name: YAG IIITM Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 4, 2004 Received: August 10, 2004

Dear Mr. Crompton:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & neve reviewed 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 for answer and 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). that Oosmeter For (110) warket 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 r fouse be actived 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 - Mr. R. Michael Crompton

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter with are with a made of substantial equivalence of your device to a legally prematics notification. "The stars 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 dome office of Compliance at (301) 594-4659. 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 general miormation of Jour 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,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): KOH 2139

Device Name: YAG III™

Indications for Use: This device will be used in ophthalmic applications, including posterior capsulotomy and peripheral iridotomy. This device is intended for use primarily by physicians and health care workers and may only be used under the supervision of a physician. This device will not be sold to the general public.

(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 C.F.R. § 801.109)

Over-the-Counter Use_ ________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.