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The UC-PLUS Solution Unicondylar Knee is intended for use in uni-compartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium uni-compartmental destruction of the knee joint due to idiopathic and posttraumatic degenerative arthritis, traumatic uni-compartmental bone and/or cartilage lesions. It is intended for use with bone cement only.

This knee system consists of a femoral component. The femoral component is fabricated from cast CoCrMo alloy (ASTM F79) and is 4mm thick. Symmetrical, the femoral components can be used on right or left knees. Cement pockets are cast into the components to provide a minimum 1mm cement mantle. The femoral component is available in four sizes.

The tibial component is manufactured from ultra-high molecular weight polyethylene. A cemented metal backed tibial component is also available. Both tibial components are available in five sizes and four thicknesses.

The subject of this Special 510(k) submission is the modification to the implant/bone interface of the femoral component and the elimination of the smallest size femoral component.

The provided text describes a Special 510(k) submission for a modification to an existing medical device, the UC-PLUS Solution Unicondylar Knee. This type of submission focuses on demonstrating that the modified device is substantially equivalent to its predicate device, primarily through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not specify a distinct "test set" in the context of a clinical study or a large number of physical units. The testing described is non-clinical, focusing on the mechanical properties of the femoral component. Therefore, the "sample size" would refer to the number of femoral components subjected to stress and fatigue analysis. This number is not explicitly stated but would likely be a small number of physical samples or computational models.
• Data Provenance: The data is derived from non-clinical tests conducted on the device's femoral component. The provenance is internal testing performed by PLUS Orthopedics. No geographical origin of data (country) is mentioned, nor is it described as retrospective or prospective in a clinical sense.

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

This question is not applicable in the traditional sense of clinical studies with expert-established ground truth. The "ground truth" for the non-clinical tests is established by engineering principles and validated testing methods for material strength, stress distribution, and fatigue. There are no "experts" in the sense of clinical reviewers establishing diagnostic ground truth. The experts involved would be biomechanical engineers or materials scientists conducting the tests and interpreting the results, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple human readers or experts evaluate cases. The study described is a non-clinical, engineering-based assessment.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a mechanical knee implant modification.

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

This question is not applicable. There is no AI algorithm or standalone software component described for this device. The device is a physical knee implant.

7. The Type of Ground Truth Used

The ground truth used in this context is engineering and materials science standards and principles. This involves:

• Physical measurements of stress and strain.
• Fatigue testing results.
• Comparison against established biomechanical performance requirements for knee implants.
• Analytical or computational models demonstrating reduced stress.

8. The Sample Size for the Training Set

This is not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device. The design, analysis, and testing of the implant are based on established engineering principles and prior knowledge.

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 UC-PLUS Solution Unicondylar Knee System is intended for use in unicompartmental degenerative arthritis, local osteonecrosis of the femoral condyle, light to medium unicompartmental destruction of the knee joint due to idiopathic and post-traumatic degenerative arthritis, traumatic unicompartmental bone and/or cartilage lesions. For use with bone cement only.

The UC-PLUS Solution Unicondylar Knee System consists of a femoral component and a tibial component. The femoral component is made of a cobalt chrome cast alloy and is 4mm thick. Symetrical components can be used with right or left. The cement pockets are continuous for a minimal cement thickness of 1mm. The femoral component is available in 5 sizes. The tibial component has a flat articulating surface which provides more flexibility. The all-poly tibial component is made of UHMWPE. A cemented metal back tibial component is also available, made of cobalt chrome cast alloy and a UHMWPE insert. Both tibial components come in 5 sizes, 4 thicknesses each. All materials conform to ASTM standards.

The provided text describes a 510(k) summary for the UC-PLUS Solution Unicondylar Knee System, a knee joint prosthesis. It outlines the characteristics, indications for use, and contraindications. However, the document specifically states that "Biomechanical Testing has been provided" for performance data, but it does NOT actually detail the acceptance criteria or the results of a study to prove the device meets specific performance criteria.

Therefore, I cannot provide the requested table and detailed information about a study proving the device meets acceptance criteria because that information is not present in the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set, data provenance, or the number of experts for ground truth.
• Adjudication methods.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

The document primarily focuses on the description of the device and its regulatory clearance based on substantial equivalence to a predicate device (Sigma Uni-Compartmental Knee System P.F.C.). The mention of "Biomechanical Testing has been provided" indicates that such testing was submitted to the FDA, but the results and acceptance criteria are not included in this summary.

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