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Coonrad/Morrey Total Elbow: Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain: revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures. The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.

Zimmer Nexel Total Elbow: Indications for use include: Elbow joint destruction which significantly compromises the activities of daily living; Post-traumatic lesions or bone loss contributing to elbow instability; Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis; Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain; Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis; Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus; Revision arthroplasty. Caution: This device is intended for cemented use only.

The Coonrad/Morrey Total Elbow and Zimmer Nexel Total Elbow are total elbow prosthesis designed for use with bone cement. They are available in multiple sizes and in right and left configurations. The devices are designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implants are constrained in design and consist of a humeral component and an ulna component joined through bearings in a hinged fashion. The purpose of this submission is the addition of MR conditional language to the labeling for these products. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging or sterilization. Additionally, this submission includes minor modifications to the subject device systems.

The provided text is a 510(k) summary for the Zimmer Nexel Total Elbow and Coonrad/Morrey Total Elbow. It concerns the addition of MR conditional language to the product labeling and minor design modifications, not a study evaluating device performance against specific clinical acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document.

However, I can provide information on what was studied and the conclusions drawn related to substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present clinical acceptance criteria for the elbow prostheses themselves (e.g., pain reduction, range of motion improvement). Instead, it focuses on the performance related to MR Conditional safety. The acceptance criteria are implicit in the adherence to ASTM standards for MRI compatibility.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not applicable in the traditional sense of a clinical trial. The "test set" here refers to the Zimmer Nexel Total Elbow and Coonrad/Morrey Total Elbow implants that underwent MRI compatibility testing. The document does not specify the number of individual implants tested for these non-clinical evaluations, but it refers to the performance of "implants."
• Data Provenance: The tests were non-clinical (laboratory/engineering) as performed by Biomet (presumably the manufacturer, as Zimmer is also the manufacturer listed). The location/country of origin of the testing facility is not specified. The studies are by nature prospective in the sense that they were conducted specifically for this submission to address MRI safety.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This was a non-clinical evaluation based on adherence to engineering standards (ASTM) for MRI safety. Ground truth was established by the specified ASTM test methods. No human expert consensus was used for establishing MRI compatibility ground truth; it's a technical outcome.

4. Adjudication Method for Test Set:

Not applicable. Non-clinical engineering tests do not typically involve adjudication methods like those used in clinical image interpretation studies. The results are quantitative and determined by the test protocol.

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

• No, a MRMC comparative effectiveness study was not done. The submission is for non-clinical testing related to MRI safety and minor design modifications, not for assessing human reader performance or the clinical effectiveness of the elbow prostheses themselves.

6. Standalone Performance (Algorithm Only):

• Not applicable. This submission is for medical devices (total elbow prostheses), not a software algorithm.

7. Type of Ground Truth Used:

• For the MRI compatibility studies, the ground truth was based on established engineering standards and measurements as defined by ASTM F2503-13, F2182-11a, F2119-07, and F2052-14.
• For the minor design modifications, the ground truth was based on engineering rationale and testing to demonstrate that the modifications do not negatively impact device performance or safety.

8. Sample Size for Training Set:

• Not applicable, as this is not a machine learning or AI-based device requiring a training set.

9. How Ground Truth for Training Set Was Established:

• Not applicable.

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Indications for use include:

• Elbow joint destruction which significantly compromises the activities of daily living
• Post-traumatic lesions or bone loss contributing to elbow instability
• Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis
• Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain
• Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
• Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
• Revision arthroplasty
  CAUTION: This device is intended for cemented use only.

The Zimmer Nexel Total Elbow system includes a cemented total elbow prosthesis and instrumentation. No changes are being made to the implants, but two changes to the instrumentation are being proposed in this submission.
• The Zimmer Nexel Total Elbow surgical technique is being modified to include a back table utilization of the Ulnar Bearing Assembly Tool (UBAT).
• As a result of the surgical technique change, the subject Zimmer Nexel Total Elbow Ulnar Cement Diverter is being added as an accessory instrument to the existing Zimmer Nexel Total Elbow system. The proposed cement diverter is a sterile, single-use manual orthopedic instrument manufactured from Ultra High Molecular Weight Polyethylene in conformance with ASTM F648-14. The subject component diverts excess bone cement from the articular surfaces of the existing ulnar implant component during implantation.

This document describes the Zimmer® Nexel® Total Elbow Ulnar Cement Diverter. Based on the provided text, the device is an accessory instrument to an existing total elbow replacement system, designed to divert excess bone cement during implantation. The document does not describe a clinical study in the typical sense (e.g., no patient data, no comparison of outcomes with and without the diverter). Instead, it relies on non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the "study" (non-clinical) that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the typical format of a clinical trial (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, the acceptance is based on demonstrating the safety and effectiveness of the cement diverter and the updated surgical technique through non-clinical evaluations.

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

• Test Set Sample Size: The document mentions a "Cadaveric Evaluation." While the specific number of cadavers or test instances is not explicitly stated in this summary, cadaveric studies typically involve a small number of specimens.
• Data Provenance: The study is non-clinical, involving cadavers. The country of origin for the cadavers is not specified. It is inherently a prospective evaluation in the context of the device's development and regulatory submission, even though it uses post-mortem tissue.

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)

The document does not specify the number or qualifications of experts involved in the cadaveric evaluation. While such studies would ideally involve orthopedic surgeons or biomechanical engineers, this information is not provided in the 510(k) summary. The "ground truth" for these tests would likely be the direct, observable performance of the device during simulated implantation on the cadaveric specimens, assessed by the researchers and potentially expert surgeons.

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

The document does not describe an adjudication method for the non-clinical test set. Methods like 2+1 or 3+1 are typically used in imaging studies where interpretations are subjective and require expert consensus. In a cadaveric mechanical/functional test, the assessment of "safety and effectiveness" would likely be based on direct observation and measurement, rather than a subjective interpretation requiring adjudication among multiple readers.

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

There was no MRMC comparative effectiveness study done. This device is an orthopedic instrument, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

There was no standalone (algorithm-only) performance study done. This device is a manual orthopedic instrument, not an algorithm.

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

The ground truth for the non-clinical evaluations was primarily direct observation and functional assessment during the cadaveric evaluation and mechanical testing (Functional Relationship Analysis). For the cadaveric study, the "ground truth" was whether the cement diverter effectively diverted cement and allowed for proper implantation without compromising the ulnar component. For the FRA, the ground truth was whether the diverter physically fit and functioned correctly with the existing components.

8. The sample size for the training set

There is no training set sample size because this is a mechanical device, not a machine learning algorithm.

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

Not applicable, as there is no training set.

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Indications for use include:

• Elbow joint destruction which significantly compromises the activities of daily living ー
• Post-traumatic lesions or bone loss contributing to elbow instability -
• Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis -
• Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain -
• Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis
• Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus
• Revision arthroplasty

Caution: This device is intended for cemented use only.

The Zimmer Nexel total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in multiple sizes and in right and left configurations.

How the Device Functions: The Zimmer Nexel Total Elbow is an implant designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implant is a constrained device assembly and consists of the following components: humeral component, ulnar component, humeral bearing-A, ulnar bearings-B, axle pin and humeral screws.

The Following Scientific Concepts, Design Features and Physical Properties form the Basis for the Zimmer Nexel Total Elbow: The humeral component has a humeral stem designed to be implanted with bone cement into the patient's humeral medullary canal, an anterior flange designed to accept a bone graft and limit torsional and posterior migration, a humeral yoke with rounded corners to avoid the creation of stress risers within the medial and lateral humeral supracondylar columns, and plasma spray region to enhance fixation to bone cement within the medullary canal, and to improve fatigue strength. The ulnar component has an ulnar stem designed to be implanted with bone cement into the patient's ulnar medullary canal, an ulnar eye that is both highly polished and nitrogen-enriched to limit wear of the apposing polymer bearings, and plasma spray region to enhance fixation to bone cement within the medullary canal. Bearings A and B are designed to broadly distribute joint reaction forces.

Materials Used: The humeral and ulnar components are made of a titanium alloy, the bearings A and B are made of Vitamin E highly cross-linked polyethylene, and the humeral screws and axle pin are made of a cobalt-chromium-molybdenum alloy.

Here's an analysis of the acceptance criteria and study information for the Zimmer Nexel Total Elbow, based on the provided text:

Based on the provided K123862 510(k) summary, the device is a medical implant (total elbow prosthesis) and the study conducted is non-clinical performance testing for demonstrating substantial equivalence to a predicate device, rather than a clinical study involving human readers or AI. Therefore, many of the requested fields are not applicable in this context.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. This was non-clinical performance testing (e.g., fatigue, wear, durability), not a study on a test set of patient data.
• Data Provenance: Not applicable. The data came from laboratory testing of the device and its components, not from patient-derived data or specific countries.

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

• Number of Experts: Not applicable. Ground truth for non-clinical performance testing typically refers to engineering specifications, industry standards, and established test methods, rather than expert human interpretation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as there was no test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

• MRMC Study: No. This was non-clinical testing of a physical implant, not an AI-assisted diagnostic tool.
• Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No. This is physical hardware, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Engineering specifications, industry standards, and established test methodologies for evaluating the mechanical properties, durability, and wear characteristics of the prosthetic components. This typically involves physical measurements against predefined limits.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This was non-clinical testing of a physical implant, not a machine learning model requiring a training set.

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

• Ground Truth Establishment: Not applicable, as there was no training set. The "ground truth" for the non-clinical testing was based on published standards, internal design specifications, and comparison to the predicate device's known performance.

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