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The A.R.C laser surgery fibers and probes are intended for delivery of laser energy to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue.

The A.R.C. Laser Surgery Fibers & Probes are indicated for use in General Surgery, Urology, Gynecology and ENT with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.

The A.R.C. surgical laser fibers & probes are single use laser delivery devices provided EO sterile and intended for medical applications in various fields of laser surgery. The devices are based on a quartz core, have a length of 6.5 feet (2 meters) to 9.9 feet (3 meters) and a wavelength range between 450nm to 2100nm. The proximal end of the fibers is connected to a cleared laser system via an SMA 905 connector, while the distal end delivers the laser energy to the target tissue in pulsed and continuous wave mode. The distal end have a bare tip which may be flat or spherical, and may be used with a variety of sterile hand pieces for the various intended uses and effects.

The provided document is a 510(k) premarket notification for the A.R.C. Laser Surgical Fibers & Probes. It describes the device's intended use and claims substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for a device performance study or the details of such a study as typically required for AI/ML medical devices.

The document details performance bench testing for the physical characteristics of the fibers and their packaging/sterilization, but not a study of clinical performance or algorithm performance. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study proving the device meets them in the context of AI/ML.

Here's why I cannot fulfill your request based on the provided text:

• No AI/ML Component: The device described is a physical laser fiber and probe. There is no mention of an AI/ML algorithm or software component.
• No Performance Metrics like Sensitivity, Specificity, AUC: The "performance" section discusses bench tests related to the physical integrity, energy transmission, and sterility of the fibers. It does not mention clinical performance metrics that would be associated with an AI/ML diagnostic or prognostic device (e.g., sensitivity, specificity, accuracy, F1-score, AUC).
• No Clinical Study Details: The document explicitly states "Clinical Performance data: None." This means there was no clinical study conducted or submitted as part of this 510(k) to evaluate the device's performance in a clinical setting with human subjects.
• No Ground Truth Establishment: Since there isn't a clinical performance study involving diagnostic or prognostic outputs, there's no ground truth to be established by experts or pathology.

Summary of what can be extracted, demonstrating why the requested information for an AI/ML device is not present:

• Table of acceptance criteria and reported device performance: Not available for AI/ML performance. The document lists physical bench tests and standards/guidelines (e.g., ASTM F1886/F1886M-09: 2013 for packaging).
• Sample size used for the test set and data provenance: Not applicable. No test set for AI/ML.
• Number of experts used to establish the ground truth...: Not applicable. No ground truth for AI/ML.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Conclusion: The provided FDA 510(k) clearance letter and summary pertain to a physical medical device (laser fibers and probes) and do not include the type of information requested for evaluating an AI/ML medical device's performance or its associated studies.

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