(27 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, PF7 is an indoor / outdoor clectric 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.
The provided document (K080242) is a 510(k) premarket notification for a medical device, specifically the HEARTWAY Power Mobility Scooter, PF7. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with strict acceptance criteria and clinical endpoints for standalone device performance.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with performance studies for novel AI/medical imaging devices, is not present in this document.
Instead, the document details the comparison to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT6 - K073044) to establish substantial equivalence. The "performance testing" mentioned is related to safety standards (EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) rather than clinical efficacy or diagnostic accuracy.
Here's a breakdown of what is available in the document, framed against your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the "acceptance criteria" for substantial equivalence are met when the new device (PF7) demonstrates that its intended use, materials, safety aspects (like electronic systems meeting UL certification), and key physical/performance characteristics (e.g., maximum speed, range per charge) are equivalent to the predicate device (PT6), and that differences (like the number of wheels) do not raise new questions of safety or effectiveness.
- Reported Device Performance:
Aspect Predicate Device (PT6) New Device (PF7) Substantial Equivalence Claim Intended Use Same Same Same Mainframes materials Fixed, strength/fatigue tests met Fixed, strength/fatigue tests met Same Maximum Speed Same Same Same Suspension of cross brace Same Same Same Footplates Same Same Same Armrest type Same Same Same Warranty Same Same Same Overall dimensions Same Same Same Back upholstery material Same fabric, passed ignition test Same fabric, passed ignition test Same Electronic Controller Same supplier, UL certified Same supplier, UL certified Same Batteries Same supplier, UL certified Same supplier, UL certified Same Recharger Same supplier, UL certified Same supplier, UL certified Same Range per charge 32 miles 32 miles Same Number of Wheels Three Four Different, but not a safety aspect Overall Weight Not explicitly stated Different (due to wheels), but not a safety aspect Differences not safety-critical Performance Testing (Safety) (Implied) EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3 EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3 All passed
2. Sample size used for the test set and the data provenance
- Not applicable. This submission relies on comparisons of device specifications and adherence to safety standards, not a clinical "test set" of patient data.
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 clinical endpoints or diagnostic accuracy is not addressed. The "ground truth" here is adherence to engineering and safety standards, and equivalence to a legally marketed device.
4. Adjudication method for the test set
- Not applicable. There is no "test set" in the clinical or diagnostic sense described here. The evaluation relies on engineering tests and comparison by the manufacturer and subsequently reviewed by the FDA.
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 motorized scooter, not an AI-powered diagnostic or imaging device. There are no "human readers" or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical/electrical product, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this submission is regulatory compliance and engineering specifications. It includes:
- Predicate Device Specifications: The established characteristics and performance of the legally marketed HEARTWAY Power Mobility Scooter, PT6 (K073044).
- Industry Standards: Adherence to standards like ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods).
- Component Certifications: For example, UL certification for electronic systems (controller, batteries, recharger).
- Material Testing: Strength and fatigue tests for mainframes, resistance ignition test for upholstery.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set. The "ground truth" for demonstrating substantial equivalence is based on established engineering and safety standards and the characteristics of the predicate device.
§ 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).