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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 Mobility Scooter(Air Classic, Air Traveller, and Air Traveller 2.0) feature a base with an aluminum frame and an ABS body shell. They come equipped with one or two front wheels, two rear wheels, two armrests, a seat, a control panel, direction handles, electrical machinery, an electromagnetic brake, and rechargeable lithium-ion batteries with an off-board charger.The movement of the scooter is controlled by control panel and direction handles.

The device is installed with an electromagnetic brake.Seat and handlebar can be folded.The maximum load capacity is 120KG.

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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 proposed Mobility Scooter (BC-MS310) provide transport for the disabled and the elderly and to be used both indoors and outdoors. The maximum loading weight is 100kg.

The proposed scooter mainly consists of aluminum alloy frame, two front wheels, two rear wheels, a seat, a tiller console, pedal, a electric motor and one rechargeable Lithium battery with an off-board charger.

The device is powered by Li-ion battery, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet when the device is not in use. Alternatively, the scooter can be charged directly through the tiller port on the control panel.

The patient can pull the right throttle control lever back with the right fingers to move forward the scooter and pull the left throttle control lever back with the left fingers to move backward the scooter. After the throttle control lever is released, the scooter will stop. The speed of the scooter could be adjusted according to the forward and backward degrees of the throttle 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 scooters are designed to be a light and compact, smart mobility scooter. The tiller can be adjusted back and forth according to human comfort. The scooter can be manually folded and unfolded including the frames and seat just in one step. It can be put into the trunk of a small, compact car. The battery is removable.

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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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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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The intended / indications for use for the FreeStyle Libre 3 system are as follows:

• The FreeStyle Libre 3 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real-time alarms capability indicated for the management of diabetes in persons aged 4 years and older.
• It is intended to replace blood glucose testing for diabetes treatment decisions unless otherwise indicated.
• The System performs a scan every minute to measure interstitial fluid glucose concentrations.

Google Wifi point and AC2200 router with Ethernet port and USB-C port

This document is an FDA 510(k) Clearance Letter for a Mobility Scooter, not an AI/Software as a Medical Device (SaMD). Therefore, the acceptance criteria and study proving device performance are based on physical and mechanical performance standards, safety, and substantial equivalence to a predicate device, not on artificial intelligence algorithms or human-in-the-loop performance.

The request asks for information typically associated with AI/SaMD submissions, such as:

• Table of acceptance criteria and reported device performance (in terms of AI metrics)
• Sample size for test set and provenance
• Number of experts for ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone (algorithm only) performance
• Type of ground truth used
• Sample size and ground truth for training set

None of this information related to AI/SaMD studies is applicable or present in the provided 510(k) clearance letter for a mobility scooter.

Instead, the document details non-clinical testing against established international standards (ISO, IEC, EN) for wheelchairs and mobility scooters, and biocompatibility testing.

Here's a breakdown of the relevant acceptance criteria and performance proof from the provided document for the Mobility Scooter:

Acceptance Criteria and Device Performance for Mobility Scooter (K242975)

The acceptance criteria for this Class II Mobility Scooter are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K201196) and compliance with recognized international performance and safety standards for motorized wheelchairs and scooters. The study's proof of performance relies on non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating compliance with the listed ISO, IEC, and EN standards, and by showing comparable performance characteristics to the predicate device. The performance data is presented as reported values from the tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a numerical sample size (e.g., number of scooters) for the non-clinical tests. These types of tests are typically performed on a limited number of production units, as specified by the respective ISO standards.
• Data Provenance: The device manufacturer, Wuyi Aichi Industry & Trade Co., Ltd., is located in Wuyi, Zhejiang Province, China. The non-clinical testing would have been conducted by the manufacturer or a contracted test lab(s), likely in China, to demonstrate compliance with international standards for regulatory submission. The data is retrospective in the context of the 510(k) submission, meaning the tests were completed prior to the submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable in the context of a mobility scooter's
  non-clinical performance testing. The "ground truth" is defined by the
  established parameters and limits within the specified international
  standards (e.g., ISO 7176 series). Performance is measured objectively
  against these defined criteria.

4. Adjudication Method for the Test Set

• Not applicable. Performance is measured objectively against
  international standards. There is no concept of "adjudication" as there
  would be for human-annotated data in an AI/SaMD context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, this is not applicable. MRMC studies are used for evaluating the interaction between human readers (e.g., radiologists) and AI algorithms in diagnostic tasks. This submission is for a physical medical device (mobility scooter), not an AI/SaMD.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No, this is not applicable. There is no "algorithm" in the sense of AI/SaMD for this device's regulatory pathway. The "standalone" performance is the scooter's physical and mechanical performance as measured by the non-clinical tests.

7. The Type of Ground Truth Used

• The "ground truth" is established by internationally recognized performance and safety standards (e.g., ISO 7176 series, IEC 60601-1-2, EN 12184) and biocompatibility standards (ISO 10993 series). These standards define the test methodologies, acceptance limits, and evaluation criteria for safe and effective operation of mobility devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are validated against quality system regulations (21 CFR Part 820), and performance is validated through non-clinical testing on a sample of the manufactured device.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set for a machine learning model, there is no ground truth established in that context. The "ground truth" for the device's design and manufacturing is adherence to engineering principles, regulatory requirements, and international consensus standards.

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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 subject device, Model MS160A scooter is mainly battery-powered and driven by a DC motor, with the speed adjusted by a user-controlled panel.

The motor is driven, and the speed is adjusted by a user-controlled panel and speed knob.

The scooter consists of two folding armrests, a seat cushion, a folding frame, two front wheels, two rear drive wheels with a motor/electromagnetic brake assembly, a rechargeable lithium-ion battery, an off-board battery charger, a control panel, and a motor controller.

The MS160A scooter is designed to provide mobility for people limited to those who walk unchanged or for the elderly.

Folding design: Pull out the seat and backrest fixing pins, push the backrest forward, the seat and backrest fold into each other, release the handlebar locking knob, push the handlebar backward, the handlebar folds down, the whole scooter is folded.

Control panel: Includes speed knob, battery gauge, power key switch, horn button, throttle control lever, headlight switch, charger port, fuse.

Wheel and frame connection method: the motor is connected to the differential, the differential is connected to the frame, the wheels are mounted on both ends of the differential, the motor rotates with the differential, thus driving the scooter.

Frame design:

1. The frame of MS160A is aluminum alloy.
2. The folding mechanism is operated in two ways:
   a. In the non-riding state, pull out the seat fixing pin, push the backrest forward, the seat and backrest can be folded.
   b. Loosen the handlebar locking knob, push the handlebar forward, the handlebar will fold down.

The front wheels of the scooter are 7 inches and the rear wheels are 10 inches.

The motor of the scooter is ST-62D24-120W; the lithium-ion battery is 25.55V 10.4AH; the charger is 24V/2A.

Max. loading cannot be over than 125kg.

The maximum distance travelled with a fully charged battery is 8.2km and the maximum forward speed is 1.8m/s.

Braking time is about 2 seconds, braking distance is ≤1.5 meters.

The provided document (K242982 510(k) Summary for the Mobility Scooter (MS160A)) is a premarket notification to the FDA for a Mobility Scooter. This type of device is a physical product and not typically associated with AI/ML software or studies involving ground truth establishment by experts, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance.

Therefore, this document does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria related to AI/ML product performance. The studies mentioned primarily confirm the device's compliance with physical safety and performance standards (e.g., ISO 7176 series for wheelchairs, biocompatibility).

Here's why the requested information cannot be extracted from this document:

• Device Type: A mobility scooter is a mechanical device, not imaging or diagnostic software that would rely on AI/ML algorithms to generate results requiring expert consensus or ground truth establishment.
• Study Types: The "non-clinical testing" section details adherence to established ISO standards for physical characteristics like stability, braking, dimensions, and biocompatibility. There is explicitly "No clinical study implemented for the scooter."
• Acceptance Criteria: The "acceptance criteria" for this device are its ability to meet the performance specifications outlined in the ISO standards, and to be "substantially equivalent" to a predicate device based on physical and functional comparisons. These are not acceptance criteria for AI model performance metrics like sensitivity, specificity, or AUC, which would be relevant for devices that interpret data or images.
• Ground Truth, Experts, Sample Sizes (for AI/ML): These concepts are entirely absent because they are not applicable to the type of device being submitted.

In summary, the provided document is for a physical medical device (mobility scooter) and does not involve AI/ML components or related performance studies that would utilize the concepts of ground truth, expert review, or statistical metrics like sensitivity/specificity for algorithm output.

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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.

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I apologize, but the provided text from the FDA 510(k) letter for the Mobility Scooter (S-01; S-02) does not contain any information regarding acceptance criteria, device performance studies, or details about artificial intelligence (AI) or machine learning (ML) components.

The letter is a standard FDA clearance document confirming substantial equivalence to predicate devices and outlines general regulatory requirements for medical devices. It focuses on:

• Device Name: Mobility Scooter (S-01); Mobility Scooter (S-02)
• Regulation Number/Name: 21 CFR 890.3800, Motorized Three-Wheeled Vehicle
• Regulatory Class: Class II
• Product Code: INI
• Indications for Use: Provides mobility to a disabled or elderly person limited to a seated position, for indoor and outdoor transportation.
• Regulatory Compliance: References to general controls, quality system regulations, adverse event reporting, UDI, etc.

Therefore, I cannot extract the specific information you requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or AI performance metrics. This type of information would typically be found in the 510(k) summary or the full 510(k) submission document, neither of which is provided in your input.

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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.

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The provided document is a 510(k) clearance letter from the FDA for a Mobility Scooter. It is a regulatory document and does not contain any information regarding acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the given input. This document is a clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices, not a study report detailing performance metrics.

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