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

The HEARTWAY Power Mobility Scooter, S9 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.

This appears to be a 510(k) premarket notification for a medical device, specifically a power mobility scooter. The document describes a comparison to a predicate device to establish substantial equivalence, rather than a study with a defined set of acceptance criteria for a novel device's performance.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.

This document focuses on demonstrating that the new device (HEARTWAY Power Mobility Scooter, S9) is substantially equivalent to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PF6 (K072104)).

Here's an breakdown of the relevant information provided in the document:

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

This document does not provide a table of acceptance criteria and reported device performance in the way a clinical trial or performance study report for a novel medical algorithm might. Instead, it compares the new device to a predicate device on various design and performance aspects to establish substantial equivalence.

The document states:

• "According to the above table that the intended use between the two devices is the same."
• "Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects."
• "Moreover, the weight limit, maximum speed, cruising range, suspension of cross brace, footplates, and armrest type 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, battery charge, and the competent switches and switching power supplies."
• "The maximum slope for the two devices is difference. This means the new device is 12°, the predicate device is 10°." (This is a difference, not an 'acceptance criterion' being met, but the document argues it's still substantially equivalent, stating "For the real life use, the two devices are substantially equivalent.")
• "The main differences for the two devices are overall appearance, wheels size, weights, and the warranty are difference between the two devices. The safety levels of the two devices are the same and the overall appearance differences are not safety aspect."

Summary Table (based on substantial equivalence comparison, not specific acceptance criteria):

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This is not a study involving a test set of data like an AI/ML algorithm. It's a comparison of device specifications.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for a test set is not relevant here as this is a device specification comparison.

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

• Not applicable.

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/ML device requiring an MRMC study.

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

• Not applicable.

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

• Not applicable in the context of "ground truth" for a dataset. The "truth" here is the documented specifications and performance of the predicate device (K072104) and the measured specifications and performance of the new device (S9), which are then compared.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable.

In summary: This document is a 510(k) submission focused on demonstrating substantial equivalence between a new power mobility scooter and a previously cleared predicate device based on design, materials, components, and performance specifications. It is not a performance study for an AI/ML device that would include acceptance criteria, test/training sets, or expert ground truth as typically defined for such a submission.

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