(31 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Tilt Seating System Power Chair, P17RT is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies:
This 510(k) summary focuses on demonstrating substantial equivalence rather than defining and meeting specific, quantitative acceptance criteria for device performance as might be seen for novel technologies or for specific diagnostic accuracy. The performance testing cited is primarily related to safety and general electrical/mechanical standards, not clinical efficacy or diagnostic performance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit from Document) | Reported Device Performance (from Document) |
|---|---|---|
| Safety and Standards Compliance | Meet EMC standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) | Device passed: "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" |
| Structural Integrity | Mainframes materials meet strength and fatigue tests. | "Mainframes materials of the two devices all meet the strength and fatigue tests" |
| Material Safety (Upholstery) | Back upholstery fabric passed resistance ignition test. | "The back upholstery material is also the same fabric and passed the resistance ignition test." |
| Electrical System Safety | Electrical systems (controller, batteries, switches, power supplies) are UL certified. | "the electronic systems... are the same suppliers, and all passed by the UL certificated" |
| Intended Use | Provide mobility to persons restricted to a seated position. | Identical to predicate device: "The intended use between the two devices is the same." |
| Substantial Equivalence to Predicate | Overall performance and safety comparable to WU'S Powered Wheelchair MAMBO 36X (K050010), despite differences in dimensions, max speed, cruising range, incline, and power tilt system. | Demonstrated as substantially equivalent by the FDA letter: "...determined the device is substantially equivalent... to legally marketed predicate devices..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense for diagnostic or clinical performance. The "test set" here refers to the device itself undergoing engineering and safety evaluations. No human subject testing data is presented in this summary for performance.
- Data Provenance: The device manufacturer, HEARTWAY Medical Products Co., Ltd., is located in Taichung, Taiwan, ROC. The testing would have been conducted by them or by certified labs. The standards referenced are international (CISPR, EN, IEC) and American (ANSI/RESNA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is not a diagnostic tool requiring expert ground truth for interpretation. The "ground truth" for the engineering and safety tests are the specifications of the standards themselves (e.g., whether a material passes a fatigue test).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving multiple human readers reviewing medical images or patient records. This summary details compliance with established engineering and safety standards.
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. MRMC studies are used for evaluating the performance of diagnostic devices or AI algorithms often with human readers. This device is a powered wheelchair and does not involve AI assistance for human diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a powered wheelchair. It does not employ an algorithm that would have standalone performance evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing cited is adherence to published engineering, safety, and electrical standards (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3, UL certification, resistance ignition tests). This can be considered a form of objective technical standard compliance.
8. The sample size for the training set
- Not applicable. There is no mention of a training set for an AI algorithm or model. This is a medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).