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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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The Surgisis® Sling is intended for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. The device is supplied sterile and is intended for one-time use.

The Surgisis® Sling is supplied in sheet form in sizes ranging from 20 cm2 to 140 cm2. The device is packaged in sterile, sealed double pouches.

This document is a 510(k) Summary for the Surgisis® Sling, a surgical mesh device. It does not provide information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or any other quantitative measures typically associated with AI/ML device evaluations.

The document focuses on demonstrating substantial equivalence to predicate devices based on:

• Intended Use: The Surgisis® Sling has the same intended use as its predicates (K980431, K954665, K980483, K963226).
• Technological Characteristics: The device is stated to have the same technological characteristics as the predicate devices.
• Testing for Biocompatibility, Integrity, and Performance: The document states that the Surgisis® Sling "passed the requirements of all tests" in these areas. However, it does not specify what these requirements or performance metrics were, nor does it provide the results of these tests in a detailed manner.

Therefore, I cannot provide the requested information for an AI/ML device as this document pertains to a traditional medical device (surgical mesh) where the evaluation criteria are different. The concept of "acceptance criteria" in this context refers to meeting the standards of biocompatibility, integrity, and equivalent performance to existing devices, rather than statistical performance metrics for an AI algorithm.

Summary of what can be extracted, and what cannot:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria (Implied): Biocompatibility, Integrity, Performance (in relation to predicate devices).
   • Reported Device Performance: "The Surgisis® Sling passed the requirements of all tests." No specific quantitative performance metrics are provided.

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

   • Not applicable/Not provided. The document refers to "tests" on the device itself (e.g., material properties), not a "test set" of patient data for an algorithm.

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

   • Not applicable/Not provided. Ground truth in the context of an AI/ML device would involve annotations by experts on medical data. This document doesn't involve that.

4. Adjudication method:

   • Not applicable/Not provided.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

   • Not applicable/Not performed. This is for evaluating AI assistance to human readers.

6. Standalone (algorithm only) performance:

   • Not applicable/Not performed. This device is not an algorithm.

7. Type of ground truth used:

   • Not applicable in the AI/ML sense. The "ground truth" for this device would be established engineering and biological standards for surgical mesh materials.

8. Sample size for the training set:

   • Not applicable/Not provided. This document describes a physical medical device, not an AI algorithm.

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

   • Not applicable.

In conclusion, the provided document describes a premarket notification (510(k)) for a conventional surgical mesh, focusing on substantial equivalence to existing devices. It does not contain the type of information related to acceptance criteria, test sets, ground truth, or study designs that would be relevant for an AI/ML medical device.

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