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MOTO Medial, MOTO Lateral and MOTO Sphere 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 compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The MOTO Partial Knee System Extension is a Medacta partial knee prosthesis portfolio extension including implantable devices, provided individually packed, sterile and single-use. Specifically, the purpose of this submission is to gain the clearance for: MOTO Sphere femoral components, made of Co-Cr-Mo according to ISO 5832-4 and available in 5 sizes with or without TiNbN coating. They are intended to replace the medial or lateral femoral compartment of the natural knee joint and must be implanted in combination with the tibial component of MOTO Medial or MOTO Lateral (K162084, K183029 and K213071); 7mm thick MOTO Medial and MOTO Lateral inserts fixed made of E-cross, available in 8 sizes and intended to be coupled with the subject MOTO Sphere femoral components as well as MOTO Medial or MOTO Lateral tibial components (K162084, K183029 and K213071).

The provided document is a 510(k) Clearance Letter from the FDA for the MOTO Partial Knee System Extension. This document grants clearance for a medical device (knee implant components) and describes its intended use and comparison to predicate devices, but it does not contain the detailed acceptance criteria and study results you are asking for regarding a software or AI-based device.

The prompt specifically asks for details about a study that proves the device meets acceptance criteria, including information on "human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)", "ground truth," "training set," etc. These are all concepts related to the validation of Artificial Intelligence (AI) / Machine Learning (ML) enabled software as a medical device (SaMD), often used in diagnostics or image analysis.

The MOTO Partial Knee System Extension is an implantable medical device (hardware). The document explicitly states:

• "No clinical studies were conducted." This is a key indicator that a comparative effectiveness study involving human readers or standalone algorithm performance was not performed or required for this type of device clearance.
• The "Performance Data" section lists "Non-Clinical Studies" focusing on mechanical properties and biocompatibility (e.g., fatigue endurance, contact pressures, wear behavior, pyrogenicity, shelf-life). These are standard tests for orthopedic implants, not AI/ML software.

Therefore, because the provided text is for a hardware implant and not an AI/ML software device, I cannot extract the detailed acceptance criteria and study information related to AI/ML performance from this document.

To answer your request, I would need a 510(k) clearance letter or summary for an AI/ML-enabled medical device.

If you were to provide a document for an AI/ML device, the table and information would be structured as follows (but cannot be populated from the current input):

Acceptance Criteria and Study Proof for an AI/ML Device (Hypothetical, based on expected content)

Since the provided document is for a hardware implant (MOTO Partial Knee System Extension) and not an AI/ML-enabled software device, it does not contain the specific performance evaluation metrics, study designs (e.g., MRMC, standalone), or ground truth establishment methods typically associated with AI/ML device validation.

If this were an AI/ML device, the information requested would be typically found in a "Performance Data" or "Clinical Performance" section of the 510(k) Summary, detailing studies conducted to demonstrate the algorithm's accuracy, sensitivity, specificity, or impact on human reader performance.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)

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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 MOTO™ 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 post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The MOTO™ Partial Knee System is a knee prosthesis designed for cemented use in medial compartment 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 post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The femoral component is made of cobalt-chromiummolybdenum (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™ Partial Knee System implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.

The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs for sizes 1 to 7 and three (3) fixation pegs for sizes 8 to 10. Available in ten (10) sizes (1 - 10), the femoral component is offered in both Right Medial (RM) and Left Medial (LM) options for each size.

The Medial Fixed Tibial Insert has a fixed design and is available in five (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).

The Medial Fixed Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability. Available in five (8) sizes (1 - 8), the Medial Fixed Tibial Tray are offered in both Right Medial (RM) and Left Medial (LM) options for each size.

The document provided is a 510(k) premarket notification for the MOTO™ Partial Knee System, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria for device performance in a clinical setting in the way an AI/ML device submission would.

Therefore, the specific information requested in your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, ground truth types) is not applicable to this type of device submission.

The "performance testing" section refers to bench testing and validation of the device's physical properties and manufacturing processes, not clinical or diagnostic performance.

Here's a breakdown of what is available in the document related to "acceptance criteria" and "device performance" in the context of this orthopedic implant:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present acceptance criteria and performance in a table for clinical metrics like sensitivity or specificity. Instead, the "performance testing" section lists various validation studies conducted to ensure the device meets engineering, material, and manufacturing standards. The implied "acceptance criteria" for these tests are generally compliance with the relevant ASTM/ISO standards. The "reported device performance" is essentially that the device passed these tests and is thus considered substantially equivalent to the predicate.

2. Sample size used for the test set and data provenance:

• Not applicable for clinical performance. The "test set" here refers to samples of the device components used in bench testing. The specific number of samples for each engineering test (e.g., number of femoral components tested for fatigue) is not provided in this summary document.
• Data Provenance: Not specified, but standard for device manufacturers conducting in-house or contracted lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This relates to clinical diagnostic performance. For mechanical and material testing, the "ground truth" is established by the test standard itself and the measurements taken by qualified technicians/engineers against the specified parameters.

4. Adjudication method for the test set:

• Not applicable. Adjudication is relevant for subjective assessments or disagreements in clinical interpretation, not for objective engineering measurements.

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 an orthopedic implant, not an AI/ML diagnostic device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is an orthopedic implant, not a standalone AI algorithm.

7. The type of ground truth used:

• Not applicable for clinical performance. For the engineering tests, the "ground truth" is defined by the physical properties of the materials and the mechanical behavior of the device components as measured against established scientific and engineering principles and standards (e.g., ASTM, ISO).

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device's submission as it's not an AI/ML device.

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

• Not applicable. As above, no training set for this device.

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