(219 days)
The Columbia Medical Pediatric Folding Wheelchair is a manually propelled wheelchair designed to provide mobility aid for children and adolescents who have limited or no ability to ambulate and require a device to aid in seated mobility in the home and community.
This pediatric wheelchair, also commonly referred to as an adaptive stroller, is constructed of the same typical components of most manual wheelchairs. The frame consists of powder coated round tubular 6061 T6 aluminum which is 1" in diameter, and is welded and bolted. The device comes standard with 13.5" rear wheels and 6" steering front casters. The back and seating area is made of a fabric material. The wheelchair is designed for everyday indoor and outdoor use in firm terrain. The wheelchair is designed to allow for adjustments of the orientation of the seat and back angles, using tools, to provide seating and back angles to support the skeletal and muscular characteristics of the individual for comfort, control and safety during sitting and mobility.
The document describes the K130644 Columbia Medical Pediatric Folding Wheelchair and its non-clinical testing. It is a Class I device, meaning it is subject to general controls and does not typically require extensive clinical trials for FDA clearance. The submission relies on demonstrating substantial equivalence to a predicate device (Convaid Cruiser CP4M, K810676).
Since this is a Class I device and the submission focuses on substantial equivalence through non-clinical testing, the information you've requested about acceptance criteria, study details, and ground truth for AI algorithms is not directly applicable or available in this document. This device is a mechanical wheelchair, not an AI-powered diagnostic or therapeutic device. Therefore, concepts like "AI assistance," "human readers," "test set," "training set," "ground truth experts," or "MRMC studies" are not relevant to its clearance.
However, I can extract the information that is relevant about its acceptance criteria and the study that proves it meets those criteria, based on the provided text, and explicitly state what information is not present due to the nature of the device.
Acceptance Criteria and Device Performance for K130644 Columbia Medical Pediatric Folding Wheelchair
| Acceptance Criterion (Based on RESNA Standards) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Front Stability | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Rear Stability | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Sideway Stability | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Dimensional Conformance | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Fatigue | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Curb Drop | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Impact Tests | Meets RESNA standards (implied by "evaluated for... which are RESNA standards") |
| Flame Retardancy (WeatherMax FR fabric) | Meets CSFM T19, CPAI-84, FMVSS 302 and AST -E84 Class A |
| Biocompatibility (fabric and footplates) | Materials are non-hazardous (indicated by "Biocompatibility test reports... indicating materials are non-hazardous") |
Study Details:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as this was non-clinical engineering testing of a physical product, not a data-driven AI study. Typically, a sample of devices would be subjected to the various physical tests.
- Data Provenance: Not applicable in the context of an AI study. The "data" here would be measurements and observations from physical tests of the wheelchair. The tests were performed by Columbia Medical or a contracted testing facility.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not an AI diagnostic. Ground truth as typically understood for AI or clinical studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests are the established thresholds and methods defined by RESNA standards and other applicable material standards (e.g., CSFM, CPAI-84, FMVSS 302, AST -E84). The experts would be the engineers and technicians conducting the tests and interpreting the results against these pre-defined standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or subjective assessments. Here, the tests likely involve objective measurements and pass/fail criteria based on engineering standards.
-
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:
- No. This is a physical wheelchair, not an AI-driven medical imaging or diagnostic device. MRMC studies are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Engineering Standards & Material Specifications: The "ground truth" for the non-clinical testing comprises established industry standards for wheelchair safety and performance (RESNA standards for stability, fatigue, etc.) and material specifications (flame retardancy standards, biocompatibility reports). The device's performance is compared against these objective, pre-defined technical criteria.
-
The sample size for the training set:
- Not Applicable. This is a physical product, not an AI model that requires a training set.
-
How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 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).