(23 days)
The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The StapleTac Bone Anchor System is substantially equivalent to Influence, Inc.'s MicroTac Bone Anchor System cleared under K990160 with respect to intended use, materials and performance of the bone anchors. The major difference between the two systems is that the anchor of the StapleTac Bone Anchor System is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate device is designed for use with sutures in both sling procedures and cystourethropexy.
The provided document is a 510(k) summary for the Influence, Inc.'s StapleTac Bone Anchor System. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not include detailed clinical study data with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader, multi-case studies as you might find for software-as-a-medical-device (SaMD) or diagnostic devices.
The information provided focuses on the device's intended use, materials, and performance testing for demonstrating equivalence to a predicate device (Influence, Inc.'s MicroTac Bone Anchor System, cleared under K990160), rather than establishing novel safety and effectiveness against specific performance metrics for an AI/algorithm-based device.
Therefore, most of the requested information cannot be extracted from this document, as it outlines a device clearance based on substantial equivalence for a physical surgical implant system, not a study proving an algorithm's performance against specific acceptance criteria.
However, I can extract the following based on the prompt's categories:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, the "acceptance criteria" is essentially substantial equivalence to the predicate device, the MicroTac Bone Anchor System (K990160). The "reported device performance" is that the StapleTac Bone Anchor System meets this equivalence.
| Acceptance Criteria Category | Acceptance Criteria (from predicate device) | Reported Device Performance (StapleTac) |
|---|---|---|
| Intended Use | Soft tissue fixation to the pubic bone for vaginal sling procedures to treat stress urinary incontinence. | Substantially equivalent to predicate. Indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. |
| Materials | Equivalent materials to MicroTac Bone Anchor System. | Substantially equivalent to predicate. |
| Performance | Safe and effective performance as demonstrated by the predicate device for soft tissue fixation to the pubic bone. Risk analysis and testing for modifications. | Substantially equivalent to predicate. "Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance. The device modifications do not raise any new questions of safety or effectiveness." |
| Technological Characteristics | Similar design with a difference in sling fixation method (staple without sutures vs. sutures). | Substantially equivalent to predicate with the major difference being the anchor is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate uses sutures in both sling procedures and cystourethropexy. |
The following information cannot be extracted from the provided 510(k) summary because it is not relevant to a substantial equivalence determination for a physical surgical device, and implies a clinical/AI performance study which is not described here:
- Sample size used for the test set and the data provenance: Not applicable. No "test set" for an algorithm is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for an algorithmic output is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No "test set" for an algorithm is described.
- 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 is a physical device, not an AI or imaging diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No "ground truth" for an algorithmic output is described.
- The sample size for the training set: Not applicable. No "training set" for an algorithm is described.
- How the ground truth for the training set was established: Not applicable. No "training set" for an algorithm is described.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.