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The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak.
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

This Special 510(k) submission is a line extension intended to add offset adapters to the Howmedica Osteonics® Modular Rotating Hinge Knee.

This submission, K060360, describes a line extension for the Howmedica Osteonics® Modular Rotating Hinge Knee, introducing offset adapters. This is a Special 510(k) submission, meaning it relies on a comparison to substantially equivalent predicate devices. Due to the nature of a Special 510(k) for a line extension of an existing device, a full-scale clinical study with acceptance criteria and device performance as typically seen for novel devices is not provided. Instead, the submission focuses on demonstrating equivalent mechanical properties to the predicate devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

This document describes an engineering analysis, not a clinical study involving human subjects or a test set in the traditional sense for evaluating diagnostic or predictive performance. Therefore, there is no mention of a "test set" sample size or data provenance (country of origin, retrospective/prospective). The "test set" would implicitly refer to the physical components of the offset adapters undergoing mechanical testing. The specific number of components tested is not detailed in this summary.

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

This information is not applicable. The "ground truth" for an engineering analysis focused on mechanical properties would be established through established scientific principles, standardized testing procedures, and validated measurement equipment, not through expert consensus in a clinical context.

4. Adjudication Method for the Test Set:

This information is not applicable, as it pertains to clinical studies involving human assessments or diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device is a mechanical knee implant, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a mechanical implant.

7. The Type of Ground Truth Used:

For the engineering analysis, the "ground truth" would be the physical and mechanical properties of the materials and component designs, measured and quantified according to industry standards for orthopedic implants. This would involve stress tests, fatigue tests, and other biomechanical evaluations to ensure the new offset adapters meet the same performance criteria as the existing predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this is not an AI/machine learning study. The development of the offset adapters would have involved engineering design, material selection, and manufacturing processes, but not a data-driven training set in the computational sense.

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

This information is not applicable. As explained above, there is no training set. The "ground truth" for the design and manufacturing of the device relies on established engineering principles, material science, and regulatory standards for medical device safety and efficacy.

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The Modular Rotating Hinge Knee is intended to be implanted with bone cement for the following conditions:

• There is destruction of the joint surfaces, with or without significant bone deformity.
• The cruciate and/or collateral ligaments do not stabilize the knee joint.
• The ligaments are inadequate and/or the musculature is weak.
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

The Modular Rotating Hinge Knee is a tricompartmental knee system. It consists of a stemmed femoral component and a stemmed tibial rotating component connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combination in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve. The metallic components are manufactured from cast cobalt-chromiummolybdenum alloy (Vitallium® Alloy) conforming to ASTM F-75. The polyethylene components are manufactured from Ultra-High Molecular-Weight Polyethylene (UHMWPE) conforming to standard ASTM F648.

The provided text describes a 510(k) premarket notification for a medical device, the Howmedica Osteonics® Modular Rotating Hinge Knee. This submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria, study design, and performance metrics (especially those related to AI or clinical effectiveness studies) are not applicable or not present in the provided document. The document mainly discusses mechanical and material equivalence.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Not explicitly stated. The document mentions "Mechanical and multi-axis static testing," but does not provide details on the sample size of tested implants or components.
• Data Provenance: Not specified, but generally, such testing would be conducted in a laboratory setting by the manufacturer (Howmedica Osteonics Corp.).

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

• Not applicable/Not stated. This type of information is typically relevant for studies involving human interpretation (e.g., medical imaging, clinical diagnosis). For mechanical testing of an orthopedic implant, the "ground truth" is typically defined by engineering specifications and physical measurements, not expert human interpretation.

4. Adjudication method for the test set:

• Not applicable/Not stated. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers. For mechanical and material testing, the assessment usually relies on standardized test methods and quantitative measurements.

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

• No. This is a medical device, a knee prosthesis, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

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

• No. As above, this is a physical medical implant, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this submission is based on engineering specifications, material standards (ASTM F-75, ASTM F648), and comparative mechanical testing results against predicate devices.

8. The sample size for the training set:

• Not applicable/Not stated. This refers to a "training set" in the context of machine learning, which is not relevant for this device.

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

• Not applicable/Not stated. Again, "training set" and its ground truth establishment are concepts for AI/ML, not for the physical medical device described.

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