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It is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Electric Scooter (model: S202572J, S2060, M2089, S2050) is an indoor electric scooter that is battery operated.

The Electric Scooter (Model: S202572J, S2060, M2089, S2050) is with 125 kg weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable frames (S202572J: carbon fiber frame, S2060, M2089, S2050: aluminum alloy frame), a sealed trans-axle motors drive system, electromagnetic braking system, electric motor controller and a Li-ion batteries with an off-board battery charger. It is powered by 25.2 V/10 AH rechargeable Lithium batteries with 15 km which maximum speed up-to 6 km/hr. The direction control lever to control the direction of the Electric Scooter.

For model S202572J, when pushing the right acceleration push rod forward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod forward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic carbon fiber frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake, two armrests and a Lithium battery with an off-board charger. The control panel has eight buttons, the acceleration push rod, a display screen showing the device status and NFC unlocking sensing area.

For model S2060, when pushing the right acceleration push rod backward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod backward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The control panel has five buttons, the acceleration push rod, a display screen showing the device status and NFC unlocking sensing area.

For model M2089, when pushing the right acceleration push rod forward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod forward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, four backline anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake, two armrests and a Lithium battery with an off-board charger. The control panel has five buttons, the acceleration push rod, a display screen showing the device status.

For model S2050, when pushing the right acceleration push rod forward with the right finger, the electric scooter moves forward, when pushing the left acceleration push rod forward with the left finger, the electric scooter moves backward, the electromagnetic brake will be actuated when the acceleration push rod is released and the electric scooter will stop. It consists of four parts which are chair part, control part, folding part and drive part. Overall, it mainly has a basic aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a control panel, an electric motor, an electromagnetic brake and a Lithium battery with an off-board charger. The control panel has a battery level indication area, a speed control knob, a horn button, a power control keyhole and the acceleration push rod.

The model S202572J, S2060, M2089, S2050 are identical in circuit structure and key components (such as battery, charger, controller, motor) except for some differences shown in the appearance and function. About appearance of the four models, the model S202572J and model S2060 are different in the material of the frame, the control panel, the size of tires, the overall size and the backrest shape. The model S2050 and model S2060 are different in the shape of seat bracket, the control panel and the backrest shape. The model M2089 and model S2060 are different in the shape of seat bracket, the pedal, the overall size and the backrest shape. The model S2060, S2050 have no armrest, while the model S202572J, M2089 have two armrests.

About function of the four models, the folding method of model M2089 are different from the model S202572J, S2060, S2050. The tiller height of model S202572J, S2060, S2050 is adjustable, while the tiller height of model M2089 is non-adjustable.

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It is motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter (T5) is a motor driven, indoor and outdoor transportation vehicle. It has an overall dimension of 1240mm610mm875mm and a steel frame. It features a foldable tiller, removable battery pack, and disassembles for transport. It has 2 rear wheels, a ground clearance of 20 mm, and a maximum loading capacity of 150kg on level ground. The minimum turn radius is 2175mm, and it is powered by a 24V 350W motor with rear-wheel drive. Braking is handled by an electromagnetic brake. It uses a Li-ion Battery 25.6Vdc 15Ah with a 29.4V/2A charger. The maximum speed is 7.92 km/h, and it can handle a maximum slope of 6°. The travel distance is 18.5 km, with a brake time of less than 1 second and a brake distance of ≤1.3m (horizontal-forward at max speed). The total mass is 54 kg. It is intended for indoor use and restricted outdoor use on pavements or paved footpaths only. It does not have a remote control. The folding mechanism includes a foldable column and a removable basket. The front and rear tire diameters are 9 inches.

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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, Model PMS105, GUT177, GCAT047 is mainly composed of frame, two front wheel, two drive wheel, control system, motor and drive device, armrest, backrest, seat cushion, pedal, battery and charger. The traveling speed is controlled by the motor, and the traveling direction is manually controlled by the accompanying personnel or passengers. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road. When encountering an obstacle in front, please make a detour to avoid the danger of overturning the scooter. It has a driving range of 9.2 km between charges. It is capable of carrying a driver weighing up to 150kg.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Folding mobility scooter, has a base with metal frame, two front wheels, two rear wheels, a seat, a LED Display, electric motor, electromagnetic brake, 1 rechargeable Lithium Battery pack (with 2 batteries) with an off-board charger. The movement of the scooter is controlled by the rider who operates the control lever. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road. The device can be folded up from front to back.

The device has 2 options, with a faucet adjustment or without a faucet adjustment.

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It is motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

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"It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position."

The product is a Mobility Scooter which provides transport for the disabled and the elderly and to be used both indoors and outdoors.

This scooter is a battery powered four wheeled vehicle. It consists two Lead-acid batteries (in the battery box) with an off-board battery charger, frame, a seat, a back support, control panel (including the key switch, throttle control lever, horn button, speed adjustment dial, and the battery condition meter), two foldable handles, two rear drive wheels with motor/ e-magnetic brake components, two front wheels, anti-tip devices, an external battery charger, a control panel and a motor controller. For convenience of transportation and reduction of possible damage, the battery and the seat unit can be dismantled and separately packaged.

The front wheels of the scooter are 8 inches and the rear wheels are 9 inches.
The motor of the scooter is 24VDC,150W,4200RPM; the Lead-acid Battery is 12 V, 22 Ah, 18.7 Ah; the charger is 24V/2A.
Max. loading cannot be over than 180kg.
The maximum distance travelled with a fully charged battery is 17.5km and the maximum forward speed is 1.6m/s(5.8km/h).
Braking time is less than 2 seconds, braking distance is ≤1.0 meters.

This document is an FDA 510(k) Clearance Letter for a Mobility Scooter (MS160C). It is not an AI/ML medical device, and therefore does not contain the information typically associated with studies proving the performance of an AI/ML algorithm.

The request asks for details like "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone performance," which are specific to the evaluation of AI/ML software. This information is irrelevant to a physical device like a mobility scooter.

Therefore, I cannot provide the requested information as it is not present in the provided document. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing against established standards (ISO, IEC).

Here's why each point in your request cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance: While the document lists performance characteristics in "Table 2 - Performance Comparison", these are not presented as "acceptance criteria" in the sense of accuracy/sensitivity/specificity targets for an AI algorithm. Instead, they are comparisons to a predicate device and compliance with established ISO standards. I can extract performance characteristics, but not "acceptance criteria" for an AI model.
2. Sample sized used for the test set and the data provenance: Not applicable. This refers to data for an AI model. The mobility scooter underwent physical product testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are for AI model validation.
4. Adjudication method: Not applicable. Adjudication is for resolving discrepancies in AI model output or expert readings.
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. MRMC studies are for evaluating AI's impact on human performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" is a concept for AI model training and validation.
8. The sample size for the training set: Not applicable. This refers to data for an AI model.
9. How the ground truth for the training set was established: Not applicable. This refers to data for an AI model.

However, I can extract information related to the device's performance testing based on the provided document:

Study that proves the device meets requirements (Non-Clinical Testing):

The study was a series of non-clinical tests conducted to verify that the proposed device (Mobility Scooter MS160C) met all design specifications and was substantially equivalent (SE) to the predicate device (Mobility Scooter Model: W3468, K220207).

1. Table of Acceptance Criteria (as reported performance against standards, not AI-specific criteria) and the Reported Device Performance:

The document describes compliance with various ISO and IEC standards as the basis for demonstrating safety and effectiveness. The "acceptance criteria" are implied by adherence to these standards, and the "reported performance" is demonstrated by the test results confirming this compliance.

Key Performance Characteristics (from Table 2 - Performance Comparison):

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

• Sample Size: The document does not specify the number of units tested. For physical device performance testing against standards, it's common to test a representative number of units, but this specific number is not provided in the summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or controlled setting, presumably as part of the manufacturer's (Suzhou Master Machinery Manufacturing Co., Ltd., China) quality assurance and regulatory submission process. There is no mention of data from human subjects or specific geographical origin for "data provenance" in the sense of patient data.

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

• Not applicable as this is a physical device, not an AI/ML algorithm requiring expert ground truth for diagnostic or similar tasks. The "ground truth" for the device's performance is established by objective measurements against international standards.

4. Adjudication method:

• Not applicable for a physical medical device.

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 type of study is specific to AI/ML devices interacting with human interpreters.

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

• Not applicable. This is a physical mobility scooter, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the mobility scooter's performance is established by objective measurements and conformance to international performance, safety, and quality standards (e.g., ISO 7176 series, IEC 60601-1-2, ISO 10993 series). This is not an "expert consensus" or "pathology" in the AI/ML context.

8. The sample size for the training set:

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

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

• Not applicable.

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The Mobility Scooter (Model: JT10) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Mobility Scooter, Model JT10 is intended to be used by individuals that are able to walk but suffer from mobility limitations. It has a base with steel frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, electric motor, electromagnetic brake, 2 rechargeable Lead-acid batteries with an off-board charger. The movement of the scooter is controlled by the rider who operates the throttle lever, speed knob and handle on the tiller console. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually. The Scooter only can be operated on the flat road.

The provided FDA 510(k) clearance letter for the Mobility Scooter (JT10) does not contain information related to an AI/ML-driven device or diagnostic study. Instead, it discusses the substantial equivalence of a physical medical device (mobility scooter) to a predicate device, based on engineering aspects and performance standards.

Therefore, I cannot extract the requested information regarding acceptance criteria, study data, sample sizes, expert involvement, ground truth, or MRMC studies, as these concepts are specifically applicable to the evaluation of AI/ML or diagnostic devices. The document focuses on physical and functional comparisons and adherence to relevant ISO standards for wheelchairs and mobility aids.

Essentially, the device cleared here is a mobility scooter, not a software or AI-based diagnostic tool. As such, the performance evaluation relies on physical testing against established ISO standards for mobility devices, not on data analysis of images or other medical data.

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It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

RS100 is a Mobility Scooter which provides mobility to a disabled or elderly person limited to a seated position. The Mobility Scooter is classified in the Class B and the maximum loading weight is 125kg. The scooter is a battery powered three-wheeled vehicle.

It consists Lithium-ion battery with an off-board battery charger, frame, controllers, motor, seat, back support, arm supports, control panel (including speed knob, battery gauge, power key switch, horn button, throttle control lever, charger port) two rear wheels, one front wheel, foot support.

For convenience of transportation and reduction of possible damage, the battery and arm supports can be dismantled and separately packaged. Users can also easily assemble these parts without use of the tools.

The provided document is an FDA 510(k) clearance letter for a "Magnesium alloy scooter (RS100)". This type of device, a motorized three-wheeled vehicle, is a physical mobility aid, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of acceptance criteria in the context of AI performance metrics (like sensitivity, specificity, AUC), ground truth establishment by experts, adjudication methods, MRMC studies, or training/test sets for AI algorithms simply do not apply to this device.

The "acceptance criteria" for this device are based on its compliance with international performance and safety standards, primarily the ISO 7176 series and ISO 10993-1 for biocompatibility, and IEC 60601 for electrical safety and electromagnetic compatibility. The "study that proves the device meets the acceptance criteria" refers to the non-clinical bench testing conducted to demonstrate compliance with these standards and substantial equivalence to a predicate device.

Given this, I cannot extract the information required by your prompt regarding AI/SaMD performance. I will explain why each point in your prompt is inapplicable to this document:

Inapplicability of Prompt Points:

1. A table of acceptance criteria and the reported device performance: While the document does compare the subject device's specifications to the predicate, and states that test results meet design specifications and ISO standards, it does not present these as a "table of acceptance criteria and reported device performance" in the way one would for AI metrics. The acceptance criteria are "compliance with ISO standards" and "meets design specifications," and the performance is implicitly satisfactory if it achieves this compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This would refer to a dataset used to evaluate an AI model. For a physical medical device like a scooter, the "test set" would be the physical prototypes tested. There's no "data provenance" in the sense of patient data. Testing is done on the device itself, likely within a lab setting.

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): Ground truth establishment by experts is relevant for diagnostic AI. For a scooter, the "ground truth" is whether it performs according to engineering specifications and safety standards, which is determined by objective physical measurements and adherence to specified test protocols (e.g., in the ISO standards), not expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication is for resolving disagreements among human experts labeling data for AI. Not applicable here.

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: MRMC studies evaluate the impact of AI on human reader performance, typically in imaging diagnostics. This is entirely irrelevant for a physical mobility scooter.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Standalone performance refers to an AI algorithm operating without human intervention. Not applicable to a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As explained in point 3, the "ground truth" for a physical device's performance is adherence to defined engineering and safety standards, measured objectively.

8. The sample size for the training set: Training sets are for machine learning algorithms. This device is not an AI.

9. How the ground truth for the training set was established: As explained in point 8, not applicable.

In conclusion, this FDA 510(k) clearance document pertains to a physical mechanical device, a scooter, and not to an AI/SaMD. Therefore, addressing the specific points of your prompt as if it were an AI device is not possible with the provided information.

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