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The SURGIMESH®XB is intended to be used for the reinforcement of tissues during surgical repair.

The SURGIMESH®XB is indicated for use in: the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The silicone layer minimizes the tissue attachment to the mesh in the case of direct contact with the viscera.

The SURGIMESH®XB surgical mesh is a non-absorbable synthetic mesh, made of nonknitted, non-woven fibers of polypropylene, one surface of which is coated with silicone. The SURGIMESH®XB mesh is supplied sterile and is available in anatomic forms in order to meet the individual patient's surgical needs. The use of SURGIMESH®XB mesh provides reinforcement of soft tissues. On the opposite side, the silicone layer minimizes tissue attachment to the mesh in case of direct contact with the viscera.

This 510(k) summary is for a medical device (SURGIMESH®XB surgical mesh) and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics in the way a diagnostic AI device submission would.

Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory document.

Here's an attempt to address the points based on the provided text, indicating "Not Applicable" or "Not Provided" where the information is not present:

Acceptance Criteria and Study for SURGIMESH®XB

The submission for SURGIMESH®XB is a 510(k) premarket notification, which establishes substantial equivalence to legally marketed predicate devices. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. It does not typically involve defining specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) in the same way an AI diagnostic algorithm would, nor does it present a clinical trial with a test set, ground truth experts, or MRMC studies.

Therefore, the "acceptance criteria" for a device like SURGIMESH®XB are implicitly tied to demonstrating that its mechanical, material, and biocompatibility characteristics are "substantially equivalent" to predicate devices, which are themselves deemed safe and effective.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not Applicable. This submission does not describe a clinical "test set" in the context of diagnostic performance. The evaluation is based on material testing and comparison to predicates.
• Data Provenance: Not Applicable. No patient data or clinical study dataset is described.

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

• Number of Experts: Not Applicable. No ground truth establishment by experts is described for this type of device submission.
• Qualifications of Experts: Not Applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not Applicable. No test set requiring expert adjudication is described.

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

• MRMC Study: No. This is a surgical mesh, not an AI diagnostic device for human readers.
• Effect Size: Not Applicable.

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

• Standalone Performance: Not Applicable. This is a surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: Not Applicable. The "ground truth" concept for a surgical mesh revolves around proven safety and effectiveness of similar devices and the demonstration of equivalent physical, mechanical, and biological properties. It's not based on case-level diagnoses or outcomes in a study, but rather on material science and biocompatibility testing.

8. The Sample Size for the Training Set

• Sample Size: Not Applicable. This is a surgical mesh, not an AI device that uses a training set.

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

• Ground Truth Establishment: Not Applicable.

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The AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The AMS Pelvic Floor Repair System consists of needles and mesh used to repair the pelvic floor.

The provided text is a 510(k) summary for the AMS Pelvic Floor Repair System. Unfortunately, it does not contain the detailed information required to answer your specific questions about acceptance criteria, device performance results, sample sizes, expert qualifications, or ground truth establishment.

The "Summary of Testing" section is very brief, stating only: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices."

This highlights a common characteristic of 510(k) summaries, which often focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details about de novo performance studies against specific acceptance criteria. For devices cleared through the 510(k) process, the primary "acceptance criterion" is usually a finding of substantial equivalence to a legally marketed predicate.

Therefore, many of your questions cannot be answered from the provided document. Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Study Information (Based on the Provided Text)

Reported Device Performance: The document states: "The components of the AMS Pelvic Floor Repair System have been tested for The oumponents of the fine ince requirements and found to be substantially equivalent to the predicate devices." No specific performance metrics (e.g., sensitivity, specificity, accuracy, mechanical strength, biocompatibility results) are provided or compared against acceptance criteria. |
| 2. Sample Size for Test Set & Data Provenance | Not provided. The summary just generally mentions "testing" without detailing the nature of the tests (e.g., clinical, bench, animal) or the sample sizes involved. |
| 3. Number of Experts & Qualifications for Ground Truth | Not applicable/provided. This device is a surgical mesh; the "ground truth" would typically refer to clinical outcomes, mechanical properties, or biocompatibility, not expert interpretation of diagnostic images. |
| 4. Adjudication Method | Not applicable/provided. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | No. This device is a surgical mesh, not an AI-assisted diagnostic tool. |
| 6. Standalone Performance Study (Algorithm Only) | No. This device is a surgical mesh, not an algorithm. Performance would relate to its physical and biological properties. |
| 7. Type of Ground Truth Used | Not explicitly stated. For a surgical mesh, "ground truth" would likely involve:

• Bench testing results: Mechanical strength, pore size, material composition, etc.
• Biocompatibility testing: In vitro and/or in vivo studies.
• Animal studies: To assess in-vivo performance and host response.
• Clinical outcomes: From studies on the predicate devices or potentially early clinical use if available (though not detailed here). |
  | 8. Sample Size for Training Set | Not applicable/provided. This is not a machine learning device. |
  | 9. How Ground Truth for Training Set Was Established | Not applicable/provided. |

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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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