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The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.

The VCS S4T scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.

The provided text pertains to a 510(k) premarket notification for a medical device, specifically the VCS S4T scooter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials or performance studies with ground truth.

Therefore, most of the information requested in your prompt related to clinical studies, acceptance criteria tables, sample sizes, expert ground truth establishment, adjudication methods, and MRMC studies is not available within this 510(k) summary.

Here's an explanation of why and what information can be extracted:

Why the requested information is largely absent:

• 510(k) Substantial Equivalence: The 510(k) pathway is for devices that are "substantially equivalent" to predicate devices already on the market. It doesn't typically require new clinical studies to establish safety and effectiveness from scratch. Instead, it relies on demonstrating that the new device has the same intended use, technological characteristics, and performs similarly to a predicate. Performance data often involves engineering testing or comparisons of specifications, not extensive clinical trials with human subjects to determine diagnostic accuracy against a "ground truth."
• Device Type: The VCS S4T scooter is a "Motorized three-wheeled vehicle" (an electrical scooter). For such devices, acceptance criteria usually relate to safety standards (e.g., electrical safety, braking, stability), performance specifications (e.g., speed, range, turning radius, weight capacity), and durability, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are common for AI/imaging devices.

Information Extracted from the provided text:

1. Acceptance Criteria & Reported Device Performance:

   • The document explicitly states: "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness."
   • This implies that the acceptance criteria are implicitly met if the device's performance specifications are comparable to or within acceptable deviations from the predicate device (Bewell SC 20).
   • However, no specific table of quantitative acceptance criteria values or the reported performance metrics of the VCS S4T scooter are provided in this summary. The document only makes a general statement of equivalency in performance.

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

   • Not applicable/Not provided. This 510(k) summary does not describe a "test set" in the context of clinical or AI performance evaluation. The substantial equivalence argument is based on comparing the device's design and specifications to a predicate.

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

   • Not applicable/Not provided. Ground truth establishment is not relevant for this type of device and submission.

4. Adjudication Method for the Test Set:

   • Not applicable/Not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is typically for evaluating the impact of AI on human reader performance for diagnostic tasks (e.g., radiologists reading images). This is a mobility scooter, so such a study would not be relevant.

6. Standalone (Algorithm Only) Performance Study:

   • No. This refers to AI algorithm performance without human intervention. The device is a physical mobility scooter; there is no "algorithm only" performance separate from the user.

7. Type of Ground Truth Used:

   • Not applicable/Not provided.

8. Sample Size for the Training Set:

   • Not applicable/Not provided. There is no "training set" for an AI model mentioned.

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

   • Not applicable/Not provided.

Summary Table of Unavailable Information:

In conclusion, this 510(k) submission successfully establishes substantial equivalence for the VCS S4T scooter to a predicate device (Bewell SC 20) based on intended use and comparable technological characteristics, but it does not contain the detailed performance study information typically associated with AI/diagnostic devices that require "acceptance criteria" and "ground truth" as described in your prompt.

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The VCS S3Y 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 VCS S3Y 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 VCS S3Y scooter is with a 136 kg (300 lbs) weight capacity.

The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steef frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-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 25 km (15 miles) with 21 AH which maximum speed upto 8.6 km/hr (5.4 mph).

Acceptance Criteria and Study for VCS S3Y scooter

The provided 510(k) summary for the VCS S3Y scooter describes a substantial equivalence determination based on compliance with established non-clinical performance standards. It does not involve a study of predictive performance using AI or clinical outcomes for diagnosis. The device is a motorized three-wheeled vehicle intended for transportation, not a diagnostic or therapeutic medical device in the typical sense that would necessitate such detailed performance metrics.

Therefore, many of the requested fields are not applicable in this context. Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not explicitly stated. The testing would have been conducted on one or more units of the VCS S3Y scooter.
• Data provenance: Not explicitly stated, but the testing was performed against international and US standards (ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings). The manufacturer is from Taiwan.

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

Not applicable. The "ground truth" for this device's performance is compliance with established engineering and safety standards, as verified by non-clinical testing. This does not involve expert consensus in a diagnostic sense.

4. Adjudication method for the test set

Not applicable. Compliance with engineering standards is typically determined by testing against predefined pass/fail criteria, not through adjudication by experts.

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 device is not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a motorized scooter, not an algorithm or software. It is a standalone physical product.

7. The type of ground truth used

The ground truth used is the defined performance specifications and safety requirements outlined in the referenced international and national standards (ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings Flammability Standards).

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set involved.

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The VCS S3T 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 VCS S3T 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 VCS S3T scooter is with a 136 kg (300 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, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-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 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).

The provided text describes a 510(k) summary for the VCS S3T scooter, which is a motorized three-wheeled vehicle intended for transportation of disabled or elderly persons. The summary primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of design, function, features, and compliance with non-clinical performance standards.

Based on the provided information, there is no study conducted to prove the device meets acceptance criteria in the typical sense of a clinical or analytical performance study with specific device performance metrics.

Instead, the "acceptance criteria" can be interpreted as demonstrating compliance with established performance standards for wheelchairs and motorized scooters, and the "study" is the non-clinical testing performed against these standards.

Here's an analysis based on your requested information:

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

Important Note: The document states that "results of 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 provide the specific numeric data or detailed results of these tests for the VCS S3T scooter. It only lists the standards tested against.

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

• Sample Size: Not explicitly stated. For non-clinical performance testing of a physical device, the "sample size" would typically refer to the number of devices tested. It is common for such tests to be performed on a small number of production units (e.g., 1-3 units). The document does not specify this.
• Data Provenance: The testing was conducted by Vehicles Technology Co., LTD. in Taiwan, as indicated by the sponsor's and manufacturer's information. It is non-clinical performance testing.

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)

• Not applicable. This information is relevant for studies involving subjective human assessment or interpretation (e.g., medical imaging, clinical diagnosis). For non-clinical performance testing against engineering standards, "ground truth" is established by the specifications defined in the standards themselves, and the testing is typically performed by qualified engineers or technicians in a testing laboratory without the need for expert consensus in the medical sense.

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

• Not applicable. As noted above, this concept applies to studies with subjective human interpretations. For objective engineering performance tests, the results are typically determined by measurements against defined limits, not by adjudication among human readers.

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-powered device or a diagnostic device. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

• Not applicable. This device is a physical product (a motorized scooter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

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

• The "ground truth" for the non-clinical tests is represented by the specified limits and methodologies defined within the referenced international and national performance standards (e.g., ANSI/RESNA, ISO, IEC, CISPR, California Bureau of Home Furnishings). The device is deemed to meet the criteria if its performance falls within the acceptable ranges and passes the tests defined by these standards.

8. The sample size for the training set

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

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

• Not applicable. As above, no training set or AI/ML algorithm is involved.

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The HOLI I 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 HOLI I 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 HOLI I 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 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).

The provided text describes the "HOLI I scooter" and its equivalence to a predicate device, focusing on non-clinical testing. It does not contain information about the acceptance criteria or a study proving device performance using human reader data, as generally understood in the context of AI/software medical devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an equivalency claim based on compliance with established performance standards for wheelchairs, not "acceptance criteria" in the sense of a study's primary endpoints for a medical device's diagnostic output. The "reported device performance" is essentially that the device meets these standards.

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

This information is not provided in the document. The testing described is for physical product standards (e.g., stability, strength, EMC) and would typically involve a small sample of the physical device rather than a "test set" of data as in software/AI. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not applicable and therefore not provided. The "ground truth" for compliance with these engineering standards is the outcome of the physical test itself (e.g., the device did not tip over, it withstood the impact, etc.), not expert interpretation of data.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretations or clinical outcomes, which is not the type of testing described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical scooter, not an AI or software device that assists human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

No, a standalone study in the context of an algorithm's performance was not done. The "studies" were non-clinical tests of the physical scooter's performance against engineering standards.

7. Type of Ground Truth Used:

The "ground truth" implicitly used is the objective outcome of the engineering and safety tests defined by the various ANSI/RESNA, ISO, IEC, CISPR, and California Bureau of Home Furnishings standards. This is not medical expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The development of a physical product like a scooter does not involve a "training set" in the context of AI/machine learning.

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

This information is not applicable and therefore not provided. There is no training set for this type of device. The design and manufacturing would be based on engineering principles and compliance with the relevant standards.

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The LANDLEX S400X 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 LANDLEX S400X 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 LANDLEX S400X scooter is with a 135 kg (300 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, automatic headlight sensor, 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 km (22 miles) with 34AH which maximum speed upto 9 km/hr (5.6 mph).

Here's a breakdown of the acceptance criteria and the study information for the LANDLEX S400X scooter, based on the provided 510(k) summary:

This device is not an AI/ML powered device, therefore some of the requested information (like MRMC studies, training set, etc.) does not apply.

Acceptance Criteria and Device Performance for LANDLEX S400X Scooter

The LANDLEX S400X scooter demonstrates substantial equivalence to its predicate device, the Bewell SC 20 (K043326), by meeting established performance and safety standards for wheelchairs and motorized scooters. The acceptance criteria are largely defined by compliance with a set of international and national standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of individual devices tested, but rather indicates that the LANDLEX S400X scooter "has been tested" to the listed wheelchair standards. It is implied that at least one functional unit of the commercial device was subjected to the full battery of tests for each standard.
• Data Provenance: The testing was non-clinical, meaning it was conducted in a laboratory or test facility setting to confirm compliance with engineering and safety standards. The manufacturer is Besteam Technology Inc. in Taiwan. The testing would have been conducted by or on behalf of the manufacturer, presumably in Taiwan or a recognized testing laboratory. This is a form of prospective engineering testing.

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

This is not applicable to this type of device and study. The "ground truth" for the test set is defined by the technical specifications and performance limits set forth in the international and national standards (e.g., ISO, ANSI/RESNA, IEC, CISPR, California Flammability Standards). Compliance is determined by objective measurements against these predefined thresholds, not by expert consensus on specific cases.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or human-in-the-loop evaluations where there's subjective interpretation or a need for consensus on expert opinions. For non-clinical engineering testing against established standards, the results are objectively measured and compared to the standard's criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for medical imaging or diagnostic AI devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The LANDLEX S400X is a motorized scooter, and its evaluation focuses on engineering performance and safety standards, not diagnostic accuracy or human interpretation.

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

This question is not applicable as the LANDLEX S400X is a physical motorized scooter, not an algorithm or AI system. Its "performance" is its mechanical and electrical function and its adherence to safety standards, not an algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily compliance with established engineering and safety standards. These standards define measurable performance criteria (e.g., static stability angles, maximum speed, electromagnetic emission limits, material flammability). The tests performed against these standards provide objective evidence of device performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (electric scooter), not an AI/ML model that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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The LANDLEX S300X 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 LANDLEX S300X 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 LANDLEX S300X scooter is with a 135 kg (300 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 auto light sensor, 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 km (22 miles) with 34AH which maximum speed upto 8 km/hr (5 mph).

This document describes the LANDLEX S300X scooter, a motorized three-wheeled vehicle intended for disabled or elderly persons. The summary indicates that the device was deemed substantially equivalent to a predicate device based on compliance testing to existing ANSI/RESNA, ISO 7176, IEC standards, and California Bureau of Home Furnishings standards.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the device has been "tested to wheelchair standards" and that these tests "demonstrate the device to be substantially equivalent to the predicate in terms of meeting performance criteria and functioning as intended." It does not provide specific numerical results or detailed performance metrics from these tests, only that compliance was achieved.

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

The provided document does not specify the sample size used for the test set (i.e., the number of devices or components tested). It also does not mention the country of origin of the data explicitly, but the manufacturer is based in Taiwan (Besteam Technology Inc., Taoyuan Hsien, Taiwan). The nature of these tests (compliance to standards) implies they were performed prospectively as part of the device development and validation process.

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

This information is not applicable to this type of device and study. The testing described is non-clinical performance and safety testing against established industrial and medical device standards (e.g., ISO, ANSI/RESNA, IEC). Ground truth in this context is defined by the objective pass/fail criteria of these standards, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for studies involving human interpretation (e.g., medical imaging reads). For engineering compliance testing, the results are typically objectively measured against predetermined specifications in the 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

There is no MRMC comparative effectiveness study mentioned in this document. This device is a mobility scooter, not an AI-assisted diagnostic or therapeutic tool for which such studies would be relevant.

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

This is not applicable. The device is a physical mobility device, not an algorithm, so a "standalone" or "algorithm-only" performance evaluation is not relevant.

7. The Type of Ground Truth Used

The ground truth used for these tests is the objective pass/fail criteria specified by the referenced international and national standards (ANSI/RESNA, ISO 7176, IEC, CISPR, California Bureau of Home Furnishings standards). These standards define acceptable levels of static stability, speed, acceleration, deceleration, strength, EMC, and flammability.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device. The development and testing revolve around engineering design, manufacturing, and compliance with established performance standards for physical products, not machine learning or AI.

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

This information is not applicable as there is no "training set" for this device.

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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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AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.

AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.

AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.

The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.

The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.

The provided text describes a 510(k) summary for the AIDC 8500-II Wheelchair, focusing on its substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of a medical AI device.

Therefore, I cannot fulfill your request for the tables and information outlined in your prompt, as the document is about a manual wheelchair and its non-clinical testing for regulatory approval, not about an AI-powered device or a study examining its performance against acceptance criteria.

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