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The canturio® se (Canturio Smart Extension) 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 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 30mm sized tibial stem extension.

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

The canturio® se with CHIRP System is compatible with Zimmer Personalized Knee System.

The canturio® se is a tibial extension implant or stem that is attached by the orthopedic surgeon to the Zimmer Biomet Persona® tibial baseplate to form the patient's tibial knee prosthesis. The software and electronics embedded within the canturio® se prosthesis collect the patient's functional movement and gait parameter data post-surgery. Like a traditional tibial extension, the canturio® se provides additional stability in the same manner as a traditional knee extension.

The canturio® se (Canturio Smart Extension or CSE) is used with the Canary Health Implanted Reporting Processor (CHIRP) System which is comprised of the following subsystems:

• Operating Room Base Station Subsystem ("OR BS"),
• Home Base Station Subsystem (“HBS”),
• Canary Cloud Data Management Platform ("Cloud" or "CMDP") subsystem and
• Canary Medical Gait Parameters (CMGP) software module.
  Each CHIRP subsystem combines physical components, electronics, software, and user interfaces to collect, store, analyze, transmit, and display patient data for use by both physicians and patients.

The provided text describes a 510(k) premarket notification for a medical device called "canturio® se (Canturio Smart Extension)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a study proving the device meets specific acceptance criteria for AI performance.

Therefore, many of the requested details, such as the specific acceptance criteria for AI/algorithm performance, ground truth establishment methods, expert qualifications, and MRMC study results, are not explicitly available in the provided text, as this is a traditional medical device submission, not specifically one for an AI/ML medical device where those details would be paramount.

However, based on the information available, here's what can be extracted and inferred:

Device Purpose and General Performance Testing:

The canturio® se 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. It's crucial to note the statement: "The objective kinematic data generated by the canturio® se with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit." This indicates that the primary function is data collection and not an AI-driven diagnostic or treatment recommendation system that would typically require extensive performance criteria and studies as outlined in your request.

The performance data summarized focuses on non-clinical tests to support modifications to the device itself, ensuring its safety and functionality as an implantable device that collects data. These tests are not "AI performance" related in the sense of accuracy, sensitivity, specificity, etc., for a machine learning model.

Acceptance Criteria and Reported Device Performance (Inferred from device type and summary):

Since the device is stated to provide "objective kinematic data" and is a "product line extension" of a predicate device, the acceptance criteria would likely revolve around the accuracy, reliability, and reproducibility of these kinematic measurements themselves. The "reported device performance" would be the successful demonstration of these factors through non-clinical testing.

Since this is a 510(k) for a hardware device that collects data, and explicitly states the data is not for clinical decision-making or benefit, the traditional AI/ML performance study criteria listed in your request are not applicable or detailed in this document. The focus for this review is substantial equivalence to the predicate device based on material, design, and general device performance.

Therefore, for the remainder of your points, the answer is:

2. Sample sizes used for the test set and the data provenance: Not specified for "kinematic measurements" in terms of subject count, nor is data provenance (country of origin, retrospective/prospective) for such measurement described. The testing described appears to be primarily bench/laboratory non-clinical testing of the device hardware and software.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. The "ground truth" for this device would be objective physical measurements, not expert interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. This device is not an AI interpretation tool for human readers; it's a data collection device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "kinematic measurements" functionality is "standalone" in that it captures data without human input beyond the system setup. However, this isn't an AI algorithm in the sense of a diagnostic or predictive model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For kinematic measurements, the ground truth would typically be established by highly accurate motion capture systems or physical measurement standards, not expert consensus or pathology.
8. The sample size for the training set: Not applicable. This device is not described as having an AI/ML model that requires a "training set" in the conventional sense for a diagnostic or prognostic application. The "software verification" refers to traditional software validation processes.
9. How the ground truth for the training set was established: Not applicable, as there's no described AI/ML training set.

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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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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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