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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.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "Electric Scooter (M2085, S2091)". This document does not contain information about acceptance criteria or a study proving that a device (specifically an AI/ML medical device, which is what your query implies) meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document discusses regulatory approval for an electric scooter, not an AI software or a clinical study's findings.

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I 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.

Electric Scooter (Model: M2020)

The provided text is an FDA 510(k) clearance letter for an electric scooter (Model: M2020) and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-driven medical device.

The document discusses:

• The FDA's determination of substantial equivalence for an electric scooter.
• Regulatory requirements for the device (e.g., registration, listing, labeling, good manufacturing practices).
• The product code (INI) and regulation number (21 CFR 890.3800), which pertain to "Motorized Three-Wheeled Vehicle."
• Indications for Use of the electric scooter: "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."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-driven device, as the provided input does not describe such a device or study.

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I 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.

Electric Scooter (Model: S3312)

I am sorry, but the provided text is a 510(k) clearance letter for an electric scooter and does not contain information about the acceptance criteria or a study proving device performance for a medical device that would have these types of criteria and studies associated with it.

Therefore, I cannot extract the requested information.

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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 Solax Electric Scooter (Models: S204311M, S204161, S204143) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has the following main components: two 6 inch solid front tires, two 7 inch solid rear tires, two anti-tip tires, control panel, steering handles, seat folding lever, backrest, arm rest, seat, steering column, seat frame, front/ rear covers, folding release lever, angle adjustment lever, height adjustment lock, carry handle, an off-board charger and aluminum alloy made frame, It is powered by two Li-ion DC rechargeable batteries with 18 km (on level surface) which maximum speed up to 6 km/hr. The movement of the scooter is controlled by the steering handles and control panel. 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.

This FDA 510(k) summary (K190737) describes the substantial equivalence of the Solax Electric Scooter to a previously cleared predicate device, rather than providing details of a study akin to those conducted for AI/ML-based medical devices. Therefore, much of the requested information regarding acceptance criteria, human reader studies, and ground truth establishment for AI systems is not applicable or present in this document.

However, I can extract information related to the performance testing and comparison to the predicate device, framing it as acceptance criteria and proof of meeting them within the context of a non-AI medical device.

Device Name: Solax Electric Scooter (Models: S204311M, S204161, S204143)
Intended Use: 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.

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

For a traditional medical device like this electric scooter, "acceptance criteria" are typically defined by performance standards (e.g., ISO standards) and by demonstrating equivalence to a predicate device. The "reported device performance" is the successful compliance with these standards and the demonstration that any differences from the predicate do not raise new safety or effectiveness concerns.

The remaining numbered points are primarily for AI/ML device studies and are not directly applicable to a traditional device 510(k) submission like this one, which relies on performance testing and substantial equivalence to a predicate.

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

• Sample Size: Not applicable in the context of an AI/ML test set. The study involves testing physical units of the scooter according to various ISO standards. The specific number of units tested is not detailed in this summary but would be determined by the requirements of each standard.
• Data Provenance: Not applicable. The "data" are results from physical performance and biocompatibility testing of the device itself, rather than a dataset of patient information. The testing would have been conducted by the manufacturer or a certified testing lab, likely in China, given the manufacturer's location. The testing is prospective in the sense that it's performed on the manufactured product to demonstrate compliance.

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

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert annotation of medical images) is not relevant here. Compliance with ISO standards is determined by prescribed test methods and objective measurements.

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

• Not applicable. This is not a human reader study requiring adjudication. Test results are objectively measured against standard specifications.

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 or an imaging device requiring human reader studies.

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

• Not applicable. This device does not use an algorithm in that capacity.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not applicable in the AI/ML sense. The "ground truth" for this device's performance is defined by the objective pass/fail criteria of the various ISO performance and safety standards, and the direct comparison of its physical and functional characteristics to the predicate device.

8. The sample size for the training set:

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

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

• Not applicable.

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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.

Not Found

I am sorry, but the provided text from the FDA letter does not contain information about an AI/ML medical device, its acceptance criteria, or any associated study details. The letter is a 510(k) premarket notification clearance for an electric scooter (Solax Electric Scooter Models S3121 and S312131), categorizing it as a Class II medical device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets those criteria based on the provided input. The document discusses regulatory aspects of device marketing, such as general controls, registration, listing, labeling, and good manufacturing practices, but it does not delve into performance metrics or study designs typically associated with AI/ML diagnostic or prognostic devices.

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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.

Solax Electric Scooter (Model: S202261B)

This document is a 510(k) clearance letter from the FDA for a medical device called the "Solax Electric Scooter." It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter is a notification that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements that the manufacturer must comply with, such as registration, labeling, and good manufacturing practices.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information) from this document. This letter pertains to a regulatory clearance, not a technical performance study report.

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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.

Not Found

This document is a 510(k) clearance letter from the FDA for a Solax Electric Scooter, a motorized three-wheeled vehicle. It does not contain any information about an AI/ML-based medical device, its acceptance criteria, or performance study details.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study for an AI/ML device based on the provided text. The document is strictly about a physical mobility device.

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lt 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 Solax Electric Scooter (Models: S302121, S302131, S302141, S302151) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a remote for folding/unfolding the device and a Lithium battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. 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.

This document is a 510(k) premarket notification for a medical device called the "Solax Electric Scooter." It describes the device, its intended use, a comparison to a predicate device, and a summary of performance and safety tests.

Here's the breakdown of the information requested, based on the provided text:

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

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the format typically associated with an AI/ML device study. Instead, it lists various ISO and IEC standards that the device was tested against to demonstrate safety and effectiveness. The "reported device performance" is implicitly that the device met the requirements of these standards.

Here's a table based on the provided information, interpreting the standards as acceptance criteria for the respective performance aspects:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "performance and safety tests" but does not specify the sample size for these tests. It is implied that tests were performed on the device itself (Solax Electric Scooter models S302121, S302131, S302141, S302151). This is a physical device, not an AI/ML algorithm processing data.

The data provenance is industrial testing of a physical product. The submitter is Dongguan Prestige Sporting Goods Co., Ltd. from China. The types of tests (ISO standards) are generally standardized laboratory or field tests.

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)

This information is not applicable. The device is a physical electric scooter, not an AI/ML diagnostic or predictive tool that requires expert consensus for ground truth on a test set. The "ground truth" for its performance is determined by adherence to the engineering and safety standards listed.

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

This information is not applicable. Adjudication methods like '2+1' or '3+1' are typically used in clinical studies involving multiple readers for diagnostic tasks (e.g., radiologists interpreting images) to establish a consensus ground truth. This document describes the testing of a physical medical device against established 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

This information is not applicable. A MRMC comparative effectiveness study is relevant for AI/ML diagnostic or imaging devices where human performance with and without AI assistance is being evaluated. The Solax Electric Scooter is a physical mobility device and does not involve human readers interpreting data.

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

This information is not applicable. The Solax Electric Scooter is a physical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the Solax Electric Scooter's performance is compliance with established international engineering and safety standards (ISO and IEC standards). These standards define performance limits and test methodologies, and the device is evaluated against these predefined criteria rather than a subjective "expert consensus" or biological "pathology" data set.

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI/ML model that requires a "training set."

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

This information is not applicable. As stated above, the device is not an AI/ML model requiring a training set with established ground truth.

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The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

The COMFORT SCOOTER, LY-EW408 is an indoor / outdoor Electric Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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 describes the submission of a 510(k) premarket notification for a medical device, the COMFORT SCOOTER, LY-EW408. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study with specific acceptance criteria and detailed performance metrics as one might find for an AI/ML medical device.

Therefore, many of the requested elements for acceptance criteria and study design are not applicable to this type of regulatory submission. The goal here is to show the new device is as safe and effective as a legally marketed one, not to quantify its performance against pre-defined accuracy thresholds using a clinical study involving experts and ground truth.

Here's an attempt to address your request based on the provided text, highlighting what is (and isn't) present:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The "acceptance criteria" in this context refer to the demonstration of substantial equivalence to a predicate device (COMFORT SCOOTER LY-EW415 (K063032)). The criteria are broad comparisons of features, safety, and functionality rather than specific statistical performance thresholds.

Regarding the other desired information points:

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

   • N/A. This submission is for a physical medical device (Electric Scooter) and does not involve an AI/ML algorithm or a "test set" of data in the manner implied by the question. Performance testing involved compliance with engineering standards (e.g., EMC, wheelchair standards) on the device itself, not on a dataset.

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

   • N/A. No "ground truth" establishment by experts on a test set of data is described. Device performance testing is against established engineering and safety standards.

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

   • N/A. No test set or adjudication method as described is applicable here.

4. 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:

   • N/A. This is a physical mobility device, not an AI-assisted diagnostic or clinical decision support tool. No human reader studies are described.

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

   • N/A. This does not involve an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • N/A. The "ground truth" for this device's performance is adherence to recognized engineering standards for safety and functionality, and verification of components' certifications (e.g., UL, SGS).

7. The sample size for the training set:

   • N/A. This is a hardware device, not an AI/ML algorithm requiring a training set.

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

   • N/A. Not applicable for this type of device.

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