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Unicompartmental knee implants are indicated for restoring either compartment of a knee that has been affected by the following:

• · Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis:
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and
• · Treatment of fractures that are unmanageable using other techniques.

Unicompartmental knee implants are single use only and are intended for implantation only with bone cement.

The subject of this Special 510(k) is the Journey II Unicompartmental Knee System (Journey II UK). The subject device is a unicondylar femoral and tibial implant set for treatment of unicompartmental osteoarthritis. The device is intended for appropriate unicondylar, medial or lateral, ACL and PCL preserving joint treatment (partial knee replacement).

Components of this premarket notification consist of a femoral implant, tibia baseplate, modular articular insert, and requisite US Class II surgical instrumentation required will consist of femoral instruments used to make appropriate resections to prepare the femur for said implants and tibial instruments used to make a planar resection and implant preparation of the proximal tibia.

The Journey II UK is a line extension of the Smith & Nephew Unicompartmental Knee line, incorporating previously cleared Smith & Nephew products. It contains design aspects of the existing Journey II Uni Tibial Baseplate and Inserts (S.E. K152315), the Journey Uni (S.E. K102069), and the ZUK (S.E. K160738).

Femoral components are manufactured from Oxinium (Zr-2.5Nb), and feature ten sizes each in left medial/right lateral and right medial/left lateral side (hand) configurations.

Tibial baseplates are manufactured from Titanium alloy (Ti-6Al-4V). They are available in:

• . Ten sizes of implant with a medial primary / lateral secondary use offered in both left and right handedness (listed henceforth as "medial primary"), and
• . Eight sizes of implant with a lateral primary / medial secondary use offered in both left and right handedness (listed henceforth as "lateral primary").

Each are expected to be used in its primarily listed compartment most often, but are designed for use in either medial or lateral compartments.

Modular articular implants are manufactured from cross-linked polyethylene (XLPE) and are available in medial and lateral configurations for use with corresponding baseplate. They are symmetric for use in either right or left hand.

The provided text is a 510(k) summary for the Journey II Unicompartmental Knee System. This document is a premarket notification for a medical device and does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it details mechanical verification testing for an orthopedic implant.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study from this document, as it pertains to a different type of medical device and regulatory submission.

Specifically, the document states: "Clinical data was not needed to support the safety and effectiveness of the subject device." This indicates that no human clinical study, which would typically involve performance metrics and acceptance criteria as outlined in your request, was conducted. The device's safety and effectiveness were established through mechanical testing and comparison to predicate devices, not through a study involving human subjects or AI performance.

To reiterate, the requested information elements (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, ground truth for training set) are not applicable to the content of this 510(k) summary for a knee implant.

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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.

Detailed Information as per Request:

1. 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.

2. 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).

3. 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.

4. 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.

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 device is a knee implant, not an AI-assisted diagnostic tool. No MRMC studies were performed or relevant.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

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