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Intended Use: The Incompass Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Indications for Use: The Incompass Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The Incompass Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

Incompass™ Total Ankle System is a total ankle replacement system consisting of implants and instruments.

Incompass™ Total Ankle System will harmonize the Infinity™ and Inbone™ Total Ankle Systems into one comprehensive system consisting of modular stemmed and low-profile pegged tibial trays, tibial inserts, and talar domes. The harmonized system is facilitated by sharing the same tibial resection geometry between the pegged and the stemmed tibial tray designs.

The provided text is a 510(k) clearance letter for the Incompass Total Ankle System. It outlines the device's indications for use, its classification, and declares its substantial equivalence to predicate devices based on non-clinical evidence.

However, the clearance letter explicitly states: "Clinical testing was not necessary for the determination of substantial equivalence."

This means that the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typical for studies proving a device meets acceptance criteria, especially for AI/ML-based devices or those requiring clinical trials) is not included in this document. The clearance was based on non-clinical performance bench testing to demonstrate substantial equivalence in wear, articular stability, lock detail, manufacturing processes, static strength, fatigue strength, fretting, corrosion, and MRI safety, rather than clinical efficacy studies.

Therefore, I cannot provide the requested information from this document. If this were a submission for a device that required clinical performance data to demonstrate safety and effectiveness (e.g., an AI/ML device), this section would typically contain summaries of those studies.

Based on the provided document, here's what can be inferred or explicitly stated regarding the acceptance criteria and study proving adherence to them:

The device in question is a Total Ankle System, a type of orthopedic implant, not an AI/ML-based device or one that underwent a clinical efficacy study for its 510(k) clearance.

The "study" that proves the device meets acceptance criteria, in this context, refers to non-clinical performance bench testing.

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

Since no clinical efficacy study was conducted for this 510(k) clearance, there's no data to populate such a table detailing clinical performance metrics (like sensitivity, specificity, or human reader improvement).

The acceptance criteria for this device were related to substantial equivalence through bench testing. The document states:

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

• Sample Size: Not specified in the document, as it refers to engineering and materials testing (bench testing) rather than a dataset of patient cases. For bench testing, "samples" would refer to the number of devices or components tested.
• Data Provenance: Not applicable in the context of clinical patient data (e.g., country of origin, retrospective/prospective), as the evidence was non-clinical bench testing. The testing would have been conducted in a laboratory setting.

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

• Not applicable. Ground truth as typically defined for AI/ML or clinical studies (e.g., expert consensus on medical images) was not established. The "ground truth" for bench testing is determined by engineering standards, material science principles, and established testing methodologies.

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

• Not applicable. This is relevant for studies involving human reviewers or AI output, not for materials and mechanical bench testing.

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. This type of study is specifically for AI/ML-assisted diagnostic devices. The Incompass Total Ankle System is a physical medical implant.

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

• No. This is relevant for AI/ML algorithms.

7. The type of ground truth used:

• The "ground truth" for this clearance was established through engineering standards, material specifications, and validated bench testing protocols comparing the device's physical and mechanical properties against those of legally marketed predicate devices. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This device is not an AI/ML algorithm.

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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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Intended Use: The INFINITY™ Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Indications For Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.

The INFINITY ™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The ankle prosthesis is intended for cement use only.

The INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.

The provided text is a 510(k) summary for the INFINITY™ Total Ankle System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the medical device is at least as safe and effective as a legally marketed device (predicate device).

However, the information provided does not contain details about acceptance criteria, a study proving device performance against those criteria, or any of the specific reader study methodologies requested.

The document primarily focuses on:

• Device Description: What the INFINITY™ Total Ankle System is made of and how it functions.
• Intended Use and Indications for Use: For whom and under what conditions the device is designed to be used.
• Technological Characteristics Comparison: A high-level statement that its features are similar to predicate devices.
• Non-Clinical Evidence: A list of types of non-clinical analyses performed (Bone interface stability, Component stability, Fatigue testing, Contact area/stress testing) and a conclusion that these results show the device performs "at least as well as" predicate devices. No specific performance metrics, acceptance criteria, or detailed study results are given.
• Clinical Evidence: Explicitly states "N/A", meaning no clinical evidence was presented for this 510(k) submission.
• Substantial Equivalence Conclusion: A general statement of safety and effectiveness based on non-clinical evidence and comparison to predicate devices.

Therefore, I cannot populate the requested table and answer the specific questions because the necessary data is not present in the provided text. The document aims to demonstrate substantial equivalence to existing devices through non-clinical testing and design comparison, rather than presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/software device.

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Wright's PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total ankle replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for use with Wright's INBONE® Total Ankle Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are intended for single use only.

PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides are patient-specific guides created to fit the contours of the patient's distal tibial and proximal talar anatomy. The guides are designed and manufactured from patient imaging data (CT), and are made from biocompatible nylon. The PROPHECY® Guides serve as an alternative to traditional alignment instrumentation used with Wright's INBONE® Total Ankle System, and thereby reduce the overall number of surgical steps required during total ankle arthroplasty. The guides serve to position and align the INBONE® implants in a comparable position to that attainable with traditional INBONE® instrumentation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the PROPHECY® INBONE® Pre-Operative Navigation Alignment Guides:

The provided document does not contain specific numerical acceptance criteria for the device's performance. Instead, it describes general performance tests and states that the data supports the safety and efficacy of the device as substantially equivalent to a predicate device. Therefore, the "Reported Device Performance" column in the table below will reflect the type of validation performed rather than a specific numerical value against a pre-defined threshold.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

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

The document does not specify the sample size for the "cadaver testing" or the "repeatability testing." It also does not define the data provenance (e.g., country of origin, retrospective/prospective). Given that the device is manufactured in the US, it's highly probable the testing was conducted within the US, but this is not explicitly stated.

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

The document refers to "end users" for cadaver testing. However, it does not specify the number of these "end users" or their explicit qualifications (e.g., "radiologist with 10 years of experience"). It can be inferred that "end users" would be surgeons or individuals with relevant surgical experience, but this is not detailed.

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

The document does not describe any specific adjudication method used for the performance testing.

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 is mentioned. The device is a patient-specific surgical guide, not an AI or imaging diagnostic tool that would typically involve "human readers" in the sense of image interpretation. Its function is to assist in the physical positioning and alignment of implants.

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

The device itself (the physical guide) is designed from "patient imaging data (CT)" using a "device design algorithm." The "detailed software descriptions and documentation" and "device design algorithm" mentioned point to standalone performance of the algorithm in generating the guide design. The "repeatability testing across design engineers" likely validates the consistent output of this algorithm regardless of the engineer. However, the ultimate "performance" of the guide is human-in-the-loop (surgical use).

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

For the "cadaver testing," the ground truth was "placement location and orientation" as determined by "end users." This implies an expert-based or intra-operative assessment of the guide's accuracy in achieving desired implant positioning. It's an direct measurement of physical alignment outcomes.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of device design beyond the use of "patient imaging data (CT)" to create individual guides. There is no information regarding a distinct training set size for the software/algorithm that generates the guides.

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

As no explicit "training set" with established ground truth is described (beyond the patient's own CT data serving as the basis for design), this information is not available in the provided text. The "ground truth" for each patient's guide design essentially derived from their specific anatomical landmarks identifiable on their CT scans.

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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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