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The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized by the physician during the course of patient monitoring and treatment post-surgery.

The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension.

The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit.

The CTE with CHIRP System is compatible with Zimmer Persona® Personalized Knee System.

The Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is comprised of the following subsystems: Canary Tibial Extension (CTE) implant, Operating Room (OR) Base Station System ("BS1"), Home Base Station System ("BS2"), Canary Cloud Data Management Platform ("Cloud") and Canary Medical Gait Parameters (CMGP software module). The CTE and CHIRP System is intended to provide objective kinematic data on patient's total knee arthroplasty (TKA) function. The kinematic data produced by the CTE implant is intended as an adjunct to other physiological measurement tools post TKA surgical care while providing additional tibial stability afforded by traditional tibial extensions of similar length. The implanted CTE collects data from internal motion sensors, and when queried by a BS1 or BS2 over a communication interface, transmits the motion data to the Base Station System. The Base Station System, in turn, uploads the data to the Canary Cloud Data Management Platform. The User is defined as the Patient with the CTE and CHIRP System and their designated Health Care Professional (HCP) with access to the Patient's CTE data.

The CTE is designed for use with the Zimmer Biomet Persona Personalized Knee System tibial baseplate, to provide additional stability and collect kinematic data to assist the physician in monitoring patient activity following total knee arthroplasty (TKA) in between office visits.

The Canary Quantiles Recovery Curves software is an accessory and an optional software module for use with the CTE with CHIRP System. The software obtains kinematic data from the CTE with CHIRP System and provides aggregation and visualization of patient population data to HCPs to analyze patient recovery progress and direction of outcome.

The provided text is a 510(k) summary for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. It states that the device is substantially equivalent to a predicate device and details its description and indications for use. However, it does not contain information regarding specific acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device performance evaluation study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document only mentions "Software Verification & validation" and "System Integration Validation" as non-clinical activities performed to support modifications, indicating the assessment was likely focused on technical performance and safety/effectiveness equivalence, rather than a clinical performance study measuring diagnostic accuracy or similar metrics often associated with AI/ML systems.

This device appears to be an implanted sensor system providing kinematic data, where the "Canary Quantiles Recovery Curves software" is an accessory that aggregates and visualizes patient population data. The focus of the 510(k) is on the sensor system itself and its equivalence to a predicate, not on a specific AI/ML diagnostic or predictive algorithm being evaluated for performance against established ground truth in a clinical context.

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