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The Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

• Retinal Photocoagulation .
• Pan Retinal Photocoagulation
• Endophotocoagulation
• Macular Treatments
• Laser Trabeculoplasty

Otolaryngology:

• Stapedectomy
• · Stapedotomy
• · Myringotomy
• · Lysis of adhesions
• Control of bleeding
• · Removal of acoustic neuromas ·
• · Soft tissue adhesion in micro/macro otologic procedures.

Dermatology:

• · Vascular lesion
• · Pigmented lesion

The intended use has not changed from the predicate devices (K022327, K020071, K062369)

The Medical Frequency Doubled YAG Laser is a solid state, frequency-doubled, green Nd: YAG surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532 retinal photocoagulator to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation.

Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

The provided text is a 510(k) summary for a medical device (Medical Frequency Doubled YAG Laser, Trade Name: LightLas 532). It focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with performance metrics.

Therefore, the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth, expert opinions, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document. The document explicitly states:

• "The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Medical Frequency Doubled Y AG Laser System."
• "The LightLas 532 is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation. laser trabeculoplasty. the treatment of vascular and pigmented skin lesions, and other laser treatments."

This indicates that the submission relies on demonstrating that the new device has "similar functional elements" and "same indications for use" as already cleared devices, and that it has undergone standard safety and functional testing, rather than an effectiveness study proving performance against specific quantitative acceptance criteria for accuracy, sensitivity, or specificity.

In summary, this document does not contain the information required to populate the table or answer the specific questions about acceptance criteria and study details.

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