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Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement.

The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.

The Coonrad/Morrey Elbow Cement Restrictor is designed to impede the flow of bone cement distal to the prosthesis in the intramedullary canal during total elbow arthroplasty. The plugs are molded from polyethylene, and they are inserted into the intramedullary canal prior to the introduction of bone cement and insertion of the appropriate prosthesis.

The provided document describes the Coonrad/Morrey Elbow Cement Restrictor and its substantial equivalence to predicate devices, rather than a study detailing acceptance criteria and performance data for a novel device. Therefore, much of the requested information cannot be extracted directly from this submission.

However, based on the information provided, here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

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

Not applicable. The submission does not detail a "test set" in the context of clinical or standalone performance studies for a novel AI/device. The evaluation was based on non-clinical testing and comparison to predicate devices.

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

Not applicable. Ground truth for a test set is not relevant for this type of submission which focuses on substantial equivalence based on non-clinical performance and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable.

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

No. An MRMC comparative effectiveness study was not performed as this is not an AI-assisted device.

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

A standalone performance study for an algorithm was not done as this is a physical medical device, not an algorithm. However, "Non-clinical testing" was performed, indicating a form of standalone evaluation of the device's physical properties or functional performance in a simulated environment, without human interaction in a clinical setting.

7. The Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" would be established by engineering specifications, material properties, and functional benchmarks derived from standards and the performance of predicate devices. The document states the device "meets performance requirements" and is "as safe and effective as the predicate devices." This implies that the capabilities of the predicate devices and established industry standards served as the benchmark or "ground truth" for evaluating the new device.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device that typically involves a "training set."

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

Not applicable.

Summary from the Document:

The provided document is a 510(k) Premarket Notification for the Coonrad/Morrey Elbow Cement Restrictor, indicating that it is seeking clearance based on substantial equivalence to already legally marketed devices.

The "study" referenced is the "Non-clinical testing":

• Description of Study: Non-clinical testing demonstrated that the device meets performance requirements and is as safe and effective as the predicate devices. This type of testing typically involves bench testing, material characterization, and/or mechanical performance evaluations to ensure the device performs its intended function (impeding cement flow) reliably and safely.
• Predicate Devices: Zimmer Allen Medullary Plugs (K001733) and Zimmer Poly-Plug™ Intramedullary System (K950312).
• Conclusion: The device is equivalent to other commercially available intramedullary cement plugs by virtue of design and functionality, and has the same intended use.

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