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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.
  This device is intended for cemented use only.

The Distal Femoral Spacer is a poly(methyl methacrylate) [PMMA] cement spacer designed to help adjust extension gaps and maintain a uniform cement mantle when used with the femoral component of a cemented total knee prosthesis. It is used in pairs; each Distal Femeral Spacer fits over one of the femoral posts. This creates a defined space between the femoral component and the prepared bone, helping maintain a uniform cement mantle. The Distal Femoral Spacers themselves are then incorporated into the cement mantle by the polymerizing bone cement. The Distal Femoral Spacer is available in 2mm and 4mm thicknesses.

The provided document K050105 is a 510(k) summary for the NexGen® Complete Knee Solution Distal Femoral Spacers. It describes a medical device, its intended use, and its comparison to a predicate device. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert ground truth, or adjudication methods that would typically be found in a study proving a device meets acceptance criteria.

The document explicitly states:

• "Non-clinical performance testing was not required for this device."
• "Clinical data and conclusions were not needed for this device."

This means that the device's clearance was based on substantial equivalence to a predicate device, and not on the results of a performance study with acceptance criteria. Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

Explanation: The 510(k) summary states that "Non-clinical performance testing was not required for this device" and "Clinical data and conclusions were not needed for this device." The clearance was based on substantial equivalence to a predicate device (ZCA® All-Poly Acetabular Cup, Snap-In (PMMA spacer), K030153). Therefore, there are no specific acceptance criteria or performance results from a study to report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable. No performance study data was generated or analyzed.

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)

• Number of Experts: Not applicable. No ground truth was established for a test set, as no performance study was conducted.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No test set or adjudication 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

• MRMC Study: No. This is a physical medical device (knee spacers), not an AI/software device involving human readers or AI assistance.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not a software algorithm; it is a physical implantable device.

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

• Type of Ground Truth: Not applicable. No performance study requiring a gold standard or ground truth was conducted for this 510(k) submission.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. This is not an AI/machine learning device, so there is no training set.

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

• Ground Truth Establishment (Training Set): Not applicable.

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