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The Salto Talaris Anatomic Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. All components are intended for cemented use only.

The Salto Talaris Total Ankle Prosthesis is a semi-constrained anatomical design, which reproduces the kinematics of the ankle joint. The Tornier Salto Talaris Total Ankle Prosthesis consists of two mating components; a metal tibial base in association with a conforming polyethylene articulating insert, and a metal talar resurfacing component.

The provided document is a 510(k) premarket notification for the Salto Talaris Total Ankle Prosthesis. It describes the device, its indications for use, materials, and establishes its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria using a test set, ground truth, or expert evaluations.

The sections below are therefore not applicable as the information is not present in the provided text.

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

No acceptance criteria or reported device performance metrics are provided in the document.

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

Not applicable. No test set or associated data provenance is mentioned.

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. No experts or ground truth establishment for a test set are mentioned.

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

Not applicable. No adjudication method for a test set is mentioned.

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 document pertains to a medical device (prosthesis), not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

Not applicable. This document pertains to a medical device (prosthesis), not an algorithm.

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

Not applicable. No ground truth is discussed in the context of device performance evaluation.

8. The sample size for the training set

Not applicable. No training set is mentioned as this document does not describe the development or evaluation of an algorithm or AI.

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

Not applicable. No training set or ground truth establishment for it is mentioned.

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