(85 days)
The ConforMIS Unicondylar Knee Replacement System (iUni KRS) with curved tibial insert is intended for use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of adequate healthy bone sufficient for support of the implanted components.
Candidates for unicondylar knee repair include those with:
• joint impairment due to osteoarthritis or traumatic arthritis of the knee
• previous femoral condyle or tibial plateau fracture, creating loss of function and
• valgus or varus deformity of the knee.
This implant is intended for cemented use only.
The ConforMIS iUni Implant System is comprised of a set of implants designed from patient images. The implants consist of
- 1 Femoral Implant .
- 1 Tibial Trav o
- 2 or 3 Tibial Inserts 0
The implants of the iUni Implant System will be composed of individually packaged femoral and tibial components.
The femoral implant will be made of Cobalt Chrome Molydenum (CoCrMo) and will be personalized to match a patient's anatomy, thus becoming patient specific.
The tibial implants will consist of a CoCrMo tibial tray and two or three Ultra High Molecular Weight Polyethylene (UHMWPE) tibial inserts of varying thicknesses.
The outline bone contacting and articular surfaces of the femoral component as well as the outline of both tibial components are personalized to match the patient's femoral and tibial anatomy. The design of the implant is derived from an analysis, using proprietary software, of images obtained by MRI or CT Scan.
Disposable, patient- specific instrumentation is provided to assist in the implantation of the iUni Unicondylar Knee Replacement System
The provided text describes a 510(k) summary for the ConforMIS® iUni Unicondylar Knee Replacement System. This submission is for a medical device (knee implant), not an AI/ML-driven device or study assessing algorithm performance. Therefore, many of the requested fields are not applicable.
Here's the information that can be extracted from the provided text, along with indications where the requested information is not available or relevant to this type of device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance |
|---|---|---|
| Safety & Performance Equivalence | To demonstrate substantial equivalence to predicate devices (K043570, K063432, K072368, K072586, K092441) and other marketed cemented unicondylar knee replacement systems. | Non-clinical laboratory testing (Femoral Fatigue, Femoral Implant fixation, Cadaveric testing, Software validation testing) demonstrated the device is safe and substantially equivalent for its proposed intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not applicable for a non-clinical device submission. The "test set" here refers to components used in non-clinical lab testing. Specific numbers for units tested are not detailed in the summary.
- Data Provenance: Not applicable in the context of clinical data for this type of submission. The tests performed are described as "Femoral Fatigue," "Femoral Implant fixation," "Cadaveric testing," and "Software validation testing." These are laboratory-based tests, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to human-labeled data. This submission describes physical device testing and software validation, not interpretation of data by experts to establish a "ground truth."
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations of data, which is not relevant to the non-clinical lab tests 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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which this is not.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical knee implant. While it uses proprietary software for design based on patient images, "standalone performance" in the context of an algorithm refers to its diagnostic or predictive capability without human intervention. The software here is a design tool, not a diagnostic algorithm. Software validation testing was performed to support changes, but this is validation of the software's ability to correctly design implants, not a "standalone performance" as in AI/ML.
7. The type of ground truth used
- Type of Ground Truth: For the non-clinical tests (femoral fatigue, fixation, cadaveric), the "ground truth" would be engineering specifications, biomechanical expectations, and potentially anatomical landmarks from cadaveric studies. For software validation, the "ground truth" would be the expected output or design parameters based on input images. This is not "expert consensus, pathology, or outcomes data" as typically understood in AI/ML.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device is a physical implant designed using proprietary software, not an AI/ML model trained on a dataset. The software is used to design personalized implants from patient images, implying it's an image processing and design tool, not a learning algorithm that undergoes a training phase in the AI sense.
9. How the ground truth for the training set was established
- How Ground Truth Established: Not applicable, as there is no "training set" in the AI/ML sense. The software's accuracy in generating designs from patient images would typically be validated against known anatomical models or expert-reviewed designs, but this is part of software validation, not AI/ML training ground truth.
§ 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.