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The 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 semiconstrained liner is used, an extension stem must be implanted both on the fibial and on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted.

The GMK Sphere CR Tibial Inserts are a line extension to the GMK Sphere Total Knee System and are comprised of the following products:

• Tibial insert fixed CR: Left and Right, Sizes 1-6, Thicknesses 10-11-12-13-14 mm, UHMWPE (ISO 5834-2) Type 1.

The purpose of this submission is to introduce a new GMK Sphere insert design that does not require Posterior Cruciate Ligament (PCL) release. The introduction of the subject items does not require additional instrumentation needed during the surgical procedure (with exception of the specific CR trial tibial inserts) and does not alter the intended use or outcomes.

The provided text is a 510(k) summary for a medical device (GMK Sphere CR Tibial Inserts). It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the context of an AI/ML algorithm or software.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, or training set information. This document pertains to the regulatory clearance of a physical medical implant (a knee replacement component) through a substantial equivalence pathway, not the evaluation of an AI-powered diagnostic or predictive tool.

The "Performance Data" section mentions mechanical data, constraint measurements, contact pressures, dynamic physiological loads, and range of motion, but these are related to the physical properties and biomechanical function of the implant, not the performance of an algorithm.

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The 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, theumatoid 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 Sphere Tibial Insert Flex is a line extension to the GMK Sphere Total Knee System and is comprised of the following products:

• Tibial Insert Fixed Flex: Left and Right, Sizes 1-6, 10-20mm (including intermediate ● sizes 11mm and 13mm) UHMWPE (ISO 5834-2)Type 1, Fixation Screw: Ti6Al5V (ISO 5232-3)

The purpose of this submission is to modify the surgical technique provided to surgeons to show that the GMK Sphere Tibial Insert Flex titanium screws' use as optional, instead of required. This technique modification does not alter the intended use or outcomes.

This document describes a 510(k) premarket notification for the GMK® Sphere Tibial Insert Flex. The purpose of this submission is to modify the surgical technique for the device, making the use of titanium screws optional instead of required, and to introduce additional thickness sizes.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and the lack of new safety and effectiveness questions arising from the proposed changes. The performance is assessed through various tests and analyses.

   Acceptance Criterion (Implied)	Reported Device Performance
   Biocompatibility	"Biocompatibility testing conducted on the predicate devices for the same material supports the biological safety of the GMK Sphere Tibial Insert Flex. Additional testing was deemed unnecessary."
   Mechanical Performance (with optional screw use)	"Based on the risk analysis, static analysis combined with previous static and dynamic/fatigue test on the clipping system, the GMK Sphere Tibial Insert Flex remains safe and consistent for the intended use though the fixation screw is not used."
   Sterilization Validation	One of the analyses conducted or leveraged was "Sterilization Validation". No specific performance outcome is detailed, but the inclusion implies it met established standards.
   Shelf Life	One of the analyses conducted or leveraged was "Shelf Life". No specific performance outcome is detailed, but the inclusion implies it met established standards. The shelf life is stated as 5 years in the comparison table (Page 5).
   Pyrogenicity (for applicable components, if claimed non-pyrogenic)	"Limulus Amebocyte Lysate (LAL) testing was evaluated to establish the device meets pyrogen limit specifications." (Medacta does not intend to claim "non-pyrogenic" for Femoral Distal Augmentations, implying pyrogenicity was evaluated where relevant but not necessarily claimed as part of the primary device's properties).
   Safety and Effectiveness (overall, for modified features)	"The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the subject device is adequately supported by the substantial equivalence information, materials information, and analysis data provided..."

2. Sample Size Used for the Test Set and Data Provenance:

   The document describes engineering and laboratory tests rather than clinical studies with human subjects or a "test set" of patient data in the typical sense for an AI/diagnostic device. The tests mentioned include:

   • Static and Dynamic/Fatigue Test on Clipping System (K090988): This test was leveraged from a previous submission (K090988). The sample size (e.g., number of components tested) for this mechanical testing is not specified in this document. The provenance is internal laboratory testing.
   • Sterilization Validation, Shelf Life, LAL testing: These are standard laboratory tests conducted on device materials or products. The sample sizes for these tests are not specified, but would typically involve a statistically appropriate number of units as per relevant international standards (e.g., ISO, ASTM). The provenance is internal laboratory testing.

   There is no mention of country of origin of data or whether it was retrospective or prospective, as it pertains to device testing, not patient data analysis.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   This information is not applicable to this submission. This document pertains to a medical device modification and its mechanical and material properties, not an AI/diagnostic device that requires expert-established ground truth from a test set of patient data. The "ground truth" here is established through engineering principles, material science, and regulatory standards.

4. Adjudication Method for the Test Set:

   This is not applicable as there is no "test set" of patient cases requiring adjudication by experts. The determination of device safety and effectiveness is based on engineering analyses and adherence to material and manufacturing standards.

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

   This is not applicable. This document describes a traditional medical device (knee prosthesis) modification and does not involve AI assistance or human reader performance.

6. Standalone (Algorithm Only) Performance:

   This is not applicable. The device is a physical knee prosthesis, not an algorithm.

7. Type of Ground Truth Used:

   The "ground truth" in this context is established by:

   • Engineering principles and performance standards: For static and dynamic/fatigue testing, the "ground truth" is that the device must withstand certain forces and cycles without failure, as determined by established engineering specifications and benchmarks for similar devices.
   • Material properties and biocompatibility standards: For materials, sterilization, and LAL testing, the "ground truth" is adherence to ISO standards (e.g., ISO 5834-2 for UHMWPE, ISO 5832-3/4 for metals) and regulatory limits for pyrogens, ensuring biological safety.
   • Substantial equivalence: The ultimate "ground truth" for this 510(k) submission is that the modified device is "as safe and effective as the predicate devices" based on the provided data and analyses.

8. Sample Size for the Training Set:

   This is not applicable. There is no "training set" in the context of this traditional medical device submission. The device's design is based on established engineering principles and prior device designs, not machine learning training.

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

   This is not applicable as there is no training set.

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The 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 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 Sphere Total Knee System allows for medial-pivot rotation of the knee joint. The GMK Sphere Extension is a line extension to the GMK Sphere Total Knee System and is comprised of the following implants:

• . Femoral Component Left and Right, Sizes 1+ to 6+ (intermediate sizes) Co-Cr-Mo (ISO 5832-4)
• Tibial Insert Fixed Flex, Left and Right, Sizes 1-6, 11mm and 13mm . (intermediate sizes)

UHMWPE (ISO 5834 -2) Type 1, Ti6Al4V (ISO 5232-3)

The following components of the GMK Sphere have been previously cleared under the K121416 predicate device:

• · Femoral Component Left and Right, Sizes 1-7 Co-Cr-Mo (ISO 5832-4)
• Tibial tray fixed cemented Left and Right, 4 intermediate sizes . Co-Cr-Mo (ISO 5832-4)
• Tibial Insert Fixed Flex and Congruent, Left and Right, Sizes 1-6, 10mm-20mm . UHMWPE (ISO 5834 -2) Type 1, Ti6AI4V (ISO 5232-3)

The following components of the GMK Sphere have been previously cleared under the Medacta GMK Total Knee System, which is the primary predicate to K121416 GMK Sphere:

• . Resurfacing patella Sizes 1-4 (K090988 and K113571)
• Tibial tray fixed cemented Left and Right, Sizes 1-6 (K090988) .
• Primary extension stem Ø11mm / L 65 mm (K090988) and L 30mm (K133630) .

The provided document is a 510(k) summary for a medical device (GMK Sphere Extension) and focuses on demonstrating substantial equivalence to predicate devices, not on proving device performance against acceptance criteria in the context of an AI/ML study.

Therefore, many of the requested sections about AI/ML study details (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it does not describe such a study.

However, I can extract the information related to the performance testing described in the document, which pertains to the mechanical and material performance of the device rather than an AI's diagnostic performance.

Here's the information extracted from the provided text, focusing on the mechanical performance testing described for the device:

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)

• Not Applicable (N/A): This document describes a 510(k) submission for a physical medical device (knee implant components) and its mechanical/material performance testing. It does not involve a "test set" of data in the context of AI/ML or a clinical study with human subjects. The testing was likely conducted in a lab environment.

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)

• Not Applicable (N/A): This information does not apply to the type of performance testing described (mechanical and material attributes of an implant).

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

• Not Applicable (N/A): This information does not apply to the type of performance testing described.

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 (N/A): This type of study is irrelevant for the mechanical and material testing of a knee implant.

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

• Not Applicable (N/A): This concept applies to AI/ML algorithms, not to the mechanical performance of a physical implant.

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

• The "ground truth" for this type of device is the established mechanical and material performance standards (e.g., ISO, FDA guidance documents) and the performance characteristics of the predicate device. The GMK Sphere Extension device was tested to ensure it met these engineering standards and performed comparably to, or better than, the "worst-case predicate device."

8. The sample size for the training set

• Not Applicable (N/A): This pertains to AI/ML models, not the mechanical testing of an implant.

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

• Not Applicable (N/A): This pertains to AI/ML models, not the mechanical testing of an implant.

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