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The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.

The Winco Mfg., LLC Stretchair is a battery powered device designed for use in healthcare facilities. Its intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.

The Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.

The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.

This is a submission for a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria based on performance metrics. Therefore, many of the requested categories for AI/algorithm performance studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a medical device submission for a physical product (a stretcher), not an AI/algorithm-based device. Performance was assessed against electrical safety and flame retardancy standards, not through clinical data sets.

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

Not applicable. This is a medical device submission for a physical product. "Ground truth" in the context of AI/algorithm performance is not relevant here. Compliance with standards is typically verified by certified testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. The evaluation was based on compliance with established safety and material standards, not on expert consensus or adjudication of a test set in the AI sense.

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 device is a powered wheeled stretcher, not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product; there is no algorithm or standalone performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" in this context is the fulfillment of requirements outlined in recognized safety and material standards:

• UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards
• CAL 117 for Flame Retardancy

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. There is no training set for this type of device submission.

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