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The MEMOMETAL implants (K-Snap® & Ti-Fuse®) are indicated for fixation of bone fracture, for bone reconstruction or arthrodesis in presence of appropriate immobilization. The size of the implant should be adapted to the specific indication.

MEMOMETAL implants are single-use bone fixation appliances intended to be permanently implanted. MEMOMETAL implants are available in 2 different designs: - Snap-off pin, smooth with a stop and a sharp self drilling tip - Notched with a T-shaped head.

The provided 510(k) Premarket Notification for MEMOMETAL Technologies Osteosynthesis implants (K102072) describes performance data related to the mechanical properties of the implants. This submission focuses on demonstrating substantial equivalence to predicate devices through engineering rationale and mechanical testing, rather than clinical outcome studies involving human or animal subjects that would typically involve acceptance criteria for a study with a test set, ground truth, and expert evaluation as you've outlined.

Therefore, many of the requested categories (2-9) are not applicable to the type of information presented in this regulatory submission. The performance data provided is primarily engineering-based.

Here's a breakdown of the relevant information from the provided text:

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

Study Description (based on available information):

This submission relies on engineering rationale and mechanical testing to demonstrate the substantial equivalence of the MEMOMETAL implants (K-Snap® & Ti-Fuse®) to their predicate devices. The study is a comparative mechanical performance study rather than a clinical trial.

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 in the summary (typical for mechanical testing, where the number of test samples for each mechanical property is usually defined by a standard).
• Data Provenance: The study was conducted by MEMOMETAL Technologies (a French company). The testing is likely prospective in nature (i.e., designed and performed for this submission).

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. Ground truth as typically understood for clinical or image-based studies (e.g., expert consensus on diagnoses) is not relevant for this type of mechanical testing. The "ground truth" here is physics and engineering principles, with measurements taken from the devices and comparator.

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

Not applicable. This is not a human-reader-based study.

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 a human reader or AI-assisted study.

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

The "stand-alone" performance is the mechanical performance of the devices themselves, as tested. There is no algorithm involved in the clinical sense.

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

The ground truth is based on objective mechanical measurements (e.g., force, displacement, material properties) as defined by established engineering and materials science standards for such implants. There is no expert consensus, pathology, or outcomes data used as ground truth for this mechanical study.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of mechanical performance testing for medical devices.

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

Not applicable.

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