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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™ 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 Evolis®/GMK® knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, traumator arthritis, theumatord arthritis.
• Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

The GMK Sphere Revision is a Medacta GMK line extension to provide a larger product offering. The subject devices are designed for cemented use in total knee arthroplasty procedures. The GMK Sphere Revision system includes:

• Femoral components, left and right, sizes from 2 to 8, with or without TiNbN coating; ●
• . Tibial trays, left and right, sizes T3I4 and T4I3, with or without TiNbN coating;
• Distal wedges, 4 sizes (2, 3-4, 5-6, 7-8) with thicknesses 4, 8, 12, 16 and 20 mm; ●
• Posterior wedges, 6 sizes (2, 3-4, 5, 6, 7, 8) with thicknesses 4, 8 and 12 mm; ●
• Offset connectors from 2 to 5 mm. ●

The GMK Sphere Revision implants, both femoral components and tibial trays, are manufactured from cobalt-chromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4 and they are available with or without Titanium Niobium Nitride (TiNbN) coating.

The GMK Sphere Revision wedges and offset connectors, are manufactured from Ti6A14V per ISO 5832-3.

The provided document describes a 510(k) premarket notification for a medical device, specifically a knee prosthesis called "GMK Sphere Revision." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through extensive clinical studies as one might find for novel AI/ML devices or high-risk devices.

Therefore, the information you've requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with the development and validation of sophisticated medical software or AI/ML algorithms, is largely not present in this document. This document emphasizes non-clinical performance testing to show the new device (GMK Sphere Revision) is comparable to existing predicate devices, rather than an AI/ML system proving its diagnostic accuracy against human experts or a gold standard.

Here's how to interpret the available information concerning your request, and where the requested details are not applicable or not provided:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics for clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" are implicitly met by demonstrating that the device's technical characteristics and performance in non-clinical tests are comparable to the predicate devices and meet relevant ISO and ASTM standards for biomechanical properties, wear, and material safety.
• Reported Device Performance: Instead of specific performance numbers against clinical metrics, the document lists the types of non-clinical tests performed. The implication is that the device passed these tests and exhibited performance comparable to the predicate.

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

• Test Set (for performance testing): For a medical device like a knee prosthesis, "test set" refers to the physical samples of the device components used for biomechanical and material testing. The document does not specify the number of samples used for each non-clinical test.
• Data Provenance: Not applicable in the context of clinical data for this type of submission. The tests are benchtop, in-vitro, or material characterization tests.

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

• Not Applicable. This document is for a traditional medical device (implantable prosthesis), not an AI/ML diagnostic system that requires expert ground truth labeling of patient data.

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

• Not Applicable. Adjudication methods are relevant for human reader studies or expert consensus for AI/ML ground truth, neither of which are described here.

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:

• No. This is a 510(k) for a physical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are not relevant and were not performed.

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

• Not Applicable. This is not an algorithm-based device.

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

• Not Applicable. For the non-clinical tests, the "ground truth" is defined by the accepted and validated methodologies of the ISO and ASTM standards themselves (e.g., how much force a component can withstand, how much wear occurs under specified conditions, etc.). There is no clinical "ground truth" such as pathology or outcomes data presented here.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set for an algorithm is involved.

In summary, the provided FDA 510(k) clearance letter and its summary are for a conventional orthopedic implant. The substantial equivalence pathway for such devices primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and comparable performance (through non-clinical bench testing) to a predicate device. It does not involve the types of studies, ground truth establishment, or expert-based evaluations typically associated with AI/ML-driven medical devices.

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The Evolis/GMK knee prosthesis is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases:

• · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis or polyarthritis.
• Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate.

In case a semi-constrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

GMK Sphere/Spherika can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases:
· Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis.

• · Collagen disorders, and/or avascular necrosis of the femoral condyle.
• · Moderate valgus, varus, or flexion deformities.

The purpose of this submission is to notify the FDA of the GMK SPHERE range Extension, that includes GMK Spherika Femurs and GMK Fixed Tibial Trays Plus.

Subject devices are sterile implantable devices designed for tricompartment of the natural knee joint.

The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures.

GMK Spherika femoral component is an implantable device intended to be used in case of total knee arthroplasty to replace the femoral articular surfaces of the knee joint. GMK Spherika femoral component can be used in Kinematic Alignment surgical technique. The Kinematic Alignment surgical technique was already cleared in K173890.

GMK Tibial Trays Plus are a range extension of the GMK Tibial trays already cleared, in details they are fixed intermediate sizes of the tibia trays.

The subject devices are a line extension to Medacta previously cleared implants: GMK Sphere (K121416), GMK Sphere Extension (K140826), GMK Knee Prosthesis- GMK Sphere Tibial Insert Flex (K162035), GMK Sphere - Kinematic Alignment ( K173890), GMK Sphere CR Tibial Inserts (K181635), GMK Sphere E-Cross (K202022), GMK Total Knee System-TiNbN Coating (K202684), Medacta International SA, GMK Total Knee System (K090988), GMK Line Extension (K120790), GMK Narrow K122232, MK Extension (K142069) and

The subject devices are manufactured with the same materials of the previous cleared femurs and tibial trays.

The submission includes the following implants:

• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• . GMK Spherika Femoral Component Anatomical, Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4)
• GMK Spherika Femoral Component Anatomical, Left and Right, Sizes from 1 to 7 and . from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes ● made in Co-Cr-Mo (ISO 5832-4)
• Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated

The subject devices, both Femoral Components and Tibial Trays, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Allov.

In regards to the Femurs and Tibial Trays TiNbN Coating, they are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating.

Like the predicate tibial trays devices, the tibial trays plus subject of this submission have a Fixed Tibial Tray Plug that is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms.

The subject device also includes the utilization of the GMK Sphere E-cross tibial insert FLEX, already cleared (K202022) in case of retention of an efficient posterior cruciate ligament in the Kinematic Alignment configuration.

The Kinematic Alignment surgical technique was already cleared in K173890.

In this case there are no new implants or instruments, GMK Sphere E-cross tibial insert FLEX, already cleared (K202022).

The provided text describes mechanical performance tests for knee implants, not a study evaluating an AI/ML powered device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or human-in-the-loop performance for an AI/ML device.

The document is a 510(k) summary for a submission by Medacta International SA for a knee prosthesis, the "GMK-SPHERE Spherika Femurs and Tibial Trays plus". It focuses on demonstrating substantial equivalence to already cleared predicate devices through design comparisons and non-clinical mechanical testing, which is typical for traditional (non-AI/ML) medical devices.

No information about an AI/ML device, its acceptance criteria, or a study proving those criteria are met is present in this regulatory document.

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