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The Powered Mobility scooteris intended for medical purposes to provide mobility to persons restricted to a sitting position.

Powered Mobility Scooter

I am sorry, but the provided text from the FDA letter (K250027) does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is a clearance letter for a "Powered Mobility Scooter," a Class II medical device. It primarily covers:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements and general controls applicable to the device (e.g., Quality System Regulation, UDI Rule, adverse event reporting, labeling).
• Standard disclaimers regarding FDA's review and the manufacturer's responsibility for compliance.
• The "Indications for Use" for the device, stating it is "intended for medical purposes to provide mobility to persons restricted to a sitting position."

The letter does not include details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance of a study.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for training sets.
9. How ground truth for training data was established.

These details are typically found in the 510(k) submission itself (the "premarket notification"), which is a much more extensive document than the FDA's clearance letter. The clearance letter only announces the outcome of the FDA's review of that submission.

Therefore, I cannot fulfill your request based on the provided input.

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The Powered Mobility Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.

The Powered Mobility Scooter. Models: PMS101. GUT112, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor .It has a driving range of 15.6 km between charges. It is capable of carrying a driver weighing up to 125 kg.

The Powered Mobility Scooter, Models: PMS103, GUT140, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, Armrest, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor. It has a driving range of 10.4 km between charges. It is capable of carrying a driver weighing up to 125 kg.

The provided text is an FDA 510(k) summary for a Powered Mobility Scooter. It outlines the safety and performance testing conducted for the device to demonstrate its substantial equivalence to a predicate device. However, this document does not describe a study that uses AI or machine learning, involves diagnostic imaging, or establishes ground truth through expert consensus, pathology, or outcomes data in the way a medical AI device submission would.

Therefore, many of the requested criteria (e.g., sample size for test set, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document as it pertains to a physical medical device (a mobility scooter) and traditional engineering and biocompatibility testing, not an AI/ML medical device.

Based on the provided text, here is the information that can be extracted, with explanations for why certain criteria cannot be met:

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

The acceptance criteria for this device are compliance with a comprehensive set of ISO standards related to wheelchairs and scooters, along with biocompatibility testing and EMC. The "reported device performance" is the demonstration that the subject device meets the requirements of these standards and is substantially equivalent to the predicate device. The tables provided in the document (Table 1, 2, and 3) show comparisons between the subject device and the predicate device across various parameters and confirm compliance with relevant ISO standards.

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

• Sample Size for Test Set: This document does not specify a "sample size" in terms of cases or subjects in the way an AI/ML study would. Instead, it refers to non-clinical laboratory testing performed on the physical device itself (the Powered Mobility Scooter models PMS101, GUT112, PMS103, GUT140). The testing involves subjecting units of the device to various mechanical, electrical, and biocompatibility tests according to the listed ISO standards. The "sample" is implicitly the physical device units tested to demonstrate compliance.
• Data Provenance: The testing was conducted by Intradin (Shanghai) Machinery Co., Ltd located in Shanghai, China. The data provenance is from non-clinical laboratory tests performed on manufactured units of the device, not from retrospective or prospective patient data.

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

• Not Applicable. This is not an AI/ML or diagnostic imaging device. "Ground truth" in this context refers to engineering specifications and compliance with established international standards for mobility devices, which are validated through physical testing, not expert interpretation of medical images or data.

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

• Not Applicable. As above, this is not an AI/ML or diagnostic imaging device involving human reviewers or adjudication. Test results are objective measurements against defined engineering 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:

• No. This is not an AI-assisted device for human readers. 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 mobility device, not a standalone algorithm.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device's performance is adherence to defined parameters within the listed international ISO standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, IEC 60601-1-2 for EMC). Compliance is determined by whether the device's measured performance falls within the acceptable ranges or meets the criteria specified by these widely accepted engineering and safety standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm.

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

• Not Applicable. No training set exists for this device.

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