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The In-Fast Bone Screw System is intended for soft tissue fixation to the publo bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws threaded with suture. It consists of a transvaginal inserter and bone screws with attached suture.

The provided text describes a 510(k) summary for the In-Fast Bone Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness through extensive clinical trials with the kind of detailed acceptance criteria and study designs that would be typical for a novel device or drug.

Therefore, many of the requested elements (sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types beyond basic compliance) are not applicable to this document as it pertains to a 510(k) submission for a device modification.

Here's an analysis based on the information provided:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The In-Fast Bone Screw System's acceptance criteria and proof of performance are primarily based on achieving "substantial equivalence" to a legally marketed predicate device (K970292), specifically regarding the addition of braided suture. The study conducted was a bench test of mechanical properties to ensure compatibility and compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified. This type of engineering bench test would typically use a sufficient number of samples to ensure statistical validity for mechanical properties, but the exact number is not provided in a 510(k) summary.
• Data Provenance: The study was a "bench test," meaning it was conducted in a laboratory setting. No country of origin is specified for the data itself, but the submitting company is American Medical Systems, Inc. (Minnetonka, MN, USA). The study is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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. For mechanical bench testing and compliance with a USP Monograph, the "ground truth" is established by adherence to standardized testing protocols and the specifications within the USP Monograph, not by expert consensus in the typical sense of clinical expert review. The experts involved would be engineers or quality control personnel familiar with testing methodologies and material science, but their number and specific qualifications are not detailed.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. This submission involves mechanical bench testing against a standard.

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 medical device for soft tissue fixation, not an image analysis or AI-driven diagnostic tool. Therefore, MRMC studies are not relevant nor mentioned.

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):

• The "ground truth" for the performance evaluation was primarily compliance with the USP Monograph for Non-Absorbable Sutures and the mechanical specifications for compatibility with the In-Fast system. This relies on established material science standards and engineering principles.

8. The sample size for the training set:

• Not Applicable. This type of device submission (510(k) for a modification) does not involve a "training set" in the context of machine learning or complex statistical modeling from a large dataset. The testing performed was for product validation, not model training.

9. How the ground truth for the training set was established:
* Not Applicable. As there is no "training set" in this context, this question is not relevant.

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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 with attached suture. The In-Fast Bone Screw System is indicated for the treatment of stress type (female) 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 with attached suture. In both devices, fixation of soft tissue to bone is accomplished by a sharp tipped small diameter bone screw/anchor anchor threaded with polypropylene suture which is inserted pervaginally through soft tissue and into the pubic bone, without drilling holes or performing soft tissue dissection. The screw/anchor is loaded into an inserter which is positioned in the vagina. Pulling force is applied on the user handle to pass the screw/anchor's tip into the bone cortex. The inserter's safety lock is released and screw/anchor is inserted into the prescribed depth in the pubic bone. In the In-Fast system, the screw is threaded into the bone by the inserter's rotating shaft.

This submission is for a medical device (In-Fast Bone Screw System), not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance (e.g., sample size for test set, ground truth, MRMC studies, standalone performance, training set details) is not applicable.

The 510(k) summary focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance metrics against specific acceptance criteria for AI algorithms.

Here's a breakdown of what can be extracted from the provided text, reframed to address the spirit of your request where possible for a medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally that the device is substantially equivalent to a legally marketed predicate device (or devices) in terms of intended use, technological characteristics, safety, and effectiveness. The "reported device performance" in this context refers to how the new device compares to the predicate.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria (i.e., substantial equivalence) is presented through a comparison to multiple predicate devices that have already been cleared by the FDA.

• Primary Predicate: Influence, Inc.'s UroTac Bone Screw System (K962372).
  • Basis for Equivalence: "mechanical properties and technical procedure of the two systems are almost identical."
• Other Predicates for Comparison:
  • Mitek GII Anchor (K920213): "proven to provide substantially equivalent fixation strength."
  • Vesica Suture Anchor System (K932925): Substantially equivalent for use in the vaginal sling procedure.
  • Questus™ Polyester Soft Tissue Anchor System (K953264 and K963200): Screw in In-Fast closely resembles the screw used in Questus™.

2. Sample Size Used for the Test Set and the Data Provenance

This information is not provided as the submission relies on bench testing and comparison to predicates, not a clinical study with a "test set" in the AI/ML sense. The "test set" here would implicitly be the performance characteristics of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This is not applicable. Ground truth, in the AI/ML context, refers to a definitive label or outcome for data points. For a classic medical device 510(k), the "ground truth" is established by regulatory clearance of the predicate devices and the generally accepted understanding of their safety and effectiveness, supported by engineering (bench) tests and material science.

4. Adjudication Method for the Test Set

This is not applicable. There's no "test set" or adjudication process described in the context of evaluating an AI model's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This is not relevant for a 510(k) submission for a bone screw system. MRMC studies are used to evaluate diagnostic imaging devices or AI tools that assist human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical medical implant and associated inserter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Established performance of predicate devices: Their regulatory clearance implies their safety and effectiveness.
• Bench testing: Engineering tests demonstrating physical properties, fixation strength, and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it's not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not involve a "training set" or a ground truth established for one.

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