(83 days)
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.
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.
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.
§ 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.