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The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are:

1. UN III AXS Screws packed in sterile procedure packs, and
2. UN III AXS Screws packed in a sterile screw cartridge.

This document describes the performance data for the Stryker Universal Neuro III System AXS Screw, specifically regarding the transition to sterile packaging configurations. The focus of the provided text is on demonstrating substantial equivalence to a predicate device, not on validating the performance of an AI algorithm. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are often implied as "met" or "proven" in this summary rather than explicitly stated with numerical values, which is common for regulatory submissions demonstrating equivalence to an existing product, especially for changes in manufacturing or packaging.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual test (e.g., sterilization validation, packaging tests). Instead, it states that "validations were performed and referenced."

• Data Provenance: The tests were conducted to support the market clearance of a device by Stryker Leibinger GmbH& Co. KG (Germany) for the US market. The nature of these tests (e.g., sterilization, packaging integrity) suggests they are laboratory-based, prospective studies conducted by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not an AI algorithm requiring expert ground truth for its performance. The tests described are engineering and manufacturing validations.

4. Adjudication method for the test set

Not applicable. This is not an AI device requiring diagnostic adjudication.

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 not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

Not applicable in the context of an AI device. The "ground truth" for the tests performed relates to established engineering standards, regulatory requirements for sterility, pyrogenicity, biocompatibility, and packaging integrity. For example:

• Sterility: Achieved based on a demonstrated SAL of 1 x 10-6.
• Biocompatibility: Determined through assessment against ISO standards for medical device biocompatibility.
• Packaging Integrity: Evaluated against industry standards for sterile barrier systems (e.g., ASTM, ISO).

8. The sample size for the training set

Not applicable. This is not an AI device that utilizes a training set.

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

Not applicable. This is not an AI device.

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