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The Stryker Leibinger Skeletal Anchoring System is a plating system intended to be placed in the mouth, for use as an anchor in orthodontic procedures.

The Stryker® Leibinger Universal Skcletal Anchoring System is a plating system intended to he placed in the mouth f be placed in the mouth for use as an anchor in orthodontic procedures.

The provided text contains information about the Stryker® Leibinger Skeletal Anchoring System, primarily its 510(k) summary and FDA clearance letter. However, it does not include detailed information about acceptance criteria for device performance or the study that proves the device meets such criteria.

The document describes the device's intended use and its substantial equivalence to a predicate device (K033483 KLS-Martin Ortho Anchorage System), which is part of the 510(k) clearance process. Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, but it doesn't necessarily involve new performance studies with specific acceptance criteria as would be typical for novel devices or performance claims.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis of what can and cannot be answered:

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

• Cannot be provided. The document does not describe specific performance acceptance criteria or report performance data for the Stryker® Leibinger Skeletal Anchoring System. The 510(k) pathway often relies on demonstrating substantial equivalence to a predicate device rather than conducting new performance studies with pre-defined acceptance criteria for the new device.

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

• Cannot be provided. No new performance studies or test sets are described. The clearance is based on substantial equivalence to an existing device.

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)

• Cannot be provided. Not applicable as no new test set or ground truth establishment is described for a performance study of the device itself.

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

• Cannot be provided. Not applicable.

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

• Cannot be provided. This device is a skeletal anchoring system, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

• Cannot be provided. This refers to AI algorithms. The device is a physical medical implant.

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

• Cannot be provided. No new performance studies requiring ground truth for device evaluation are described.

8. The sample size for the training set

• Cannot be provided. Not applicable. The device is a physical implant, not a machine learning model.

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

• Cannot be provided. Not applicable.

Summary of what is known from the document regarding regulatory clearance:

• Device Name: Stryker® Leibinger Skeletal Anchoring System
• Intended Use: A plating system intended to be placed in the mouth for use as an anchor in orthodontic procedures.
• Regulatory Pathway: 510(k) premarket notification.
• Substantial Equivalence: The device was deemed substantially equivalent to the K033483 KLS-Martin Ortho Anchorage System. This means the FDA concluded that the new device is at least as safe and effective as the predicate device already on the market.
• Classification: Class II device, product code DZE (872.3640 - Endosseous Implant).
• Clearance Date: September 30, 2004.

To reiterate, the provided text concerns the regulatory clearance of a physical medical device based on substantial equivalence, not the performance evaluation of a device through a study with specific acceptance criteria.

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