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Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use.

The provided document is a 510(k) premarket notification for a medical device called Acu-Sinch Knotless Mini. It describes the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI/ML devices. Instead, the acceptance criteria are framed in terms of substantial equivalence to a predicate device (Arthrex CMC Mini Tightrope). The key performance criteria evaluated through non-clinical testing are static and dynamic fatigue, and MRI compatibility.

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

The document describes non-clinical bench testing. For such tests (static and dynamic fatigue, MRI compatibility, endotoxin, aging), the "sample size" typically refers to the number of physical devices tested. The document does not specify the sample size (number of devices) used for these tests.

The data provenance is from laboratory bench tests, not human subjects. Therefore, there is no country of origin for data or retrospective/prospective distinction in the typical sense.

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

This question is not applicable as the described study is a non-clinical bench test of a physical medical device (Acu-Sinch Knotless Mini) and not a study involving human subjects, interpretation of medical images, or AI/ML model performance that would require expert-established ground truth. The "ground truth" for the mechanical and material tests are the predefined ASTM standards and performance benchmarks.

4. Adjudication Method for the Test Set

This question is not applicable for the same reasons as point 3. There is no human interpretation or diagnostic decision-making involved that would necessitate an adjudication method.

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

This question is not applicable. The device is a physical medical implant (knotless mini-anchor system), not an AI/ML diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

This question is not applicable. The device is a physical medical implant, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithmic output.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily engineering specifications and established test standards.

• For mechanical performance (fatigue): The "ground truth" is the performance of the legally marketed predicate device (Arthrex CMC Mini Tightrope) and general engineering principles of sufficient strength and durability for the intended orthopedic application. The study aimed to demonstrate "statistically equivalent" or "better" performance relative to the predicate.
• For MRI compatibility: The "ground truth" is compliance with specific ASTM standards (F2052, F2119, F2182, F2213) which define acceptable limits for magnetic inducement, heating, and artifact generation.
• For biocompatibility: The "ground truth" is the specified endotoxin limit (<20 EU/device).
• For material degradation: The "ground truth" is maintaining performance after accelerated and real-time aging, indicating material stability over time.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant, not an AI/ML model that requires a training set.

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

This question is not applicable for the same reasons as point 8.

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