(63 days)
AXS-1 Lite Wheelchairs are indicated for providing mobility to persons limited to a sitting position
The Access Point Medical Explorer Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical. steel frame and leatherette or nylon upholstery that meets FN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors, over smooth Transport Series. Transport Chair is and China C standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
This document is a 510(k) premarket notification for the AXS-1 Lite Wheelchair (originally submitted as Explorer Wheelchair). It primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and results.
Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available and indicate when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from this document) | Reported Device Performance (from this document) |
|---|---|
| Compliance with ISO 7171-1: Wheelchair: Determination of static stability | Access Point Medical wheelchair production meets ISO 7171-1. |
| Compliance with ISO 7176-3: Wheelchair: Determination of efficiency of brakes | Access Point Medical wheelchair production meets ISO 7176-3. |
| Compliance with ISO 7176-8: Wheelchair: Requirements and test methods for static, impact, and fatigue strengths | Access Point Medical wheelchair production meets ISO 7176-8. |
| Compliance with ISO 7176-11: Wheelchair: Test dummies | Access Point Medical wheelchair production meets ISO 7176-11. |
| Compliance with ISO 7176-15: Wheelchair: Requirements for information disclosure, documentation and labeling. | Access Point Medical wheelchair production meets ISO 7176-15. |
| Compliance with ISO 7176-16: Wheelchair: Resistance of ignition of upholstered parts – Requirements and test methods | Access Point Medical wheelchair production meets ISO 7176-16. |
| Compliance with EN 1021-1: Furniture – Assessment of the Ignitability of Upholstered Furniture | Access Point Medical wheelchair production meets EN 1021-1 (specifically, leatherette or nylon upholstery meets this standard). |
| Conformance to applicable 21 CFR references | Access Point Medical Explorer Wheelchair conforms fully to applicable 21 CFR references. |
| Meets pinhole FDA requirements | Access Point Medical Explorer Wheelchair meets pinhole FDA requirements. |
| Meets biocompatibility requirements | Access Point Medical Explorer Wheelchair meets biocompatibility requirements. |
| Meets labeling claims required by standards | Access Point Medical Explorer Wheelchair meets labeling claims required by these standards. |
| No safety/efficiency issues or claims that differ from the predicate device | "There are no safety/efficiency issues or claims that differ from the predicate device cited." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical study or a specific test set with a sample size for evaluating device performance in humans. The device's substantial equivalence is established through conformance to recognized standards, which typically involve laboratory testing, not human subject testing in the context of this 510(k). The "data provenance" in terms of country of origin or retrospective/prospective is not applicable here as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe a study involving expert assessment or ground truth establishment in a clinical context.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
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 device is a mechanical wheelchair, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance in a clinical read.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
For the safety and performance claims, the "ground truth" is defined by the compliance with the listed international and national standards (ISO, EN, and 21 CFR regulations). These standards outline specific test methods and criteria that, when met, are considered evidence of safety and effectiveness for a device of this class.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this 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).