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The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.

Faros is used for these surgical interventions in the anterior eye segment:

• Irrigation and aspiration (I/Afunction)
• Ultrasound phaco (PHACO function)
• Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
• Bipolar diathermic capsulotomy (CAPS function)
• Operation of a vitrectomy instrument (VIT function)

The device may only be used with the instruments recommended and supplied by Oertli.

The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens, which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery.

The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.

I apologize, but the provided text from the FDA 510(k) notification for the Oertli Instrumente AG Faros Surgical System does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria in the context of an AI/ML-driven medical device.

Here's why and what information is missing:

• Device Type: The Faros Surgical System is a phacoemulsification system, which is a hardware device used in cataract surgery. It is not described as an AI/ML software device or a device that relies on complex AI algorithms for diagnosis or prediction.
• Performance Data Scope: The "Summary of Performance Data" section primarily details compliance with various consensus standards (electrical safety, EMC, software lifecycle, cybersecurity, usability, biocompatibility, reprocessing, sterility). These are performance aspects of the hardware and its embedded software, not the performance of an AI model in interpreting medical images or data.
• Absence of AI/ML Specifics: There is no mention of:
  • Diagnostic accuracy metrics (sensitivity, specificity, AUC)
  • Test sets, training sets, or validation sets for an AI model
  • Ground truth establishment by expert consensus or pathology for AI model evaluation
  • Multireader multicase (MRMC) studies
  • Comparison of human readers with and without AI assistance
  • Standalone algorithm performance

Therefore, I cannot generate the requested table and study description based on the provided document. The document is a standard 510(k) clearance letter for a conventional medical device, not an AI/ML medical device.

If you have a document describing an AI/ML medical device, please provide that, and I would be happy to help describe its acceptance criteria and the supporting study.

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