(88 days)
The Coherent Popeye Ophthalmic Laser is indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd: YAG laser. These indications include: discission of the posterior capsule of the eye (posterior capsulotomy) discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients. The Coherent Popeye Ophthalmic Laser in Combination with the Ultima 2000 or Ultima 2000SE Argon Photocoagulator is indicated for: Popeye Nd: Y AG 1064 nm wavelength Indicated for use in photodisruption of ocular tissue using laser energy emitted by a Nd: YAG laser. These indications include: discission of the posterior capsule of the eye (posterior capsulotomy) and; discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients. Ultima 2000/Ultima 2000SE Indicated for use in the treatment of ocular pathology using blue-green and green argon laser energy. These indications include: photocoagulation of both anterior and posterior segments including: iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma; retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including; diabetic retinopathy; choroidal neovascularization; branch retinal vein occlusion; subretinal neovascularization in disciform macular degeneration. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (pan-retinal photocoagulation); retinopexy: segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia). The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery including panretinal photocoagulation, retinopexy, and treatment of neovascularization.
The Coherent Popeye Ophthalmic Laser is intended to be used to deliver Q-switched Nd:YAG laser energy for use in photodisruption of ocular tissue, including: discission of the posterior capsule of the eye (posterior capsulotomy) discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients. The Coherent Popeye Ophthalmic Laser when used in combination with a Coherent Ultima 2000 or Ultima 2000SE Argon Laser Photocoagulator is intended to be used to deliver argon laser energy for use in the treatment of ocular pathology. The Coherent Popeye Ophthalmic Lasers are comprised of the following main components: a laser/optics module: . a laser power supply/control console; . a remote control unit; . a covered footswitch; . a laserized mirror.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary statement for the Coherent Popeye Ophthalmic Lasers, focusing on establishing substantial equivalence to predicate devices rather than providing performance study details against specific acceptance criteria.
The 510(k) summary primarily discusses:
- General information about the submitter and device names.
- Predicate devices.
- Product description.
- Indications for use.
- The rationale for substantial equivalence, which is based on comparing technical characteristics, design features, and functional features to existing predicate devices.
- A statement that system and software hazard analysis and verification/validation information was submitted, but no details of such studies or their results are included.
- A conclusion of substantial equivalence.
- An official FDA letter confirming the 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.
§ 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.