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The Cadence 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 Cadence Ankle PSI System is intended for use with Smith + Nephew's Cadence 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' Cadence Ankle PSI System consists of patient specific outputs including surgical guides, anatomical models, and case reports. The Cadence 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 Cadence Total Ankle System instruments, facilitate the positioning of Cadence Total Ankle Prostheses.

The provided text does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria in a format that would allow for a precise population of the requested table and points. The document is a 510(k) summary for a medical device (Cadence Ankle PSI System), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance study results like those typically found for AI/ML-based diagnostic devices.

However, I can extract the available information regarding non-clinical performance testing:

Non-clinical Performance Testing:

The relevant section states: "Non-clinical performance testing on the Cadence 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 Cadence Total Ankle System."

This indicates that the study focused on Implant Alignment Accuracy and Guide Usability. The acceptance criteria are implied to be "similar to that of the standard instrumentation used for the Cadence Total Ankle System," which served as the reference device.

Based on the provided text, the following information is not available:

• A formal table of acceptance criteria with reported device performance metrics (e.g., specific thresholds for accuracy or usability scores).
• Detailed sample size for the test set (only "cadaveric comparison testing" is mentioned).
• Data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
• If a standalone (algorithm only) performance was measured (this device is a surgical guide system, not an AI diagnostic algorithm in the typical sense).
• The specific type of ground truth used beyond "comparison to the standard instrumentation."
• Sample size for the training set.
• How the ground truth for the training set was established.

In summary, the document states performance testing focused on implant alignment accuracy and guide usability through cadaveric comparison, indicating similarity to standard instrumentation as the performance benchmark. However, granular details about specific acceptance criteria metrics, study design, and ground truth establishment are not provided.

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