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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 compartment of the joint is affected due to the compartmental primary degenerative or posttraumatic decenerative disease, previous tibial condule or plateau fractures, deformity or revious arthroplasty.

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, 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™ Partial Knee & MOTO™ PFJ Systems is a line extension to provide a larger product offering. The subject devices are sterile implantable devices designed for cemented use in partial knee arthroplasty procedures. The MOTO™ Partial Knee & MOTO™ PFJ Systems extension includes:

• Medial femoral components TiNbN coated, left medial, sizes from 1 to 10; ●
• Lateral femoral components TiNbN coated, sizes from 1 to 7; ●
• Medial tibial inserts fixed E-cross, left medial and right medial, sizes from 1 to 8 and 6 thicknesses ● from 8 to 14;
• . Lateral tibial inserts fixed E-cross, sizes from 1 to 8 and 6 thicknesses from 8 to 14;
• . Patello Femoral Joint TiNbN coated, left and right, sizes from 1 to 6;
• MOTO Patella E-cross, 6 sizes. ●

The subject femoral components, as well as the patello femoral joint, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 with Titanium Nitride (TiNbN) coating.

The subject tibial inserts, as well as the MOTO patella, are made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).

This looks like a 510(k) Summary for a medical device, which typically describes a device's substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study proving the device meets those criteria from scratch. The document states that no clinical studies were conducted (page 7). Therefore, it directly addresses several of your points by stating they are not applicable or were not performed.

Here's a breakdown of the provided information relative to your request:

Acceptance Criteria and Study for This Specific Device

The document does not present a table of acceptance criteria for a new, independent performance study and then report the device's performance against those criteria. Instead, it asserts substantial equivalence to predicate devices based on technological characteristics and performance testing. The "performance testing" described (Section VII) is primarily non-clinical and aims to demonstrate that the new variations of the device (e.g., new materials for inserts, new coatings for femoral components) perform similarly to or are at least as safe and effective as the existing predicate devices.

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

This information is not provided in the document in the format requested for this specific device as if it were an entirely new product undergoing de-novo evaluation against explicit performance criteria. The document states:

• "Based on the risk analysis, performance testing were conducted to written protocols." (page 6)
• It lists various performance tests conducted (e.g., mechanical performance, wear behavior, static ML shear, AP draw test, contact pressures, constraint comparison) and notes they were performed "according to ASTM F2083" or "European Pharmacopoeia." These standards inherently contain their own acceptance criteria, but these specific criteria and the detailed results showing compliance are not presented in this summary document. The summary only states that these tests were performed to support substantial equivalence.

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

• Sample Size: The sample sizes for the non-clinical performance tests are not specified in this summary document.
• Data Provenance: The studies are non-clinical (laboratory testing) and were conducted to support the substantial equivalence of device modifications. The country of origin of the data is not explicitly stated beyond Medacta's corporate locations (Switzerland and USA).

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

This is not applicable. Since no clinical studies were conducted and the performance tests are mechanical/material-based, there was no "ground truth" derived from expert consensus on patient data.

4. Adjudication method for the test set

This is not applicable for the same reason as point 3.

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

This is not applicable. This device is an orthopedic implant (knee prosthesis components), not an AI diagnostic imaging device.

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

This is not applicable. This device is an orthopedic implant.

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

This is not applicable in the traditional sense of clinical ground truth. For the non-clinical performance testing, the "ground truth" would be established by the specifications in the relevant ASTM standards or pharmacopoeia, which define the expected performance or material properties.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as point 8.

Summary of what is available from the document:

• No Clinical Studies: The document explicitly states, "No clinical studies were conducted" (page 7).
• Basis for Clearance: Substantial equivalence is claimed based on a comparison of technological characteristics (indications for use, sizes, shape, fixation, biocompatibility, device usage, sterility, shelf-life, packaging) with predicate devices (K162084, K183029, K200122).
• Non-Clinical Performance Testing: A range of non-clinical tests were performed (mechanical, wear, static shear, contact pressure, constraint) on the specific components with new materials/coatings (TiNbN coated femoral components/PFJ, E-Cross tibial inserts/patella). These tests were conducted according to various standards (e.g., ASTM F2083, European Pharmacopoeia $2.6.14, USP chapter ). The specific results are not detailed, but the conclusion is that these data support substantial equivalence.
• No "Acceptance Criteria Table" or "Study Proving Acceptance" in the requested format: The document does not provide a direct table of acceptance criteria and reported performance outcomes for a de novo submission. Instead, it supports substantial equivalence within the framework of a 510(k) by demonstrating that new device elements perform comparably to previously cleared predicate devices according to established engineering and material standards.

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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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