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The Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

The Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The Bewell SC 20 scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 35.2 km (22 miles) with 36AH which maximum speed upto 9 km/hr (5.6 mph).

The available text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving such performance. Instead, the document is a 510(k) summary for a mobility scooter, the Bewell SC 20. The summary primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to relevant safety standards.

Therefore, I cannot provide the requested information. The document does not contain:

1. A table of acceptance criteria and reported device performance related to a medical outcome.
2. Information on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth in a clinical or performance study.
3. Details about a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI assistance.
4. Information about a standalone algorithm-only performance study.
5. The type of ground truth used in a clinical study.
6. Sample size for a training set or how ground truth for a training set was established.

What the document does include regarding performance is:

• Non-Clinical testing: The Bewell SC 20 scooter was tested to various wheelchair standards, including:
  • ANSI/RESNA WC/Vo1.1 section 1-1998 / ISO7176-1-1999 Determination of static stability
  • ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 Static, impact and fatigue strengths-Requirements and test methods
  • ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 Requirements and test methods for electromagnetic compatibility of powered wheelchairs and motorized scooters
  • CISPR 11-1990 Industrial, scientific and medical (ISM) Radio-Frequency equipment- electromagnetic disturbance characteristics -- limits and methods of measurement
  • IEC 61000-4-2-1995 EMC-Electrostatic discharge immunity test (ESD)
  • IEC 61000-4-3-1995 EMC-Testing and measurement techniques-Radiated, RF, electromagnetic field immunity test
  • California Bureau of Home Furnishings 116 Flammability Standards

The document states that "compliance testing to existing ANSI/RESNA, ISO 7176 and IEC standards, demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended." However, it does not specify the numerical acceptance criteria for each of these tests or the detailed results beyond a general statement of compliance.

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