(63 days)
AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
The Access Point Medical AXS-1 Basic 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 EN102-1: 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 and outdoors, over smooth surfaces (all 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 Basic Wheelchair. It describes the device, its intended use, and compares it to a predicate device. The primary method used to demonstrate substantial equivalence is through compliance with recognized international standards for wheelchairs.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Wheelchair: Determination of static stability ISO 7171-1 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Determination of efficiency of brakes ISO 7176-3 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Requirements and test methods for static, impact and fatigue strengths ISO 7176-8 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Test dummies ISO 7176-11 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Requirements for information disclosure, documentation and labeling. ISO 7176-15 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Resistance of ignition of upholstered parts --Requirements and test methods ISO 7176-16 | Access Point Medical wheelchair production meets this standard |
| Furniture – Assessment of the Ignitability of Upholstered Furniture EN 1021-1 | Access Point Medical wheelchair production meets this standard |
| Applicable 21 CFR references | AXS-1 Basic Wheelchair conforms fully to applicable 21 CFR references |
| Pinhole FDA requirements | AXS-1 Basic Wheelchair meets pinhole FDA requirements |
| Biocompatibility requirements | AXS-1 Basic Wheelchair meets biocompatibility requirements |
| Labeling claims required by these standards | AXS-1 Basic Wheelchair meets labeling claims |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set in the traditional sense of a clinical or performance study with human subjects or a dataset. The demonstration of compliance is based on the design and manufacturing adherence to recognized international standards. This is typical for Class I medical devices like a basic wheelchair, where safety and effectiveness are primarily established through engineering design, material specifications, and testing to recognized standards, rather than large-scale clinical trials. The data provenance is implied to be from the manufacturer's internal testing and quality control processes to ensure compliance with the stated standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of device performance testing through standard compliance, refers to whether the device physically performs according to the standard's specifications. This is determined by engineering tests and measurements, not expert consensus on a dataset.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, the compliance is based on engineering tests against standards, not on expert adjudication of a test set.
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 basic mechanical wheelchair and does not involve AI or human "readers" in its function or evaluation.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This device is a basic mechanical wheelchair and does not involve algorithms or human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is compliance with recognized international performance and safety standards (ISO and EN standards listed in Section P). This means the device was designed and tested to meet the objective, measurable requirements set forth in those standards.
8. The sample size for the training set
Not applicable. The AXS-1 Basic Wheelchair is a mechanical device, and the submission does not involve machine learning or AI models that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as 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).