(27 days)
photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta 1064: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy
selective laser trabeculoplasty Selecta SLT:
photodisruption of ocular tissue using light energy emitted by a Nd: Y AG Selecta Duet: laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy/iridectomy; and
selective laser trabeculoplasty
laser delivery system for use by an ophthalmologist in the treatment of LaserLink S: ocular tissue;
laser delivery system indicated for use for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, Indications for Use section.
The Selecta 1064, Selecta SLT and Selecta Duet Ophthalmic Lasers are also intended for use as a diagnostic slit lamp, specifically,
An AC-powered slit lamp biomicroscope intended for use in eye examination of the anterior segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior segment.
same indications for use as a Selecta 10648 and LaserLink S slit lamp Selecta Duo: delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta Trio: same indications for use as a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
The Lumenis Selecta is a fully integrated flash lamp pumped, solid state, Nd:YAG ophthalmic surgical laser system intended for use in the treatment of ocular pathology and for use as a diagnostic slit lamp.
The Selecta Family of Ophthalmic Lasers, Delivery Device and Accessories are comprised of the following configurations:
Selecta 1064 - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, iridotomy). The 1064nm treatment beam delivers a 4 nsec, 0.3-10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned through beam shaping optics to generate a photodisruption micro pulse of plasma at a precision location relative to the visual focal plane (located at slit lamp center of adjustable rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 20um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 0-350μm in the posterior direction by the physician relative to this convergence of the twin aiming beams.
Selecta SLT® - a Nd:YAG laser providing Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty. The treatment beam delivers a 4nsec, 0.1-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens.
Selecta Duet® - a Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or Q-switched frequency doubled pulses at a wavelength of 532nm for use in selective laser trabeculoplasty, depending upon the mode selected. The Selecta Duo contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively.
LaserLink S - a laser slit lamp delivery adaptor that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532nm photocoagulator to allow the physician to use the Selecta slit lamp to deliver 532nm continuous wave laser energy for photocoagulation.
Selecta Duo - a Selecta 1064® and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta Trio - a Selecta Duet and LaserLink S slit lamp delivery device with a currently cleared Lumenis 532nm photocoagulator
Selecta SLT and LaserLink S with a currently cleared Lumenis 532nm photocoagulator
The provided text is a 510(k) summary statement for the Lumenis Family of Selecta Ophthalmic Laser Systems. It explicitly states that no performance data was submitted because the purpose of the 510(k) was for a name change only, with no changes to the device or its indications for use. The submission claims substantial equivalence to previously cleared predicate devices.
Therefore, the following information directly addresses the points in your request:
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Table of acceptance criteria and the reported device performance: Not applicable. No performance data or acceptance criteria are reported in this 510(k) summary, as it explicitly states "Performance Data: None."
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No performance study was conducted or reported.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. No performance study was conducted or reported.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No performance study was conducted or reported.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an ophthalmic laser system, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an ophthalmic laser system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance study was conducted or reported.
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The sample size for the training set: Not applicable. This document pertains to a physical medical device, not a machine learning algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable. This document pertains to a physical medical device, not a machine learning algorithm.
In summary, the provided 510(k) notification explicitly states that no performance data was included or required, as the submission was solely for a name change and claimed substantial equivalence to already cleared predicate devices without any changes to the device itself or its intended use.
§ 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.