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

The HEARTWAY Electrically Powered Wheelchair, Model P27 is battery powered and configured with 2 PU solid front castors and 2 pneumatic rear drive wheels, a width adjustable seat, a controller to control the lighting function and driving function, a main frame, a foot-rest, a pair of arm-rest, a back-rest, a seat cushion, a pair of skirts, a set of anti-tippers.

P27 powered wheelchair is rear-wheel driven and operated by two pneumatic rear wheels as the drive wheels, two solid front wheels as the front casters and uses upper joystick to control the driving direction, driving speed, and lighting function. Main frame carries a width adjustable seat system and a set of anti-tipper to prevent a patient from tipping their wheelchairs backward. Main frame is equipped with the front & rear independent suspensions to enhance the stability. A width-adjustable seat system carries a set of back rest system, a seat cushion, a pair of arm-rest, a pair of foot-rest, and a pair of skirts to provide seat posture positioning functions. P27 power wheelchair maximum weight capacity is 265 lbs (120kg). Maximum speed is 3.75 mph (6 kph). The device can be disassembled for transport and is provided with an external battery charger.

This document describes a 510(k) premarket notification for the HEARTWAY Electrically Powered Wheelchair P27. The information provided focuses on demonstrating substantial equivalence to a predicate device (HEARTWAY Power Tilt Seating System Power Chair, P16RT) rather than presenting a study to prove a device meets specific acceptance criteria for diagnostic performance or treatment efficacy.

Therefore, many of the requested categories for acceptance criteria and study details (such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information) are not applicable to this type of regulatory submission. The "acceptance criteria" here are essentially the performance standards met to ensure safety and effectiveness in comparison to the predicate device.

Here's the breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The "acceptance criteria" in this context are the international standards (ISO 7176 series and ANSI/RESNA WC 2, Section 21 for EMC) that the device must pass to demonstrate safety and effectiveness. The reported device performance is that the subject device completed these performance tests. The document doesn't provide specific numerical results or thresholds for each test, but rather states that the device "function[s] safely and effectively" after completing them.

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: Not specified. This type of submission generally involves testing a single or a small number of devices against the listed standards. It is not a clinical study with a patient test set.
• Data provenance: The document indicates the manufacturer is HEARTWAY Medical Products Co., Ltd. located in Taichung City, Taiwan. The testing was conducted against international standards (ISO, 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 is a performance testing submission against engineering and safety standards, not a clinical study requiring expert ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical adjudication process is described. The tests are defined by the referenced 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 is not an AI/software device and no MRMC study was performed.

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

• Not applicable. This is a physical medical device (powered wheelchair), not an algorithm or AI.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for this device's performance is adherence to the specified international safety and performance standards (ISO 7176 series and ANSI/RESNA WC 2, Section 21).

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.

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