(23 days)
The MAKO Surgical Unicondylar Knee System, Additional Components is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.
This device consists of an asymmetrical cast CoCr distal femoral component and a symmetrical ultra-high molecular weight polyethylene tibial resurfacing component. These components are intended for cemented, one-time use only. The femoral components are available in five sizes (1 through 5) and there is a left and right component for each size. There are five sizes of tibial components and each size is available in three thicknesses designated as 6.5mm, 7.5mm and 8.5mm. The thinnest section of the 6.5mm component is 6.0mm. The additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the MAKO Surgical Unicondylar Knee System (K060017). The previously cleared device is an "inlay" designed unicondylar system where the polyethylene component sits inside the tibial cavity. The device described in this submission adds the "onlay" designed unicondylar components which sit on the tibial ridge.
The provided text describes a 510(k) summary for the MAKO Surgical Unicondylar Knee System, Additional Components. It claims substantial equivalence to a previously cleared device (MAKO Surgical Unicondylar Knee System, K060017) based on risk analysis and verification/validation activities.
Crucially, this document is a 510(k) submission for a medical device which focuses on substantial equivalence rather than AI/software performance. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not applicable to this type of regulatory submission in the way it would be for an AI/ML-driven device.
Here's why and what information can be gleaned:
- No AI/ML Component: The device described is a physical implant (femoral and tibial components for knee replacement), not an AI/ML algorithm. Therefore, the concept of "device performance" in terms of accuracy, sensitivity, or specificity against a ground truth as would be relevant for an AI system does not apply.
- Substantial Equivalence: The approval process for this device relies on demonstrating that the modified device is as safe and effective as a legally marketed predicate device. This is typically achieved through engineering tests, biocompatibility assessments, and design comparisons, not clinical performance studies with acceptance criteria for diagnostic output.
However, I can extract the following relevant information based on the context of a 510(k) submission for a physical medical device:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a physical implant, acceptance criteria would typically relate to:
- Mechanical Strength/Wear: Meeting ISO or ASTM standards for implant materials and design under mechanical stress.
- Biocompatibility: Absence of adverse biological reactions as per ISO 10993 standards.
- Sterilization Validation: Ensuring the device can be consistently sterilized.
- Dimensional Accuracy: Components meeting specified dimensions.
- Material Specifications: Components made of the specified materials (e.g., CoCr, UHMWPE).
- Functionality: Components fit together as intended.
- Reported Device Performance: The document states: "As required by risk analysis, all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence." This is the primary "performance" metric for a 510(k) – that it meets the safety and effectiveness profile of its predicate. Specific test results (e.g., individual load-bearing capacities, wear rates) are not provided in this summary but would be part of the full submission.
Table (Conceptual, as specific numbers are not in the document):
| Acceptance Criteria Category | Specific Criteria (Example) | Reported Device Performance (as stated in document) |
|---|---|---|
| Material Composition | CoCr distal femoral component; UHMWPE tibial resurfacing component. | "This device consists of an asymmetrical cast CoCr distal femoral component and a symmetrical ultra-high molecular weight polyethylene tibial resurfacing component." - Meets material specification. |
| Functional Design | Compatibility with existing MAKO Surgical Unicondylar Knee System femoral components (K060017). | The additional components "are to be used with the femoral components of the MAKO Surgical Unicondylar Knee System (K060017)." - Demonstrates compatibility. |
| Biocompatibility | No adverse biological reactions. | Not explicitly stated in this summary, but would be covered by "all verification and validation activities performed... demonstrated substantial equivalence." - Assumed to meet predicate's biocompatibility profile. |
| Mechanical Integrity | Meets relevant ISO/ASTM standards for knee implant strength and wear (e.g., fatigue strength, static strength, wear resistance). | Not explicitly stated in this summary, but covered by "all verification and validation activities performed... demonstrated substantial equivalence." - Assumed to meet predicate's mechanical integrity profile. |
| Intended Use | Suitable for cemented reconstruction of the medial/lateral femur and corresponding tibial surface for specified conditions. | "Intended for cemented reconstruction of the medial femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis..." - Aligns with intended use. |
| Substantial Equivalence | Demonstrates safety and effectiveness comparable to predicate device K060017. | "The modification as described in this submission is shown to be substantially equivalent to the previously cleared system." - Regulatory outcome achieved. |
Regarding items 2-9 (which are primarily for AI/ML performance studies):
These are not applicable to this 510(k) submission because it pertains to a physical medical device (knee implant components) and not to a software algorithm or AI system. The submission focuses on demonstrating substantial equivalence to a predicate device, which involves engineering assessments and comparisons of design, materials, and intended use, rather than performance metrics related to diagnostic accuracy or clinical outcomes against a defined ground truth in a study involving human readers or AI.
- Sample size used for the test set and the data provenance: Not applicable. (No "test set" in the AI/ML sense).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. (No "ground truth" in the AI/ML sense).
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. (This is for diagnostic software, not an implant).
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes a regulatory filing for a physical medical device, not an AI or software product. Therefore, the detailed questions about data, studies, and ground truth for AI performance are not addressed within this type of 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.