(35 days)
The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.
The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.
The provided text describes a 510(k) premarket notification for a medical device, the TiLite Aero X folding manual wheelchair. It does not contain information about acceptance criteria or a study proving its performance in the context of AI/ML or diagnostic accuracy. Instead, it focuses on the device's classification, predicate device, and compliance with existing standards for manual wheelchairs.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of an AI/ML device.
The only relevant information regarding "testing results" is:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/RESNA WC/Volume 1: 1998, Section 1 | Meets requirements |
| ANSI/RESNA WC/Volume 1: 1998, Section 5 | Meets requirements |
| ANSI/RESNA WC/Volume 1: 1998, Section 7 | Meets requirements |
| ANSI/RESNA WC/Volume 1: 1998, Section 8 | Meets requirements |
| ANSI/RESNA WC/Volume 1: 1998, Section 16 | Meets requirements |
| ANSI/RESNA WC/Volume 1: 1998, Section 93 | Meets requirements |
The following information cannot be extracted from the provided text as it pertains to AI/ML device evaluation, which is not applicable to this document:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done and its effect size.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).