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The Straight-In Bone Screw System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region 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 System consists of a motorized inserter and bone screws with attached suture. It is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region is needed.

The provided K020446 document describes a 510(k) premarket notification for a medical device called the "Straight-In Bone Screw Fixation System." This submission is for a modification to an existing device, where the only change is the addition of braided suture. The document is a 510(k) summary and the FDA's clearance letter.

Based on the provided text, this document does not describe a software-based medical device that would have acceptance criteria, a study with a test set, ground truth, or training data in the typical sense associated with AI/ML or complex diagnostic algorithms.

Here's why and what information can be extracted:

• Device Type: This is a physical, implantable medical device (bone screws with suture and an inserter) used for fixation, not a diagnostic or AI/ML-driven device.
• "Study" Description: The "Supporting Information" section states: "The mechanical properties of the braided suture have been tested on the bench for compatibility with the Straight-In system. The suture complies with the USP Monograph for Non-Absorbable Sutures." This indicates bench testing of mechanical properties, not a clinical study to evaluate diagnostic performance against acceptance criteria using patient data.

Therefore, most of the requested information regarding acceptance criteria for device performance in the context of a diagnostic algorithm or AI/ML study, sample sizes, experts, ground truth, MRMC studies, or training sets is not applicable to this 510(k) submission.

However, I can populate the table with the closest interpretation of "acceptance criteria" and "reported device performance" based on the provided text for a physical device, and explain why other fields are not relevant.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of number of samples, but implied to be sufficient for mechanical bench testing.
• Data Provenance: Bench test data; not from human subjects, countries, or retrospective/prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device does not involve expert readers establishing ground truth for a diagnostic test. Performance was evaluated against a standard (USP Monograph) and mechanical properties.

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

• Not applicable. There was no clinical test set requiring adjudication.

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 not an AI-assisted diagnostic device.

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):

• Ground Truth: USP Monograph for Non-Absorbable Sutures (a recognized industry standard for suture properties) and established mechanical properties for compatibility.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or corresponding ground truth.

In summary, this 510(k) submission is for a modification to a physical medical device, and the "study" described is limited to bench testing of the mechanical properties of a new suture material against established standards and compatibility requirements. The concepts of acceptance criteria for diagnostic performance, human readers, ground truth from experts, and training/test sets for algorithms do not apply in this context.

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