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The intended use for the Selecta Family of Ophthalmic Laser Systems (Selecta 1064, Selecta SLT, Selecta Duet, LaserLink S, Selecta Duo, and Selecta Trio) and Accessories are as follows:

• Selecta 1064: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, includinq 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.
• Selecta SLT: Selective laser trabeculoplasty.
• Selecta Duet: Photodisruption of ocular tissue using light energy emitted by a Nd: YAG 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.
• LaserLink S: Laser delivery system for use by an ophthalmologist in the treatment of ocular tissue. The laser delivery system is intended for a variety of ophthalmic uses, including the indications specified in the laser operator manual. Refer to the laser operator manual, General Intended Use section.
• Selecta Duo: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG 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/iridectorny and retinal photocoaqulation.
• Selecta Trio: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG 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, retinal photocoaqulation and selective laser trabeculoplasty.

The Lumenis Selecta is a fully integrated, high-performance diagnostic slit lamp and therapeutic laser delivery system. Selecta has all of the standard controls and functions of a diagnostic slit lamp and is intended for use in eve examination of the anterior segment, from the cornea epithelium to the posterior capsule.

The Lumenis Selecta is also an ophthalmic surqical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser trabeculoplasty.

The Selecta Family of Ophthalmic Lasers is comprised of:

Selecta 1064: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, papillary membranectomy, and iridotomy).

Selecta SLT: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty.

Selecta Duet: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption or Q-switched frequency doubled laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, depending on the mode selected.

LaserLink S: Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared Lumenis 532 nm retinal photocoaqulator (Novus Spectra, Novus Varia) to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation.

Selecta Duo: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption or Q-switched 532 nm continuous wave laser energy for retinal photocoagulation.

Selecta Trio: A Nd:YAG laser providing Q-switched laser pulses at a wavelength of 1064 nm for use in photodisruption, Q-switched frequency doubled laser pulses at a wavelength of 532 nm for use in selective laser trabeculoplasty, or Q-switched 532 nm continuous wave laser energy for retinal photocoagulation, depending on the mode selected.

The Selecta produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye.

When the photodisruptor mode is selected, the treatment wavelength is 1064 nm. A twin-aiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue.

When the SLT mode is selected, the treatment wavelength is 532 nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.

If the optional LaserLink S adapter is attached to the Selecta system and the compatible Lumenis Spectra 532 nm retinal photocoagulator laser, the Selecta works strictly as a diagnostic slit lamp - all photodisruptor and SLT laser functions are disabled. The Laser delivery adaptor is used for treatments specifically cleared for the compatible laser retinal photocoaqulator.

The provided 510(k) summary for the Lumenis Selecta Family of Ophthalmic Laser Systems (K081704) does not present an acceptance criteria table or a detailed study proving the device meets specific performance criteria with metrics like sensitivity, specificity, or accuracy.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, general design, and fundamental scientific technology. The "Performance Data Summary" section is very brief and states: "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Selecta Family of Laser Systems has been conducted." It does not provide any specifics about these tests, their results, or how they relate to numerical acceptance criteria.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth, and expert evaluation cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or is explicitly missing, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission relies on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided. There is no mention of a clinical "test set" in the context of diagnostic performance or AI model evaluation. The "testing" mentioned is likely focused on engineering safety and functional performance for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not provided. Ground truth establishment is not described as there's no clinical performance study presented that would require it.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods are relevant for studies involving human interpretation or multi-expert evaluations, which are not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not provided. The document describes a medical device (laser system) and does not involve AI or human reader interpretation that would necessitate an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/Not provided. This device is a physical laser system, not an algorithm, and its performance is inherently human-in-the-loop (operated by an ophthalmologist).

7. Type of Ground Truth Used

Not applicable/Not provided. The concept of "ground truth" as it pertains to diagnostic accuracy (e.g., pathology, outcomes data) is not relevant or described for this type of device submission. The "ground truth" in this context would likely be defined by physical measurements of laser output and functional operation, but these details are not provided in the summary.

8. Sample Size for the Training Set

Not applicable/Not provided. This is a physical laser system, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided, as there is no training set for an AI model.

Summary of the Study (Based on 510(k) Content):

The "study" presented in this 510(k) summary is not a clinical efficacy or performance study in the traditional sense, but rather a substantial equivalence determination. The manufacturer, Lumenis, Inc., states that they have conducted "appropriate testing including safety, performance and functional testing" to demonstrate that the Selecta Family of Ophthalmic Laser Systems is substantially equivalent to previously cleared predicate devices:

• Lumenis Selecta Duet (K021550)
• Coherent Popeye Ophthalmic Laser System (EPIC I and EPIC IV), (K97340)
• LaserLink Z-1000 (Z022181)

The basis for this substantial equivalence is stated as having the "same intended use, general design and fundamental scientific technology" as the predicate devices, and that "There are no new hazards introduced by the Selecta Family of Laser Systems as compared with the predicate devices." No specific data from these "appropriate tests" are included in the provided summary.

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