(30 days)
The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:
· Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
· Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
· As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
The RESTORIS ® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
The RESTORIS® Porous Partial Knee System is a knee joint femorotibial (unicompartmental) prosthesis. The RESTORIS® Porous Partial Knee System consists of femoral components and tibial baseplate components that are compatible with and intended for use with MAKO's predicate RESTORIS MCK Tibial Onlay Insert Components (K090763 or K133039).
The RESTORIS® Porous Femoral Component and PST® Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application. The implants are single-use devices.
The Porous Femur components: sizes 1 through 8, CoCr with a CoCr porous coating for cementless fixation, asymmetric design (meaning that left medial implants can be used on the right lateral compartment and right medial implants can be used on the left lateral compartment; abbreviated hereafter as LM/RL and RM/LL)
PST® Tibial Baseplate components: sizes 1 through 8. Ti6Al4V allov with MAKO's predicate porous surface (porous structured technology, referred to as "PST®"), asymmetric (LM/RL-RM/LL).
The provided document is a 510(k) premarket notification for a medical device, the RESTORIS® Porous Partial Knee System. It focuses on demonstrating substantial equivalence to a predicate device based on manufacturing materials, design, technological characteristics, and performance data.
However, this document does not contain the information requested regarding acceptance criteria and the study proving a device meets them in the context of AI/ML performance. The device described is a physical knee implant, not an AI-powered diagnostic or therapeutic tool.
Therefore, I cannot extract the following information from this document:
- A table of acceptance criteria and the reported device performance: This document reports on non-clinical performance testing for a physical implant (e.g., snaplock strength, micromotion, wear), not AI model metrics like sensitivity, specificity, or AUC.
- Sample size used for the test set and the data provenance: Not applicable to this type of device submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical implant, not an AI-assisted diagnostic.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to physical implant performance testing in this context.
- The sample size for the training set: Not applicable (no AI model).
- How the ground truth for the training set was established: Not applicable (no AI model).
The "Performance Data" section lists non-clinical performance testing related to the physical characteristics and function of the knee implant, such as:
- Insert Snaplock Strength
- Tibial Insert / Baseplate Micromotion
- Tibio-Femoral Range of Motion
- Tibio-Femoral Instability
- Tibio-Femoral Contact Area and Stress
- Tibial Insert Fatigue
- Tibial Insert Wear
The conclusion states that "The results of performance testing indicated the device performed within the intended use and did not raise any new safety and efficacy issues. The device was found to be substantially equivalent to the predicate devices." This is the general "acceptance" for a 510(k) submission for this type of device, demonstrating it functions as intended and is as safe and effective as a legally marketed predicate. However, detailed, quantitative acceptance criteria for each test (e.g., "snaplock strength > X N") are not provided in this summary, nor are the specific results for each test.
§ 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.