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The Duracon® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, irreparable fracture of the knee. These products are intended to achieve fixation with and without the use of bone cement.

The device includes femoral, tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

The provided text describes the Duracon® Total Knee System and its regulatory submission (K032163) for an additional indication for use without bone cement. The study described focuses on demonstrating equivalence to predicate devices rather than a typical clinical study with acceptance criteria for device performance in patients.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance (e.g., pain reduction, range of motion improvement) that a new device would need to meet through a clinical study. Instead, the "acceptance criteria" are related to established engineering and material standards for knee prostheses. The "reported device performance" refers to the results of testing demonstrating compliance with these standards.

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

The document discusses "research and development testing" on the components of the Duracon Total Knee System. This implies in-vitro or bench testing on a sample of the manufactured devices or their materials.

• Sample Size: Not explicitly stated. The testing would have been conducted on a representative sample of device components (e.g., a certain number of porous coatings, baseplates, UHMWPe samples).
• Data Provenance: The testing was likely conducted in a laboratory setting by Howmedica Osteonics Corp. (the manufacturer) or a contracted lab. It is not clinical data from patients, therefore concepts like "country of origin" or "retrospective/prospective" don't apply in the human data sense.

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

This information is not applicable as the "study" described is not a clinical study involving human patients, and therefore, there is no "ground truth" to be established by experts in a clinical context (e.g., radiologists, pathologists). The "ground truth" in this context is the physical and mechanical properties of the device components as measured by scientific instruments and methods, compared against engineering specifications.

4. Adjudication Method for the Test Set:

This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used for expert review of clinical cases.

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

No, an MRMC comparative effectiveness study was not done. The study described is a benchtop engineering and materials testing study, not a clinical study involving human readers or patients.

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

This concept is not applicable. The device is a physical knee implant, not a software algorithm or AI-driven system.

7. The Type of Ground Truth Used:

The "ground truth" used for this type of submission is:

• Engineering Specifications and Standardized Test Methods: Compliance with established industry standards and guidance documents (e.g., from the FDA) for mechanical strength, material properties, porous coating characteristics, etc.
• Predicate Device Performance: Documentation that the proposed device performs equivalently to the legally marketed predicate devices, particularly regarding its mechanical and material aspects.

8. The Sample Size for the Training Set:

This concept is not applicable. There is no "training set" in the context of an engineering and materials testing study for a physical medical device. Training sets are relevant for machine learning algorithms.

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

This concept is not applicable for the same reasons as point 8.

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The Duracon® Total Knee System components are for use in total knee arthroplasty to relieve pain and restore knee function for indications such as: noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, irreparable fracture of the knee. These products are intended to achieve fixation without the use of bone cement.

The device includes femoral, tibial and patellar components of a total knee system. These components are used for the replacement of the bearing and/or articulating surfaces of the distal femur, proximal tibia and patella to relieve pain, instability and the restriction of motion due to degenerative bone disease, including osteoarthritis, rheumatoid arthritis, failure of other devices or trauma.

I am sorry, but based on the provided text, there is no information about a study that used a test set, expert readers, or ground truth to evaluate device performance. The document describes a 510(k) premarket notification for a medical device (Duracon® Total Knee System with Peri-Apatite Coating) and primarily focuses on demonstrating substantial equivalence to a predicate device through engineering testing and material characterization.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to a clinical or AI-based study.
• Sample size used for a test set or its provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• MRMC comparative effectiveness study results.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text only mentions:

• Summary of Data: "A risk analysis and research and development testing have been performed to demonstrate equivalence of the proposed products to the predicate devices. The testing includes porous coating characterization, baseplate fatigue testing, contact area / stress analyses; range of motion range of constraint testing; locking mechanism testing; UHMWPe material properties in accordance with the Class II Special Controls Guidance Document... The testing also includes safety testing for the Peri-Apatite coating."
• Conclusion of Data: "The results demonstrate that the Duracon Total Knee System with Peri-Apatite coating is safe and effective for total knee replacement without bone cement."

These are engineering and material-specific tests, not studies involving human readers or AI algorithms to interpret data or make diagnoses.

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