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

This knee replacement system is indicated in the following cases:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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

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The 3DMetal Tibial Cones are indicated for use with the GMK Hinge knee systems, as well as the GMK tibial extension stems and offsets.

Specific indications are as follows:

• · Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis.
• · Post traumatic loss of joint configuration.
• · Considerable loss of function of the knee joint.
• · High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
• · Primary implantation failure.
• · Former revision arthroplasty.

The 3DMetal Tibial Cones are implantable devices to be used as fillers in cases of severe bone deficiency. The subject devices are to be cemented to the GMK Revision and GMK Hinge systems' tibial trays. The subject devices have a full-density layer that prevents cement occluding the pores of the external layer.

The purpose of this submission is to gain clearance for the tibial cones available in centred and eccentric versions. The tibial cones are available in sizes XS, S, M, and L with heights of 20 mm and 25 mm.

The subject devices are intended to be used with the cleared indications for use and the tibial trays of Medacta's GMK Revision (K102437) and GMK Hinge (K130299) systems.

The 3DMetal Tibial Cones are manufactured with titanium alloy substrate, which is identical to predicate devices Regenerex Porous Titanium Sleeve Augments (K072336). However the subject devices' material is processed using electron beam melting (EBM) similar to the material of referenced device Delta TT Acetabular System (K141395).

This document is a 510(k) premarket notification for a medical device called "3DMetal Tibial Cones." The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with specific numerical targets and reported device performance. Instead, it states that "testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance documents." The performance data is described qualitatively, referencing compliance with various ASTM standards.

However, based on the performance data section, we can infer the types of tests conducted and their implied acceptance criteria (compliance with standards).

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

The document does not specify the sample size for any of the non-clinical mechanical or pyrogenicity tests. It simply states that "testing was conducted to written protocols."

The data provenance is from non-clinical laboratory testing performed by the manufacturer, Medacta International SA. There is no mention of country of origin for the data beyond the manufacturer's location (Switzerland), and the studies are inherently prospective as they were conducted to support this submission.

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

Not applicable. This submission focuses on the substantial equivalence of a physical medical device (tibial cones) for knee replacement, based on mechanical testing and material properties, not on diagnostic performance or interpretation by experts. Therefore, there is no "ground truth" in the traditional sense established by experts for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As there is no ground truth requiring expert consensus or interpretation, no adjudication method was used.

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 an implantable medical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was 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 or AI-based device.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established scientific and engineering standards and principles demonstrated through laboratory testing. The device is evaluated against:

• Mechanical performance standards: ASTM F1800-12, ASTM F1044-05, ASTM F1160-14, ASTM F1147-05, ASTM F1854-09.
• Biocompatibility standards: Implied by comparison to predicate devices and general standards for implantable materials.
• Material composition standards: ISO 5832-3:1996, ASTM F2924-12a.
• Pyrogenicity standards: European Pharmacopoeia §2.6.14, USP chapter .

Essentially, the ground truth is the device's ability to consistently meet these recognized safety and performance benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device's design and manufacturing processes are based on established engineering principles and material science.

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

Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.

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The LOSPA Modular Knee System is intended for the treatment of diseases as follows:

· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis;

· Post-traumatic loss of knee joint configuration and function;

· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;

· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.

The LOSPA Knee System is intended for cemented application only.

The LOSPA Modular Knee System components are similar to "LOSPA Total Knee System" cleared under K110404, K121037 & K130673 which consists of Femoral Components, Tibial Base plate, Tibial Insert, Patellar Components and related Instrumentation and are Patella Femoral Tibial Knee Prosthesis Systems, intended for cemented total knee arthroplasty, and all have same indications for use. The subject components, is a line extension to include extension stems with stem plugs and offset adaptors, distal and posterior femoral augments.

The provided text describes a 510(k) premarket notification for the LOSPA Modular Knee System. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in relation to an AI system.

The document is a clearance letter from the FDA, a 510(k) summary, and indications for use for a medical device (a knee replacement system). The "Performance Testing - Bench" section describes mechanical tests performed on the physical knee implant components to demonstrate substantial equivalence to predicate devices, not performance criteria for an AI system.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets those criteria from this document.

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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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