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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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The Short Shaft Straight-In Bone Screw Fixation 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 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, sling procedure for male stress urinary incontinence resulting from prostatectomy).

This 510(k) notification describes a device intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. The Short Shaft Straight-In Bone Screw Fixation System is indicated for use during open 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, sling procedure for male stress urinary incontinence resulting from prostatectomy). The design and materials of the Short Shaft Straight-In and Straight-In systems are identical. The only difference is that the Inserter of the Short Straight-In device is shorter to serve the needs of users who prefer the maneuverability of a shorter device in open surgical procedures.

The provided text describes a 510(k) submission for a medical device, the "Short Shaft Straight-In Bone Screw Fixation System." It details the device's intended use and claims substantial equivalence to a predicate device (Influence, Inc.'s Straight-In Bone Screw System, K972622).

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with advanced AI/ML medical devices. This is because the submission is for a mechanical fixation system, not a software-driven diagnostic or treatment algorithm.

Therefore, many of the requested categories (expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The submission is for a mechanical surgical device, not a data-driven diagnostic tool. Performance equivalence was likely assessed through bench testing and comparison of design specifications with the predicate device. No "test set" in the context of data points is mentioned.

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

Not applicable. As this is not an AI/ML device, there is no mention of expert-established ground truth for a test set in this document.

4. Adjudication method for the test set

Not applicable. No "test set" in the context of data is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

Not applicable. MRMC studies are typically for diagnostic imaging software or similar devices involving human interpretation. This is a mechanical surgical device.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

Not applicable. The "truth" here relates to the safety and effectiveness of the mechanical fixation system, assessed through engineering principles, material science, and comparison to a legally marketed predicate device, rather than a "ground truth" derived from expert labels or pathology.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is a mechanical device, not an AI/ML system.

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

Not applicable. There is no training set.

Summary of the Study Information Provided in the Document:

The document states: "Information and performance testing provided and referenced in the application demonstrates equivalence to the predicate devices with respect to performance."

• Study Type: This would have been an un-detailed equivalence study focused on showing that the new device (Short Shaft Straight-In Bone Screw Fixation System) performs comparably to the predicate device (Straight-In Bone Screw System, K972622).
• Nature of Study: Given the device type (mechanical bone screw), this likely involved:
  • Mechanical bench testing: To compare properties like screw strength, pull-out force, material properties, and dimensional conformity.
  • Design analysis: A review of the design and materials to confirm their identity or equivalence to the predicate.
  • Clinical rationale: Justification for the shorter inserter not negatively impacting performance, potentially through physician feedback or direct observation during simulated use.
• Key Finding: The only stated difference between the new device and the predicate is the shorter inserter for improved maneuverability. The 510(k) summary asserts that this difference does not alter the fundamental technological characteristics or performance of the device in comparison to its predicate.

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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.

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