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The Salto Talaris Ankle PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris Ankle PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging CT scans.

3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.

The provided document describes the FDA clearance (K243173) for the Salto Talaris Ankle PSI System. However, it does not contain a detailed study with acceptance criteria and reported device performance in the format requested.

The document states:

• "Non-clinical performance testing on the Salto Talaris Ankle PSI System included cadaveric comparison testing in order to compare Implant Alignment Accuracy and Guide Usability between the subject device and reference device."
• "Accuracy and functionality were shown to be similar to that of the standard instrumentation used for the Salto Talaris Total Ankle System."

This indicates that a comparison study was performed, but the specific acceptance criteria, reported performance values, sample size, ground truth establishment, or expert details are not provided in this 510(k) summary. The summary concludes that the device is substantially equivalent and "performs as well as the predicate device" based on this testing, but the numerical data from the study is not included.

Therefore, I cannot populate the table or answer the specific questions about the study design with the information available in the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than a detailed presentation of performance study results against predefined acceptance criteria.

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The Salto Talaris PSI System is intended to be used as patient specific surgical planning and instrumentation to assist in the positioning of total ankle replacement components intraoperatively, and in guiding bone cutting. The Salto Talaris PSI System is intended for use with Smith + Nephew's Salto Talaris Total Ankle System and its cleared indications for use.

3D Systems' Salto Talaris Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Salto Talaris Ankle PSI System guides are made from biocompatible nylon and surgical grade stainless steel and are designed to fit the contours of the patient's distal tibial and proximal talar anatomy. The surgical guides in combination with the Smith+Nephew Salto Talaris Total Ankle System instruments, facilitate the positioning of Salto Talaris Total Ankle Prostheses.

The provided text is a 510(k) summary for the Salto Talaris Ankle PSI System. It describes the device, its intended use, and a summary of non-clinical testing. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria, expert qualifications, adjudication methods, details of ground truth establishment, or specific sample sizes for training and testing sets in the context of an AI-based system.

The Salto Talaris Ankle PSI System is described as patient-specific surgical planning and instrumentation to assist in positioning total ankle replacement components and guiding bone cutting. This device primarily involves physical surgical guides and anatomical models derived from CT data, rather than a standalone AI algorithm for diagnosis or image analysis. Therefore, some of the requested information, such as an MRMC comparative effectiveness study with AI assistance or standalone algorithm performance, is not directly applicable to this type of device as typically described for AI/ML-based diagnostic software.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document states that the Salto Talaris Ankle PSI System met all acceptance criteria for mechanical integrity, debris generation, and inter-designer variability analysis. For implant alignment accuracy and guide usability, cadaveric comparison testing showed similarity to standard instrumentation. The specific quantitative acceptance criteria values (e.g., specific thresholds for mechanical integrity or debris generation, or a numerical range for alignment accuracy) are not provided in this summary.

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

The document mentions "Non-clinical cadaveric comparison testing." However, it does not specify the sample size (number of cadavers or cases) used for this test set, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide this information. Since the device involves surgical guides and bone cutting, "ground truth" in this context would likely relate to anatomical measurements or surgical outcomes, potentially assessed by orthopedic surgeons. However, no details on experts or their qualifications are given.

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

The document does not specify any adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study of the type typically performed for AI/ML diagnostic software (where human readers evaluate cases with and without AI assistance) was not mentioned and is unlikely to be applicable based on the device description. This device provides physical guides for surgery, not AI-based image analysis for diagnosis. The non-clinical cadaveric testing compared the device to standard instrumentation, not to human readers using or not using AI.

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

The device is described as "patient specific surgical planning and instrumentation to assist in the positioning... and in guiding bone cutting." This inherently implies a "human-in-the-loop" scenario (a surgeon using the guides). The "non-clinical cadaveric comparison testing" assessed the performance of the device in use, which is a form of standalone performance for the instrumentation itself but not in the context of an AI algorithm without human interaction for diagnosis or interpretation. The document does not describe a standalone algorithm performance test in the way it would be applied to AI/ML diagnostic software.

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

For the cadaveric comparison testing, the "ground truth" implicitly relates to implant alignment accuracy and guide usability, compared against the results achieved using standard (non-PSI) instrumentation. The summary doesn't explicitly state how this ground truth was definitively established (e.g., by highly accurate post-operative CT measurements validated by multiple experts), but it refers to comparison rather than an absolute ground truth method.

8. The sample size for the training set

The document describes the device as being "designed with CT-based methods to produce patient-specific instrumentation." This suggests a design process based on anatomical data, but there is no mention of a "training set" in the context of an AI/ML algorithm. The device is a custom-manufactured surgical guide, not a learned AI model.

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

Since there's no mention of a "training set" for an AI/ML algorithm, this question is not applicable in the context of the provided document. The "design" information would likely come from anatomical studies, engineering specifications, and clinical experience with total ankle arthroplasty, rather than a formal "ground truth" establishment for an AI training set.

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The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:

• Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
• Primary arthritis (e.g. degenerative disease)
• Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
  Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
  Provided sufficient bone stock is present.
  Note - In the United States, this device is intended for cemented use only.
  Note - Outside the United States, this device is intended for cemented or cementless use.

The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talar dome and an insert. The tibial tray and talar dome are secured to patient anatomy. The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint. Each of the three components is available in a variety of sizes and design configurations intended for both primary and revision surgery applications. The Cadence System also consists of various instrumentation to allow for appropriate implantation of the Cadence Prosthesis.
The scope of the Cadence System is being extended to include additional options for the talar domes. The new talar dome option features a flat cut design in comparison to the currently commercialized talar dome chamfer cut design. New instrumentation will also be introduced to aid in the implantation of the new flat cut talar dome design.

The provided document is a 510(k) premarket notification for a medical device called the "Cadence Total Ankle System". This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate.

Crucially, this document describes a comparative study for substantial equivalence, not a study proving an AI/software device meets specific performance acceptance criteria for a novel functionality. Therefore, the information requested in the prompt, such as acceptance criteria for reported device performance (e.g., accuracy, sensitivity, specificity for an algorithm), sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details, are not applicable to this type of medical device submission.

The document states:

• "Clinical performance data is not required to demonstrate substantial equivalence to the predicate device." (Page 5)
• The substantial equivalence conclusion is based on:
  • The modified and predicate device having exactly the same intended use.
  • Both devices operating using the same fundamental scientific technology.
  • Both devices sharing the same functional and technological characteristics via the same operational principles.
  • No new issues or concerns related to safety or effectiveness raised by the modified device.

Instead of clinical performance data, the submission relies on nonclinical performance data to show that the modified device (Cadence Total Ankle System) is substantially equivalent to the unmodified device (Integra Total Ankle Replacement System, K151459).

Here's an analysis of the provided information, addressing the prompt's points where applicable, and clarifying why others are not relevant given the document's nature:

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

Explanation: The "acceptance criteria" here are not performance metrics like accuracy or sensitivity for an algorithm, but rather engineering and biomechanical equivalence to the predicate device. The document states these tests were performed and imply they met the necessary thresholds to demonstrate substantial equivalence. Specific quantitative results are not provided in this summary.

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. This document describes non-clinical (mechanical/materials) testing for a physical implant, not a study involving patient data or test sets in the context of an algorithm. The "data" refers to engineering test results, not clinical patient data. Therefore, concepts like country of origin for patient data or retrospective/prospective studies are not relevant.

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 human experts (like radiologists) were involved in establishing "ground truth" for the non-clinical tests described. The "ground truth" for these tests would be established by engineering standards and measurement techniques.

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

• Not Applicable. As no expert review or human interpretation of a "test set" (like medical images) was performed, no adjudication method was needed.

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 not an AI/software device, so MRMC studies and human reader improvement with AI assistance are irrelevant.

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

• Not Applicable. This is not an algorithm, so standalone performance is not relevant.

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

• The "ground truth" for this device's testing is based on engineering and biomechanical standards and measurements. For example, force applied, displacement, material properties, and wear rates would be measured against established benchmarks and the performance of the predicate device.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set."

Summary of the Study Proving the Device Meets Substantial Equivalence Criteria:

The "study" in this context is a series of nonclinical verification tests and analyses designed to demonstrate that the modified Cadence Total Ankle System is as safe and effective as its predicate device (Integra Total Ankle Replacement System, K151459). These tests focus on the physical and mechanical properties of the implant.

• Nonclinical Performance Data: The device was subjected to testing and/or analyses related to:

  1. Constraint
  2. Bone Stability
  3. Range of Motion
  4. Fatigue Strength
  5. Contact Area and Pressure Distribution
  6. Wear

• Conclusion: The submission concludes that "substantial equivalence of the modified device and predicate device is based on" the factors listed above, and that "After evaluation of the risks and performance data, the modified device does not raise any new issues or concerns related to safety or effectiveness." This implies that the device met the implicit acceptance criteria for these nonclinical tests by performing comparably to the predicate or within acceptable engineering limits.

In essence, this document is a regulatory submission for a physical medical device, not an AI/software device, and thus the prompt's questions related to AI/software performance validation are not answered because they are not relevant to this type of submission.

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