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The Stryker T4 Powerpack and Accessories are components of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.

The Stryker T4 Personal Protection System: Stryker T4 Powerpack and Accessories

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Stryker T4 Power Pack, Stryker T4 Eight Station Battery CH" (K994053) does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document primarily states that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. It outlines the regulatory classification and general controls provisions of the Act. The "Indications for Use Statement" on page 2 describes the intended purpose of the device as a component of a personal protection system.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of detailed performance data and study methodology is typically found in the 510(k) submission itself, rather than in the clearance letter issued by the FDA.

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