(5 days)
Partial replacement of articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The devices covered in this 510(k) are intended to be used with Repicci™ Femoral Components.
The device is a single use implant intended for implantation w/ bone cement.
The Repicci IITM Unicondylar Knee System consists of a femoral and tibial component. The Worland tibial bearing is used with the Repicci II™ femoral components (K971938).
The all polyethylene tibial components are anatomical in geometry with right and left medial/lateral allocations. Located on the inferior surface of the implant is a patterned face with holes and a fin.
The provided document is a 510(k) summary for a medical device called the "Worland Unicondylar Tibial Bearing." This type of submission is for demonstrating substantial equivalence to a predicate device, not for a novel device requiring extensive clinical trials to prove efficacy against acceptance criteria. Therefore, most of the requested information (acceptance criteria, specific study details, ground truth, expert involvement, MRMC studies, etc.) is not applicable or available in this document.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of performance metrics. The underlying acceptance criteria for a 510(k) submission is "substantial equivalence" to a predicate device. This means the device is as safe and effective as a legally marketed device.
- Reported Device Performance:
- Non-Clinical Testing: "Fatigue testing and stress analysis determined that the Worland Unicondylar Tibular components presented no new risks and were; therefore, substantially equivalent to the predicate device."
- Clinical Testing: "None provided as a basis for substantial equivalence."
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. No clinical test set or data provenance is mentioned as substantial equivalence was based on non-clinical testing.
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. No clinical test set or ground truth was established. The "ground truth" for substantial equivalence was the predicate device's established safety and effectiveness.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication was performed.
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 not an AI-based device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the purpose of this 510(k) submission, the "ground truth" or benchmark for safety and effectiveness was the predicate device (Repicci II™ Unicondylar All Poly Tibial Bearing - K980665). The new device was deemed substantially equivalent based on similarities in materials, design, sizing, indications, and non-clinical testing results.
8. The sample size for the training set
- Not applicable. This is not a machine learning device, and no training set was used.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
In summary, this document describes a device (a unicondylar tibial bearing) seeking market clearance through the 510(k) pathway, which primarily relies on demonstrating substantial equivalence to an existing predicate device rather than novel clinical performance studies against specific acceptance criteria. The equivalence was established through non-clinical fatigue testing and stress analysis, showing no new risks compared to the predicate.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.