(128 days)
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.
§ 888.3600 Implantable post-surgical kinematic measurement knee device.
(a)
Identification. An implantable post-surgical kinematic measurement knee device is a device that provides objective kinematic data after total knee arthroplasty surgery. The kinematic data provided by the device are used as an adjunct to other physiological parameter measurement tools utilized during the course of patient monitoring and treatment post surgery.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following tests must be conducted:
(i) Mechanical testing must evaluate the mechanical function (mechanical fatigue, static mechanical strength) and durability of the implant.
(ii) Simulated use testing must evaluate the ability of the device to be sized, inserted, and sufficiently secured to any compatible components.
(iii) Testing must demonstrate the accuracy, reliability, and reproducibility of kinematic measurements.
(iv) Testing must demonstrate diagnostic and therapeutic ultrasound conditions for safe use.
(v) Testing must demonstrate that the device performs as intended under anticipated conditions of use demonstrating the following performance characteristics, if applicable:
(A) Magnetic pulse output testing;
(B) Magnetic and electrical field testing; and
(C) Testing of the safety features built into the device.
(vi) Testing must demonstrate hermeticity of any electronic component enclosures.
(2) Performance testing must evaluate the compatibility of the device in a magnetic resonance (MR) environment.
(3) Human factors testing must demonstrate that the intended user(s) can correctly use the device for its intended use, including for implantation and post-procedure data access.
(4) Performance data must demonstrate the sterility of the device implant and patient-contacting components.
(5) Performance data must validate the reprocessing instructions for the reusable components of the device.
(6) The patient-contacting components of the device must be demonstrated to be biocompatible.
(7) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(8) Performance testing must demonstrate the electromagnetic compatibility/interference, (EMC/EMI), electrical safety, thermal safety, battery safety, and wireless performance of the device.
(9) Software verification, validation, and hazard analysis must be performed.
(10) The labeling must include the following:
(i) A shelf life;
(ii) Physician and patient instructions for use, including images that demonstrate how to interact with the device;
(iii) Detailed instruction of the surgical technique;
(iv) Hardware and software requirements for interacting with the device;
(v) A clear description of the technological features of the device including identification of the device materials, compatible components, and the principles of operation;
(vi) Identification of magnetic resonance (MR) compatibility status;
(vii) Validated methods and instructions for reprocessing of any reusable components; and
(viii) A statement regarding the limitations of the clinical significance of the kinematic data.