(22 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, P16RT 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.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the HEARTWAY Power Tilt Seating System Power Chair, P16RT. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting de novo studies with specific acceptance criteria as you'd find for a novel device.
Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with performance evaluations of AI algorithms or diagnostics, is not applicable in this context. The 510(k) submission focuses on comparing the new device against an existing one to show it's equally safe and effective.
Here's how to interpret the provided information within the framework of a 510(k):
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for 510(k)s): The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use as the predicate and is as safe and effective, or has different technological characteristics but those differences do not raise different questions of safety and effectiveness.
- Reported Device Performance: The submission argues for substantial equivalence by stating:
- "The intended use between the two devices is the same."
- "Mainframes materials of the two devices all meet the strength and fatigue tests and they use the same material aspects." (Implies the new device passed these tests, aligning with predicate performance.)
- "The suspension of cross brace, footplates, armrest type, and the warranty are all the same."
- "The back upholstery material is also the same fabric and passed the resistance ignition test."
- "Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured."
- The document also lists specific performance testing standards it met: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. These standards themselves contain specific acceptance criteria for various aspects of powered wheelchairs (e.g., stability, braking, durability, electromagnetic compatibility). The implication is that the HEARTWAY device passed all relevant criteria within these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a 510(k) substantial equivalence submission. The "test set" here refers to the device itself being tested against established industry standards. There isn't an external "data set" in the sense of patient data or algorithm performance data. The device itself undergoes performance testing.
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. "Ground truth" in the context of device performance testing generally refers to the physical measurements and evaluations against predefined standards by qualified testing engineers and laboratories (e.g., UL certified labs).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical trials or studies assessing clinical endpoints or subjective interpretations (e.g., image reading). This submission focuses on 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. This relates to AI or diagnostic device performance, not a powered wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI or diagnostic device performance, not a powered wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. The "ground truth" for the performance testing mentioned (e.g., strength, fatigue, ignition resistance, EMC) would be the measured values of the device's performance against the specified limits in the referenced ANSI/RESNA, CISPR, EN, and IEC standards.
8. The sample size for the training set:
- Not applicable. "Training set" refers to data used to train AI algorithms. This is a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable. Same reason as above.
In summary, for K070489:
This submission is a traditional 510(k) for a physical medical device (powered wheelchair). The "proof" that it meets acceptance criteria comes from demonstrating that its technological characteristics are substantially equivalent to a predicate device and that it complies with relevant industry performance and safety standards. The detailed questions about studies, experts, ground truth, and AI-related metrics do not apply to this type of regulatory submission.
§ 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).