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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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