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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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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.

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 manufacturer, 3D Systems, Inc., has introduced the Cadence Ankle PSI System, a device intended for patient-specific surgical planning and instrumentation to assist in total ankle replacement component positioning and bone cutting. This device is designed for use with Smith + Nephew's Cadence Total Ankle System.

The information provided by the FDA 510(k) summary for K241326 primarily focuses on non-clinical performance testing to demonstrate substantial equivalence to the predicate device, not on clinical performance with human readers or standalone AI performance. Therefore, many of the requested details regarding clinical study design (e.g., MRMC studies, human reader improvement, expert consensus for ground truth) are not applicable based on the provided document.

Here's an analysis of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary mentions "all acceptance criteria for all performance tests" were met, but it does not explicitly list the quantitative acceptance criteria. It broadly states the types of tests conducted and their qualitative outcomes.

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

The document indicates "Non-clinical cadaveric comparison testing", which implies a test set was used. However, the exact sample size (number of cadavers or anatomic specimens) is not specified.
The data provenance is cadaveric testing, which is a form of pre-clinical, laboratory-based testing, not human patient data (retrospective or prospective). The country of origin for the data is not specified, though 3D Systems, Inc. is based in the USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the studies described are non-clinical, cadaveric, and mechanical/design verification tests. There is no mention of experts establishing a "ground truth" in the context of diagnostic or clinical interpretation. Performance was assessed mechanically or by comparison to standard instrumentation.

4. Adjudication Method for the Test Set

This is not applicable as the studies are non-clinical and do not involve human diagnostic interpretation requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical and cadaveric testing, not studies involving human readers or clinical cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a "patient specific surgical planning and instrumentation" system. While it likely involves algorithms for design and manufacturing, the studies described are for the physical outputs (surgical guides, anatomical models) and their performance (mechanical integrity, debris, accuracy in cadavers), rather than a standalone AI algorithm's diagnostic performance. Therefore, a standalone AI performance study in the typical sense of evaluating an algorithm’s output without human-in-the-loop was not explicitly described for this submission. The focus is on the device's accuracy in physical guidance.

7. The Type of Ground Truth Used

For the non-clinical tests (mechanical integrity, debris generation, intra-/inter-designer variability), the "ground truth" would be established by engineering specifications, quality control standards, and measurement protocols.
For the cadaveric comparison testing, the "ground truth" for "Implant Alignment Accuracy" and "Guide Usability" would be based on direct measurements against design specifications and comparison to the performance of established standard instrumentation (the reference device, K151459 Cadence Total Ankle Replacement System). This is a technical, rather than a clinical, ground truth.

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" in the context of machine learning or AI algorithm development. The device is a patient-specific instrument system, and its design is CADD-based. If there's an underlying AI component that uses a training set, this information is not provided in the summary.

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

As no training set is described for an AI algorithm, this information is not applicable based on the provided document. If there are proprietary algorithms involved in the patient-specific design, the "training" data (if any) and its ground truth would be part of the manufacturer's internal development process, not typically disclosed in this level of detail in a 510(k) summary focused on the final product's performance.

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