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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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The CataRhex 3 is used for surgical interventions in the anterior eye segment.

• Irrigation and aspiration (I/A function)
• Ultrasound phaco (PHACO function)
• Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function)
• Diathermic capsulotomy (CAPS function)
• . Operation of a vitrectomy instrument (VIT function)

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

The CataRhex 3 is medical electrical equipment to be used during eye surgery and is intended for ophthalmic anterior segment surgery.

It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectomy and capsulotomy. The equipment has a display and buttons for selecting and activating the functions. With the equipment a footswitch is delivered for control by the surgeon.

This document is a 510(k) Premarket Notification for the CataRhex 3 Cataract Surgery System. It aims to demonstrate substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria in a table format nor does it report detailed device performance metrics. Instead, it relies on a statement of substantial equivalence to predicate devices and adherence to general safety standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The document states: "No clinical studies were deemed necessary to determine the safety and effectiveness or substantial equivalence of CataRhex 3 to their predicate devices." This implies that there was no specific "test set" of patient data in the context of clinical performance evaluation. The evaluation was based on non-clinical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Since no clinical studies were performed, there was no test set with ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

As no clinical studies were performed, no adjudication method was used for a test set.

5. If a multi-reader multi-case (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:

This device is a surgical system, not an imaging diagnostic AI tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed. There is no AI component mentioned that would assist human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This device is a surgical system requiring human operation, not a standalone AI algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the absence of clinical studies, no clinical "ground truth" (such as expert consensus, pathology, or outcomes data) was used. The evaluation was based on non-clinical testing to ensure the device performs as intended and meets safety standards, similar to its predicate devices.

8. The sample size for the training set:

The document states that no clinical studies were performed, and the evaluation was based on non-clinical testing. Therefore, there is no concept of a "training set" in the context of clinical data for this device.

9. How the ground truth for the training set was established:

As there was no training set for clinical data, no ground truth for a training set was established.

Summary of the Study and Acceptance Criteria Basis:

The document indicates that the CataRhex 3 Cataract Surgery System's safety and effectiveness are based on:

• Substantial Equivalence: The device is considered substantially equivalent to the predicate devices:
  • K081877 ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
  • K101325 STELLARIS PC VISION ENHANCEMENT SYSTEM
• Non-Clinical Testing: The device underwent non-clinical testing to ensure compliance with applicable safety standards and to demonstrate that it performs equivalently to the predicate devices.
• Compliance with Quality Systems: The device will be manufactured in compliance with FDA and ISO quality systems requirements.
• Validation and Verification: Functional requirements and specifications were met prior to commercial release, as shown through validation and verification processes.

Conclusion stated in the document: "The data presented from the nonclinical tests demonstrate that the device is safe and effective, and performs as safely and effectively as the legally marketed predicate devices. Validation and verification demonstrates that the functional requirements and specifications have been met prior to commercial release."

In essence, the "acceptance criteria" here implicitly refer to meeting the performance, safety, and functional characteristics of the predicate devices through non-clinical testing and adherence to regulatory standards, rather than through a clinical study with defined performance metrics against a clinical ground truth.

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