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The Laser peripherals bare laser fibers, ENT fibers and Endoprobes are intended for use in laser surgical procedure for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, Ho: YAG, KTP and Diode lasers have been cleared.

Fiber Optic Delivery Systems and Handpieces are intended to vaporize, coagulate, incise and excise tissue and which are designed for any indication for which compatible laser systems have been cleared by FDA. Similarly, the predicate devices are also components of delivery systems designed to deliver laser radiation to a specified point. FiberTech's Fiber Optic Delivery System's fiber optical Handpiece and Tip has a similar material composition as its predicate devices. Third, the Fiber Optic Delivery System is available in sizes between 200 micron and 1000 micron. Ceramoptec's and Coherent Laser Delivery Systems is available also in sizes ranging from 200 micron to 1000 micron. Fourth, the reusable and the disposable Fiber Optic Delivery Systems are available in the same tip shapes and handpiece configurations. Further, both the reusable and the disposable devices are prepackaged sterile and fit lasers which employ SMA 905 connectors or lasers which have suitable adapters to allow SMA 905 connectors to be used. Finally, the reusable Fiber Optic Delivery System can be reused only once the optical fiber tip is properly cleaned, inspected, stripped and cleaved.

The provided text is a 510(k) summary for the FiberTech's USA Fiber Optic Delivery System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically associated with AI/ML-based device performance evaluations (e.g., accuracy, sensitivity, specificity studies).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the standard for 510(k) clearances. The "Performance Data" section primarily refers to certifications, not clinical performance metrics.

Therefore, I cannot fulfill your request for the specific points about acceptance criteria and study details because the provided document does not contain that type of information. It's a regulatory document for a physical medical device, not an AI/ML software as a medical device.

Here's a breakdown of why the requested information is absent:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "no new questions of safety and effectiveness raised by the introduction of this devices" based on similarity to predicates, rather than quantifiable performance metrics against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable. Performance is established through comparison to predicate devices and existing certifications, not through a separate clinical test set in the traditional sense for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section (Section 2) mentions:

• CE marking (Medical Device Directive 95.E.02)
• Certification under EN ISO 19407:2009
• Certification for Quality EN ISO 9001:2000

These are quality management system and regulatory compliance certifications, not direct performance metrics of the device itself (like accuracy of an AI algorithm). The basis for clearance is substantial equivalence to the predicate devices listed (Ceramoptec's Fiber Optic Delivery Sytems, InnovaQuartz Fiber Optic Delivery System, Laser Peripherals Fiber Optic Delivery System, Trymedyne Inc., Fiber Optic Delivery System). The argument for substantial equivalence is based on:

• Intended Use
• Technological Characteristics (material composition, available sizes, tip shapes, handpiece configurations, sterile packaging, connector types, reusability)

In summary, this document is a 510(k) submission for a physical medical device. It relies on demonstrating similarity to already cleared devices and adherence to manufacturing and quality standards, rather than presenting a performance study with acceptance criteria and ground truth, as would be expected for an AI/ML-based medical device.

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