(12 days)
The NISSIN series Mechanical Wheelchair is intended to be used to empower persons physically challenged to a sitting position by providing a means of mobility.
Intended for medical purposes to provide mobility to persons restricted to a sitting position
The NISSIN series Mechanical Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Many of these components are available in a range of sizes, shapes, angles, forms, materials or coverings. Theses variations allow the chairs to be configured to meet the specific desires and needs of the user.
The provided text describes a 510(k) summary for the NISSIN Mechanical Wheelchair, a declaration of substantial equivalence, and its intended use. However, it does not include information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert ground truth establishment, or comparative effectiveness studies. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to present a detailed performance study with quantitative acceptance criteria.
Therefore, many of the requested elements for a detailed performance study are not present in the provided documentation.
Here's a breakdown of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantitative metrics. The acceptance criteria for this 510(k) submission are implicitly demonstrating compliance with:
- The "Guidance document for the preparation of premarket notification [510(k)] applications for mechanical and powered wheelchairs, and motorized three-wheeled vehicles" (July 26, 1995, reformatted 12/18/97).
- ISO 7176 standards.
- The general controls provisions of the Federal Food, Drug, and Cosmetic Act.
- Reported Device Performance: The document states that "Data was provided that demonstrated compliance with the Guidance document [...] and ISO 7176. All issues of safety and effectiveness have been addressed." Specific quantitative performance metrics (e.g., durability, weight capacity, maneuverability) and their values are not detailed in this summary.
2. Sample sized 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 in the given text. The submission refers to "data was provided" but does not specify the nature, sample size, or provenance of this data.
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)
- This information is not applicable and not provided. For a mechanical device like a wheelchair, "ground truth" as it relates to expert consensus for diagnostic image interpretation is not a relevant concept. Device performance (e.g., strength, stability, durability) is typically assessed through engineering tests and adherence to standards, not expert medical opinion on a "test set" in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not provided. See point 3.
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
- This information is not applicable and not provided. This type of study is relevant for AI-powered diagnostic or assistive devices involving human interpretation, not for a mechanical wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable and not provided. This concept relates to AI algorithms, not a mechanical wheelchair.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for a mechanical wheelchair's safety and effectiveness is established through adherence to recognized engineering standards (like ISO 7176) and regulatory guidance documents. This involves physical testing, material specifications, and design verification, rather than medical "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic devices.
8. The sample size for the training set
- This information is not applicable and not provided. A training set is relevant for machine learning models, which is not what this submission is about.
9. How the ground truth for the training set was established
- This information is not applicable and not provided. See point 8.
In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the NISSIN Mechanical Wheelchair to a predicate device (Quickie Suspension Wheelchair Series Model XTR). This process heavily relies on demonstrating compliance with established standards (ISO 7176) and guidance documents for wheelchairs, ensuring that the new device meets general safety and effectiveness requirements. It does not present a detailed clinical study with specific performance metrics, expert adjudication, or AI-related evaluations as described in your request.
§ 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).