(87 days)
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."
| Acceptance Criteria (for 510(k) Clearance) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated substantial equivalence in indications, design (non-constrained, unicompartmental knee prostheses), materials, and mechanical safety to the Miller/Galante Precoat Unicompartmental Knee System. |
| Safety and Effectiveness based on Non-Clinical Testing | Performance testing (design assurance, FMEA) demonstrated the device is safe and effective. Specific metrics not provided. |
| Clinical Data | 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.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.