(83 days)
To provide mobility to persons limited to a sitting position
To provide mobility to persons limited to a seated position.
The PDG Model Luna wheelchair is manually operated, self propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons that may be limited to a seated position. It may also be used as attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
The provided document describes a 510(k) submission for the PDG Product Design Group Luna Manual Wheelchair, which is a mechanical device, not an AI or software-based device. Therefore, many of the requested categories related to AI performance studies (sample sizes for test and training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable in this context.
However, I can extract the information relevant to mechanical device testing and conformance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Applicability to ISO 7176 - Standard for Manual, Mechanical Wheelchairs | The Luna manual wheelchair is designed to meet the applicable requirements of ISO 7176. |
2. Sample size used for the test set and the data provenance
The document does not specify a specific sample size for a test set or data provenance for the performance data. It broadly states the device is "designed to meet" ISO 7176, implying conformance through manufacturing and design processes, rather than a specific clinical or performance test on a defined sample that would be typical for AI/software.
3. 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 one requiring expert interpretation of output.
4. Adjudication method for the test set
Not applicable. This is a mechanical device.
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 mechanical device, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the AI sense. For mechanical devices, "ground truth" typically refers to engineering specifications, performance standards (like ISO 7176), and material properties, which are verified through engineering tests and quality control, not medical ground truth as in diagnostics.
8. The sample size for the training set
Not applicable. This is a mechanical device.
9. How the ground truth for the training set was established
Not applicable. This is a mechanical device.
§ 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).