Search Results

The Straight-In Bone Screw Fixation System is intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency).

This 510(k) notification describes a bone screw and bone screw inserter intended for soft tissue fixation to the pubic bone by means of bone screws threaded with suture. The Straight-In Bone Screw Fixation System is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency). The Straight-In Bone Screw Fixation System uses the identical bone screws and suture, but has a long, straight and narrow Inserter suitable for use in open and laparoscopic surgical procedures where soft tissue fixation to the pubic bone is needed.

This document is a 510(k) summary for a medical device called the "Straight-In Bone Screw Fixation System." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and validation data as might be expected for a novel AI/software medical device.

Therefore, many of the requested categories (e.g., acceptance criteria table, sample sizes, expert qualifications, MRMC study, ground truth details) are not applicable or cannot be extracted from this type of regulatory submission. The submission is for a physical medical device (bone screw and inserter), not an AI/software device.

Here's an analysis based on the provided text, indicating where information is present versus not applicable:

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

• Not Applicable. This submission is for a physical medical device (bone screw and inserter), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC against acceptance criteria. The "performance testing" mentioned refers to mechanical and material equivalence rather than diagnostic or analytical performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. The submission states "Performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance." This typically refers to benchtop mechanical testing rather than a clinical "test set" in the context of an AI/software device. No details on sample size, origin, or retrospective/prospective nature are provided for such testing in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. Ground truth, experts, and their qualifications are not relevant for a physical medical device like a bone screw system in establishing substantial equivalence. This type of information is typically associated with validating diagnostic or prognostic AI/software.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As there is no "test set" or ground truth establishment in the context of an AI/software device validation, adjudication methods are not relevant here.

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 is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. See previous points; ground truth in this context is not relevant. The "ground truth" for demonstrating substantial equivalence for this device would be the established performance and material characteristics of the predicate devices.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is a physical medical device, not an AI/software product that undergoes machine learning.

9. How the ground truth for the training set was established

• Not Applicable. There is no "training set" for this device.

Ask a specific question about this device