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The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh 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 the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

The AMS Triangle™ Siliconc-Coated Sling and Surgical Mesh is made of a The AMS THangle - Omeone with a thin layer of solid silicone elastomer. The polyester mesil that is obverted the Sling and Surgical Mesh is available in sizes AMO Triangle - Binoo.144 cm2, including 2 cm x 5 cm, 2 cm x 4 cm, 2 cm x 10 cm, 2 cm x 7 cm, 2 cm x 20 cm, 6 cm x 6cm and 12 cm x 12cm.

The provided text describes a 510(k) premarket notification for the AMS Triangle™ Silicone-Coated Sling and Surgical Mesh. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with acceptance criteria and detailed study results as would be typical for pharmaceuticals or novel high-risk devices.

Therefore, the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, and standalone performance for a clinical outcome or diagnostic performance is not applicable in this context. The "study" mentioned here refers to material property tests to demonstrate equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a clinical test set. The "test set" here refers to the AMS Triangle™ material and its physical properties. No specific number of units tested is provided, nor is a 'test set' in the traditional clinical performance sense mentioned.
• Data Provenance: Not applicable. The tests were material property tests, not based on human data or retrospective/prospective studies on patients.

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

• Not applicable. Ground truth in a clinical or diagnostic sense is not relevant for material property testing. The "ground truth" was established by comparing the AMS Triangle™'s material properties against those of the established predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No clinical adjudication was performed.

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

• No. This type of study is not relevant for a 510(k) submission focused on material equivalence.

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

• Not applicable. This device is a surgical mesh/sling; there is no "algorithm" or standalone AI performance to evaluate.

7. The Type of Ground Truth Used

• Engineering/Material Ground Truth: The physical and biocompatibility properties of the predicate devices (TriAngleTM Sling - K980482, Bard® Marlex Mesh - K922916, Ethicon™ Prolene™ Mesh - K962530, Mersilene™ Mesh Mentor SUSPEND™ Sling - K980483) served as the "ground truth" or benchmark for comparison. The AMS Triangle™ was tested to show it met equivalent performance to these established devices.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI/machine learning model. The concept of a "training set" doesn't apply to this type of medical device submission.

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

• Not applicable, as there is no training set.

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