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Salto Talaris Total Ankle Prosthesis:
The Salto Talaris Total Ankle Prosthesis is indicated as a total ankle replacement in primary or revision surgery for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
Components are intended for cemented use only.

RHS:
The RHS is intended for:
l) Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with:
Joint destruction and/or subluxation visible on x-ray a.
b. Resistance to conservative treatment
2) Primary replacement after fracture of the radial head
3) Symptomatic sequelae after radial head resection
4) Revision following failed radial head arthroplasty
The long stem is for single cemented use only. The short stem coated with titanium plasma-spray is for single use with or without cement.

For the Salto Talaris Total Ankle Prosthesis:
The goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankle Prosthesis is intended to accomplish these goals. 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.

For the RHS:
The RHS has been designed in order to provide surgeons and patients with a joint prosthesis to restore function and relieve pain of the radial part of the elbow joint. The RHS has an anatomical design, which reproduces the kinematics of the radial joint. The RHS consists of two components: a metal radial stem and a metal-polyethylene radial head.

The present submission corresponds to the following modification:

• Addition of a new coating subcontractor (titanium coating): Eurocoating S.p.A on cobalt chromium components.
  All the prostheses of this application are strictly identical to the previously cleared devices except for the coating supplier. The indications for use of each device are not modified.

Here's an analysis of the provided text regarding the Salto Talaris Total Ankle Prosthesis and RHS, focusing on acceptance criteria and supporting studies.

Important Note: The provided text is a 510(k) summary for a modification to an existing device (specifically, a change in coating subcontractor). Therefore, the "study" described is not a clinical trial demonstrating efficacy of the entire device, but rather a non-clinical assessment to prove that the modification does not alter safety or effectiveness compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of specific "samples" in a traditional sense. The testing was conducted on samples of the coating material and/or coated components. The extent of testing is implied by the mention of "characterization" and various mechanical tests.
• Data Provenance: The data is based on non-clinical testing of the coating and coated components. The specific origin country for the testing laboratory is not mentioned, but the submitting company (Tornier SAS) is based in France. The data is prospective in the sense that the tests were performed to evaluate the new subcontractor's coating.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable in the context of this non-clinical submission. "Ground truth" for this submission would be defined by established engineering and materials standards (e.g., ISO, ASTM).
• Qualifications of Experts: Not applicable. The "experts" involved would be materials scientists and engineers performing the tests and comparing the results to established standards and the predicate device's performance.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This was a non-clinical comparative analysis against a predicate's performance and established standards, rather than expert adjudication of clinical outcomes or images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Was it done?: No. This submission describes a non-clinical evaluation of a manufacturing change (coating subcontractor) for existing orthopedic implants. It is not a clinical study involving human readers or cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Was it done?: No. This is not an AI or algorithm-based device. It's a physical orthopedic implant.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for this submission is based on established engineering and materials standards (ISO standard 5834-2, ISO standard 5832-7 or ISO 5832-12, ASTM standard F1580), and the performance characteristics of the predicate device's coating (BioCoat Company). The goal was to prove the new coating was "substantially equivalent" and introduced no new risks.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The "training" for such a device would be the extensive research, development, and testing that led to the original design and material choices, which is outside the scope of this specific 510(k) modification.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Established: Not applicable, as this is not an AI/ML device.

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The Salto Talaris Total Ankle Prosthesis 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 goal of total ankle replacement is to restore function and relieve pain. The Salto Talaris Total Ankle Prosthesis is intended to accomplish these goals. 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.

This document is a 510(k) premarket notification for the Salto Talaris Total Ankle Prosthesis, not a study report. Therefore, it does not contain the detailed information required to describe acceptance criteria and a study proving the device meets them in the format requested.

Specifically, the document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study with performance metrics, sample sizes, expert involvement, or statistical analysis.

However, based on the provided text, here's what can be inferred or stated about the device's intended use and regulatory status:

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

This document does not provide a table of acceptance criteria or reported device performance in terms of clinical outcomes or specific metrics (e.g., success rates, pain reduction scores, range of motion improvements). The regulatory approval process for this type of device (510(k)) is based on demonstrating substantial equivalence to existing, legally marketed predicate devices, not on meeting predefined clinical performance acceptance criteria from a new clinical study.

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

• Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a test set of patients.
• Data Provenance: Not applicable. The document references predicate devices (K060544, K920802, K020541, K051023) as a basis for substantial equivalence, but it doesn't provide new clinical data from a prospective or retrospective study for the Salto Talaris Total Ankle Prosthesis to evaluate its performance against specific criteria.

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

Not applicable. No new clinical test set is described, and therefore no ground truth established by experts for such a set.

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

Not applicable. No new clinical test set is described.

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 medical device (prosthesis), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (prosthesis), not an algorithm.

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

Not applicable in the context of a new clinical study for this 510(k). The "ground truth" for the device's approvability is its substantial equivalence to predicate devices, which implies that the predicate devices have established safety and effectiveness.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is discussed.

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

Not applicable. No training set for an algorithm is discussed.

Summary based on the provided text:

The document is a regulatory submission demonstrating the substantial equivalence of the Salto Talaris Total Ankle Prosthesis to previously marketed devices. The "acceptance criteria" in this context are primarily regulatory – demonstrating that the device has similar technological characteristics and indications for use as existing predicate devices and does not raise new questions of safety or effectiveness. The "study" that "proves" this is the comparative analysis against the predicate devices presented in the 510(k) submission (though the details of this comparison are not elaborated in the provided excerpts beyond listing the predicates).

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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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Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis in elderly individuals with reduced activity levels.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

The Agility™ LP Total Ankle Prosthesis proposed in this submission are a line extension to the Agility™ Total Ankle system components (cleared as DePuy Alvine Total Ankle Prosthesis under K920802, December 17, 1992). The Agility LP Ankle is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a talar component.

The provided text is a 510(k) summary for the Agility™ LP Total Ankle Prosthesis. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria for device performance, nor details of a study demonstrating such performance.

The 510(k) process for this type of medical device (an ankle prosthesis) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria in the same way a diagnostic AI device or novel therapeutic might.

Therefore, I cannot fulfill your request for details on acceptance criteria and a study proving the device meets them because this information is not present in the provided text.

Specifically, the document states:

• "The substantial equivalence of the Agility LP Ankle Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle)."

This statement indicates that the regulatory clearance was based on similarity to a previously approved device, not on specific performance metrics established through a new study with acceptance criteria.

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