(29 days)
RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
- Medial unicondylar
- Lateral unicondylar
- · Patellofemoral
- · Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
RESTORIS™ Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (RESTORIS™ MCK Uni) and a patellofemoral implant system (RESTORISTM MCK PF).
- RESTORIS™ MCK Uni: ●
- o Unicompartmental femoral condyle components
- Unicompartmental tibial onlay components (tibial baseplate and tibial o onlay insert)
- Unicompartmental tibial inlay components o
- RESTORISTM MCK PF: o
- o Patellofemoral trochlear components
- o Patella components
The RESTORIS™ MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In RESTORIS™ MCK combinations where multicompartmental areas are being treated, the RESTORIS™ MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere.
The provided document describes the RESTORIS™ Multicompartmental Knee (MCK) System, but it is a 510(k) summary for a medical device modification, not a study evaluating an AI algorithm's performance. Therefore, the acceptance criteria and study detailed in the document are for the mechanical performance and safety of the knee implant device itself, not for an AI device.
Many of the requested points, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "training set details," are specific to the evaluation of AI algorithms. This document does not contain information relevant to those points because it is about a physical medical implant.
However, I can extract the information related to the performance data and conclusions for the RESTORIS™ Multicompartmental Knee (MCK) System as described in the 510(k) submission.
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported performance values for each test. Instead, it lists the types of nonclinical performance tests conducted and states a general conclusion that the device performed "within the intended use" and "did not raise any new safety and efficacy issues."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device performs within intended use. | "The results of performance testing indicated the device performed within the intended use" |
| No new safety and efficacy issues raised | "and did not raise any new safety and efficacy issues." |
| Substantially equivalent to predicate devices | "The device was found to be substantially equivalent to the predicate devices." |
| Adequate to withstand anticipated physiological loading | Device has "performance characteristics adequate to withstand anticipated physiological loading." |
| Satisfactory results for specific tests | Performance testing conducted for: 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, Packaging Validation, Gas Plasma Sterilization Validation, 5 Year Aging. (Specific quantitative results or pass/fail thresholds are not provided in this summary.) |
2. Sample size used for the test set and the data provenance:
This information is not provided in the 510(k) summary. Nonclinical performance testing for medical implants typically involves a certain number of test samples (e.g., several implants for fatigue testing, a few for micromotion), but the exact sample sizes are not detailed here. "Data provenance" such as country of origin or retrospective/prospective is not applicable in the context of mechanical device testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the mechanical testing of a knee implant and is not provided in the document. Ground truth as typically understood for AI algorithms (e.g., expert labels on images) is not relevant to this type of device submission.
4. Adjudication method for the test set:
Not applicable. Adjudication methods are typically used for establishing ground truth in expert-dependent evaluations, especially for AI or diagnostic devices. This document describes physical device testing.
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 device, and therefore no MRMC study was performed. The device, the RESTORIS™ Multicompartmental Knee (MCK) System, is referred to as being used "in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System," but the 510(k) is for the implant itself, and it doesn't describe an AI algorithm that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used:
For mechanical performance testing of an implant, "ground truth" would be the engineering specifications, industry standards, and established biomechanical principles against which the device's performance is measured. The document implies compliance with these standards through its statement of "satisfactory results" and "performance characteristics adequate to withstand anticipated physiological loading."
8. The sample size for the training set:
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI algorithm.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.