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The Stryker Powered Wheeled Stretcher is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications.
The drive-assist Big Wheel provides the healthcare caregiver greater maneuverability in steering and moving the stretcher with significantly less force.

The Stryker Powered Wheeled Stretcher is a powered patient transport device with a motorized drive-assist fifth wheel. This stretcher is a motorized device to be used to transport patients with the many contract, and patient securement straps. The stretcher will have a motorized drive-assist fifth wheel that will assist the caregiver in maneuvering the stretcher. Only the caregiver, not the patient, will have controls to adjust patient positioning. As with the predicate device, the stretcher of this submission will be a movable, caster mounted stretcher. In addition, as with the predicate stretcher, the lift system provides both support and height and life surface to the patient surface. The stretcher is designed to meet UL and IEC stability requirements.

The provided text is a 510(k) premarket notification for the Stryker Powered Wheeled Stretcher. It focuses on demonstrating substantial equivalence to a predicate device and outlines general safety and performance characteristics, but it does not contain specific acceptance criteria, study data, or detailed performance results in the format requested.

Therefore, the following information is not present in the provided document:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set, data provenance, number of experts, and adjudication methods for ground truth establishment.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance studies.
4. Specific type of ground truth used (e.g., pathology, outcomes data).
5. Sample size for the training set and how its ground truth was established.

What the document does provide in relation to performance and testing is:

• General Statement about Testing: "Significant safety and performance characteristics are tested to ensure compliance with specifications. After testing is complete, the test reports become part of the Device Master Record."
• Risk Management: "A review of risks and hazards of the product was conducted. This included complaints, recalls, and medical device reports analyses. Also, a review was also conducted to identify other device reports and performance hazards by a cross-functional team... A verification and validation plan has been developed to ensure these hazards have been considered and their occurrence minimized."
• Compliance with Voluntary Standards: The device will comply with several voluntary standards related to medical electrical equipment safety and electromagnetic compatibility (IEC 601-1-1, IEC 601-1-2, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90). These standards typically involve specific tests and acceptance criteria, but the document does not elaborate on the specific results from those tests.

In summary, this document is a regulatory submission for substantial equivalence based on safety characteristics and compliance with general standards, rather than a detailed clinical or performance study report with explicit acceptance criteria and results for the device's functional performance.

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