The Ophthalas 532 laser is intended to be used in all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation: Transcleral Cyclophotocoagulation: Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

Device Description

The Ophthalas 532 Solid State Photocoagulator, and/or equivalent devices, are a pulsed solid state frequency doubled Nd:YAG laser producing a characteristic 532 nanometer (nm) wavelength light as the therapeutic beam. A 633 nm helium-neon (HeNe) laser is used for the aiming beam source.

AI/ML Overview

The provided text is a 510(k) summary for the Ophthalas® 532 Solid State Photocoagulator. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data or acceptance criteria in the manner one would typically find for new AI/ML-based medical devices.

Therefore, the requested information regarding acceptance criteria, specific study design details, ground truth establishment, expert qualifications, sample sizes, and multi-reader comparative effectiveness studies is not available in the provided document.

The document primarily focuses on:

Predicate Device: Ophthalas® 532 Photocoagulator (also by Alcon) and blue-green Argon Ophthalmic Lasers.
Device Description: A pulsed solid-state frequency-doubled Nd:YAG laser producing a 532 nm therapeutic beam and a 633 nm HeNe aiming beam.
Intended Use: All clinical applications for which an Argon laser would be used in ophthalmic surgery.
Technological Characteristics: Neodymium-doped Yttrium Aluminum Garnet (Nd:YAG) laser with frequency doubling to produce 532 nm, using a 633 nm HeNe aiming beam and a 1064 nm infrared beam.
Performance Data (Summary): Stating that it "consistently and safely produces a thermal lesion equivalent to those produced by conventional Argon lasers." This is a qualitative claim of equivalence, not a quantitative performance metric with defined acceptance criteria.
Conclusion: Substantially equivalent to Argon lasers for the specified ophthalmic applications.

In summary, the provided document does not contain the information required to answer your specific questions related to acceptance criteria, detailed study design, sample sizes, or expert involvement for a modern AI/ML device. This is because the device (a laser photocoagulator) and the regulatory submission (510(k) summary) predate the common regulatory requirements for performance studies of AI/ML software as a medical device.

Summary

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SEP 23 1988

K962592

Image /page/0/Picture/2 description: The image shows the logo and contact information for Alcon Laboratories, Inc. The logo is a stylized, bold typeface. Below the logo is the company name, address, and phone number. The address is 6201 South Freeway, Fort Worth, TX 76134, and the phone number is (817) 551-8388.

May 14, 1996

510(K) SUMMARY

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Submitted by:

Martin A. Kaufman Manager, Regulatory Affairs, Surgical Devices Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76132 (817) 551-8388 (Phone) (817) 551-4630 (Fax)

Trade Name: Ophthalas® 532 Solid State Photocoagulator Common Name: Solid state ophthalmic laser photocoagulator Classification Name: Ophthalmic Laser (per 21 CFR 886.4390)

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1. Predicate Device

The legally marketed device(s) to which we are claiming equivalence to are the Ophthalas® 532 Photocoagulator marketed by Alcon Laboratories, and blue-green Argon Ophthalmic Lasers cleared for the Trabeculoplasty indication.

2. Device Description

3. Intended Use of the Device

4. Summary of the Technological Characteristics of the Device

The Ophthalas 532 is a Neodymium-doped Yttrium Aluminum Garnet type laser which has been designed for ophthalmic use. LASER is an acronym for "Light Amplified by Stimulated Emission of Radiation." This laser delivers a 532 nm green laser beam (frequency doubled), a 633 nm HeNe (Helium-Neon) aiming beam, and a 1064 nm infrared laser beam.

The laser beam may be defined as a visible (i.e.; green 532 nm) or invisible (i.e.; 1064 nm), coherent monochromatic light beam.

The doubling process of the 1064 wavelength results when the infrared beam goes through a special crystal. The crystal is an optical dielectric that exhibits a non-linear optical response. The 532nm wavelength is produced by harmonic generation of the 1064nm laser beam.

5. Summary of the Performance Data

The Ophthalas 532 Laser consistently and safely produces a thermal lesion equivalent to those produced by conventional Argon lasers.

6. Conclusions

The Ophthalas 532 Laser is substantially equivalent to Argon lasers for the treatment of all clinical applications for which an Argon laser would be used in ophthalmic surgery, including, but not limited to Retinal and Macular Photocoagulation; Transcleral Cyclophotocoagulation; Internal Sclerostomy; Iridotomy; and Trabeculoplasty.

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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.