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The Prime Series® Stretcher with Zoom® Motorized Drive 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, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.

The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

The Prime Series® Stretcher with Zoom® Motorized Drive, is a powered wheeled stretcher that consists of a platform mounted on a wheeled frame that is designed to transport patients in a substantially horizontal position within the interior of a healthcare facility by health professionals and/or trained representatives of the user facility. The electric-drive system, called the Zoom Drive System, assists the health professional and/or trained representative by assisting stretcher movement and maneuverability in various healthcare facilities. The device can be manually pushed by the user in the event of power loss to the Zoom Drive System. The device has siderails, supports for fluid infusion equipment, and various options and accessories that assist with the transport of the patient. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

The provided text describes the Stryker Prime Series® Stretcher with Zoom® Motorized Drive, and its acceptance criteria are primarily demonstrated through substantial equivalence to a predicate device and verification and validation (V&V) testing to ensure safety and effectiveness.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the format of defined thresholds with corresponding "device performance" results. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and passing functional, performance, safety, and efficacy specifications through V&V testing. The reported device performance is largely a direct comparison to the predicate device, indicating that the new device performs at least as well as the predicate and meets relevant standards.

Here's an attempt to extract and present the closest information to your request, focusing on comparative aspects and testing outcomes:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Physical and mechanical testing has been performed on individual components and on the system" and "bench and software testing." However, it does not specify the sample size for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a physical medical device like a stretcher, the testing would be considered prospective as it's conducted specifically for demonstrating compliance before market approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes a physical medical device (a stretcher), not an AI/diagnostic software. "Ground truth" in the context of expert consensus is typically relevant for evaluating diagnostic accuracy, which is not the primary concern for a patient transport stretcher. The "truth" in this context is defined by engineering specifications and recognized performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies.

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

This is not applicable. The device is a motorized stretcher, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and effect size in improving human reader performance with AI is irrelevant to this device.

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

This is not applicable. There is no algorithm in the sense of an AI or diagnostic software being evaluated. The "Zoom Motorized Drive" is an electromechanical system that assists a human caregiver. Its performance is always "human-in-the-loop" as it requires a caregiver to operate it.

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

For this device, the "ground truth" is established by engineering specifications, performance standards (e.g., IEC, ISO, AAMI), and predefined functional requirements. These are generally objective, measurable parameters rather than subjective expert consensus, pathology, or outcomes data. For example, the "ground truth" for patient capacity (700 lbs max) would be determined by structural integrity tests and engineering calculations.

8. The sample size for the training set

This is not applicable. This is a physical electromechanical device, not a machine learning model that requires a "training set" of data.

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

This is not applicable for the same reason as point 8.

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