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The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.

The Hill-Rom Procedural Stretcher product is a movable, castermounted stretcher. The product has side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. The stretcher is available with an optional that consists of the addition of a battery-powered drive mechanism which is integrated into the stretcher platform provides propulsion of the platform along the floor with minimal force applied by the caregiver. The powered drive mechanism is only controllable by the caregiver and not the patient. The Intellidrive® option aids in the transportation of patients by providing healthcare personnel with the ability to more easily move and maneuver the stretcher.

The provided text describes a medical device, the Hill-Rom Procedural Stretcher with Intellidrive®, and its 510(k) summary for substantial equivalence review by the FDA. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with a ground truth as would typically be done for a novel AI/ML device.

Therefore, the information requested in your prompt (e.g., acceptance criteria, reported device performance in a table, sample size for test set, expert qualifications, adjudication methods, MRMC study, standalone performance, type of ground truth, training set details) is not applicable in the context of this 510(k) submission for a mechanical medical device like a stretcher with a powered drive.

Here's why and what information is available in the provided text:

• Acceptance Criteria and Reported Device Performance: Not presented in the context of a clinical study with specific performance metrics. Instead, the submission focuses on meeting safety standards and demonstrating substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it meets the design requirements and voluntary standards.

• Sample Size for Test Set and Data Provenance: Not applicable. The "testing" referred to is engineering verification and validation (V&V) against design requirements and safety standards, not a clinical study involving a dataset of patient cases.

• Experts and Qualifications for Ground Truth: Not applicable. There's no "ground truth" in the sense of expert-reviewed medical images or patient outcomes for this type of device submission.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is relevant for diagnostic devices, especially those with AI assistance, not for a powered stretcher.

• Standalone Performance: Not applicable.

• Type of Ground Truth Used: Not applicable. The "ground truth" for this device's safety and effectiveness is established by meeting engineering design specifications, applicable safety standards (like IEC 60601 series, UL 60601-1, CAN/CSA C22.2 601.1-M90), and demonstrating equivalence to a predicate device.

• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or artificial intelligence in the way a diagnostic imaging device would. Therefore, there's no "training set" in the context of AI/ML.

What the document does provide regarding device evaluation:

• Verification and Validation Plan: The document states that a "verification and validation plan has been developed that defines the testing parameters that ensure that the product meets its design requirements and that the hazards that were identified were eliminated by design features or that the occurrence rate is as low as reasonably possible." This includes system-level and module-level testing.
• Voluntary Standards Met: The device successfully meets several electrical safety and electromagnetic compatibility (EMC) standards:
  • IEC 60601-1 (Electrical Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • UL 60601-1
  • CAN/CSA C22.2 601.1-M90
  • IEC 60601-1-4 (Programmable electrical medical systems)
  • IEC 60601-2-38 (Electrically operated hospital beds)
• Comparison to Predicate Device: The submission demonstrates substantial equivalence to the Stryker Powered Wheeled Stretcher (#K022309) in terms of function, intended use, classification, basic technology, and performance characteristics. Hazards were identified and evaluated, including a review of complaints and recalls for similar products.

In summary, the provided document is a 510(k) submission for a mechanical medical device, not an AI/ML-powered diagnostic device. Therefore, the questions related to clinical study design, ground truth, and AI-specific performance metrics are not relevant to this submission.

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