Search Results

The Power Wheelchair 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.

This Power wheelchair, W5538, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.

The device is powered by a Li-ion Battery pack (24V 12Ah, 288Wh) with 15 Km (9.3 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

Here's a breakdown of the acceptance criteria and study information for the Power Wheelchair (W5538), based on the provided text:

Important Note: This device is a power wheelchair, a physical product, not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test/training set, training set sample size, how ground truth for training set was established) are not applicable to this type of medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device through adherence to recognized performance standards and comparative analysis of physical and technical specifications.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • This information is not directly applicable to a physical power wheelchair submission based on recognized standards. The "test set" here refers to the physical device itself being subjected to various ISO standard tests. The ISO standards specify test methodologies, but typically do not define a "sample size" in the context of clinical trials or data-driven AI systems.
   • The provenance is that the tests were conducted by the manufacturer (or a testing lab on their behalf) to demonstrate compliance with the specified ISO standards for the Power Wheelchair (W5538).

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

   • Not applicable (N/A). This is a hardware device. "Ground truth" in this context would refer to the physical and functional parameters of the wheelchair, which are measured and compared against established engineering standards (ISO 7176 series). There are no "experts" establishing a diagnostic "ground truth" as there would be for an AI-driven diagnostic tool.

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

   • N/A. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-labeled datasets, typically for AI/software evaluations. In hardware testing, the device's performance is measured against objective, quantifiable criteria defined by the ISO standards. There is no subjective interpretation requiring adjudication.

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:

   • No. This is a power wheelchair, a physical mobility device. An MRMC study is designed for evaluating the impact of AI assistance on human diagnostic performance (e.g., radiologists reading images). It is not relevant to this device.

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

   • N/A. This is not an algorithm or AI system. It's a complete physical device (power wheelchair). However, the "standalone performance" could be viewed as the wheelchair's ability to perform safely and effectively on its own (e.g., maintaining stability, braking distance) when operated by a user, which is what the ISO standards verify.

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

   • International Standards and Engineering Specifications. The "ground truth" for this device's performance is established by widely recognized international standards for wheelchairs (ISO 7176 series) and general medical device standards (ISO 14971 for risk management, IEC 60601-1-2 for electromagnetic compatibility, ISO 10993 series for biocompatibility). These standards define acceptable performance ranges and test methodologies.

7. The sample size for the training set:

   • N/A. This refers to machine learning models. For a physical device, there is no "training set."

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

   • N/A. As there is no training set for a physical device, this question is not applicable.

Ask a specific question about this device

The mobility scooter 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.

This mobility scooter 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 N3473, has a base with magnesium alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, a tiller console, an electric motor, an electromagnetic brake, 1 rechargeable Lithium Battery with an off-board charger, a remote control switch. The movement of the scooter is controlled by the rider who operates the throttle lever, speed control dial 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 text is a 510(k) Summary for a Mobility Scooter (N3473), a medical device. It does not contain information about an AI/ML-driven medical device.

Therefore, I cannot provide information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, number of experts, adjudication methods for training or test sets in the context of AI/ML.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used for AI/ML.
• How ground truth for training sets was established for AI/ML.

The document discusses the non-clinical testing performed for a physical device (mobility scooter) to demonstrate its substantial equivalence to a predicate device. This testing primarily involves adherence to ISO 7176 series standards related to wheelchairs and scooters, covering aspects like stability, brakes, speed, dimensions, strength, climatic tests, obstacle climbing, power/control systems, and electromagnetic compatibility.

Here's what can be extracted from the document regarding the mobility scooter's acceptance criteria and study:

1. Acceptance Criteria and Reported Device Performance (Non-AI Device)

The general acceptance criteria are that the subject device's performance meets the relevant ISO standards and exhibits no deleterious effect on safety and effectiveness compared to the predicate device, despite minor differences. The document asserts that "All test results meet the requirements" of the specified ISO standards for the subject device.

Here's a table based on the explicit comparisons provided, specifically focusing on measurable performance attributes mentioned in the "Comparison with the predicate device" section. While a direct "acceptance criterion" value isn't always given, the "Result" column implies acceptance if "Same" or if the difference is deemed non-deleterious after testing.

Ask a specific question about this device

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

The provided document is an FDA 510(k) clearance letter for a "Mobility Scooter". It is a regulatory document confirming substantial equivalence to a predicate device, which allows the manufacturer to market the product.

This type of document does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or a detailed technical report would. It is not a performance study report.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This is not included in an FDA clearance letter.
2. Sample size used for the test set and the data provenance: Not applicable for this type of document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. MRMC comparativeeffectiveness study: Not applicable.
6. Standalone performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The FDA clearance letter primarily focuses on:

• The device's trade name and regulatory classification.
• The determination of substantial equivalence to a legally marketed predicate device.
• The applicable regulatory requirements (e.g., general controls, quality system regulations, UDI rule).
• The stated Indications for Use: "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."

To get the kind of information you are asking for, one would typically need to review the 510(k) summary or the full 510(k) submission (if publicly available and containing such details), which would include details of the design verification and validation testing, risk analyses, and performance data submitted by the manufacturer to demonstrate substantial equivalence and safety/effectiveness. This clearance letter is the result of that review, not the review itself.

Ask a specific question about this device

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. Models: W3331. has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, 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 control dial 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 text is a 510(k) summary for a Mobility Scooter (Model W3331). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an AI/ML powered device, and therefore the majority of the requested information regarding acceptance criteria, study design for AI models, and performance metrics for AI assistance is not applicable.

However, I can extract the general acceptance criteria and the methods used to prove the device meets these criteria as described in the document.

Device: Mobility Scooter (W3331)

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

The acceptance criteria are primarily derived from various ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The reported device performance indicates compliance with these standards.

Ask a specific question about this device

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, Model: W3431, has a base with Steal frame, two front wheels, a seat, a tiller console, 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 control dial 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 document is a 510(k) Premarket Notification for a Mobility Scooter (Model W3431). This document assesses the substantial equivalence of the new device to a predicate device, primarily through non-clinical testing and comparison to established industry standards. Critically, it does not contain information related to a study involving acceptance criteria for an AI/ML device as it pertains to human-in-the-loop performance, algorithmic standalone performance, or the use of expert consensus for ground truth. The device in question is a physical mobility scooter, not an AI/ML-based medical device.

Therefore, I cannot fulfill your request for information on acceptance criteria and study details for an AI/ML device based on the provided text. The document specifically states:

• "No clinical study is included in this submission." (Page 6, Section G)
• The non-clinical tests were conducted to verify that the proposed device met design specifications and was "Substantially Equivalent (SE) to the predicate device." (Page 6, Section F)

The tables presented (Tables 1, 2, and 3) are comparisons between the proposed mobility scooter and its predicate device across various physical and performance characteristics, adhering to ISO 7176 series standards for wheelchairs. These standards cover aspects like static stability, dynamic stability, effectiveness of brakes, energy consumption, dimensions, maximum speed, obstacle-climbing ability, biocompatibility, and electromagnetic compatibility.

To answer your prompt, I would need a document related to the submission or evaluation of an AI/ML medical device.

Ask a specific question about this device

The Power Wheelchair (N5909) 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.

This Power wheelchair, N5909, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties. The device consists of front wheel, drive wheel, frame, controller, motor, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.

The provided text describes the regulatory clearance of a Power Wheelchair (N5909) and establishes its substantial equivalence to a predicate device (K220747). The acceptance criteria are based on various performance standards and safety evaluations, with the study demonstrating compliance through non-clinical testing.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of ISO and IEC standards for wheelchairs. The reported device performance is demonstrated by the successful completion of tests adhering to these standards, ensuring the subject device meets or exceeds the specifications of the predicate device for relevant attributes.

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

The document does not explicitly state the sample size for the test set used for the performance testing. The provenance of the data is non-clinical bench testing, conducted according to various international standards (ISO, IEC). The location of the testing is not specified, but the manufacturer is based in China. The testing is implicitly prospective in the sense that the new device was subjected to these tests to demonstrate compliance.

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

This information is not applicable. The "ground truth" for a power wheelchair's performance is established by objective engineering measurements against defined international standards (ISO, IEC). It does not involve expert interpretation or clinical judgment in the same way an AI diagnostic device would require.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for medical images or diagnoses. For a physical device like a power wheelchair, adherence to predefined measurement procedures and standards is the primary method of evaluation.

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 MRMC comparative effectiveness study was done. This type of study is relevant for AI image analysis or diagnostic tools, not for the regulatory clearance of a physical medical device like a powered wheelchair.

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

This information is not applicable. "Standalone" performance refers to AI algorithms operating without human intervention for diagnostic or analytical tasks. The device in question is a physical power wheelchair; its "performance" is its mechanical and electrical function, not an algorithm's output. Software validation was performed, but it's not "algorithm only" performance in the context of an AI diagnostic.

7. The type of ground truth used

The ground truth used is primarily objective engineering measurements and adherence to international performance standards (ISO, IEC). For example, braking distance is measured directly, not subject to expert consensus. Biocompatibility is determined by standardized laboratory tests.

8. The sample size for the training set

The concept of a "training set" is not applicable here because this is not an AI/machine learning device that requires a training phase.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Power Wheelchair, W5521, 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.

This Power wheelchair, W5521, is a motor driven, indoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor and drive devices, armrest, push-handle, backrest, seat cushion, footrest, battery box and charger.

The device is powered by a Li-ion Battery pack (24V 10Ah, 240Wh) with 10 Km (6.2 miles) range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The user can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided FDA 510(k) summary for the Power Wheelchair, W5521 (K231508) focuses on demonstrating "substantial equivalence" to a predicate device (Power Wheelchair, N5515B, K220747) through non-clinical testing. It does not involve AI/ML components or clinical effectiveness studies in the typical sense of a comparative effectiveness study with human readers for image-based diagnostics.

Therefore, many of the requested elements pertaining to AI/ML device performance (like acceptance criteria for accuracy, recall, F1-score, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable to this specific device submission.

The "acceptance criteria" in this context refer to compliance with various ISO and IEC standards for wheelchairs, which are physical and electrical performance benchmarks, not AI model metrics.

Here's a breakdown of the information provided in relation to your questions, noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are the successful compliance with the listed ISO and IEC standards. The "performance" is stated as meeting these standards.

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

• This device is a physical product (power wheelchair), not an AI/ML diagnostic software. The "tests" are performance and safety evaluations against engineering standards, typically involving a limited number of physical units, not a large data set in the usual sense. The document does not specify the number of units tested.
• Data Provenance: Not applicable in the context of clinical data sets (e.g., country of origin, retrospective/prospective). The tests are engineering bench tests.

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

• Not applicable. "Ground truth" in this context is defined by engineering standards (e.g., a specific static stability angle, braking distance, maximum speed). No human experts are establishing "ground truth" for a test set in the way a radiologist would for medical images. Compliance is measured instrumentally against predefined criteria in the standards.

4. Adjudication Method for the Test Set

• Not applicable. Since there are no human interpretations or "readings" to adjudicate, this concept does not apply.

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

• No. This is a power wheelchair, not a diagnostic device involving human readers or AI assistance in interpretation. Thus, MRMC studies and effect sizes related to human reader improvement with AI are not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. There is no AI algorithm in the diagnostic sense that performs "standalone." The device itself is a standalone product. It has a control system with software, and the document states "Software validation" was performed, which refers to validating the functional correctness and safety of the embedded software controlling the wheelchair's operations as per ISO 7176-14:2008.

7. The Type of Ground Truth Used

• For physical performance and safety (e.g., stability, braking, speed, obstacle climbing, EMC): The "ground truth" is defined by the technical specifications and limits established in the various ISO and IEC performance standards (e.g., "Maximum safe operational incline degree: 6°", "Braking distance: ≤1 m").
• For material safety (biocompatibility): Ground truth is established by declaration of identical materials to a previously cleared predicate device, which had already demonstrated biocompatibility per ISO 10993 standards.

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML model trained on a data set.

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

• Not applicable. As there is no AI/ML training set, this question is not relevant.

In summary, this 510(k) submission is for a conventional medical device (a power wheelchair) and relies on compliance with established international performance and safety standards, as well as substantial equivalence to a previously cleared predicate device. It does not involve the type of AI/ML performance evaluation studies that your questions are designed to address.

Ask a specific question about this device

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, Models: W3431D, has a base with Steal frame, two front wheel, two rear wheels, a seat, a tiller console, 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 control dial 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 device discussed is a Mobility Scooter (Models: W3431D). Its acceptance criteria and performance are based on non-clinical testing against a series of ISO 7176 standards.

Here's the breakdown of the information requested:

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

The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted to verify that the proposed device met all design specifications and was substantially equivalent (SE) to the predicate device (K222507). These tests were performed in accordance with the specified ISO standards mentioned above.

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

The document does not explicitly state the sample size for the test set. It refers to "the device" implying testing was done on one or more units of the Mobility Scooter (Models: W3431D). The tests are non-clinical, meaning they are likely engineering/performance tests on manufactured units, not studies involving human subjects or medical data. The provenance of the data is from Zhejiang Innuovo Rehabilitation Devices Co., Ltd, located in Dongyang, Zhejiang, China. The testing appears to be prospective in nature, performed on the device to demonstrate compliance.

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 is a non-clinical device safety and performance study. Therefore, the concept of "experts establishing ground truth for a test set" as would be used in a medical imaging or diagnostic device study is not applicable. The "ground truth" here is compliance with the engineering and safety standards (ISO 7176 series and ISO 10993 series). The evaluation would have been performed by qualified testing personnel and engineers, whose qualifications are not detailed in this submission.

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

Not applicable for this type of non-clinical device performance testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective expert review of medical data. The tests performed are objective, quantitative measurements against established international 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

Not applicable. This is a non-clinical submission for a mobility scooter, which does not involve "human readers" or "AI assistance" in the context of medical image interpretation or diagnosis.

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

Not applicable. This is not an AI/algorithm-driven device. It is a physical medical device (mobility scooter).

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

The "ground truth" for this device's acceptance is its compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The tests are designed to objectively measure the device's physical and mechanical properties and performance against the specified criteria within these standards.

8. The sample size for the training set

Not applicable. This is a non-clinical device performance and safety study for a physical device, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for an AI or machine learning model in this submission.

Ask a specific question about this device

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 Scooters, Models: W3431Q, W3431R, have a base with Steal frame, two front wheel, two rear 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 control dial 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 document is a 510(k) Summary for a Mobility Scooter (Models: W3431Q, W3431R). This type of regulatory submission is for a medical device that aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or significant improvements over existing technology through clinical studies.

Therefore, the acceptance criteria and study that proves the device meets those criteria are not related to a traditional clinical trial or AI/imaging performance metrics. Instead, the "acceptance criteria" here refer to demonstrating that the new device meets established safety and performance standards relevant for a mobility scooter and is substantially equivalent to a previously cleared device.

Here's an analysis based on the provided document, addressing the prompt's points where applicable for this type of submission:

Acceptance Criteria and Device Performance (for a Mobility Scooter)

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device (K220206) and compliance with relevant international standards for wheelchairs and mobility scooters (ISO 7176 series and ISO 10993 for biocompatibility). The study undertaken to prove this involved non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

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, Models: W3331F, has a base with Steal frame, one front wheel, two rear wheels, a seat, a tiller console, 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 control dial 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 document is a 510(k) summary for a Mobility Scooter, Model W3331F, and focuses on demonstrating substantial equivalence to a predicate device (K220206). It primarily relies on non-clinical performance testing against established ISO standards rather than clinical studies or AI performance metrics.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are based on compliance with specifically cited ISO 7176 series standards for wheelchairs and scooters, and ISO 10993 for biocompatibility. The "reported device performance" is a statement of compliance with these standards.

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

• Sample Size for Test Set: Not specified. The document describes non-clinical testing against ISO standards for a single device model (Mobility Scooter, Model W3331F). It does not involve a "test set" in the context of a dataset for an AI algorithm. The testing is on the physical device itself.
• Data Provenance: Not applicable in the context of patient data. The "data" are the results of physical and electrical engineering tests performed on the device. No country of origin for the data is explicitly mentioned, but the manufacturer is Zhejiang Innuovo Rehabilitation Devices Co.,Ltd in China, suggesting the testing likely occurred there. The tests are non-clinical, so the "retrospective or prospective" distinction does not apply.

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

This section is not applicable as the document describes physical device testing against engineering standards, not a clinical study requiring expert ground truth for interpretation of medical data.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical mobility scooter, not an AI diagnostic or assistance tool that would typically undergo such a study.

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

This section is not applicable. The device is a physical mobility scooter and does not involve an AI algorithm with standalone performance to be evaluated.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with internationally recognized engineering and safety standards (ISO 7176 series and ISO 10993 series). The test results demonstrate that the device meets the specifications outlined in these standards.

8. The Sample Size for the Training Set

This section is not applicable. The document does not describe an AI algorithm that requires a training set. The device is a physical product.

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

This section is not applicable as there is no AI algorithm or training set for this device.

Ask a specific question about this device