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The AMS Mainstay™ Urologic Bone Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Device Description

The AMS Mainstay™ Urologic Bone Anchor for bladder neck suspension procedures are titanium alloy implants. They are used to anchor suture material within cortical or cancellous bone sites, thereby providing a means for firmly securing soft tissue to bone. Two (2) Mainstay™ anchors are packaged in one box.

The recommended nonabsorbable suture size for the 3.5 mm Mainstay™ anchor is up to a maximum size of #0 (USP) when using two (2) strands and up to a maximum size of #2 when using a single strand.

AI/ML Overview

The provided text describes the AMS Mainstay™ Urologic Bone Anchor, a medical device intended for bladder neck suspension. The document focuses on demonstrating substantial equivalence to a predicate device rather than outright acceptance criteria and a detailed study proving the device meets those criteria in a quantitative sense as might be seen for a new, novel device. However, based on the information provided, we can infer the acceptance criteria and the "study" (bench testing) performed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and the specific bench testing performed. The "reported device performance" refers to the results of the bench testing.

Acceptance Criteria	Reported Device Performance
Functional Equivalence: Must have the same intended use as predicate device (fixation of surgical suture material to the pelvis for bladder neck suspension for female urinary incontinence).	The AMS Mainstay™ Urologic Bone Anchor has the same intended use as the predicate device (Howmedica® Mainstay™ Soft Tissue Anchor) for bladder neck suspension.
Material Equivalence: Must be made of Ti-6Al-4V.	The AMS Mainstay™ Urologic Bone Anchor is made of Ti-6Al-4V, equivalent to the predicate.
Design Equivalence: Must feature cancellous screw thread, be self-drilling/self-tapping, and have a proximal hole for suture attachment.	The AMS Mainstay™ Urologic Bone Anchor has a cancellous screw thread, is self-drilling/self-tapping, and has a proximal hole for suture attachment, equivalent to the predicate.
Operational Principle Equivalence: Must serve as an attachment site for suture, be anchored by screw threads, and be removable.	The AMS Mainstay™ Urologic Bone Anchor serves as an attachment site for suture, is anchored by screw threads, and is removable, equivalent to the predicate.
Suture-to-Bone Anchor Interface Strength: Maximum force required to break monofilament suture attached to the bone anchor must exceed the USP recommended minimum knot-pull strength for the respective class and size of suture (non-absorbable, Class I).	All sutures tested (#3-0 and #2 monofilament) exceeded the USP recommended minimum knot-pull strength by more than a factor of four (4).

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

Sample Size for Test Set: The document states that "Two (2) sizes of a nonabsorbable monofilament suture were evaluated in this test" for the Maximum Suture to Bone Anchor Interface Break Force. It does not explicitly state the number of anchors or individual tests performed for each suture size.
Data Provenance: The bench testing was performed by American Medical Systems. The country of origin of the data is not explicitly stated but is implied to be the USA given the company's address and submission to the FDA. The study was prospective in nature, as it was a specific performance test conducted for this 510(k) submission.

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

This type of information is not applicable for this submission. The "ground truth" for the bench testing was based on established engineering and material science principles, specifically the USP (United States Pharmacopeia) recommended minimum knot-pull strength for sutures. There were no human experts establishing a "ground truth" for the bench test results in the way one might for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" refers to the bench testing of suture strength, there was no subjective interpretation or adjudication needed. The results were quantitative measurements compared against a predefined standard (USP).

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

No. A MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. This device is a surgical implant, not a diagnostic tool.

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

Not applicable. This device is a physical implant, not an algorithm or AI system. There is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for the bench testing (suture-to-bone anchor interface strength) was based on USP (United States Pharmacopeia) recommended minimum knot-pull strength standards for non-absorbable, Class I sutures. For the substantial equivalence claim, the ground truth was the performance and characteristics of the legally marketed predicate device (Howmedica® Mainstay™ Soft Tissue Anchor).

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI or machine learning model that requires a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

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