(20 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The WH Convertible Lightweight Wheelchair MC-281S and MC-200S is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
The Medcare Mechanical Wheelchairs (MC-281S and MC-200S) are Class I medical devices intended to provide mobility to persons restricted to a seated position.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Standards) | Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 requirements | Meets applicable performance requirements |
| ISO 7176 Wheelchair Standards | Meets applicable performance requirements |
| Weight Limit: 250 lbs (Predicate) | Subject device: 100 kgs / 220 lbs |
Note: The provided document states that the devices "meet the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." However, specific numerical or qualitative performance metrics (e.g., stability tests, fatigue tests, braking efficiency, maneuverability) from these standards are not explicitly detailed in the summary. The weight limit shows a difference from the predicate device that is addressed in the substantial equivalence comparison.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a test set sample size or data provenance in the context of a clinical study or performance testing involving patient data. The "Performance Testing" section refers to adherence to industry standards, not a specific clinical test with human subjects or a dataset.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a study involving a test set that requires expert-established ground truth (e.g., for diagnostic accuracy). The performance testing refers to engineering standards for mechanical function, not interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study, an effectiveness study with human readers, or an effect size for human readers improving with AI assistance. This type of study is not relevant to the described device, which is a mechanical wheelchair.
6. Standalone (Algorithm Only) Performance Study
There is no mention of a standalone (algorithm only) performance study. The device is a mechanical wheelchair and does not involve AI algorithms.
7. Type of Ground Truth Used
The ground truth for the device's performance is established by its compliance with the engineering and safety requirements outlined in the ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards. This is a technical validation against established industry benchmarks, not a clinical "ground truth" (e.g., pathology, outcomes data, or expert consensus) typically associated with AI/diagnostic devices.
8. Sample Size for the Training Set
This information is not applicable as the document does not describe a study involving machine learning or a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as 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).