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The Impress SFS System is indicated for general orthopaedic repair procedures. The Impress SFS System is also intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The Impress SFS System is cable system which includes components such as cables and which are manufactured from stainless steel. These components are used together to address the indications as outlined in the next section. The implantable components in the Impress SFS System are provided sterile as indicated on the outer carton label.

This document is a 510(k) premarket notification for the Impress SFS System, a bone fixation cerclage device. It aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish novel performance through a clinical study with acceptance criteria in the typical sense for AI/software devices.

Therefore, many of the requested elements for describing acceptance criteria and a study to prove device performance are not applicable to this type of submission. This device is a physical orthopedic implant, not an AI or software device.

Here's an attempt to answer the questions based on the provided document, noting when a question is not applicable:

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

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

• Not applicable in the context of a clinical study or AI model validation. The document describes mechanical testing and pyrogen testing performed on the device itself.
• The exact sample sizes for these tests (e.g., number of cables tested for strength) are not specified in the provided summary.
• Data provenance (country of origin, retrospective/prospective) is not relevant for this type of mechanical and material testing described.

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. This submission relies on engineering standards and comparisons, not on expert ground truth for interpretation of outputs like an AI device would. The "ground truth" here is established by engineering specifications and comparative test results against predicate devices.

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

• Not applicable. No expert adjudication method is described or relevant for mechanical testing of a physical device.

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 a physical orthopedic implant, not an AI or diagnostic software device, so no MRMC study was performed.

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

• Not applicable. This is a physical orthopedic implant, not an AI algorithm.

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

• Mechanical and material property standards/specifications and performance data from legally marketed predicate devices are the "ground truth" for demonstrating equivalence. The device's performance characteristics (stop strength, washer locking strength, cable strength) were compared directly to those of the predicate devices. Pyrogenicity was confirmed against established endotoxin requirements.

8. The sample size for the training set

• Not applicable. This submission relates to a physical medical device, not an AI model requiring a training set.

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

• Not applicable. No training set exists for this type of device submission.

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