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The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to pubourethral support and bladder support.

The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is available in the size 4 cm x 7 cm. This pre-cut piece is mmbileono -------------------------------------------------------------------------------------------------------------------------------------------------------------------procedures.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™.

Unfortunately, the provided text is a 510(k) summary for a medical device submitted to the FDA. While it discusses the device's indications for use, description, and states that testing was performed, it does not contain detailed information about specific acceptance criteria or the study data that "proves" the device meets those criteria, as one would expect in a clinical trial report or a more comprehensive study document.

510(k) summaries primarily focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or outlining detailed performance metrics against specific acceptance thresholds.

Therefore, many of the requested fields cannot be directly extracted from the provided document. I will fill in what can be inferred and explicitly state what information is not present.

Acceptance Criteria and Study for AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "has been shown to be equivalent to the listed predicate device." This implies that the acceptance criteria for these physical characteristics were likely based on matching or falling within a specified range of the predicate device's performance. However, the specific numerical thresholds or ranges are not provided.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not applicable. The "ground truth" here relates to physical and biological properties of the mesh, not human interpretation of medical images or conditions.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The testing described (biocompatibility, tensile strength, suture pull strength, response to antibiotics) are laboratory/benchtop tests, not a clinical review process.

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

• No. This type of study is typically for evaluating diagnostic algorithms or imaging systems where human readers interpret data. The device is a surgical mesh.

6. If a Standalone Study (Algorithm only without human-in-the-loop performance) Was Done

• Yes, in a sense. The described testing (biocompatibility, physical characteristics, response to antibiotics) evaluates the device itself and its materials, without human clinical judgment in-the-loop during these specific tests. However, it's not "algorithm-only" performance as one might describe for AI/software, but rather standalone device performance testing.

7. The Type of Ground Truth Used

• Biocompatibility: Established through standard biocompatibility testing methods (e.g., ISO 10993 series), which involves analytical chemistry, in vitro, and in vivo studies to assess biological response. The "ground truth" would be compliance with these standards and lack of adverse biological reactions.
• Physical Characteristics (Tensile Strength, Suture Pull Strength): Established through standardized mechanical testing methods. The "ground truth" would be the measured physical properties of the material.
• Response to Antibiotics: Established through laboratory testing (e.g., antimicrobial efficacy assays), likely comparing the release profile or inhibitory effect of the InhibiZone™ on target microorganisms or tissue response.

8. The Sample Size for the Training Set

• Not applicable in the context of device performance testing. This concept is relevant for machine learning algorithms.

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

• Not applicable.

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