Search Results

These devices are indicated for patients with:

• Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
• Previous tibial condyle or plateau fractures with loss of anatomy or function.
• Varus or valgus deformities.
• Revision of previous arthroplasty procedures.
  These devices are indicated for cemented use only.
  The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Zimmer Unicompartmental Knee System (ZUK) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.

The Zimmer Unicompartmental Knee System Vivacit-E Articular Surface is a medical device. The provided text describes the non-clinical performance and conclusions for this device, focusing on material characteristics and mechanical properties. There are no clinical performance studies described.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text details non-clinical performance and conclusions based on bench testing. Therefore, there is no human "test set" or associated patient data from which to derive sample size or data provenance (country of origin, retrospective/prospective). The "test set" in this context refers to the physical samples of the device components and materials subjected to laboratory testing. The document does not specify the number of samples used for each bench test.

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

As this is a non-clinical, bench-testing study, the concept of "experts" establishing ground truth in the context of clinical interpretation or diagnosis does not apply. The ground truth for these tests is based on the physical and mechanical properties of the device components as measured by standardized testing methods and engineering principles. The experts involved would be engineers, material scientists, and quality assurance personnel who design, conduct, and interpret these tests, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes. Since this report describes non-clinical bench testing, no such adjudication method was used. The "results" are objective measurements against predefined engineering specifications and standards.

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

No MRMC comparative effectiveness study was done. The description explicitly states: "Clinical data and conclusions were not needed for this device." The study focuses on the physical properties and performance of the device's material and components through bench testing, not on human reader performance.

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

This question relates to AI/algorithm performance. No AI/algorithm standalone performance study was done. The device is a physical knee prosthesis component, not an AI software or system.

7. Type of Ground Truth Used

The ground truth used for these non-clinical performance studies is derived from established engineering standards, material science principles, and functional requirements for knee prostheses. Results from bench tests (e.g., wear rate measurements, fatigue strength, delamination resistance, assembly force) are compared against these predetermined specifications and accepted industry benchmarks to determine if the device meets its performance objectives.

8. Sample Size for the Training Set

Similar to the "test set," the concept of a "training set" is not applicable here as this is a non-clinical, bench-testing study of a physical medical device. There is no machine learning model being trained.

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

As there is no training set mentioned in the context of this non-clinical bench study, this question is not applicable.

Ask a specific question about this device

These devices are indicated for patients with:

• Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis.
• Previous tibial condyle or plateau fractures with loss of anatomy or function.
• Varus or valgus deformities.
• Revision of previous arthroplasty procedures.

These devices are indicated for cemented use only.

The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

The Zimmer Unicompartmental Knee System (Zimmer Uni) is a prosthesis that replaces only one compartment of the knee condyles. It is unconstrained in the anteroposterior and mediolateral directions and also allows unconstrained internal/external rotation between the femoral and tibial components. This movement is limited only by the ligaments and other soft tissues surrounding the device.

This document is a 510(k) summary for the Zimmer Unicompartmental Knee System and does not contain information about the acceptance criteria or a study proving the device meets said criteria as typically found in reports for AI/software devices. Instead, it describes a traditional medical device (a knee prosthesis) and its clearance based on substantial equivalence to predicate devices, rather than performance metrics from a specific study against acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text because they pertain to performance testing and validation typically associated with AI or diagnostic devices, which is not the subject of this 510(k) summary.

Here's what can be extracted based on traditional medical device clearance:

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

• Acceptance Criteria: For traditional medical devices like this knee prosthesis cleared via 510(k), the primary "acceptance criterion" for market clearance is substantial equivalence to a legally marketed predicate device. This means demonstrating that the new device is as safe and effective as the predicate. The document states this explicitly.
• Reported Device Performance:
  • Non-Clinical Performance: "Performance testing completed as part of the design assurance procedure for the Zimmer Unicompartmental Knee System and FMEA demonstrated that this device is safe and effective and substantially equivalent to the predicate devices." No specific quantitative metrics or acceptance criteria for this non-clinical testing are provided in this summary.
  • Clinical Performance: "Clinical data and conclusions were not needed for this device."

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

• This information is not applicable and not provided. The clearance is based on substantial equivalence and non-clinical testing, not a clinical study with a "test set" in the context of AI/diagnostic device validation.

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)

• This information is not applicable and not provided. There was no clinical ground truth established for a test set in the context of this 510(k) clearance.

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

• This information is not applicable and not provided.

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

• This information is not applicable and not provided. This is a physical medical implant, not an AI or diagnostic software.

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

• This information is not applicable and not provided.

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

• The "ground truth" for this device's clearance is its demonstrated substantial equivalence to already approved predicate devices through non-clinical testing and comparison of design, materials, and intended use. There is no specific clinical "ground truth" (like pathology or outcomes data from a prospective study) described as being used for this 510(k) clearance.

8. The sample size for the training set

• This information is not applicable and not provided. There is no "training set" in the context of this device's clearance.

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

• This information is not applicable and not provided.

Ask a specific question about this device