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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 postsurgery.

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 Svstem.

The Canary Tibial Extension is a physical implant component that is attached to the Zimmer Biomet Persona® tibial baseplate (K113369) to form the patient's tibial knee prosthesis. Like a traditional tibial extension, the CTE provides additional stability to the replacement knee joint. In addition, the software and electronics embedded within the CTE collect the patient's functional movement and gait parameter information post-surgery. The CTE is provided sterile via Ethylene Oxide (EtO).

The CHIRP system collects unprocessed 3D accelerometer and 3D gyroscopic sensor data over the course of a day.

The electronic and other unique elements incorporated within the CTE implant include an antenna, X-ray ID, printed circuit assembly, three-axis gyroscope, three-axis accelerometer, and a Lithium Carbon Mono-Fluoride (CFx) battery.

The CTE with CHIRP system is composed of external base station units with embedded firmware that facilitate communication with the CTE implant. The main function of the base station units is to act as a conduit to receive and transmit encrypted raw kinematic data from the CTE to the Cloud Based software system.

The Operating Room (OR) Base Station (BS1) subsystem consists of a laptop computer with the customized OR Application (OR App) software to initialize the CTE implant and record implant and procedural information, an OR base station unit, a bar code reader to incorporate TKA component and CTE serial number information, and USB cables to attach the OR base station unit and bar code reader to the computer.

The Home Base Station (BS2) subsystem is located in the patient's home, is set up by the patient prior to the date of surgery, and is used to transmit patient's gait and activity information collected by the CTE. BS2 consists of a Home Base Station unit, a USB power and data cable, and a power adapter. These items are used in concert with a USB-enabled personal computer and the patient's home wireless Internet connection.

The Cloud subsystem is intended to receive and store all healthcare professional (HCP) and patient data for pre-operative, day of operation, and post-operation activities, including unprocessed, patient kinematic data from the CTE implant. The post-operation processed, patient Canary Medical Gait Parameter (CMGP) data will be used by HCPs to monitor the patient's post-TKA procedure function as an adjunct to other physiological parameter measurement tools. The Cloud is accessible through a browser-based web application.

Manual Instruments and Accessories: Impaction Sleeve, Canary Tibia Cut Guide (5 DEGREE - L/R), Canary Drill Bit, CTE Provisional, CTE Template.

The provided text is a De Novo classification request for the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System. It details the device, its intended use, background, and various non-clinical/bench studies conducted to demonstrate its safety and performance.

However, the document does not contain information about acceptance criteria and a study that specifically proves the device meets those acceptance criteria in the context of an AI/ML algorithm's performance on a test set, expert ground truth establishment, or human reader improvement with AI assistance (MRMC study).

The "PERFORMANCE TESTING - BENCH" section describes various engineering and design validation tests (e.g., mechanical, electrical, IMU performance, cadaver studies, gait parameter validation), but these are primarily focused on the device's physical and functional integrity, data accuracy against a "gold standard" motion capture system, and surgical usability, rather than the performance of an AI/ML component on a distinct test set with expert-adjudicated ground truth.

Specifically, the "Gait Parameters Design Validation" section describes a study comparing the device's kinematic measurements (walking speed, cadence, stride length, Knee ROM, Tibia ROM) to a "gold standard" kinematic gait measurement system. This is the closest to a performance study mentioned, but it's measuring the accuracy of sensor data processing, not an AI/ML diagnostic or classification output.

Therefore, for the requested information regarding AI/ML acceptance criteria and a study proving it meets them, this document does not provide the necessary details. There is no mention of:

• A table of AI/ML acceptance criteria and reported device performance against those criteria.
• Sample sizes for an AI/ML test set (only for the gait validation study and bench tests).
• Data provenance for an AI/ML test set.
• Number/qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI algorithm performance.
• Type of ground truth for an AI/ML model (beyond the "gold standard" motion capture for kinematic data validation).
• Training set size or ground truth establishment for an AI/ML model.

The document focuses on the hardware, embedded firmware, and system-level functional performance. The "Canary Medical Gait Parameters (CMGP)" application is mentioned as calculating kinematic gait parameters from raw sensor data, but its design validation is based on comparing its output to a motion capture system, not an AI/ML classification task with an independent test set and expert ground truth in the way typically seen for diagnostic AI.

Conclusion: The provided text does not contain the information required to answer the prompt regarding AI/ML acceptance criteria and a study proving the device meets them. The device described appears to be a sensor-based measurement system where the "performance" relates to the accuracy and reliability of its kinematic data collection and processing, not an AI/ML diagnostic or classification system as implied by the prompt's detailed questions on expert adjudication, MRMC studies, and training/test sets for an AI model.

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Indications for Persona Partial Knee System:

The Persona Partial Knee system is limited to the medial tibiofemoral compartment of the knee intended for patients with painful and/or disabling knee joints due to the following indications:

• Noninflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, avascular necrosis;

• traumatic arthritis;

• previous tibial condyle or plateau fractures with loss of anatomy or function;

• varus deformities; and

• revision of the articular surface of a previously implanted Persona Partial Knee Systemknee surgeries providing that the tibial plate locking mechanism is not compromised and tibial plate components remain well fixed and undamaged.

The Persona Partial Knee System is a single use implantation with bone cement.

Indications for combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ):

• Osteoarthritis, traumatic arthritis, and/or severe chondrocalcinosis of the patellofemoral joint.

• The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation).

• History of patellar dislocation or patella fracture.

• Dysplasia-induced degeneration.

These indications will be used for the combined medial unicompartmental and patello-femoral implant device, whereby a single condyle and patello-femoral regions have been affected by one or more of these conditions.

Combined Persona Partial Knee System and Zimmer Gender Solutions Patello-Femoral Joint (PFJ) implants are intended for implantation with bone cement.

The Persona Partial Knee (PPK) System is a partial knee replacement for the medial compartment of the knee and is modular in design consisting of three components: a unicondylar cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, a unicondylar titanium (Ti-6Al-4V) alloy tibial tray, and a unicondylar articular surface manufactured using the previously cleared Vivacit-E ® Vitamin-E Highly Crosslinked Polyethylene (VEHXPE).

The Persona Partial Knee System is compatible with the following devices:

• Zimmer Patellofemoral Joint Prosthesis (K070695)

The provided text is a 510(k) Summary for the Persona Partial Knee System, a medical device. This document focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than establishing acceptance criteria and proving performance through a standalone study in the way a de novo or PMA submission might.

Therefore, the typical acceptance criteria and study design for validating an AI/ML device's performance are not applicable here. The device is a physical knee implant, not a software algorithm, and the submission does not describe a clinical study in the traditional sense, but rather non-clinical mechanical testing and engineering analyses.

Here's an breakdown based on the information provided, highlighting why many requested points are not present in this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in a table format and does not represent clinical "performance" in the sense of accuracy, sensitivity, or specificity as would be expected for an AI/ML device. Instead, it lists mechanical tests and analyses performed to demonstrate the physical device's safety and effectiveness compared to predicates.

Acceptance Criteria: The document states that "Results from mechanical tests and engineering analyses demonstrate the proposed PPK components are substantially equivalent to the predicate devices." While specific numerical acceptance criteria (e.g., maximum deflection, minimum fatigue cycles) are implied by performing these tests to a standard or internal method and achieving "substantial equivalence," they are not explicitly listed in this summary. The general acceptance is that the device performs comparably or better than the predicate devices under these conditions.

Regarding other requested information points:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This submission focuses on non-clinical mechanical testing and engineering analyses, not human clinical data or AI/ML model performance on a test set. There isn't a "test set" of patient data in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This submission relies on engineering and material science principles, not expert consensus on medical images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No adjudication process is described as there is no clinical test set involved.

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

• Not applicable. This is a physical implant, not an AI/ML diagnostic or assistive device. No MRMC study was performed. The document explicitly states: "No animal or clinical testing was required to support substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Implied: For the mechanical tests, the "ground truth" would be established engineering standards (like ASTM F2083, ASTM F1223) or validated internal test methods, and the performance of the predicate devices. The aim is to show the new device meets these engineering benchmarks or performs comparably to the predicates.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set" for this device.

Conclusion from document:

The Persona Partial Knee System gained 510(k) clearance (K161592) based on demonstrating substantial equivalence to existing legally marketed predicate devices. This was achieved through:

• Similar intended use (limited to medial tibiofemoral compartment, cemented use).
• Use of similar materials (Co-Cr-Mo alloy for femoral, Ti-6Al-4V alloy for tibial, Vivacit-E Vitamin E Highly Crosslinked Polyethylene for articular surfaces), which are already used in predicate/reference devices.
• Similar design features.
• Similar sterilization methods.
• Non-clinical mechanical tests and engineering analyses that showed the device performed comparably or acceptably against established engineering standards and predicate device performance. The specific quantitative acceptance criteria for each test are not detailed in this summary document but would have been part of the full 510(k) submission.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Porous coated components may be used cemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Persona Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. With this submission, femoral components made from Titanium alloy (ASTM F136-13) with a Titanium Nitride surface treatment are being added to the system (5050, 5056, 5070, 5076 femoral component families). These femoral components articulate against tibial and patellar articular surfaces to form a total knee system. They are available in Cruciate Retaining (CR) and Posterior Stabilized (PS) designs. Both designs are available in multiple sizing options to accommodate a wide range of anatomies. "Narrow" femoral components have a smaller M/L dimension than the "Standard" femoral components. The PS and CR femoral components, when used with a PS or CR articular surface component, can accommodate a maximum active flexion of 155°. The CR femoral component, when used with an Ultra-Congruent (UC) articular surface, can accommodate a maximum active flexion of 145°. The PS femoral component, when used with a Constrained Posterior Stabilized (CPS) articular surface, can accommodate a maximum active flexion of 135°. These femoral components are provided sterile and single use to the healthcare facility/hospital.

The provided document is a 510(k) summary for the Zimmer® Persona® Personalized Knee System. It is a medical device submission to the FDA, and as such, it does not describe a study involving an AI algorithm or software. Instead, it describes non-clinical performance testing for a physical orthopedic implant.

Therefore, many of the requested fields related to AI algorithm performance evaluation (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information regarding the acceptance criteria and study results for the physical device's performance, as outlined in the "Non-Clinical Performance and Conclusions" section.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the AI-specific questions, I must state that these are not applicable to the provided document as it concerns a physical orthopedic implant and its non-clinical performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable: This document describes non-clinical performance testing of a physical medical device, not an AI algorithm evaluated on a data set. The "test set" would refer to physical prototypes or materials tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable: Ground truth, in the context of expert consensus, is not relevant for the physical performance tests conducted for this device. Ground truth for these tests would be established by scientific measurement and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable: Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant to the non-clinical physical testing described.

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

• Not Applicable: This type of study is for evaluating AI in diagnostic contexts with human readers, which does not apply to a knee implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable: There is no AI algorithm discussed in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Analytical/Empirical Standards: For the physical device, the "ground truth" or reference for assessment relies on established international standards (ISO 10993-1 for biocompatibility, ISO 14243-3 for wear testing) and engineering analyses for MRI compatibility.

8. The sample size for the training set

• Not Applicable: There is no AI algorithm or training set discussed in this document.

9. How the ground truth for the training set was established

• Not Applicable: There is no AI algorithm or training set discussed in this document.

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Total Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer NexGen CR-Flex fixed bearing, Zimmer NexGen CR fixed bearing, Zimmer NexGen LPS-Flex fixed bearing, Zimmer NexGen LPS fixed bearing, Zimmer Gender Solutions Natural - Knee Flex fixed bearing, Zimmer Persona™ CR fixed bearing, Zimmer Persono™ PS fixed bearing and Zimmer Persona™ Trabecular Metal™ prostheses families only.

Unicompartmental Knee Replacement

The Zimmer® Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Unicompartmental Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer® Patient Specific Instruments System is to be used with Zimmer Unicompartmental High Flex Knee System prostheses families only.

The Zimmer® Patient Specific Instruments are intended for single use only.

The subject device Zimmer® Patient Specific Instruments System 6.0 is a modification to the predicate device Zimmer® Patient Specific Instruments System 4.0 (K113829) to accommodate the new compatible implant system Zimmer® Persona'''' components, cleared via 510(k)s K113369, K122745 and K121771. A similar change was done for Zimmer® Patient Specific Instruments System 5.0 (K121640) where the Zimmer® Personal™ components, cleared via 510(k) K113369, were added to MRI image based system. Zimmer® Patient Specific Instruments System 6.0 is designed to assist a surgeon in the placement of total knee replacement components for Zimmer® Persona'" components. The system consists of a software device, branded as Zimmer® Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer® Patient Specific Instruments (ZPSI).

The provided text is a 510(k) Premarket Notification for the Zimmer Patient Specific Instruments System 6.0. It describes the device, its intended use, and its technological characteristics as compared to predicate devices. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or detailed performance studies.

Instead, the document states: "Results of software verification and validation testing demonstrated the device's safety and effectiveness is substantially equivalent to the predicate device." This indicates that the device's performance was evaluated against the predicate device, Zimmer Patient Specific Instruments System 4.0 (K113829) and 5.0 (K121640), rather than against pre-defined, quantitative acceptance criteria for new performance claims.

Therefore, I cannot provide the requested information for the following points:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes 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
6. If a standalone performance (algorithm only) 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 focuses on demonstrating substantial equivalence to previously cleared devices through technological similarity and general software verification and validation, rather than presenting a standalone performance study with specific acceptance criteria.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

This device is intended to be used with cemented knee constructs.

The Persona 14 x+30mm Tapered Stem Extension is intended for implantation for total knee arthroplasty (TKA) when supplemental tibial baseplate support is needed. Extending into the intramedullary canal from the base of the Persona Cemented Stemmed Tibia Baseplate, the Persona 14 x+30mm Stem Extension provides supplemental support and shields the fixation interfaces from excessive stress by resisting bending and torsional moments. The subject device is intended to be used with cement knee constructs.

Here's an analysis of the provided text regarding the Zimmer® Persona The Personalized Knee System 14 x+30mm Tapered Stem Extension, focusing on acceptance criteria and the supporting study:

The provided document (K133737) is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It's important to note that this device is a physical implant (a knee system component), not an AI/software device. Therefore, many of the requested fields related to AI study design (like MRMC, human readers, ground truth for training data, etc.) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it describes "performance characteristics" and the "Test Results" demonstrating that the device meets these characteristics. The context implies that the acceptable outcome is for the device to demonstrate sufficient strength or to be assessed for risk in comparison to existing devices, aligning with established FDA guidance for orthopedic implants.

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

• Sample Size: The document does not specify the exact sample size (e.g., number of test specimens) for each bench test. For mechanical tests like fatigue and strength, multiple samples are typically tested, but no numbers are provided here.
• Data Provenance: The data is non-clinical bench testing, meaning it was generated in a laboratory setting, not from human or animal subjects. The location of the testing is not explicitly stated but would typically be in the sponsor's (Zimmer, Inc.) labs or a qualified contract testing facility. This is retrospective in the sense that the testing was performed and then reported, but it is not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable as the study involves mechanical bench testing of an orthopedic implant component, not an AI or diagnostic device requiring expert interpretation for ground truth. The "ground truth" for these tests is defined by engineering principles and measurement of physical properties.

4. Adjudication Method for the Test Set

This question is not applicable. Mechanical tests rely on objective measurements from standardized equipment rather than subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable. This is a submission for a physical orthopedic implant component, not a diagnostic device or AI system that would involve human readers. Clinical data and conclusions "were not needed for this device."

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable as the device is a physical knee implant component, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is defined by:

• Mechanical Properties: Measured physical characteristics such as fatigue life, axial strength, torsional strength.
• Engineering Standards and FDA Guidance: Compliance with relevant ASTM (American Society for Testing and Materials) or ISO (International Organization for Standardization) standards (implied by the FDA guidance documents cited) that define appropriate testing methodologies and performance expectations for such devices.
• Comparison to Predicate Devices: Performance relative to legally marketed predicate devices, demonstrating similarity in performance characteristics.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is a physical medical device and not an AI or machine learning model.

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

This question is not applicable for the same reasons as #8.

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The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.

The Zimmer Patient Specific Instruments System is to be used with Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses families only.

The Zimmer Patient Specific Instruments are intended for single use only.

The subject device Zimmer Patient Specific Instruments System 5.0 is a modification to the predicate device Zimmer Patient Specific Instruments System 2.5 (K111492) to accommodate the new compatible implant system Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses cleared via 510(k) K113369. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly detail specific quantitative acceptance criteria. Instead, it states that "the accuracy and performance of the system is adequate to perform as intended" based on non-clinical testing.

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

• Sample Size: Not explicitly stated in terms of a specific number of cases or patients. The testing was conducted using "cadaveric specimens and saw bones."
• Data Provenance: The testing was non-clinical. The "cadaveric specimens and saw bones" represent simulated rather than real patient data. There is no information on the country of origin, and it is inherently a prospective test on these simulated models.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. The ground truth for the non-clinical tests on cadaveric specimens and saw bones would likely be established through precise measurements and physical verification, not expert consensus. There is no mention of experts being involved in establishing the ground truth for this testing.

4. Adjudication Method for the Test Set:

Not applicable. As the testing was non-clinical using cadaveric specimens and saw bones, and ground truth was likely established through physical measurements, there would be no need for an adjudication method among experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document focuses on the device's standalone performance and its substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance evaluation of the algorithm (referred to as the "system") was done. The "Performance Data" section states: "Non-clinical tests using cadaveric specimens and saw bones have been performed to assess the safety and effectiveness of the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Results of software verification testing demonstrated the device can be used safe and effective as intended." This indicates that the device's functional performance was evaluated independently.

7. Type of Ground Truth Used:

The ground truth used for the non-clinical tests would have been based on physical measurements and known anatomical features/target positions on the cadaveric specimens and saw bones. This is a form of objective, empirical ground truth rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical studies.

8. Sample Size for the Training Set:

The document does not provide any information about a training set or its sample size. The focus is on the testing of the final device, not on its development or training phase.

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

Not applicable, as no information on a training set is provided.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.

Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Persona™ Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. The addition of the Trabecular Metal™ femoral component will provide surgeons with the ability to implant with, or without cement (biological fixation).

The Zimmer® Persona™ Personalized Knee System is a medical device for knee replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing an extensive study report with detailed acceptance criteria and performance metrics typically found in efficacy trials.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Clinical data and conclusions were not needed for this device" because it is a Class II device demonstrating substantial equivalence to existing predicate devices. Therefore, the acceptance criteria are met by demonstrating that the new device exhibits similar or identical performance characteristics to these predicate devices through non-clinical (bench) testing. The acceptance criteria are implicit in the FDA guidance documents followed for testing.

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

• Sample Size: The document does not specify the exact sample sizes (number of components tested) for each non-clinical bench test. These details would typically be found in the full test protocols and reports, but are not included in this summary.
• Data Provenance: The data provenance is "Non-Clinical Performance and Conclusions," meaning the tests were conducted in a laboratory setting (bench testing) rather than on human subjects. This is not retrospective or prospective clinical data. The location of the testing laboratories is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This is not applicable. For bench testing of medical devices like knee implants, ground truth is established by engineering specifications, material properties, and relevant industry standards (e.g., ISO, ASTM), rather than expert medical consensus on patient cases. The "experts" involved are likely engineering and materials science professionals who design and conduct the tests according to the FDA guidance.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert opinions on clinical data are resolved. Since this submission relies on non-clinical bench testing, such an adjudication method is not relevant. The "adjudication" is essentially the adherence to pre-defined test protocols and acceptance criteria based on FDA guidance and engineering standards.

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:

Not applicable. This device is a knee implant, not an AI-powered diagnostic tool requiring MRMC studies to assess the impact of AI on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. As above, this is a physical implant, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests is established by:

• Engineering Specifications: Designed tolerances, material strengths, and fatigue limits.
• Industry Standards: ASTM, ISO, and other relevant standards for orthopedic implant testing.
• FDA Guidance Documents: The specific guidance documents cited (e.g., Class II Special Controls Guidance Document for Knee Joints, Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces, Guidance for MR Safety) define the methods and performance expectations for validating the device's properties.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for such a device would be the extensive research and development phases involving finite element analysis, material science studies, and repeated experimental bench testing, but these are not considered "training sets" in the context of AI.

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

Not applicable, as there is no "training set" in the AI sense for this device.

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