(25 days)
The intended use of the Invacare Model Storm TDX Power Wheelchair is to provide mobility to persons limited to a sitting position, that have the capability of operating a powered wheelchair.
The Invacare Storm TDX power wheelchair is a battery powered, motor driven device with the intended function and use of providing mobility to those persons limited to a sitting position that have the capability of operating a power wheelchair. It is a rigid or "non- folding" type power wheelchair, with mid wheel drive capability.
The Invacare Model Storm TDX Power Wheelchair underwent testing to demonstrate its performance and safety, specifically focusing on its electromagnetic compatibility (EMC).
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ISO EMC Draft Standard 7176-14 ("Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995) for powered wheelchairs and motorized scooters. | The Invacare Storm TDX Power Wheelchair met the required performance criteria and functioned as intended in all instances. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size (number of units tested) for the performance evaluation. It refers to "the Invacare Storm TDX Power Wheelchair" in the singular, which could imply testing of one unit, or it could be a general reference to the model. The data provenance is implied to be directly from the manufacturer's testing (Invacare Corporation). The study appears to be prospective as it was conducted specifically for the submission. The country of origin of the data is not explicitly stated, but given Invacare Corporation is based in Elyria, Ohio, USA, it is likely the testing was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This type of device performance testing (electromagnetic compatibility) does not typically involve expert consensus to establish "ground truth" in the same way a diagnostic medical device would. The ground truth here is defined by the technical specifications and requirements outlined in the ISO EMC Draft Standard 7176-14.
4. Adjudication Method for the Test Set:
Not applicable. Performance against a technical standard (ISO EMC Draft Standard 7176-14) does not involve an adjudication method in the context of human expert review. The pass/fail criteria are defined by the standard itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic imaging devices where human interpretation is involved. The performance data presented relates to the technical specifications and safety (EMC) of the device.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was performed. The testing described in the "PERFORMANCE DATA" section evaluates the Invacare Storm TDX Power Wheelchair in isolation against the ISO EMC Draft Standard 7176-14. It is an evaluation of the device itself, without human intervention or interpretation as part of the performance metric.
7. The Type of Ground Truth Used:
The ground truth used was the technical specifications and requirements outlined in the ISO EMC Draft Standard 7176-14 (Titled "Draft ISO EMC Group Proposal: Electromagnetic Compatibility Addition" And Dated April 3, 1995). This standard sets the acceptable levels of electromagnetic emissions and immunity for powered wheelchairs.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML-driven device, therefore, there is no "training set." The testing performed is to demonstrate compliance with an engineering standard.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
§ 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).