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The MEMOMETAL Micro ARIM® is indicated for

• Hand: Ligament reconstruction
• Ankle: Midfoot reconstruction
• Foot: Hallux Valgus reconstruction
• Wrist: Scapholunate Ligament reconstruction
• Pubis: Fixation in the pubis for bladder neck suspension to resolve stress urinary incontinence

MEMOMETAL Micro ARIM® anchors are single-use bone fixation appliances intended to be permanently implanted. Micro ARIM® anchors made of shape memory nickel titanium alloy. MEMOMETAL Micro ARIM anchors can be used in 2 versions with USP2-0 to USP 4-0 sutures (1 or 2 needles) listed below: Anchors Micro ARIM® th. 1mm - Length 3,8mm polyester suture (K012201) Anchors Micro ARIM® th. 1mm - Length 3,8mm Fiberwire suture (K041589) MEMOMETAL Micro ARIM® Anchors adopt an opened position after introducing into bone which allows a permanent fixation, thus supporting a secure ligament restoration.

The provided text is a 510(k) Premarket Notification for a medical device (MEMOMETAL Micro ARIM® anchor), not a study assessing AI software performance. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence to a predicate device based on material, design, function, and intended use, rather than presenting a clinical study with detailed performance metrics against acceptance criteria that would typically be associated with software or AI claims.

Here's what can be extracted and what cannot:

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

• Cannot be extracted. This document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against a clinical outcome. It focuses on conforming to a material standard and substantial equivalence to a predicate device.

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

• Cannot be extracted. This document does not describe a clinical study with a test set.

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)

• Cannot be extracted. This document does not describe a clinical study requiring expert-established ground truth.

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

• Cannot be extracted. This document does not describe a clinical study with 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

• Cannot be extracted. This document is for a physical bone anchor, not an AI-assisted diagnostic device. Therefore, no MRMC study involving human readers and AI assistance was conducted or reported here.

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

• Cannot be extracted. This document is for a physical bone anchor, not an algorithm.

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

• Cannot be extracted. This document does not describe a clinical study requiring ground truth.

8. The sample size for the training set

• Cannot be extracted. This document does not describe an AI training set.

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

• Cannot be extracted. This document does not describe an AI training set or its ground truth establishment.

What can be inferred from the document regarding "acceptance criteria" and "study":

The document focuses on demonstrating that the MEMOMETAL Micro ARIM® anchor meets general safety and effectiveness requirements by:

• Material Conformance: "THE MEMOMETAL Micro ARIM® conform to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants." This is the primary acceptance criterion explicitly stated for the material. The "study" proving this would be material testing to verify compliance with this ASTM standard.
• Substantial Equivalence: "[THE MEMOMETAL Micro ARIM®] are substantially equivalent to their predicate devices MITEK MiniQUICKANCHOR Plus in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness." This is the overarching "acceptance criterion" for 510(k) clearance. The "study" demonstrating this involves a comparison of the new device to the predicate across various attributes as detailed in the submission, confirmed by the FDA's review.

In summary, for K071941, the "acceptance criteria" revolve around conforming to an industry standard for the material and demonstrating substantial equivalence to a legally marketed predicate device, rather than specific clinical performance metrics from a device-specific study against a defined ground truth.

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