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The ACHIEVE PARTIAL KNEE SYSTEM is intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

• · Moderately disabling joint disease of the knee resulting from painful osteo or post traumatic arthritis.
• · Revision of previous unsuccessful surgical procedures, including prior unicompartmental knee arthroplasty.
• · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The ACHIEVE™ PARTIAL KNEE SYSTEM is a knee joint femorotibial (unicompartmental) prosthesis that is intended for cementless or cemented fixation.
The implant system consists of individually packaged implants: a metal tibial tray (titanium alloy), a polyethylene tibial insert, and a metal femoral component (titanium alloy or cobalt-chromium). All tibial inserts are composed of a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-Linked, VE UHMWPE).

This document does not contain information about the acceptance criteria and study detailed in the request. The document is a 510(k) premarket notification for a medical device (ACHIEVE™ Partial Knee System) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not necessary to demonstrate substantial equivalence.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, ground truth, or MRMC studies, as these aspects are typically associated with clinical trials or performance studies involving AI/software devices.

The document describes engineering tests and analyses performed on the physical components of the knee system. For instance:

• Range of Motion (RoM) Evaluation: Acceptance criteria met per ASTM F2083.
• Femoral Fatigue Testing: Acceptance criteria met per modified ASTM F3210 (10 Mc).
• Tibial Tray Fatigue Testing: Acceptance criteria met per modified ASTM F3140 (10 Mc).
• Component Interlock Strength Testing: Acceptance criteria met for static AP and ML shear testing and static tensile pull-off testing.
• Wear Resistance Evaluation: Wear rate does not represent a new worst-case compared to the predicate device per ISO 14243-3.
• Biocompatibility Assessments: Devices found to be biocompatible per ISO 10993-1 and FDA Guidance.
• Porous Structure Characterization: Meets recommendations of Class II Special Controls Guidance Document per ASTM F1044, ASTM F1147, ASTM F1160, ASTM F1978, and ASTM F1854.
• Shelf-Life Evaluation: Five-year shelf life established per ISO 11607-1 and ISO 11607-2.
• Sterilization Validation: Sterility Assurance Level (SAL) of 10-6 found per ISO 11137-1 and ISO 11137-2.

However, these are all engineering benchmarks for the physical orthopedic implant, not performance metrics for a diagnostic AI/software device.

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The MOTO PFJ is designed for cemented use in partial knee arthroplasty, if there is evidence of enough sound bone to seat and support the components. Patellofemoral replacement is indicated in the following cases:

Osteoarthritis, post-traumatic arthritis, polyarthritis, severe chondrocalcinosis of the patellofemoral joint.

Previously failed surgical attempts (i.e. arthroscopy, lateral release, tibial tubercle elevation, cartilage transplantation). History of patellar dislocation or fracture, resulting in cartilage degeneration of the patellofemoral joint.

Degeneration induced by dysplasia.

If the surgeon evaluates an unequivocal indication for replacement of the patellofemoral joint, with or without a patella resurfacing, which outweighs the risks associated with the surgery, PFJ replacement may be considered, particularly for young patients.

The MOTO PFJ System, subject of this submission, consists of:

• o Patello Femoral Joint, made of Cobalt-Chromium-Molybdenum alloy
• MOTO Patella, made of UHMWPE ●

The MOTO PFJ System is intended for replacement of the femoral trochlea of the patellafemoral joint affected by injury and/or disease process.

The MOTO PFJ System is intended for cemented use only.

The MOTO PFJ System may be used alone or in combination with the MOTO Partial Knee System Unicompartmental Prosthesis (Medial K161741 and Lateral K183029) and GMK UNI Prosthesis (K162084), to treat multiple conditions of patellofemoral and tibiofemoral regions of the natural knee. The Patello Femoral Joint component is designed to articulate with natural patella or with the dedicated MOTO Patella.

The provided document is a 510(k) summary for the Medacta International SA MOTO PFJ System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, this document does not describe an AI/ML medical device. It details a knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.

Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML medical device (such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable or present in this document.

The document focuses on non-clinical performance data to demonstrate substantial equivalence to predicate devices, which is typical for implantable medical devices of this type.

Here's an analysis of what is available and what is not for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

• For an AI/ML device: This would typically involve metrics like sensitivity, specificity, accuracy, F1-score, AUC, etc., with pre-defined thresholds for acceptance.

• For this device: The acceptance criteria are based on mechanical and material performance, and biological safety. The "performance" is demonstrated through various non-clinical tests.

  • Acceptance Criteria (Implied from tests): The device must demonstrate sufficient fatigue endurance under walking and squatting scenarios, proper articular surface congruence, acceptable range of motion, comparable constraints to predicate, comparable contact pressure and areas to predicate, and acceptable wear behavior. Biocompatibility (pyrogenicity, LAL test) is also an acceptance criterion.
  • Reported Device Performance:
    • Non-Clinical Studies (Validation & Characterization):
      • Shape and Dimension Validation
      • Cadaveric workshop validation
      • Fatigue Endurance Test (Walking Scenario) - Test Reports A3
      • Fatigue Endurance Test (Squatting Scenario) - Test Reports A4
      • Articular Surface Fully Congruent - Test Report B1
      • Range of Motion - Test Report B2
      • Comparison within Medacta MOTO Patella and Zimmer NexGen Patella Constraints - Test Report B3
      • Comparison within Medacta MOTO Patella and Zimmer NexGen Patella in relation to Contact Pressure and Areas - Test Report B4
      • Wear Behaviour - Test Report B5
      • Bacterial Endotoxin Test (LAL test) - passed (equivalent to USP chapter )
      • Pyrogen test - passed (according to USP )

  Table (Reinterpreting for this hardware device):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• For an AI/ML device: This would refer to the number of cases/images in the independent test set.
• For this device: The "test set" here refers to the number of physical devices or components subjected to mechanical and biological testing. The document does not specify the exact number of samples for each test (e.g., how many femoral components were tested for fatigue), nor the specific origin of these physical samples beyond being manufactured by Medacta International SA (Switzerland). The testing is "prospective" in the sense that the tests were performed on newly manufactured devices.

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

• For an AI/ML device: This refers to human expert annotations.
• For this device: "Ground truth" is established by engineering specifications, biomechanical principles, and established international standards (e.g., ISO, ASTM, Pharmacopoeia) for material properties and mechanical performance. Experts would be engineers, material scientists, and toxicologists interpreting these results. The document does not list the number or qualifications of these experts analyzing the test results, as it's typically part of the company's internal quality system.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• For an AI/ML device: This refers to resolving disagreements between human annotators.
• For this device: Not applicable. Performance is measured against physical and chemical standards, not subjective human interpretations.

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

• For an AI/ML device: Refers to studies evaluating AI's impact on human performance.
• For this device: Not applicable, as this is a physical implant, not a diagnostic AI. The document explicitly states: "No clinical studies were conducted."

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

• For an AI/ML device: Refers to algorithm performance metrics without human interaction.
• For this device: Not applicable. There is no algorithm. The performance is the inherent mechanical and biological performance of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For an AI/ML device: Refers to the definitive determination of the condition being detected/diagnosed.
• For this device: The 'ground truth' is based on engineering and material science standards and protocols. For example, fatigue endurance is measured against a specific load cycle standard, wear is measured according to a wear test standard, and biocompatibility is measured against pharmacopoeia standards. There is no "disease state" ground truth for this type of device.

8. The sample size for the training set

• For an AI/ML device: Refers to the data used to train the algorithm.
• For this device: Not applicable, as there is no AI/ML algorithm requiring a training set. The "training" for such devices would be the iterative design and manufacturing process, and knowledge gained from previous designs, but not in the context of data used to train a machine learning model.

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

• For an AI/ML device: Refers to how training data was annotated or labeled.
• For this device: Not applicable.

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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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