(93 days)
The Future Mobility Healthcare Inc. Galaxy Lite Wheelchair is intended to provide mobility to persons limited to a sitting position.
The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames for use by patients weighing up to 250 lbs.
The provided document is a 510(k) summary for the Future Mobility Healthcare Inc. Galaxy Lite manual wheelchair. This type of medical device submission does not typically involve the kind of performance studies or acceptance criteria you've requested that are common for AI/ML or diagnostic devices.
Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices based on indications for use, design characteristics, and compliance with recognized standards.
Therefore, I cannot provide the specific details you've asked for regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance, as these are not relevant to this type of device submission.
Here's what I can extract from the document regarding the device and its compliance:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, as would be seen for AI/ML or diagnostic devices. Instead, the "acceptance criteria" are implied by adherence to established standards and similarity to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance/Compliance |
|---|---|
| Indication for Use Equivalence: Provide mobility to persons limited to a sitting position. | Same Indications for use: "providing mobility to persons limited to a sitting position." |
| Technical Characteristics Equivalence: Similar design, manual operation, self-propelled/attendant-propelled. | Similar key design technical characteristics: "The Quickie 2 HP, Stellato and Galaxy Lite are mechanical wheelchairs which have technical similarities. The Quickie 2 HP and Galaxy Lite contain an adjustable rear wheel location and provide similar performance. The Quickie 2 HP, Stellato and Galaxy Lite folding wheelchairs are manually operated, self propelled mechanical wheelchairs, and may also be used as attendant propelled transport devices. They consist of folding mechanical aluminum frames..." |
| Patient Weight Limit Equivalence: Accommodate patients up to 250 lbs. | Used by patients weighing up to 250 lbs. (Matches description of predicate devices.) |
| Safety and Effectiveness Standards Compliance: Developed in accordance with relevant ISO standards. | Compliance with ISO 7176: "Future Mobility HealthCare Galaxy Lite folding mechanical wheelchair was developed in accordance with ISO 7176, parts 1, 5, 7, 8 and 11." (These parts relate to dimensional characteristics, test methods for stability, determination of seating and wheel dimensions, static, impact and fatigue strengths, and test dummies, among others, for wheelchairs). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided because it's not applicable to a 510(k) submission for a mechanical wheelchair based on substantial equivalence and standards compliance. There isn't a "test set" in the sense of a dataset for algorithmic evaluation. The "testing" refers to physical product testing against ISO standards.
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)
Not applicable. Ground truth for a test set is specific to diagnostic or AI/ML performance evaluation, not to a mechanical device's substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 type of study is for evaluating human-AI interaction in diagnostic tasks, which is not relevant to a manual wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm in this mechanical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would relate to the physical properties and performance of the wheelchair as measured against engineering standards (e.g., stability, strength), rather than a diagnostic outcome.
8. The sample size for the training set
Not applicable. This device does not use a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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).