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The GMK knee cemented prosthesis is designed for cemented application in total knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components.

The use of the cementless GMK femur is limited to cases in which the surgeon considers the bone quality to be sufficient for cementless applications.

The GMK 3D Metal Tibial Baseplate is indicated for cemented application 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
• Collagen disorders, and avascular necrosis of the 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 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.

It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal Tibial Baseplate.

Limitations for use for GMK Sphere/GMK SpheriKA used with kinematic alignment

GMK Sphere and GMK SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Moderate valgus, varus, or flexion deformities.

The GMK Sphere & GMK SpheriKA Cementless is a line extension to the GMK Total Knee System and includes the following devices:

• GMK Sphere Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
• GMK SpheriKA Cementless Femoral Components. Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes);
• GMK SpheriKA ST Cementless Femoral Components, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ (intermediate sizes).

The subject devices are marketed as individually packaged femoral components, designed for cementless use in total knee arthroplasty procedures where the surgeon considers the bone quality to be sufficient for cementless applications.

The GMK Sphere & GMK SpheriKA Cementless implants 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 double-layer coating composed of Titanium plasma spray according to ISO 13179-1 Implants for surgery--Plasma-sprayed unalloyed titanium coatings on metallic surgical implants -- Part 1: General requirements and Hydroxyapatite according to ISO 13779-2 Implants for surgery - Hydroxyapatite - Part 2: Thermally sprayed coatings of hydroxyapatite on the internal surface pockets.

This document refers to the review of a 510(k) premarket notification for the "GMK Sphere & GMK SpheriKA Cementless" knee prosthesis. Based on the provided text, there is no acceptance criteria and study that proves the device meets the acceptance criteria in the traditional sense of evaluating an algorithm's performance against predefined metrics (e.g., sensitivity, specificity for diagnostic devices).

This submission is for a medical device (knee prosthesis), not an AI/ML powered device, and the "performance data" provided refers to engineering and biocompatibility testing, not clinical performance metrics or studies involving human readers or ground truth as would be relevant for AI.

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

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes a comparison to predicate devices, not the setting of specific performance targets (like accuracy, precision, etc.) for an AI/ML algorithm. The "performance data" listed are non-clinical engineering tests (mechanical properties, microscopy, pyrogenicity, biocompatibility, shelf-life) which are not presented with acceptance criteria and results in the format requested.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm's performance evaluation. The "tests" performed are on the physical device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of AI/ML, refers to an independently verified correct answer for a given input. This concept is not relevant to the described premarket notification for a knee prosthesis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no adjudication process described as it pertains to medical image interpretation or similar tasks for an algorithm.

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 document explicitly states: "No clinical studies were conducted." The device is a physical knee implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" as an expert-derived annotation or definitive diagnosis is not relevant to the evaluation of a physical knee implant.

8. The sample size for the training set: Not applicable. There is no AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no AI/ML algorithm or training set.

In summary, the provided FDA 510(k) clearance letter and summary describe the regulatory review for a physical orthopedic implant (a knee prosthesis), not an AI/ML-powered medical device. Therefore, the questions related to acceptance criteria and study design for AI/ML performance evaluation are not applicable to this document. The "Performance Data" section details non-clinical laboratory testing for material properties, sterility, and biocompatibility to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation from AI/ML performance studies.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device

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, theumatoid 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 purpose of this submission is to gain clearance for the GMK Sphere – Kinematic Alignment surgical technique and the technique specific instruments. The proposed kinematic alignment technique is an alternative alignment strategy to the traditional mechanical alignment used for total knee arthroplasty. The purpose of the kinematic alignment technique is to restore normal knee function by aligning the distal and posterior femoral joint lines of the tibial component to those of the normal or pre-arthritic state.

The GMK Sphere - Kinematic Alignment surgical technique will be used with the following components of the GMK Sphere System cleared under K121416, K140826, and K162035:

• o Tibial Insert Fixed Flex: Left and Right, Sizes 1 - 6, 10 - 20 mm (including intermediate sizes 11 mm and 12 mm), UHMWPE Type 1, Fixation Screw: Ti6Al4V;
• Femoral Component Left and Right, Sizes 1 7, Co-Cr-Mo; ●
• Femoral Component Left and Right, Sizes 1+ 6+ (intermediate sizes), Co-Cr-Mo; ●
• Tibial Tray Fixed Cemented Left and Right, 4 intermediate sizes, Co-Cr-Mo; ●
• o Tibial Insert Fixed Flex, Left and Right, Sizes 1 - 6, 10 mm - 20 mm, UHMWPE Type 1, Ti6Al4V:
• o Tibial Insert Fixed Flex, Left and Right, Sizes 1 - 6, 11 mm and 13 mm, UHMWPE Type 1. Ti6Al4V: and
• instrumentation. ●

This document is a 510(k) premarket notification for the "GMK Sphere - Kinematic Alignment" knee replacement system. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, particularly concerning the introduction of a new kinematic alignment surgical technique and associated instruments.

Based on the provided text, the device itself is a "Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis." The study described is a demonstration of substantial equivalence rather than a study proving the device meets clinical acceptance criteria through, for example, a clinical trial or a study assessing AI performance.

Therefore, the information requested in the prompt, especially concerning AI performance metrics, expert roles, and multi-reader multi-case studies, is not applicable to the content of this 510(k) submission.

However, I can extract information related to the engineering and mechanical performance testing of the device, which aligns with device acceptance criteria for a physical medical device.

Here's an interpretation based on the provided document:

Study Type: This is a 510(k) Premarket Notification, which aims to demonstrate substantial equivalence to legally marketed predicate devices, not specifically to prove AI performance or the effect of AI assistance on human readers. The "study" described is a series of non-clinical, benchtop and cadaveric performance tests to ensure the new surgical technique and instruments maintain the safety and effectiveness of the existing GMK Sphere system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that "verification activities, as identified through risk analysis, were conducted to written protocols with pre-defined acceptance criteria." However, the specific numerical acceptance criteria and the detailed reported performance values are not provided in this summary document. Only the types of tests performed are listed.

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

• Sample Size: The document does not specify the numerical sample sizes for the various mechanical and cadaveric tests (e.g., number of components tested, number of cadavers used). It refers to "verification activities... conducted to written protocols."
• Data Provenance: The tests are described as non-clinical (benchtop) and cadaveric, meaning they are laboratory or ex-vivo studies. The document does not provide information about the country of origin of the data beyond implicitly being part of Medacta's internal R&D process (Medacta International SA is based in Switzerland). The data is prospective in the sense that these tests were conducted specifically for this submission.

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

This concept, as it relates to expert review of medical images for ground truth, is not applicable to this type of device and submission. The "ground truth" for mechanical and cadaveric tests would be established by the physical and engineering properties of the materials and the biomechanical behavior observed, measured against engineering standards and specifications. There's no mention of interpreting visual data by human experts for this purpose.

4. Adjudication Method for the Test Set:

Not applicable in the context of expert consensus for imaging or clinical outcomes. Test results are likely adjudicated against pre-defined engineering specifications and standards, not through a human consensus process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study (MRMC) is relevant for AI-powered diagnostic devices where human readers interpret medical images. This 510(k) is for a physical knee implant and surgical technique, not an AI product assisting in diagnosis.

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

No. This concept applies to AI algorithms. The "device" here is a physical implant and surgical instruments.

7. The Type of Ground Truth Used:

The "ground truth" for these tests are:

• Engineering Specifications/Standards: Performance measured against established industry standards and internal design specifications for mechanical properties (e.g., strength, wear, range of motion).
• Biomechanical Principles: For cadaveric studies, the "ground truth" is the observed anatomical and biomechanical response of the tissues and device under simulated physiological conditions.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of an AI algorithm described here. The development of the device (implant and technique) is based on engineering design, material science, and prior surgical experience, not machine learning from a dataset.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant to the provided document.

Ask a specific question about this device

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.

Ask a specific question about this device

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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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 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.

The GMK Sphere Total Knee System allows for medial-pivot rotation of the knee joint and is comprised of the following components: - 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, Ti6Al4V (ISO 5232-3)

The provided text does not contain detailed information about specific acceptance criteria with numerical thresholds, nor does it describe a study where a medical device's performance is measured against such criteria.

Instead, the document is a 510(k) summary for the GMK Sphere Total Knee System, which focuses on demonstrating substantial equivalence to predicate devices. This type of submission relies on showing that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness.

Here's a breakdown of what the document does provide in relation to performance and equivalence:

1. Acceptance Criteria and Reported Device Performance (as inferred from the substantial equivalence claim):

The document states that "A review of the mechanical data indicates that the GMK Sphere is equivalent to devices currently cleared for use and is capable of withstanding expected in vivo loading without failure." This implies that the acceptance criteria are essentially equivalence to predicate devices in terms of mechanical performance and the ability to withstand physiological loads without failure.

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

• Sample Size: Not specified. The document mentions "mechanical data" but does not detail the number of samples or specific tests performed, or the number of simulated uses, etc..
• Data Provenance: Not specified. It's likely laboratory testing.

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

This information is not applicable and not provided. The testing described is mechanical, not involving human interpretation of data for ground truth establishment.

4. Adjudication method for the test set:

Not applicable, as it's mechanical testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is typically for evaluating diagnostic devices where reader performance is a key factor. This document is for a Class II knee prosthesis.

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

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

7. The type of ground truth used:

For mechanical testing of implants, the "ground truth" is typically defined by engineering standards (e.g., ASTM standards for range of motion, fatigue life, strength) and the performance characteristics of predicate devices that have been deemed safe and effective.

8. The sample size for the training set:

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable.

In summary:

The provided text describes a 510(k) submission for a knee prosthesis, which focuses on demonstrating substantial equivalence to previously cleared devices through mechanical performance testing. It does not describe a study that uses acceptance criteria with specific numerical thresholds met by the device's performance in a way that would be typical for, for example, an AI/ML-driven diagnostic device. The "acceptance criteria" here are implicitly linked to the performance of the legally marketed predicate devices, and the "study" is the mechanical testing conducted and reviewed to support the equivalence claim.

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