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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) postsurgical 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 decisionmaking and have not been shown to provide any clinical benefit.

The CTE with CHIRP System is compatible with Zimmer 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 provided text is a Traditional 510(k) Summary for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. This document focuses on demonstrating substantial equivalence to a predicate device and primarily describes the device's technological characteristics, indications for use, and summaries of performance data related to modifications.

The text does not include the type of detailed information requested in the prompt, such as:

• Specific acceptance criteria and reported device performance for kinematic data accuracy. The document states the device provides objective kinematic data but does not establish or report performance metrics for this data (e.g., accuracy, precision of angle measurement). The Indications for Use section explicitly states: "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." This suggests that the kinematic data itself is not the primary subject of a performance claim requiring detailed acceptance criteria in this submission.
• Sample sizes for test or training sets, data provenance, expert adjudication details. The submission describes non-clinical tests (Shock Survival, Electrical Life, Battery Longevity, Electronic Functionality, Software Verification) to support modifications to the subject device (addition of a low-power accelerometer), but it does not detail studies investigating the performance of the kinematic data collection itself in a clinical context.
• MRMC comparative effectiveness study results or standalone algorithm performance. Since the kinematic data is stated as "not intended to support clinical decision-making and have not been shown to provide any clinical benefit," a comparative effectiveness study with human readers or standalone performance metrics for an AI algorithm (beyond software verification) would not be expected or included.
• Type of ground truth and how it was established for kinematic data.

Based on the provided document, the only "acceptance criteria" and "reported performance" that can be inferred relates to the modifications made to the device, not the accuracy of the kinematic data itself. The performance data section lists generic non-clinical tests.

Therefore, I cannot populate the table or answer the specific questions as requested regarding acceptance criteria and a study proving the device meets those criteria for its primary function (kinematic data provision). The document focuses on demonstrating that the modified device remains as safe and effective as the predicate device, not on proving new performance claims.

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