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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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The Journey Unicondylar Knee System is indicated for restoring either compartment of a knee that has been affected by the following:

• 1. Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• Correction of functional deformity; 2.
• ల్లా Revision procedures where other treatments or devices have failed; and
• 4. Treatment of fractures that are unmanageable using other techniques.

The Journey Unicondylar Knee System components are single use only and are intended for implantation only with bone cement.

The devices, subject of this Premarket Notification, are the Smith & Nephew, Inc. Journey Unicondylar Femoral Implant components. The Journey unicondylar femoral implants are intended for cemented medial and lateral tibiofemoral replacement. The femoral implants will be offered in both Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM) materials in sizes 1 through 7. The Smith & Nephew Journey Unicondylar femoral components feature the same articular surface geometry as existing femoral implants cleared in K073175.

The Journey Unicondylar femoral components are intended to be used in combination with the Competitor Unicondvlar All-Poly Tibial Baseplates IK061779), or the Competitor Unicondylar Knee Tibial Baseplates and Polyethylene Inserts {K061011}.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Smith & Nephew Journey Unicondylar Femoral Implant.

Based on the provided 510(k) summary, this document is a premarket notification for a medical device (a unicondylar femoral implant), which primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices. It does not describe a study to prove the device meets specific performance acceptance criteria in the way a clinical trial or a diagnostic algorithm study would.

Therefore, I cannot populate most of the requested fields as they pertain to a type of study that isn't presented in this 510(k) document. Medical device 510(k) submissions, especially for orthopedic implants, often rely on design control activities and comparisons to predicate devices rather than human-in-the-loop diagnostic studies.

Here's what can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) in the context of a diagnostic or comparative effectiveness study. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device.

• Noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis)
• Correction of functional deformity
• Revision procedures where other treatments or devices have failed
• Treatment of fractures that are unmanageable using other techniques.
  These indications align with common uses for unicondylar knee prostheses. |
  | Material Composition | Same as/similar to predicate device(s) | Offered in Cobalt Chrome and Oxidized Zirconium alloy (OXINIUM). (These are common materials for implants). |
  | Design Features | Same as/similar to predicate device(s) | The femoral implants feature the same articular surface geometry as existing femoral implants cleared in K073175 (a predicate device). |
  | Safety and Effectiveness | Demonstrated through design control activities and equivalence to predicate. | "Design Control Activities have been completed and the results indicated that the subject device is safe and effective." (No specific performance data is provided). |

2. Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance or comparative effectiveness with a "test set" of data in the manner implied by the question. The "test" for this submission is the comparison to predicates and internal design control verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method for the test set: Not applicable.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For a 510(k) submission for an implant, the "ground truth" essentially comes from:
* Clinical history and established performance of predicate devices: The implicit understanding that similar devices with similar materials and designs have a history of safe and effective use.
* Engineering and materials science principles: The "ground truth" for the device's physical properties (strength, wear resistance, biocompatibility) are established through standard engineering tests and material specifications. The submission only states "Design Control Activities have been completed."

8. The sample size for the training set: Not applicable. This is not an AI/machine learning study requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" presented in the 510(k):

The "study" in this context is a substantial equivalence demonstration as part of the 510(k) premarket notification process for a Class II medical device.

• Objective: To demonstrate that the Smith & Nephew Journey Unicondylar Femoral Implant is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective.
• Methodology:
  • Comparison of Intended Use: The device's indications for use are presented and implicitly compared to those of predicate devices.
  • Comparison of Technological Characteristics: The device's design features (articular surface geometry), materials (Cobalt Chrome, OXINIUM), and intended combination with other components are compared to cleared predicate devices, specifically K073175 (earlier Journey Unicondylar Femoral Implants), K912735 (GENESIS Unicompartmental Knee System), K030301 (Unicondylar Femoral Component), and K033363 (Zimmer Unicompartmental Knee System).
  • Reliance on Design Controls: The submission states that "Design Control Activities have been completed and the results indicated that the subject device is safe and effective." This refers to internal company processes for designing, developing, and verifying the device meets its specifications, often including mechanical testing, biocompatibility testing (if new materials are used, though here they are common), and software verification (if applicable).
• Data Provenance: The "data" primarily comes from in-house design and testing records ("Design Control Activities") and regulatory records of previously cleared devices (510(k) numbers K073175, K912735, K030301, K033363). The country of origin for the data is implicitly the USA (Smith & Nephew's location), and it is retrospective in the sense of referencing previously cleared devices and established design control processes.
• Conclusion: The FDA reviewed the submission and determined the device is substantially equivalent to the identified predicate devices, allowing it to be marketed.

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