(32 days)
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
To provide mobility for the disabled.
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The Dignity 100 functions like a standard mechanical wheelchair with the addition of a custom cushion. This 21 CFR Sec. 890.3920 wheelchair component is intended for medical o rurgoses and surface an integral part of the wheelchair, but will also be sold separately as a replacement part. The custom cushion is designed with a keyhole shaped drop down panel which is replacement by the patient when he or she wishes to use the toilet.
The Dignity 100 is constructed from 7/8 inch outside diameter (OD) round, mechanical steel tubing. The chair is of welded construction. The sewn components are secured to the frame using screws and bolts. This device is a rigid wheelchair that incorporates a seating surface. The Dignity 10 has removable footrests.
The Dignity 100 is a manual wheelchair. The provided text, a 510(k) Premarket Notification summary, describes the device and its substantial equivalence to a predicate device, but does not contain acceptance criteria or a study proving that the device meets such criteria in the manner requested for AI/software devices.
This document is for a physical medical device, specifically a manual wheelchair, which falls under different regulatory requirements than AI/software as a medical device (SaMD). The performance data for this type of device typically involves demonstrating compliance with recognized safety and performance standards rather than metrics like sensitivity, specificity, or inter-reader agreement.
However, based on the information provided, here's a breakdown of what can be extracted and how it relates (or doesn't relate) to your requested format:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/RESNA parts 1, 3, 5, 7, 8 and 93 standards (safety and function for wheelchairs) | The Dignity 100 wheelchair passed all technical requirements identified in ANSI/RESNA parts 1, 3, 5, 7, 8 and 93. |
Explanation: For a manual wheelchair, "acceptance criteria" are implied by the conformance to recognized industry standards for safety, durability, and functionality. The "reported device performance" is a statement of successful adherence to these standards.
The remaining information requested in your prompt (sample size, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not applicable or not provided in the context of this 510(k) submission for a manual wheelchair. This type of device does not involve algorithms, AI, or diagnostic interpretations that would require such detailed study designs.
Summary of missing/non-applicable information based on the prompt's focus on AI/software:
- Sample sized used for the test set and the data provenance: Not applicable. Performance testing for wheelchairs typically involves physical product testing, not data sets.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is relevant for diagnostic performance, not mechanical device performance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used: Not applicable in the sense of diagnostic ground truth. The "ground truth" for a wheelchair would be its physical properties meeting engineering specifications.
- The sample size for the training set: Not applicable.
- 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).