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The Activmotion range is intended for knee osteotomy in adults.

The Activmotion range consists of pre-contoured tibial and femoral plates and screws in various sizes designed for knee osteotomy in adults. The plates and screws are manufactured from titanium alloy and color anodized. The implants of the Activmotion range will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization. The instruments of the Activmotion range will be provided non sterile for sterilization by health care professionals prior to use.

This document is a 510(k) summary for the ACTIVMOTION range, a medical device for knee osteotomy. It details the device's substantial equivalence to previously marketed devices rather than presenting a standalone study with acceptance criteria and performance data in the typical sense of algorithm-based AI devices.

Therefore, many of the requested elements for AI device studies, such as specific acceptance criteria for performance metrics (e.g., sensitivity, specificity), sample sizes for test sets in an AI context, expert qualifications for ground truth in AI, MRMC studies, and training set details, are not applicable here because this document describes a traditional, non-AI medical device (bone plates and screws).

However, I can extract the information relevant to the "study" that proves the device meets the acceptance criteria, which in this context means proving substantial equivalence through non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Bending Strength & Stiffness: Engineering analysis conducted to compare to predicates. (Page 5)
• Torsional Strength: ASTM F543 torsional testing performed on screws. (Page 5)
• Axial Pull-out Strength: Engineering analysis conducted to compare. (Page 5) |
  | Biocompatibility/Non-Pyrogenicity (endotoxin levels) | Endotoxin testing performed using LAL quantitative kinetic chromogenic method. (Page 5) The conclusion implies it met standards to be "as safe and as effective as the predicates." |

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of an AI device. For this hardware device, the "test set" refers to the physical samples of plates and screws subjected to engineering and mechanical testing. The specific number of samples for each test (e.g., how many screws for torsional testing) is not provided in this summary.
• Data Provenance: Not applicable in the context of an AI device. The tests were non-clinical, conducted as part of the device's development and regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as this is a traditional hardware medical device, not an AI/algorithm-based device requiring expert annotation for ground truth. Technical experts (engineers, material scientists) would have performed and interpreted the mechanical and material tests.

4. Adjudication method for the test set

• Not applicable for this type of device. Adjudication methods are typically used for expert review of images or data in AI studies where there might be disagreements among human experts.

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 device is a surgical implant (bone plates and screws), not an imaging or diagnostic AI tool. No human reader performance is involved.

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

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

7. The type of ground truth used

• The "ground truth" for this device is based on established engineering standards and specifications (e.g., ASTM F543, ASTM F136, ISO 5832-3) and the mechanical performance of the predicate devices. The device's performance in terms of bending, torsion, pull-out strength, and material composition is compared against these benchmarks to establish substantial equivalence.

8. The sample size for the training set

• Not applicable, as this is not an AI device that requires a training set.

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

• Not applicable, as this is not an AI device.

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