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The subject Tibial Tray Screw Hole Plugs are intended to occlude all tibial tray screw holes not occupied by bone screws. The Tibial Tray Screw Hole Plugs are factory assembled to the tibial tray screw holes. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. By occluding the tibial tray screw holes, the Tibial Tray Screw Hole Plugs help prevent intrusion of bone cement onto the tibial tray.

The subject Tibial Tray Screw Hole Plugs are a line extension to the existing Howmedica Osteonics Tibial Tray Screw Hole plugs found substantially equivalent in premarket notification K970779. The predicate Tibial Tray Screw Hole Plugs are fabricated from low-density polyethylene, and are circular in design. The subject Tibial Tray Screw Hole Plugs are manufactured from ultra high molecular weight polyethylene, and incorporate a tapered design, with a flat bottom with a lip, tapering to a flat top surface.

The provided text does not contain information about acceptance criteria or a study proving the device meets these criteria in the typical sense of performance metrics for AI/ML devices. This document is a 510(k) submission for a medical device that is a "Line Extension to Howmedica Osteonics Tibial Tray Screw Hole Plugs."

Here's why the requested information cannot be fully provided based on the given text:

• Device Type: The device described is a physical implant component (tibial tray screw hole plugs) for knee replacement surgery, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the concept of "acceptance criteria" and "study performance" as typically applied to AI/ML would not be relevant in the same way.
• 510(k) Process: This is a premarket notification for substantial equivalence (510(k)). The primary goal of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to meet specific performance criteria on a test dataset using AI/ML methodology.
• Content of Document: The document focuses on:
  • Description and technological comparison to a predicate device.
  • Intended use, which is identical to the predicate device.
  • Regulatory classification.
  • The FDA's determination of substantial equivalence.

Given this, I will address the parts of your request that can be inferred or explained in the context of this specific regulatory submission for a physical medical device.

1. A table of acceptance criteria and the reported device performance

This information is not explicitly stated in the document as performance metrics common for AI/ML products (e.g., sensitivity, specificity, AUC). For this type of device (a physical implant component), "acceptance criteria" would typically relate to material properties, dimensions, mechanical integrity, biocompatibility, and sterilization, along with functional equivalence to the predicate device. The document states that the intended use is the same as the predicate and describes technological differences (material and design). The FDA's finding of "substantial equivalence" implies that these underlying performance aspects have been deemed acceptable compared to the predicate device.

Important Note: The document does not provide specific test results or data for these inferred criteria; rather, the basis for approval is substantial equivalence to a predicate.

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

Not applicable. This is a physical device submission, not an AI/ML study. There is no concept of a "test set" or data provenance in the context of evaluating an algorithm. The evaluation for substantial equivalence would involve engineering tests, material characterization, and potentially bench testing, rather than a clinical dataset in the manner of an AI/ML product.

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)

Not applicable. This is a physical device submission. "Ground truth" as applied to expert interpretation for AI/ML algorithms is not relevant here. Decisions are made based on engineering principles, materials science, and regulatory precedent.

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

Not applicable. This is a physical device submission. Adjudication methods are used for resolving disagreements among human readers or experts establishing ground truth for AI/ML performance evaluation. This concept is not relevant here.

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

Not applicable. This is a physical device submission. MRMC studies are used to evaluate diagnostic imaging systems or AI/ML algorithms in a clinical context. This device is a component of a knee prosthesis.

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

Not applicable. This is a physical device submission. There is no algorithm.

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

Not applicable in the AI/ML sense. The "truth" for this device's efficacy and safety is established through:

• Its design specifications.
• Material properties (UHMWPE is a known and accepted biomaterial).
• Bench testing (mechanical, fit, etc. - though details aren't in this summary).
• Clinical history and performance of the substantially equivalent predicate device (K970779).
• Compliance with relevant standards.

8. The sample size for the training set

Not applicable. This is a physical device submission. There is no training set for an algorithm.

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

Not applicable. This is a physical device submission.

Ask a specific question about this device

The Osteonics® Tibial Tray Screw Hole Plugs are intended to occlude the unused tibial screw holes of any Osteonics tibial tray component. The Osteonics® Tibial Tray Screw Hole Plugs will be used with bone cement. The Osteonics® Tibial Tray Screw Hole Plugs do not carry their own indications and contraindications, but -- as accessories to tibial tray components -- would be subject to all of the indications and contraindications of the associated tibial trays.

The Osteonics® Tibial Tray Screw Hole Plugs are small circular plugs which are manufactured from low density polyethylene (LDPE) and which are intended to occlude all tibial tray screw holes not occupied by bone screws. The Osteonics® Tibial Tray Screw Hole Plugs will be factory-assembled into every tibial tray hole. Intraoperatively, the surgeon will remove the plugs from whichever screw holes will be filled with a bone screw. The Osteonics® Tibial Tray Screw Hole Plugs, by occluding the tibial tray screw holes, will help prevent intrusion of bone cement onto the surface of the tibial tray.

This document is a 510(k) Premarket Notification Summary for the Osteonics Tibial Tray Screw Hole Plugs. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance results, or any study design details that would typically be associated with AI/ML device testing.

Specifically, most of the requested information (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is entirely absent because the device in question is a physical medical device (tibial tray screw hole plugs), not an AI/ML-driven software or diagnostic tool.

The "Performance Data" section merely states: "Laboratory testing has been performed to evaluate the ability of the screw hole plugs to perform as intended under simulated physiological loading." No results, acceptance criteria, or experimental details are provided.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about study design, as this information is not present in the provided document.

Ask a specific question about this device