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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, rheumatoid arthritis.
• Avascular necrosis of femoral condyle.
• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

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

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 Flex insert E-CROSS (Vitamin E Highly Crosslinked UHMWPE) , GMK Sphere CR E-CROSS (Vitamin E Highly Crosslinked UHMWPE) inserts and the Resurfacing Patella (Vitamin E Highly Crosslinked UHMWPE) are a line extension to the GMK Sphere Total Knee System and are:

• o Tibial insert Fixed Sphere FLEX: Left and Right, Sizes 1-6, Thicknesses 10-11-12-13-14-17-20 mm, E-cross-Vitamin-E Highly Crosslinked UHMWPE;
• Tibial Insert Fixed SPHERE CR: Left and Right, Sizes 1-6, Thicknesses 10-11-12-13-● 14mm, E-cross-Vitamin-E Highly Crosslinked UHMWPE;
• Patella resurfacing E-Cross: Sizes 1-4 E-Cross Vitamin-E Highly Crosslinked ● UHMWPE

GMK Sphere implants are sterile implantable devices designed for tricompartmental replacement of the natural knee joint.

They 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 CR Tibial Inserts (K181635) and GMK Total Knee System (K0909889) and GMK Resurfacing Patella Size 4 (K113571).

Liners and Resurfacing patella subject of this submission are implants made of E-Cross (Vitamin-E Highly Crosslinked UHMWPE).

The introduction of the subject items do not require additional instrumentation needed during the surgical procedure and do not alter the indented use or outcomes.

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with clinical outcomes. Therefore, much of the requested information (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, and detailed ground truth establishment for training sets) is not applicable or not provided in this type of submission.

The "acceptance criteria" here primarily refer to the documented performance standards that the device must meet to demonstrate its safety and effectiveness, usually through non-clinical (mechanical) testing, in comparison to the predicate device.

Here's the information that can be extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance tests conducted. The acceptance criteria for these tests are generally that the new device performs equivalently to or better than the predicate devices, or within established limits for such devices, as per relevant standards. Specific numerical acceptance criteria or detailed reported performance values are not explicitly given in this summary document, but the conclusion states that the tests demonstrated safety and effectiveness.

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

• Sample Size for Test Set: Not specified in the summary document. These are typically mechanical, benchtop tests, not clinical trials with patient populations.
• Data Provenance: The tests are "Non-Clinical Studies" and "Performance Data" conducted by Medacta International SA. The exact location of the testing laboratories (country) is not specified, but the company is based in Switzerland. The studies are prospective in the sense that they were designed and executed to support this submission.

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

• Not Applicable. For non-clinical, mechanical testing of medical devices, "ground truth" as established by medical experts (e.g., radiologists) is not relevant. The "ground truth" is defined by established engineering and material science standards and physical measurements.

4. Adjudication method for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation studies where expert consensus is needed to define a definitive diagnosis or outcome. For mechanical engineering tests, results are based on objective measurements and adherence to specified test protocols and 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

• Not Applicable. This submission is for a knee implant component (tibial inserts and patella), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical implant, not a software algorithm.

7. The type of ground truth used

• Defined by Mechanical Engineering Standards and Specifications: The "ground truth" for these tests is based on objective physical properties, mechanical performance criteria, and material characterization standards (e.g., ISO, USP, European Pharmacopoeia). These standards specify the acceptable ranges or thresholds for device performance.

8. The sample size for the training set

• Not Applicable/Not Provided. The concept of a "training set" is relevant for AI/machine learning models. For mechanical device testing, there isn't a "training set" in the same sense. Design and material selection for the device would have involved extensive R&D and prior testing, but this isn't framed as a "training set" within this regulatory context.

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

• Not Applicable/Not Provided. As there is no "training set" in the AI sense, this question is not applicable. The design and material choices are based on established engineering principles and prior research in UHMWPE and knee arthroplasty.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces. The addition of the Constrained Posterior Stabilized (CPS) Vivacit-E® articular surface components will provide surgeons with the ability to obtain moderate varus/valgus and/or internal/external rotation constraint compared to the existing Persona PS articular surfaces. CPS articular surfaces are for use with cemented nonporous tibial and femoral components only.

The Zimmer Persona Personalized Knee System is a medical device. Clinical data and conclusions were explicitly stated as NOT needed for this device. Therefore, the information provided focuses on non-clinical performance (bench testing).

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated in the provided text for individual bench tests. The description refers to "testing" which implies a sample size appropriate for engineering validation (e.g., usually 3-6 samples per test).
• Data Provenance: The data is from "bench testing" conducted by Zimmer, Inc. This is non-clinical, laboratory-based data. No information about country of origin for data or retrospective/prospective nature is applicable as it's not human or animal study data.

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

• Not applicable. The ground truth for this device is based on engineering specifications and validated bench test methodologies, not expert interpretation of clinical data.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench testing, results are typically analyzed against predefined engineering specifications or industry 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:

• Not applicable. This device is a knee prosthesis, not an AI-powered diagnostic or interpretive system. Therefore, no MRMC study involving human readers and AI assistance was conducted.

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

• Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is based on engineering specifications, established industry standards for orthopaedic implants, and the performance characteristics of predicate devices. Bench tests are designed to simulate in-vivo conditions and measure physical properties against these predetermined criteria.

8. The sample size for the training set:

• Not applicable. This device is a knee prosthesis, not a machine learning model. There is no "training set" in the context of an algorithm.

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

• Not applicable, as there is no training set for this device.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous coated tibial baseplate components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplates and all-polyethylene (UHMWPE and VEXLPE) patella components are indicated for cemented use only.

The Zimmer® Persona™ Personalized Knee System is a semi-constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial and patellar bones. The Persona Knee System utilizes a modular design between the tibial plates and articular surfaces.

This submission describes the Zimmer Persona Personalized Knee System. The device is a modular knee prosthesis for resurfacing the articulating surfaces of the femoral, tibial, and patellar bones. The submission focuses on non-clinical performance and a comparison of the device's material characteristics to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: The document does not specify exact sample sizes for each test. However, it indicates that "bench testing outlined below was conducted according to FDA guidance documents," which implies that appropriate sample sizes were used as per relevant standards (e.g., ISO 14243 for wear testing).
• Data Provenance: The data is from non-clinical bench testing performed by Zimmer, Inc., a company located in Warsaw, IN, USA. This is prospective data generated specifically for this submission.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. This submission relies on non-clinical bench testing, not expert-derived ground truth from human data. The "ground truth" for these tests comes from established engineering and biocompatibility standards and predicate device performance.

4. Adjudication Method:

• Not applicable. Adjudication methods are typically used in clinical studies or studies involving human readers/experts to resolve discrepancies in interpretation. This submission focuses on objective bench testing.

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

• No. This submission describes the clearance of a medical device based on non-clinical performance data and substantial equivalence to predicate devices, not a comparative effectiveness study involving human readers or AI.

6. Standalone Performance (Algorithm Only):

• Not applicable. This device is a physical knee prosthesis, not an AI algorithm. Its "performance" is assessed through its mechanical, wear, and material characteristics, not through algorithmic accuracy.

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests is derived from:
  • Established engineering standards: Such as ISO 14243 for wear testing.
  • FDA guidance documents: Which outline appropriate test methodologies and performance expectations for orthopedic implants.
  • Predicate device characteristics: The Vivacit-E material characteristics for the Persona Knee System are stated to be "identical to the predicate Zimmer Vivacit-E Acetabular Polyethylene Liners (K120370)," and other performance metrics are compared to "Persona Conventional UHMWPE articular surfaces."

8. Sample Size for Training Set:

• Not applicable. This submission describes a physical medical device, not an AI system that requires a "training set."

9. How Ground Truth for Training Set was Established:

• Not applicable. As above, there is no AI training set involved.

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