(32 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The SINON Power Wheelchair, SN-P401 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of medical efficacy or diagnostic performance. Instead, it details a 510(k) premarket notification for a powered wheelchair, focusing on substantial equivalence to a predicate device.
The "Performance Testing" section mentions:
- EMC Report
- ANSI / RESNA WC/Vol.2-1998
- CISPR 11: 1990
- EN61000-3-2: 1995
- IEC61000-3-3: 1995 (Electrically Powered Wheelchairs, controller, and their chargers - requirements and test methods)
These are standards related to electromagnetic compatibility and general safety and performance for wheelchairs, not acceptance criteria for a diagnostic or AI-driven medical device. The document states that "electronic systems between two devices are the same and all passed by the UL." This implies compliance with safety standards rather than a clinical study evaluating performance metrics like sensitivity, specificity, or reader improvement.
Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.
However, based on the limited information related to "Performance Testing" and the nature of this submission (510(k) for a powered wheelchair), a hypothetical interpretation of "acceptance criteria" for a physical device would be compliance with recognized safety and performance standards.
Here's how I would attempt to answer based on the given context, with significant caveats that the document does not provide the detail usually associated with AI/diagnostic device studies:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Hypothetical for a powered wheelchair) | Reported Device Performance (Based on provided text) |
|---|---|
| Compliance with EMC standards (e.g., CISPR 11, EN61000-3-2, IEC61000-3-3) | "EMC Report," "all passed by the UL" |
| Compliance with Powered Wheelchair safety and performance standards (e.g., ANSI/RESNA WC/Vol.2-1998) | "ANSI / RESNA WC/Vol.2-1998" listed as a test |
| Electronic system safety | "electronic systems between two devices are the same and all passed by the UL" |
2. Sample size used for the test set and the data provenance: Not applicable. The document refers to engineering and safety standards compliance, not data sets for clinical or algorithmic performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in the context of a powered wheelchair would be linked to engineering specifications and safety testing, not expert consensus on medical images or diagnoses.
4. Adjudication method for the test set: Not applicable.
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: Not applicable. This is a physical device, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For safety and performance standards, the "ground truth" would be the engineering specifications, test protocols, and pass/fail criteria defined by the listed standards (e.g., ANSI/RESNA, CISPR, IEC).
8. The sample size for the training set: Not applicable. This device does not use a training set in the AI sense.
9. How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence for a physical medical device (a powered wheelchair) through compliance with recognized safety and performance standards, rather than presenting a study evaluating diagnostic accuracy or AI performance against specific acceptance criteria.
§ 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).