(63 days)
The ConforMIS Unicondylar Knee Replacement System (iUni) 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 replacement 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,
- valgus or varus deformity of the knee,
- revision procedures provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
This implant is intended for cemented use only.
ConforMIS iUni Unicondylar Knee Replacement System ("iUni KRS") is a patient-specific unicompartmental knee replacement system. The iUni is comprised of a set of implants designed from patient images. The implant system consist of:
- 1 Femoral Implant
- 1 Tibial Component (all-polyethylene or metal backed)
The implants of the iUni KRS will be composed of individually packaged femoral and tibial components and will be provided with ancillary instrumentation to assist in the implantation procedure.
The patient-specific femoral implant will be made of Cobalt Chrome Molybdenum alloy (CoCrMo) and will be personalized to match a patient's anatomy.
The all poly tibial component is made from UHMWPE. The metal backed tibial component will consist of a CoCrMo tibial tray and with an Ultra High Molecular Weight Polyethylene (UHMWPE) tibial insert. Multiple inserts of varying thicknesses may be provided to accommodate surgeon preferences.
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) submission for the ConforMIS iUni Unicondylar Knee Replacement System. This submission is for clarifying the indications for use statement and does not involve any changes to the device itself. Therefore, a study to prove device performance relative to acceptance criteria as if it were a new AI/software device is not relevant in this context.
The document explicitly states:
- "Non-clinical laboratory testing was not performed as there is no change to the device."
- "Clinical data is not necessary to demonstrate substantial equivalence."
- "The determination of substantial equivalence for this device was based on the indications for use statements and the device design. The design of the iUni KRS was previously determined to be substantially equivalent to predicate devices. A comparison of the designs and the indications for use statements confirmed that the modification to the indications for use does not affect device performance and is, therefore, also substantially equivalent."
This 510(k) is essentially an administrative update to align the indications for use with previous clearances and FDA guidance. There are no performance metrics or detailed studies presented for this particular submission. The "device performance" in question here is the device's substantial equivalence to existing predicate devices based on its design and intended use, not on specific quantitative performance metrics tested in a study for this submission.
Therefore, most of the requested information regarding acceptance criteria and performance studies cannot be extracted from this document, as such studies were not part of this specific 510(k) submission.
However, I can provide information based on the premise of the submission, which is about substantial equivalence, not new performance data.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The updated Indications for Use statement and device design must not affect device performance compared to predicate devices, maintaining substantial equivalence. | The ConforMIS iUni Unicondylar Knee Replacement System with the updated indications for use statement is concluded to be substantially equivalent to the iUni Unicondylar Knee Replacement System (K111916, K092441, K072586, K072368, K063432, K043570); Smith & Nephew Journey Unicondylar (K102069); and Zimmer Unicompartmental Knee System (K033363) based on detailed device description and indications for use statement comparisons. |
| Device Design Comparison | The device design must be consistent with previously cleared devices. | The design of the iUni KRS was previously determined to be substantially equivalent to predicate devices. (No changes in design for this submission). |
| Indications for Use Alignment | The updated indications for use statement must be consistent with predicate devices and FDA guidance. | The purpose of this submission is to clarify the indications for use statement and make it consistent with predicate devices and FDA guidance. (This was the primary goal and was achieved by comparing statements). |
| Clinical Data Requirement | Clinical data should be unnecessary if substantial equivalence is demonstrated without device change. | Clinical data is not necessary to demonstrate substantial equivalence as there is no change to the device, and the substantial equivalence is based on comparisons of descriptions and indications for use. |
2. Sample size used for the test set and the data provenance
Not applicable for this submission. No new test set data was generated or analyzed as there was no change to the device. The evaluation was based on a comparison of device descriptions and indications for use statements against existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this submission. No new ground truth was established as there was no study for device performance.
4. Adjudication method for the test set
Not applicable for this submission.
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 for this submission. This device is a physical knee replacement system, not an AI/software device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for this submission. This device is a physical knee replacement system, not an algorithm.
7. The type of ground truth used
Not applicable for this submission. The "ground truth" for this 510(k) was the existing regulatory clearances and indication statements of the predicate devices.
8. The sample size for the training set
Not applicable for this submission.
9. How the ground truth for the training set was established
Not applicable for this submission.
§ 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.