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The Easyret® is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and uvea including:

• Proliferative and severe nonproliferative diabetic retinopathy,
• Choroidal neovascularization
• Branch retinal vein occlusion
• Treatment of choroidal neovascularization associated with wet age-related macular degeneration
• Retinal tears and detachments,
• Certain forms of macular edema
• Retinopathy of Prematurity
• Iridotomy in angle closure glaucoma, and trabeculoplasty in open angle glaucoma

Easyret® is an integrated photocoagulation laser system including a slit lamp and a single column table. It provides a yellow laser beam (577nm).

Easyret® laser is available with the following configurations: - A single slit lamp delivery system: With this model two different slit lamps manufactured by CSO (CSO SL 9800 5x and CSO SL 9900 5x) are available. These slit lamps models have been cleared under K992836. - A slit lamp delivery system and a laser indirect ophthalmoscope (LIO) optional port In addition to the slit lamp delivery system, an optional LIO (laser indirect ophthalmoscope) can be used with the laser. Quantel Medical recommends the use of the following LIO models: Heine Omega 500 and Keeler Vantage +.

The touch screen includes a user interface where laser treatment settings such as power, pulse duration, spot size treatment and aiming beam intensity level can be programmed.

The user interface allows the physician to quickly select and access the following 3 treatment modes:

• Monospot treatment: This selection allows the user to carry out thermal "traditional" laser treatment using single spot via 4 delivery modes: Single, Repeat, Painting or Continuous.
• -MultiSpot treatment: The MultiSpot mode allows automatically consecutive several laser spots according a pattern selected and the treatment patterns are customizable: square, circle, triple arc and macular grid.
• SubLiminal treatment: The sequencing (SubLiminal mode, or sub-threshold) is used to split the energy delivery into several successive very short pulses (microseconds) separated by a cooling time (interval).

Feedback to the user, such as laser operating state, number of performed laser spots, etc. is provided through the user interface. The laser treatment can be initiated by pressing on a footswitch and aborted by releasing it.

This document is a 510(k) premarket notification for a medical device called Easyret®, an ophthalmic laser system. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device (Quantel Medical Supra Scan K120825). Therefore, the document does not contain information related to acceptance criteria, device performance details from a study proving it meets those criteria, sample sizes, expert qualifications, or comparative effectiveness studies in the way typically associated with clinical performance validation of diagnostic AI/ML devices.

The document primarily focuses on:

• Indications for Use: The Easyret® is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and uvea, as listed in pages 2 and 4-5.
• Device Description: Easyret® is an integrated photocoagulation laser system including a slit lamp and a single column table, providing a yellow laser beam (577nm). It supports Monospot, MultiSpot, and SubLiminal treatment modes (page 4).
• Substantial Equivalence Argument: The core of the submission is to demonstrate that Easyret® is substantially equivalent to the predicate device (Quantel Medical Supra Scan). This is argued based on:
  • Same intended use/indications for use (page 5).
  • Similar technological characteristics: Both use a 577nm laser. Differences primarily relate to the integration of components (scanner and zoom integrated into the slit lamp in Easyret® vs. added to the slit lamp in the predicate) and the type of laser cavity (fiber laser cavity in Easyret® vs. Optically Pumped Semiconductor Laser (OPSL) cavity in the predicate) (page 5-6).
  • Similar performance parameters: While some ranges (exposure time, spot size) have been slightly adjusted, the document states that the delivered power, spot size, and exposure time can be adjusted in the same ranges as the predicate, resulting in the same range of fluence delivered (page 6).
• Performance Data: This section only lists the recognized consensus standards to which performance testing was conducted (e.g., electrical safety, electromagnetic compatibility, usability, particular requirements for surgical laser equipment, laser product safety). It also states that hardware and software validation activities were performed and appropriate software documentation was provided. It does not provide specific performance results, acceptance criteria, or a study report demonstrating the device's clinical performance against acceptance criteria.

Therefore, based on the provided document, I cannot answer the requested questions regarding acceptance criteria and performance data for a study proving the device meets those criteria, including sample sizes, ground truth establishment, or any comparative effectiveness studies, because this information is not present in the 510(k) summary.

The document's purpose is a regulatory submission for substantial equivalence to a predicate laser device, not a detailed clinical performance study of a diagnostic or AI/ML device. It focuses on engineering and regulatory compliance rather than clinical trial results with performance metrics against predefined acceptance criteria for AI algorithms.

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