(363 days)
The RH 3500 EZ Transport Chair is intended to transport patients within acute, and long-term care facilities. The device can be operated indoors on carpeting, linoleum and other floors, and on sidewalks. The RH 3500 EZ Transport Chair is controlled, steered and operated completely by a trained caregiver.
The Harris Medical RH 3500 Transport Chair is a manually operated wheelchair that is propelled by human power. Its intended function and use is to provide mobility to a person limited to a sitting position. It may be used as an attendant propelled transport device in a healthcare environment such as a hospital, nursing home or extended care facility. The wheelchair consists primarily of an aluminum frame; 5 inch rear and front casters and handles for the wheelchair to be pushed. It is a rigid or non-folding type of wheelchair that is designed for use by a patient weighing up to 250 lbs.
The frame is constructed of one inch (1) outside diameter Aluminum tube that is welded that has a wall thickness of 1/8 inch. The rear urethane wheels are fixed and front are urethane casters.
The provided text describes a 510(k) summary for a medical device, the RH 3500 EZ Transport Chair. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner an AI or diagnostic device would.
Therefore, the requested details regarding acceptance criteria for an algorithm, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set information are not applicable (N/A) to this document, as it pertains to a mechanical transport chair and not a device that generates diagnostic outputs or uses an algorithm in that context.
However, I can extract the closest equivalents to "acceptance criteria" and the "study that proves the device meets them" based on the information provided for this mechanical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Strength | - Ability to withstand certain loads for extended periods (50% overload for 24 hours). |
- Adherence to a maximum patient weight. | - Tested with loads of 375 lbs. (50% overload) for 24 hours without adverse events.
- Hydraulic system held without any position changes.
- Confirmed an allowable patient load of 250 lbs. |
| Stability | - Withstand "latelaterally, posteriorly and anteriorly tiltover test" as per guidance for mechanical wheelchairs. | - Tiltover test performed. - Conclusion: Chair is "as safe as the predicate devices." |
| Material Safety/Compliance | - Flame resistance (Cal TB 117). - Antibacterial properties (AATCC 147-2004).
- Antifungal properties (AATC 30-2004).
- Non-irritant (Draize Dermal Toxicity OECD testing #404, 2002).
- Seat belt compliance (Federal standard FMVSS209-302). | - Seat cover material (4-way stretch urethane knit fabric) certified by the manufacturer to be fully compliant with Cal TB 117, AATCC 147-2004, AATC 30-2004, and Draize Dermal Toxicity OECD testing #404, 2002.
- Seat belt meets Federal standard FMVSS209-302. |
| Mobility Standards | - Compliance with ANSI/RESNA WC-4: 2012, Section 19 (Wheelchairs used as Seats in Motor Vehicles). - Compliance with ANSI/RESNA WC-1: 2009, section 15 (Requirements for Information Disclosure Documentation and Labeling). | - Tested and passed in accordance with Annex A, B, C, and E of ANSI/RESNA WC-4: 2012, Section 19.
- Meets the requirements of ANSI/RESNA WC-1: 2009, section 15. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as a "test set" in the context of diagnostic performance. However, for the physical tests (overload, tiltover), it refers to one RH 3500 EZ Transport Chair unit being subjected to these tests.
- Data Provenance: The document does not specify country of origin for test data, but the submission is to the U.S. FDA. The testing appears to be prospective (i.e., conducted specifically for this submission on the device).
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)
- N/A. This is a mechanical device, not an AI or diagnostic device requiring expert consensus for ground truth determination. The "ground truth" here is the physical performance of the device against engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication is not relevant for the physical testing of a mechanical device against defined standards. The tests have pass/fail criteria based on measured physical properties and observations.
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
- N/A. This is a mechanical transport chair, not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- N/A. This is a mechanical device without an algorithm in the sense of AI or diagnostic processing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this mechanical device, the ground truth or reference standard is the specified engineering and safety standards (e.g., ANSI/RESNA standards, material certifications, load capacity requirements) and the observed physical performance of the device under test conditions.
8. The sample size for the training set
- N/A. There is no "training set" as this is a mechanical device, not an AI model.
9. How the ground truth for the training set was established
- N/A. (See point 8).
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).