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The 23 mm Single Peg Patella Components intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   The device is indicated for cemented application only.

The 23 mm Single-Peg Patella Component has the following features: (1) 23 mm diameter with a 1″ true dome shape with grooves on the underside; (2) single-peg design; (3) made with ArCom® polyethylene. The 23 mm Single-Peg Patellae are intended for inset into the host patella only using bone cement

This 510(k) submission (K061340) for the 23 mm Single-Peg Patella Component does not include any clinical study data or acceptance criteria related to device performance in a clinical setting.

The submission explicitly states under "Clinical Testing": "None provided as a basis for substantial equivalence." This means there was no study performed to evaluate the device's performance against specific acceptance criteria in humans.

Instead, the substantial equivalence was based on non-clinical testing and comparison to legally marketed predicate devices.

Here's a breakdown of the requested information based on the provided text, while also highlighting what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical test set data was provided. Non-clinical testing would have involved specific sample sizes for mechanical tests, but these details are not present in the summary.

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

Not applicable. No clinical test set and thus no ground truth established by experts in this context.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was used.

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

No. This is a medical implant, not an AI software, and no clinical comparative effectiveness study was conducted for this 510(k) submission.

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

Not applicable. This is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in a clinical sense. For non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and biomechanical principles, evaluated through laboratory testing.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an algorithm or machine learning.

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

Not applicable.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The 510(k) submission for the 23 mm Single-Peg Patella Component relies entirely on non-clinical laboratory testing and substantial equivalence to predicate devices to demonstrate safety and effectiveness.

• Non-Clinical Testing: The summary broadly states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This type of testing would typically include mechanical, fatigue, wear, and possibly material characterization tests to ensure the device's physical properties and performance meet design specifications and relevant industry standards. However, specific details about the tests performed, the acceptance criteria for those tests, or the results are not provided in this 510(k) summary.
• Substantial Equivalence: The primary "proof" of meeting acceptance criteria for market clearance is its "substantial equivalence" to three legally marketed predicate devices: Vanquard™ Patella (K040770), Ultra High Molecular Weight Components Knees (K921182), and AGC Revision Knee Prosthesis (K912245). The applicant argues that the "technological characteristics (material, design, sizing, and indications)" are "similar or identical" to these predicates. The FDA concurred with this assessment, allowing the device to be marketed.

In essence, the device was deemed to meet acceptance criteria not through a clinical study demonstrating its performance in patients, but by showing it is functionally similar to already approved devices and performs acceptably in laboratory tests.

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