(90 days)
The MOTO™ Lateral Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
The MOTO™ Lateral Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
MOTO™ Lateral Partial Knee System design is characterized by:
- a femoral component designed to anatomically fit the lateral femoral condyle
- a tibia component, designed to anatomically fit the lateral tibial condyle
- a fixed tibia insert, with a flat articulating surface with rounded border
MOTO™ Lateral Partial Knee System has been designed in cemented version only. The femoral component is made of cobalt-chromium-molybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Lateral Partial Knee System implants are offered sterile (via gamma irradiation for the femoral and tibial tray components and ethylene oxide for the tibial insert components), are intended for single use only, and may not be re-sterilized
The Lateral Femoral Component (cemented) is symmetrically shaped (suitable for both left and right side) and designed with two (2) fixation pegs for all the sizes. It is available in seven (7) sizes (1 - 7).
The Lateral Fixed Tibial Insert has a fixed design, is symmetrically shaped (suitable for both left and right side) and is available in eight (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm). It is fixed through a snapping mechanism with baseplate.
The Lateral Fixed Tibial Tray (cemented) has a fixed bearing design with one (1) triangular keel and two (2) 'mushroom' shaped pegs to ensure primary stability. Available in eight (8) sizes (1 - 8), the Lateral Fixed Tibial Tray is offered in both Right Lateral (RL) and Left Lateral (LL) options for each size.
This document is a 510(k) Premarket Notification for the MOTO™ Lateral Partial Knee System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of AI/ML device performance. Therefore, most of the requested information regarding AI/ML device performance is not applicable or available in this document.
However, I can extract the information related to the device's performance testing and general acceptance criteria as presented in the document.
Acceptance Criteria and Device Performance for Mechanical Testing:
The document states: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, the specific quantitative acceptance criteria and the numerical reported device performance are not explicitly detailed in the summary tables provided. Instead, the document lists the types of tests performed.
| Acceptance Criteria Category (Implied by Test Type) | Reported Device Performance (Implied by Study Conclusion) |
|---|---|
| Design Validation (Cadaveric Workshop) | Successful validation (implied by "Design Validation Report") |
| Fatigue Endurance of Posterior Condyle | Met standards (implied by "Test Report A1, rev.0") |
| Comparative Coverage of Lateral Femoral Component | Met standards (implied by "Test Report A2, rev.0") |
| Mechanical Resistance of Lateral Tibial Tray | Demonstrated conservative design (implied by "Test Report B1, rev.0") |
| Comparative Coverage of Lateral Tibia Tray | Met standards (implied by "Test Report B2, rev.0") |
| Contact Area and Pressure (Conservative Design) | Demonstrated conservative design (implied by "Rationale C1, rev 0") |
| Insert-Tray Clipping System Static Shear and Draw | Met standards (implied by "Test Report C2 rev.0") |
| Range of Motion (Femoral Component - Tibia Insert) | Met standards (implied by "Test Report C3, rev.0") |
| Bacterial Endotoxin (Pyrogenicity) | Passed (implied by test according to European Pharmacopoeia §2.6.14) |
| Pyrogenicity (USP chapter ) | Passed (implied by test according to USP chapter ) |
Detailed Information as per Request:
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A table of acceptance criteria and the reported device performance:
- As noted above, specific numerical acceptance criteria and reported performance values are not explicitly stated in this 510(k) summary. The document mentions that "acceptance criteria... were based on standards" and lists the types of tests conducted. The conclusion of substantial equivalence implies that these criteria were met.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- For mechanical/non-clinical studies, sample sizes are not specified. The document mentions a "Cadaveric Workshop" for design validation, implying prospective testing on cadaveric specimens, but details on the number of specimens are absent.
- The document mentions "EndoLab Report IL test 167.180320.20.838 rev.0, dated 03.May.2018," which might contain sample size information in the full report, but it's not present in this summary.
- Data provenance (country of origin for test data) is not explicitly stated, though the manufacturer, Medacta International SA, is based in Switzerland, and test reports mention "EndoLab" (likely a testing lab).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable as the document is for a medical device (knee system), not an AI/ML diagnostic or predictive device that would typically involve expert ground truth establishment for a test set. The validation involves mechanical and design testing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of mechanical device submission. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations involving human interpretation.
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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 device is a knee implant, not an AI-assisted diagnostic tool. No MRMC studies were performed or relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (knee implant), not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For mechanical testing, the "ground truth" refers to established engineering standards (e.g., ASTM, ISO), mechanical properties of materials, and design specifications.
- Biocompatibility was supported by previous testing on predicate devices using similar materials.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The design and manufacturing process involves engineering principles and material science, not machine learning training.
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How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.