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The implants of the Activmotion S DTO range are intended for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula.

The Activmotion S DTO range consists of plates and screws designed for bone reconstruction of the ankle joint in adults, including fixation of fractures and osteotomies of ankle, distal tibia and fibula. The Activmotion S DTO range will be provided sterile by gamma sterilization or non-sterile for sterilization by health care professionals prior to use. Materials: CP Titanium (conform to ASTM F67 and ISO 5832-2) and Titanium alloy Ti-6Al-4V ELI (conform to ASTM F136 and ISO 5832-3).

The provided text is a 510(k) summary for a medical device called the "Activmotion S DTO range." This document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical testing. It explicitly states that no clinical studies were performed. Therefore, this document does not contain information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

Here's a breakdown of what can be gleaned from the text regarding the required information:

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

• Acceptance Criteria: Not explicitly stated as pass/fail values for specific performance metrics in the provided text. The document generally implies equivalence to predicate devices.
• Reported Device Performance:
  • "Engineering analysis and comparative 4-point-bending tests in static and dynamic condition were conducted to compare the bending strength of the subject device plates to the predicates."
  • "Static and dynamic tests were conducted according to according to ASTM F382."
  • "Engineering analysis: torsional, driving torque, and pullout tests according to ASTM F543 were performed on the subject screws."
  • "Endotoxin testing is performed using LAL quantitative kinetic chromogenic method."
  • "The analysis showed that the Activmotion S DTO range is as safe and as effective as the predicates."

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

• The sample sizes for the engineering tests (e.g., number of plates, screws tested) are not specified in this document.
• The data provenance is not explicitly stated as country of origin or retrospective/prospective. These were non-clinical, lab-based engineering tests.

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):

• This is not applicable as the study involved non-clinical engineering tests, not clinical data requiring expert review for ground truth.

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

• This is not applicable as the studies were non-clinical engineering tests.

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:

• No MRMC study was done. The document explicitly states "No clinical studies were performed."

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

• This is not applicable as the device is a metallic bone fixation appliance, not an AI algorithm.

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

• For the non-clinical tests, the "ground truth" would be established by engineering standards and measurements, as defined by ASTM F382 and ASTM F543, and the LAL quantitative kinetic chromogenic method for endotoxin testing. There is no expert consensus, pathology, or outcomes data involved.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical device, not an AI/machine learning model that requires a training set.

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

• This is not applicable for the same reason as point 8.

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