Search Results

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.

Ask a specific question about this device

The subject stretcher and predicate are intended to be used with the general population to transport patients and to allow for patient care before, during, and after transport. The stretchers may be used in or for various patient care facilities and departments including, but not limited to, ED, transport, PACU, ambulatory surgery, long term care and home care. When fitted with the optional radiolucent surface, the stretcher may be used for acquisition of radiographic images.

A wheeled stretcher is a device consisting of a platform mounted on a wheeled frame that is designed to transport patients in a horizontal position. The device may have side rails, supports for fluid infusion equipment, and patient securement straps.

The provided text is for a 510(k) premarket notification for a wheeled stretcher, a physical medical device, not an AI/ML-based diagnostic or prognostic device. Therefore, the questions related to AI/ML device performance (acceptance criteria based on metrics like sensitivity/specificity, sample size for test sets, expert ground truth adjudication, MRMC studies, standalone performance, training set details) are not applicable.

The document discusses performance standards and testing for the physical device to assure compliance with safety specifications and voluntary standards.

Here's an attempt to extract relevant information, framed within the spirit of your request but acknowledging the different nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. For a physical device like a stretcher, "test set" typically refers to the prototype units manufactured and subjected to various engineering and safety tests. The document doesn't specify the number of prototypes tested but implies that testing was conducted.
• Data Provenance: Not applicable in the context of clinical data. The "data" here would be engineering test results generated internally by Hill-Rom, Inc.

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

• Not applicable. Ground truth, in this context, relates to compliance with engineering and safety standards, not clinical diagnostic accuracy. The "experts" would be the engineering and quality assurance personnel at Hill-Rom, Inc. who perform and verify the tests against established industry standards (UL, IEC, CSA). The document mentions "engineering" identified hazards and developed testing.

4. Adjudication method for the test set

• Not applicable. Adjudication methods like "2+1" are for resolving disagreements among multiple human readers for ground truth establishment. For a physical device, testing is against objective performance specifications and voluntary standards. Pass/fail criteria are defined for each test.

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 a physical stretcher, not an AI/ML diagnostic device.

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

• Not applicable. This is a physical stretcher.

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

• The "ground truth" for this medical device's performance is adherence to established engineering specifications and voluntary national and international safety standards (e.g., UL, IEC, CSA). This is determined through physical testing and measurement, rather than clinical outcomes or expert consensus on a diagnostic finding. The document also mentions a "complete review of hazards associated with the product was performed."

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML algorithm.

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

• Not applicable. This is a physical device, not an AI/ML algorithm.

Ask a specific question about this device