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The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.

The Stryker POWEReam Xia/Serrato is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1.

This document describes a 510(k) premarket notification for a medical device called POWEReam Xia/Serrato, which is an attachment used with a Stryker battery-powered handpiece to facilitate the placement of pedicle screws. The submission seeks to demonstrate substantial equivalence to a predicate device, the Stryker POWEReam ¼” Drive (K233300).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not explicitly list the specific acceptance criteria or provide detailed performance data in a table format. It only broadly states that the device performs as intended.

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

The document does not specify the sample size used for the test set for any of the non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation). It also does not provide information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

Since this is a non-clinical submission for a mechanical instrument, the concept of "experts" establishing ground truth in the same way it would be for diagnostic AI is not directly applicable. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and potentially a team of engineers or quality assurance personnel. The document does not specify the number of individuals involved in establishing these engineering "truths" or their specific qualifications (e.g., "mechanical engineer with 15 years of experience in medical device design").

4. Adjudication Method for the Test Set

As this is a non-clinical device focused on mechanical performance and usability, traditional adjudication methods like 2+1 or 3+1 (common in AI diagnostic studies) are not mentioned or typically used. The "adjudication" of test results would likely involve review and approval by qualified engineers and quality personnel based on established test protocols and acceptance criteria. No specific adjudication method is detailed in the document.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required for this Traditional 510(k)." MRMC studies are typically clinical studies designed to compare diagnostic performance, especially with AI assistance. This device is a surgical instrument attachment, not a diagnostic tool.

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

This question is not applicable to the device described. The POWEReam Xia/Serrato is a mechanical attachment for a surgical power tool, not an algorithm, and it inherently requires human-in-the-loop operation. "Standalone performance" in the context of an algorithm does not apply here. The non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation) assessed the device's functional performance and usability.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Engineering Specifications: The design parameters, torque outputs, speed reductions, and material properties defined during the device's development.
• Validated Test Methods: Standardized procedures and instruments used to measure the device's performance against its specifications.
• Regulatory Standards: Adherence to relevant industry and regulatory standards for medical devices.

It does not involve expert consensus, pathology, or outcomes data in the manner of diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The POWEReam Xia/Serrato is a mechanical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

This question is not applicable as there is no training set for a mechanical device.

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