(49 days)
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
| Acceptance Criteria (Voluntary Standards & Internal Specifications) | Reported Device Performance (Implied by Submission) |
|---|---|
| Safety and Functional Requirements: | |
| Meet U.L. and I.E.C. stability requirements. | Testing has been developed to assure these hazards have been eliminated or severity/probability minimized. |
| Compliance with 21 CFR 1020 "Performance Standard for Ionizing Radiation Emitting Products" (for radiolucent surface). | Testing and procedures for the surface have been implemented to assure compliance. |
| Voluntary Standards Compliance: | |
| IEC 601-1: Medical electrical equipment; Part 1: General requirements for safety (2nd ed., 1988). | The device "will also comply with the following voluntary standards." (Implied successful testing). |
| IEC 601-2-38: Medical electrical equipment; Part 2: Particular requirements for the safety of electrical, energized and non-energized hospital beds. | The device "will also comply with the following voluntary standards." (Implied successful testing). |
| UL 2601-1: First edition of the standard for medical electrical equipment, Part 1: General requirements for safety. | The device "will also comply with the following voluntary standards." (Implied successful testing). |
| CAN/CSA-C22.2 No. 601.1-M90: Medical electrical equipment; Part 1: General requirements for safety. | The device "will also comply with the following voluntary standards." (Implied successful testing). |
| IEC 601-1-2: Electromagnetic Compatibility Requirements. | The device "will also comply with the following voluntary standards." (Implied successful testing). |
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.
§ 880.6910 Wheeled stretcher.
(a)
Identification. 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 frame may be fixed or collapsible for use in an ambulance.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.