(372 days)
The Theradyne Rover Express™ Powered Wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position.
The Theradyne Rover Express™ Powered Wheelchair.
The provided text describes a 510(k) summary for the "Theradyne Rover Express™ Powered Wheelchair." This document focuses on establishing substantial equivalence to a predicate device rather than detailing specific clinical studies for performance metrics. As a result, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/device performance evaluation is not present in the provided text.
Here's an analysis based on the given document:
Acceptance Criteria and Reported Device Performance
The document states that the Rover Express™ Powered Wheelchair was examined and tested according to FDA's Guidance Documents, with successful results that "did not raise any issues of safety and effectiveness of the device." However, specific numerical acceptance criteria (e.g., minimum torque, battery life, turning radius) and detailed performance metrics are not explicitly reported in the format of a table within the provided text.
The conclusion reiterates that the device is "substantially equivalent to previously marketed powered wheelchairs as demonstrated by its conformance to FDA recognized consensus standards and FDA's Guidance Documents." This implies that the 'acceptance criteria' were adherence to these standards and guidance documents, which the device met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to FDA recognized consensus standards | Conformed to FDA recognized consensus standards |
| Conformance to FDA's Guidance Documents | Conformed to FDA's Guidance Documents |
| (Specific performance metrics derived from these standards) | Not explicitly detailed in the provided document |
| No issues of safety and effectiveness | No issues of safety and effectiveness raised |
Study Information (Based on a traditional medical device, not an AI/diagnostic device)
2. Sample size used for the test set and the data provenance:
- The document does not describe a clinical "test set" in the context of an AI or diagnostic study. The testing performed was "functional & safety testing" of the physical wheelchair device.
- The sample size for this functional and safety testing is not specified.
- Data provenance is not applicable in the context of clinical data for an AI algorithm. The testing was of the manufactured device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the document describes a physical medical device (powered wheelchair) and its compliance testing, not a diagnostic or AI device that requires expert-established ground truth.
4. Adjudication method for the test set:
- This is not applicable for the type of device and testing 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:
- This is not applicable. The device is a powered wheelchair; it does not involve human readers or AI assistance in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a powered wheelchair; it is not an algorithm.
7. The type of ground truth used:
- For a physical device like a powered wheelchair, "ground truth" would relate to its physical specifications and performance against engineering standards. The document implicitly states that the 'ground truth' was established by "FDA recognized consensus standards and FDA's Guidance Documents."
8. The sample size for the training set:
- This is not applicable. There is no mention of a training set for an AI algorithm as this is a physical medical device.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for an AI algorithm.
Summary of Missing Information:
The provided 510(k) summary is for a physical medical device (Theradyne Rover Express™ Powered Wheelchair) and focuses on demonstrating substantial equivalence through compliance with recognized standards and guidance documents. It does not contain any information related to AI performance, clinical study results with human readers, ground truth for diagnostic classifications, or typical metrics associated with AI/diagnostic device evaluation. Therefore, most of the specific questions asked regarding AI evaluation criteria cannot be answered from this document.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).