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1. The Laser Photolysis System is indicated for use in fragmentation and removal of the cataractous crystalline lens.
2. The Pharo Ophthalmic Surgery System is indicated for use in anterior and posterior ophthalmic surgery.

Pharo Ophthalmic Surgery System is a class II ophthalmic surgical system intended for use in anterior and/or posterior segment ocular surgery. Functions include Irrigation/Aspiration, Ultrasound phacoemulsification, Bipolar diathermy, pneumatic vitrectomy, pneumatic cutters scissors, air and oil infusion system, and illumination. The user interfaces include a foot controller and a touch screen control panel. The vaccuum system utilizes either a venturi or peristaltic pump system. Peripherals include the printer module, cart and trolley. Accessories include an electric or manual infusion pole, cutters in several models, vitrectomes in several models, diathermy forceps and pencils in several models, ultrasound handpieces in either of two models, I/A handpieces in several models, fiber optic cables for illumination in several models, air exchange sets, tubing sets, and collection cassettes.

The Photolysis System is intended for use in Laser fragmentation of cataracts. The device consists of a laser console, which delivers energy by fiber optic via a disposable probe. The probe converts the laser light energy into acoustic energy, which is used to fragment the crystalline lens. The system is controlled by push buttons on the front panel and via footswitch. Irrigation/aspiration is provided by the Pharo system. Accessories include the laser photolysis probe and a dedicated irrigation handpiece.

The provided document is a 510(k) Summary for the Pharo Ophthalmic Surgery System/Laser Photolysis System. It describes the device and its intended use, but it does not contain information about specific acceptance criteria, formal studies, or reported device performance in the context of meeting those criteria.

A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than presenting de novo clinical study results against predefined performance metrics. The document states "The technological difference in the Laser Photolysis System does not raise new questions of Safety and Effectiveness, and/or equivalence is demonstrated by performance data," but it does not elaborate on what that performance data entailed.

Therefore, most of the requested information cannot be extracted directly from this document.

Here's what can be stated based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on demonstrating substantial equivalence to predicate devices rather than testing against specific performance criteria.

• 2. Sample size used for the test set and the data provenance: Not provided. No specific test set or clinical study details are mentioned.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. Ground truth establishment is not discussed.

• 4. Adjudication method for the test set: Not provided.

• 5. If a multi-reader multicase (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 a surgical system, not an AI-assisted diagnostic tool for human readers.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical system, not a standalone AI algorithm.

• 7. The type of ground truth used: Not provided.

• 8. The sample size for the training set: Not provided.

• 9. How the ground truth for the training set was established: Not provided.

Summary based on the document:

The document asserts substantial equivalence by comparing the Pharo Ophthalmic Surgery System to the Alcon Series 20000 Legacy, Premiere Microsurgical System (Storz), and Accuras (Alcon). Similarly, the Laser Photolysis System is compared to the Premiere Microsurgical System (Storz) and Alcon 20000 Series Legacy. The basis for equivalence includes:

• Intended use
• Surgical methods
• Materials
• Design
• Labeling
• (For Laser Photolysis System) "performance data" (without detailing what this data is)

The FDA's letter (K993154) confirms that the device is "substantially equivalent" for the stated indications for use, implying that the provided information (which is not detailed in this 510(k) summary) was sufficient for the FDA to make this determination.

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