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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, S8 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 the HEARTWAY Power Mobility Scooter, S8. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a medical AI/software device submission would.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (HEARTWAY Power Mobility Scooter, PT7 (K073044)) rather than proving performance against predefined clinical or analytical acceptance criteria with a dedicated study.

Based on the provided text, I cannot complete most of your requested information as it is not present in this type of submission. The content provided is typical for a medical device (hardware) 510(k) submission, not a medical AI/software device.

Here's an analysis of what can be extracted and what is missing:

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

The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity for a diagnostic device, or a specific functional outcome for a therapeutic device). Instead, it relies on demonstrating that the new device (S8) is similar enough to a predicate device (PT7) by having comparable characteristics and meeting certain general safety standards.

The performance testing section mentions:

• EMC Report 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)

These are standards that the device meets, not acceptance criteria in the sense of a clinical benchmark. The "reported device performance" is essentially that it complies with these standards and is comparable to the predicate device in terms of:

• Intended use
• Mainframe materials (strength and fatigue)
• Maximum speed
• Suspension of cross brace
• Footplates
• Armrest type
• Overall dimensions
• Back upholstery material (passed resistance ignition test)
• Electronic systems (same suppliers, UL certificated - electronic controller, batteries, recharger, switches, switching power supplies), assuring the "same safety level."

Differences noted (weight capabilities, maximum slope, weights, cruising range, warranty) are deemed "not safety aspect" and do not prevent substantial equivalence.

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. This is not a study involving a test set of data samples for an algorithm. It's a submission for a physical medical device.

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. There's no ground truth establishment in the context of an AI/software device.

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-assisted device.

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 consensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary:

The provided document is a 510(k) submission for a physical power mobility scooter. Its purpose is to demonstrate that the new device, HEARTWAY Power Mobility Scooter, S8, is "substantially equivalent" to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT7). This type of submission relies on comparing specifications, materials, and compliance with general safety and performance standards (like EMC and RESNA) rather than clinical studies with explicit acceptance criteria for algorithmic performance, ground truth, or human reader effectiveness, as would be expected for an AI/software as a medical device (SaMD).

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