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Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors threaded with suture. The In-Tac Bone Anchor System is indicated for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Like the UroTac Bone Anchor System, the In-Tac Bone Anchor System consists of two components: a bone anchor, and a bone anchor inserter The In-Tac Bone Anchor System has the same overall design and technological characteristics as the configuration cleared under K962372, but implements the following changes: (1) the sutures will be provided pre-threaded for user convenience, and the retractable anchor shield will be incorporated into the disposable anchor assembly; (2) the inserter will be made from a stronger grade of stainless steel; and (3) the inserter incorporates a force measuring spring to ensure the anchors are deployed only if sufficient insertion force is applied.

This document describes a 510(k) notification for the In-Tac Bone Anchor System, which is a modification of the previously cleared UroTac Bone Anchor System. This submission focuses on establishing substantial equivalence to the predicate device, K962372.

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

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

   Acceptance Criteria	Reported Device Performance
   Biocompatibility (materials commonly used in medical devices)	Bench testing demonstrated materials are biocompatible.
   Device safety and effectiveness (modifications have no effect on safety and effectiveness)	Bench testing demonstrated no effect on device safety and effectiveness.
   Substantial equivalence to predicate device (UroTac Bone Anchor System cleared under K962372)	Based on materials, design, technological characteristics, and performance, the In-Tac Bone Anchor System is substantially equivalent.

2. Sample size used for the test set and the data provenance
   The document does not specify a separate "test set" in the context of clinical or diagnostic performance evaluation. The evaluation appears to be based on bench testing for biocompatibility, safety, and effectiveness. Therefore, there's no information on sample size or data provenance in the way one might consider for a diagnostic device (e.g., patient data, country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   Not applicable. This device is not a diagnostic tool requiring expert ground truth for a test set. The evaluation relies on engineering and material science principles via bench testing.

4. Adjudication method for the test set
   Not applicable. As described in point 3, this device is not a diagnostic tool.

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 a bone anchor system for surgical fixation, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   Not applicable. This is a mechanical surgical implant system, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
   The "ground truth" for this device's evaluation is primarily established through:

   • Biocompatibility standards: Common usage of materials in medical devices and specific biocompatibility testing.
   • Engineering principles and functional testing: Bench testing to demonstrate that modifications do not negatively impact safety and effectiveness, and that the device performs as intended (e.g., sufficient insertion force).
   • Comparison to predicate device: Establishing that the modified device's characteristics and performance are "substantially equivalent" to a previously cleared device.

8. The sample size for the training set
   Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" for an algorithm.

9. How the ground truth for the training set was established
   Not applicable. As noted in point 8, there is no training set for this type of device.

Overall Context:

This 510(k) submission is for a modified version of an already cleared device. The focus is on demonstrating substantial equivalence to the predicate device (UroTac Bone Anchor System, K962372). This is typically achieved through engineering analyses, material science evaluations (biocompatibility), and bench testing, rather than extensive clinical trials or diagnostic performance studies involving patient data or human readers. The modifications are described as improving convenience and material strength, with the claim that these changes had no effect on device safety and effectiveness.

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