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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.

The GMK® HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation of a constrained prosthesis. The GMK® HINGE knee system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability · Considerable loss of function of the knee joint · High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation - · Failure of a primary prosthesis (e.g. infection, loosening) - · Former revision arthroplasty - Post traumatic loss of joint configuration - · Avascular necrosis of femoral condyle. Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws. When a GMK® HINGE implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

The GMK Revision & Hinge Extension - TiNbN Coating 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 Revision & Hinge Extension - TiNbN Coating includes the following implants: . GMK Revision Femoral Component TiNbN coated, Standard and Posterior Stabilized, Left and Right. Sizes from 1 to 6 - GMK Revision tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6 - GMK Revision SC peg TiNbN coated, sizes from 10 to 26 mm ● GMK Hinge Femoral Component TiNbN coated, Left and Right, Sizes from 1 to 6 ● GMK Hinge tibial tray TiNbN coated, Left and Right, Sizes from 1 to 6 - GMK Hinge post extension TiNbN coated, sizes from 10 to 26 mm - Screwed tibial augmentations Ti6A14V, from 0 to 6 for thicknesses 5 and 10 and sizes from 1 to 6 for thicknesses 15 and 20 mm - Femoral posterior augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 5, 8, and 10 . mm - Femoral distal augmentations Ti6A14V, sizes from 1 to 6 thicknesses 4, 8, 12, 16 and 20 mm The GMK Revision & Hinge - TiNbN Coating implants, both femoral components and Tibial trays, are manufactured from cobalt-chromium-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. The external and internal bushes, inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) according to ISO 5834-2:2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms. The GMK Revision SC peg & Hinge post extension, as well as the GMK hinge post and internal pivot inside the GMK Hinge - TiNbN Coating femoral component, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-12:2019 Implants for Surgery -Metallic Materials-Part 12: Wrought cobalt-chromium-molybdenum Alloy with Titanium Niobium Nitride (TiNbN) coating. The GMK Revision & Hinge augmentations, both tibial and femoral, are manufactured from Ti6A14V per ISO 5832-3:2016 Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.

This document (a 510(k) clearance letter) describes a medical device, the GMK Revision & Hinge Extension - TiNbN Coating, which is a line extension of an existing total knee arthroplasty system. It details the device's characteristics, indications for use, and a comparison to predicate devices, stating it is substantially equivalent. However, this document is a regulatory submission for a physical medical device (knee implant components), not an AI/ML-driven device or diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study methodologies (like sample size for test sets, expert ground truth establishment, MRMC studies, standalone performance), and training set details are not applicable to this type of device clearance. The document focuses on demonstrating physical and material equivalence and performance through non-clinical (mechanical, wear, biocompatibility) testing, not on evaluating algorithmic performance on image data.

Here's a breakdown of why the requested information cannot be provided from the given text:

• Acceptance Criteria & Reported Performance: The document provides "Performance Data" which lists various non-clinical (laboratory) tests performed on the device components (e.g., wear behavior, mechanical performance, modular connection evaluations). However, it does not present these in a table with specific quantitative acceptance criteria or detailed results in the way one would for an AI/ML diagnostic's performance metrics (e.g., sensitivity, specificity, AUC). The conclusion simply states that testing was done "in support of a substantial equivalence determination."
• Sample Size (Test Set) and Data Provenance: Not applicable. These relate to studies on a test dataset for an AI model. For this device, "testing" refers to physical product testing (e.g., a certain number of prosthetic components subjected to specified mechanical loads).
• Number/Qualifications of Experts (Ground Truth): Not applicable. This pertains to human interpretation of data for AI model validation.
• Adjudication Method: Not applicable. This is for resolving discrepancies in expert labeling of data.
• MRMC Comparative Effectiveness Study: Explicitly stated: "No clinical studies were conducted." Therefore, no MRMC study or effect size data exists.
• Standalone Performance: Not applicable. This refers to the performance of an algorithm without human intervention. The device is a physical knee prosthesis, used by surgeons.
• Type of Ground Truth: Not applicable for an AI/ML context. For this medical device, the "ground truth" for its performance is established through engineering standards, mechanical testing protocols, and material science specifications.
• Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm.
• How Ground Truth for Training Set was Established: Not applicable.

Summary of Relevant Information from the Document:

• Device Type: Physical medical device (knee implant components), not an AI/ML system.
• Regulatory Pathway: 510(k) Premarket Notification, claiming substantial equivalence to predicate devices.
• Performance Data (Non-Clinical): Various laboratory tests were conducted, including:
  • TiNbN coated Femoral Components Wear Behavior
  • Evaluation of modular tapered connection
  • Femoral Modular Connection
  • TiNbN Coating Excessive Ions Release
  • TiNbN coated Femoral Component Mechanical Performances
  • TiNbN coated Tibial Trays Mechanical Performances
  • TiNbN coated Tibial Trays Connection with the insert
  • Tibial Tray Modular Connection
  • Tibial Modular Connection
  • GMK Revision TiNbN coated SC Peg Mechanical Performances
  • GMK Hinge TiNbN coated Post Extension Mechanical Performances
  • Ti6A14V Femoral Augmentations Validation
  • Posterior Wedge Screw Design Validation
  • Ti6Al4V Tibial Augmentation Validation
  • Pyrogenicity testing (Bacterial Endotoxin Test, Pyrogen test)
  • Biocompatibility assessment.
• Clinical Studies: "No clinical studies were conducted."
• Ground Truth: For this type of device, ground truth is established through adherence to biomechanical and material standards (e.g., ISO standards for materials, recognized test protocols for wear and mechanical strength).
• Acceptance Criteria (Implied): Substantial equivalence to predicate devices and meeting established engineering and material standards for safety and performance (e.g., ISO standards for wear, strength, biocompatibility). Specific quantitative acceptance criteria are not detailed in this clearance letter but would be present in the full 510(k) submission.

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The GMK® Total Knee System 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, traumatic arthritis, rheumatoid 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 GMK HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.

The GMK HINGE knee system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability

· Considerable loss of function of the knee joint

· High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation

· Failure of a primary prosthesis (e.g. infection, loosening)

· Former revision arthroplasty

· Post traumatic loss of joint configuration

· Avascular necrosis of femoral condyle.

Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws.

When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

The GMK Revision-Femoral Distal Augmentations have been designed to allow the surgeon to selectively fill bone deficiencies and to aid in adjusting the height of the joint line. In addition, these augments can help to achieve a stable fixation between the implant and the bone.

The purpose of this submission is to gain clearance for additional femoral distal augmentation thicknesses of 12 mm, 16 mm, and 20 mm, which can be used with the 5 mm thick posterior wedges. The previously cleared femoral distal augmentation sizes (referred to K102437 as femoral distal wedges) were for 4 mm, 8 mm, and 12 mm.

The subject devices are matched with the GMK Revision STD femoral component, GMK Revision PS femoral component and the GMK Hinge femoral component. The distal wedge is fixed to the femoral component through a thickness-specific titanium alloy screw packaged with it.

The GMK Revision-Femoral Distal Augmentations are manufactured from high nitrogen stainless steel, which is identical to the predicate device GMK Revision and GMK Hinge femoral distal augmentations (also referred to as wedges) which are available in size range 1-6 with thicknesses of 4 mm, 8 mm, and 12 mm.

This document is a 510(k) premarket notification for a medical device called "GMK Revision-Femoral Distal Augmentation." It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that defines and proves the device meets specific performance acceptance criteria.

The information provided does not include:

• A table of acceptance criteria and reported device performance in the context of diagnostic or AI-driven performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information on experts (number, qualifications, adjudication methods) for establishing ground truth.
• Details about Multireader Multicase (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specific ground truth types like pathology or outcomes data.

Instead, this document focuses on mechanical and manufacturing characteristics, and a comparison with a predicate device to argue for substantial equivalence.

Here's a breakdown of what is available related to performance and testing:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense for an AI/diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, it discusses the device's ability to withstand physiological loads and maintain stability.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients." The performance data refers to "worst-case product configuration" for mechanical testing, implying a limited number of physical prototype tests. For LAL testing, no sample size is given.
• Data Provenance: Not specified regarding country of origin or whether it's retrospective/prospective. The testing appears to be lab-based mechanical and biological testing of the device itself (or its material), not clinical trial data.

3. Number of Experts and Qualifications:

• Not applicable. This document does not describe studies involving human readers or expert evaluation as part of device performance assessment.

4. Adjudication Method:

• Not applicable. No expert consensus or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is a premarket notification for a knee implant component, not an AI or diagnostic tool. Therefore, no MRMC study or AI assistance effectiveness is discussed.

6. Standalone (Algorithm Only) Performance:

• No. This is a physical medical device; there is no algorithm or AI component discussed for standalone performance.

7. Type of Ground Truth Used:

• For the mechanical tests (withstanding loads, fretting, stability), the "ground truth" is derived from the physical properties and behavior of the device under simulated physiological conditions.
• For biocompatibility, the "ground truth" is established through standardized biological safety testing (e.g., LAL testing) and material characterization.

8. Sample Size for the Training Set:

• Not applicable. There is no AI component or "training set" in the context of this device.

9. How Ground Truth for the Training Set was Established:

• Not applicable, as there is no training set.

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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, traumatic arthritis, rheumatoid 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 tibial and on the femoral components.

In case a GMK Revision tibial tray is used, an extension stem must be implanted.

The GMK Revision extension is comprised of tibial trays and tibial augments that can be used in either a Primary or Revision surgery. The only difference between the tibial trays and the tibial trays of the predicate device (K090988) is the addition of four threaded screw holes in the bottom surface to allow the connection with the tibial augments. The tibial trays are equivalent to the predicate device (K090988) in terms of material, sizes, general design features and manufacturing process. The tibial trays are offered in six sizes (1 thru 6) in left and right configuration and are made of Cobalt-Chromium-Molybdenum alloy according to ISO 5832-4:1996. The tibial augments are offered in the same seven different sizes (0 thru 6), and 5mm or 10mm thicknesses as the predicate device (K102437) and have a similar shape. They are made of High Nitrogen Stainless Steel M30NW ISO 5832-9. The tibial augments are secured to the tibial trays with either 5mm or 10mm screws made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:1996.

The provided document describes the 510(k) premarket notification for the "GMK Revision extension" Total Knee Prosthesis. It discusses the device's design, indications for use, and comparison to predicate devices, focusing on the changes and how its safety and effectiveness are supported.

However, this document does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the context of device performance as typically understood for AI/ML or diagnostic devices (e.g., sensitivity, specificity, accuracy).

Instead, the "Performance Testing" section describes mechanical testing conducted for substantial equivalence. It refers to:

1. Acceptance Criteria and Device Performance:

2. Sample size used for the test set and the data provenance: Not applicable. This was mechanical testing of physical components, not a clinical study on human data. The "test set" would be the specific physical components (worst-case configuration) tested.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineered design specifications, material properties, and relevant ASTM standards, not expert clinical consensus.

4. Adjudication method for the test set: Not applicable. Mechanical testing follows established protocols and 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 device is a knee prosthesis, not an AI/ML-enabled diagnostic or imaging device.

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

7. The type of ground truth used: For mechanical testing, the "ground truth" is defined by the ASTM F1800-07 standard, engineering design specifications, and performance of predicate devices.

8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical fatigue testing of a physical device. Design and engineering principles guide the device's creation.

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

In summary, the provided text details a regulatory submission for a knee prosthesis focused on mechanical performance and substantial equivalence to existing predicate devices, rather than a study involving human data or AI/ML algorithm performance. The "acceptance criteria" and "study" described are confined to the physical, mechanical properties of the implant component.

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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, traumatic arthritis, rheumatoid arthritis or polyarthritis.

• · Avascular necrosis of femoral condvle.
• Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

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

This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision Hybrid Liners. The GMK® Revision Hybrid Liners work with tibial baseplates from the GMK® Total Knee System, femoral components from the Evolis Total Knee System, and an extension stem, offset connector, and tibial wedges from the GMK® Total Knee System -Revision, which are optional for patient specific cases. The GMK Revision Hybrid Liners provide the surgeon with an additional option. The GMK® Revision Hybrid Liners are offered as both Ultracongruent (UC) Fixed and Posterior Stabilized (PS) Fixed in six sizes with five thicknesses from 10 mm to 20 mm. The GMK® Revision Hybrid Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System and articulate with the existing Evolis femoral component. The device is used primarily during an Evolis Revision surgery where the Evolis tibial baseplate is revised with a GMK tibial baseplate and the existing Evolis femoral component stays intact. The GMK Revision Hybrid Liners can also be used if a surgeon desires to couple a GMK tibial baseplate with an Evolis femoral component during a primary surgery. GMK Revision ultracongruent hybrid liners can be used only with standard Evolis femoral components and fixed GMK tibial baseplates. GMK Revision posterior-stabilized hybrid liners can be used only with posterior-stabilized Evolis femoral components and fixed GMK tibial baseplates.

The provided text describes a 510(k) premarket notification for the GMK® Total Knee System - GMK Revision Hybrid Liners. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance data as might be found in a De Novo submission or a PMA.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert involvement, and ground truth establishment is not available in the provided document. The document explicitly states: "No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act."

However, I can extract information about the performance testing that was conducted to demonstrate substantial equivalence.

Here's a breakdown of the available and unavailable information based on your request:

Acceptance Criteria and Device Performance (Based on available information)

Study Details (Based on available information)

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

   • Sample Size: The document states, "The testing was conducted on the worst case component size and option/design based on engineering analysis." This implies a limited sample size, likely focusing on specific configurations deemed most challenging, rather than a broad statistical sample of all possible configurations. No specific number is given.
   • Data Provenance: Not explicitly stated, but as a medical device manufacturer based in Switzerland (Medacta International SA) with a US contact, the testing would likely have been conducted in-house or by a contracted lab, adhering to international standards for medical device testing. It is a prospective test in the sense that the testing was performed specifically for this submission.

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

   • Not Applicable. This type of information (expert consensus, ground truth establishment) is typically relevant for studies involving qualitative assessments or diagnostic accuracy (e.g., image analysis, clinical decision-making). This submission is for mechanical components, and the "ground truth" is established through physical and mechanical testing protocols against engineering specifications and predicate device performance.

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

   • Not Applicable. Adjudication methods are typically used in clinical trials or studies where human interpretation of data is involved. Here, the "adjudication" is the assessment of whether the mechanical tests met pre-defined engineering acceptance criteria.

4. 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 not an AI-assisted device and no MRMC study was conducted.

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

   • No. This is a mechanical implant device, not an algorithm.

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

   • Engineering Specifications and Predicate Device Performance: The "ground truth" for mechanical performance of the GMK® Revision Hybrid Liners was established by:
     • Written protocols with pre-defined acceptance criteria based on standards and FDA guidance.
     • Comparison to the performance of the predicate device systems (GMK® Total Knee System and Evolis Total Knee System).
     • Risk analysis.
   • This is a technical ground truth, not a clinical or pathological one.

7. The sample size for the training set:

   • Not Applicable. This is a mechanical device, not an AI/machine learning algorithm, so there is no "training set."

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

   • Not Applicable. As above, no training set.

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The GMK® Total Knee System 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, traumatic arthritis, rheumatoid arthritis or polyarthritis.
• · Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

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

This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision SC (Semiconstrained) liners. The GMK® Revision SC liners work with components from the GMK® Total Knee System and from the GMK® Revision, a previously cleared Special 510(k) to the GMK® Total Knee System.

The GMK® Revision SC Liners, the subject of this 510(k), are a set of tibial inserts which work with the GMK® Revision femoral PS components and the GMK® tibial baseplates. These liners provide the surgeon with an additional option. The GMK® Revision SC Liners are offered in six sizes with seven thicknesses from 10 mm to 26 mm. The GMK® Revision SC Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System using a support peg made of CoCrMo. The device is used to replace the articular surface of the tibial plateau in the knee joint by limiting the movement of the prosthetic femoral component in translation and rotation. The GMK® Revision SC Liners attached to the GMK® tibial baseplates can also be combined with an extension stem, an offset connector and tibial wedges.

The provided text describes a 510(k) submission for a medical device (GMK® Total Knee System- Revision Semi-Constrained Liners), focusing on proving substantial equivalence to a predicate device rather than a standalone performance study with a defined acceptance criteria for diagnostic accuracy. Therefore, several of the requested sections (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC study) are not applicable or cannot be extracted from this document, as they relate to studies typically conducted for devices that perform a measurement or diagnostic function.

However, I can provide information based on the performance testing conducted to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "The testing was conducted on the worst case component size and option/design based on engineering analysis." This implies a limited physical sample size, likely representative units for specific configurations, rather than a large statistical sample of clinical data.
• Data Provenance: The testing was conducted by the manufacturer (Medacta International SA), likely in their own or contracted testing facilities. This is a retrospective analysis of the device's mechanical and functional properties against established engineering and regulatory benchmarks, not clinical data provenance.

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

Not applicable. This document describes mechanical performance testing of a knee implant component, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions. The "ground truth" for these tests would be the established engineering standards and design specifications.

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 a medical device (implantable knee component), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (implantable knee component), not an algorithm. The "standalone" performance here refers to the device's mechanical integrity and function.

7. The type of ground truth used

The ground truth used for this type of submission is based on:

• Established standards (e.g., ISO, ASTM for medical devices, though not explicitly stated which ones).
• FDA guidance documents for knee prostheses.
• Comparison to the predicate device system (GMK® Total Knee System, K090988), meaning the performance of the new device should be within the established parameters or comparable to the predicate.
• Design specifications and risk analysis outcomes defined by the manufacturer.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

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

Not applicable.

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The GMK® Total Knee System 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, traumatic arthritis, rheumatoid arthritis or polyarthritis
• avascular necrosis of femoral condyle .
• post traumatic loss of joint configuration .
• primary implantation failure. .

The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision femoral components (STD and PS), extension stems with offset adaptors, distal and posterior femoral wedges and tibial wedges.

GMK® Revision femoral components are based on the design of the GMK® Primary femoral components in the original 510(k) submission K090988. The GMK® Revision differs from GMK® Primary by an internal box that allows attachment of the extension stem and the femoral pegs are replaced by two threaded holes to attach femoral wedges.

GMK® Revision femoral components are available in two versions, standard and posterior stabilized femurs, left and right from size 1 to 6. The femoral posterior wedges include sizes 1- 6 with a thickness of 5mm and 10mm while the femoral distal wedges are available in the same size range (1- 6), in thicknesses of 4mm, 8mm and 12mm. Distal and posterior wedge screws are offered in 4mm, 8mm, and 12mm. GMK® Revision femoral components work with the same Tibial baseplates, UC tibial inserts, posterior stabilized tibial inserts and patellas cleared under the original GMK® Total Knee System, K090988.

The offset adaptors are available in 3mm and the associated extension stems are offered in diameters of 11mm, 16mm, 19mm and 20mm with each being 65mm, 105mm or 150mm in length. The tibial wedges are available in size 1- 6 at a thickness of 5mm or 10mm.

The provided text describes a 510(k) submission for a medical device, the GMK® Total Knee System - Revision. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the performance testing conducted to show that the revised device is as safe and effective as its predicate.

Here's an analysis of the provided information:

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

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

• Sample Size for Test Set: Not explicitly stated as a number of devices. The document mentions "worst case component size and option/design" for mechanical testing, implying a limited, targeted selection of components for physical evaluation. This is typical for mechanical testing of orthopedic implants, where physical samples are manufactured and subjected to rigorous testing.
• Data Provenance: The testing was conducted by or on behalf of MEDACTA International SA, based in Castel San Pietro, Switzerland. The tests were performed to FDA guidance and international standards (e.g., ASTM, ISO), which are globally recognized. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission.

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 information is not applicable to this type of submission. For a 510(k) for an orthopedic implant, "ground truth" is established through engineering and material science principles, based on recognized standards (ASTM, ISO) and laboratory testing. There are no clinical images or diagnostic cases requiring expert review for ground truth in this submission.

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

• This information is not applicable as the evaluation of this device involves mechanical and material testing against predefined engineering standards, not human interpretation of clinical data. The "adjudication" is met by the test results falling within the accepted parameters specified by the standards.

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 information is not applicable as this is a physical orthopedic implant, not a diagnostic imaging device or an AI-powered system designed to assist human readers.

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

• This information is not applicable as this is a physical orthopedic implant, not a software algorithm.

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

• The "ground truth" for this device's performance testing is established through recognized engineering standards (ASTM, ISO) and the physical properties of the materials and design. The acceptance criteria for mechanical integrity (e.g., surviving 10 million cycles under physiological loads, acceptable torsional forces) are derived from these established standards and real-world physiological demands on implants.

8. The sample size for the training set

• This information is not applicable. There is no "training set" in the context of mechanical performance testing for a physical orthopedic implant. This term is relevant for AI/machine learning models or statistical models that learn from data.

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

• This information is not applicable, as there is no training set for this type of device submission.

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