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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The HEARTWAY Lightweight Power Chair, P15 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 is a 510(k) summary for a medical device, specifically a "HEARTWAY Lightweight Power Chair, P15". It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets performance criteria in the way a clinical study for a diagnostic or therapeutic device would.

Instead, the "Performance Testing" section lists standards that the device was tested against. In the context of a 510(k) for a powered wheelchair, meeting these standards is the acceptance criteria for mechanical and electrical safety and performance. The study proving acceptance is the testing performed against those standards, documented in an "EMC Report" and likely other internal test reports.

Given the information provided, here's an attempt to answer your questions, interpreting "acceptance criteria" and "study" in the context of this device type and 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "The same maximum speed 9.6 km/hr, suspension of cross brace, footplates, armrest type, and the warranty are all the same" as the predicate device. It also notes that the overall appearance differences are "not safety aspect." The device is designed to be "more lightweight."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data. For a hardware device like a power chair, the sample size for performance testing is typically n=1 (the manufactured device itself or a representative sample), which undergoes repeated tests according to the specified standards.
• Data Provenance: The testing was conducted internally or by a contracted lab and reported by HEARTWAY Medical Products Co., Ltd. in Taiwan, ROC. This is internal company data, not clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in the typical sense for this device. "Ground truth" for a power wheelchair primarily refers to its physical characteristics and functionality meeting engineering specifications and safety standards. The "experts" involved would be:

• Engineers and technicians at HEARTWAY who designed and built the chair.
• Engineers and technicians at the testing facilities who performed the tests against the ANSI/RESNA, CISPR, EN, and IEC standards. Their qualifications would be expertise in mechanical engineering, electrical engineering, and relevant standard testing protocols.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring expert adjudication of results. Compliance is determined by whether the device's measured performance falls within the specified limits of the listed 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 device is a power wheelchair, a mobility aid. MRMC studies and "human readers improving with AI assistance" are relevant to diagnostic AI software, not physical mobility devices.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its mechanical and electrical design as operated by a user.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is:

• The engineering specifications and safety requirements outlined in the referenced international and national standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995).
• The performance characteristics of the legally marketed predicate device (HEARTWAY Power Tilt Seating System Power Chair, P16RT (K070489)) for substantial equivalence comparison.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

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