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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.

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.

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.

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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The devices are intended for soft tissue-to-bone suture fixation for the following indications: Shoulder (Bankart lesion repairs, SLAP lesion repairs, Acromio-clavicular separation repairs, Rotator cuff tear repairs, Capsular shift or capsulolabral reconstructions, Biceps tenodesis, Deltoid repairs), Foot and Ankle (Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Hallus valgus reconstructions), Elbow, Wrist, and Hand (Scapholunate ligament reconstructions, Ulnar or radial collateral ligament reconstructions, Tennis elbow repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repairs).

The Statak Soft Tissue Attachment Device anchor has a diameter of 2.5 mm, is self-tapping, self-drilling, and fully threaded. A double strand, braided, nonabsorbable Size No. 2-0 suture is attached to an eyelet at the end of the anchor. A disposable driver which can be attached to a powered handpiece holds the excess suture and delivers the anchor directly into the bone. When the driver is removed, the suture strands are left emerging from the bone. The strands are then used to secure the soft tissue to the bone.

This document is a 510(k) premarket notification for a medical device, the Statak® Soft Tissue Attachment Device. It describes the device's technical specifications, intended use, and a summary of performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of AI/ML performance evaluation.

Here's an analysis of what information is present and what is missing based on your request:

Analysis of Available Information:

This document focuses on the regulatory submission for a physical medical device (soft tissue anchor), not an AI/ML-driven device. As such, many of the requested categories related to AI/ML model evaluation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of document for a conventional medical device.

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as formal, quantitative acceptance criteria in numerical terms in this summary. Instead, the "acceptance" is implicitly defined by the comparison to a predicate device and the "as well as" performance.
• Reported Device Performance:
  • Performance Claim: "The Statak Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure."
  • Test Method: "tension loading the suture in the hand bones of cadaver specimens."
  • Comparison: Compared to "a suture-only tenodesis procedure in similar bone."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified. The document mentions "cadaver specimens" and "similar bone" but does not provide a number.
• Data Provenance: "cadaver specimens." No country of origin is specified. The study is inherently ex vivo (on cadaveric tissue), not retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable or Not present. This device's performance is measured mechanically (tension loading), not through interpretation by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable or Not present. No expert adjudication is involved in assessing a mechanical property.

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

• Not applicable. This is not an AI/ML device, so no MRMC study involving human readers and AI assistance would be performed.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Type of "Ground Truth" (or reference standard): The "ground truth" for this performance test is the mechanical strength/resistance to tension of a "suture-only tenodesis procedure." This is a direct mechanical measurement on cadaveric bone.

8. The sample size for the training set

• Not applicable or Not present. This is not an AI/ML device, so there is no "training set."

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

• Not applicable or Not present. There is no training set for a non-AI/ML device.

Summary Table of Available Information (Adapted for this Device Type):

• Specific Quantitative Criterion: Not explicitly stated (e.g., "must withstand X Newtons of force"). |
  | Device Performance | - "The Statak Soft Tissue Attachment Device performed as well as the suture-only tenodesis procedure."
• Test Method: Tension loading the suture in hand bones of cadaver specimens. |
  | Test Set Sample Size | Not specified (mentioned "cadaver specimens"). |
  | Data Provenance (Test Set) | Cadaver specimens. Ex vivo. |
  | Number & Qualifications of Experts (Test Set Ground Truth) | Not applicable (performance measured mechanically, not interpreted by experts). |
  | Adjudication Method (Test Set) | Not applicable. |
  | MRMC Comparative Effectiveness Study (AI vs. Human) | Not applicable (not an AI/ML device). |
  | Standalone Performance (Algorithm Only) | Not applicable (not an AI/ML device). |
  | Type of Ground Truth (Test Set) | Direct mechanical measurement (tension loading) in comparison to a reference standard (suture-only tenodesis) on cadaveric bone. |
  | Training Set Sample Size | Not applicable (not an AI/ML device). |
  | How Ground Truth for Training Set Established | Not applicable (not an AI/ML device). |

Conclusion:

The provided document is a regulatory submission for a traditional, physical medical device, not an AI/ML-driven diagnostic or assistive tool. Therefore, much of your requested information, which pertains to the evaluation methodology for AI/ML performance, is not relevant or present in this context. The document confirms that the Statak device performed "as well as" a comparator procedure in cadaveric tests, but lacks the detailed, quantitative metrics and study design elements typically found in AI/ML validation.

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