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The Tegress™ Implant Needles are accessories for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.

The Tegress™ Implant Needle is an accessory for currently marketed endoscopes and is used for tissue during an endoscopic procedure. The Tegress™ Implant Needle is a Transurethral Flexible Needle with Stabilizing Cannula that consists of a stainless steel non-coring needle at the tip. A full-length needle guard protects the species of a semi-rigid catheter/tubing and The Transurethral Needle and Stabilizing Cannula with Working Working Channel Seal. Working Channel Geal. - The "Transarenial and are compatible with DMSO.

The provided text is a 510(k) summary for the Tegress™ Implant Needle, a medical device. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance evaluation.

The "Performance Data Summary" section explicitly states: "The Tegress™ Implant Needle referenced in this submission is held to the same design, The Tegress™ Informance specifications as those needles currently manufactured by manufacture, and performance specification and validation activities for the modifications to the Tegress™ Implant Needle were conducted." This indicates that the claim of safety and effectiveness relies on its similarity to existing, already-approved devices, rather than a new standalone performance study with detailed acceptance criteria.

Therefore, I cannot provide the requested information from this document. The sections of your request that cannot be answered from the provided text are:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance metrics are reported.
2. Sample size used for the test set and the data provenance: No test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable; this device is an implant needle, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is an implant needle, not an algorithm.
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.

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