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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, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.

The Power Wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.

The operation of the Controller: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The Power Wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.

The Power Wheelchair has 7 inch front wheel and 12 inch rear tire.

Max. distance of travel on the fully charged battery is 7.5 km and Max. speed forward is 6.48 km/h.

When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.

The braking time is about 2s, and the braking distance is ≤1.5m.

Based on the provided FDA 510(k) clearance letter for the Vive Health LLC Power Wheelchair (MOB1107), here's an analysis addressing the acceptance criteria and study proving the device meets those criteria:

The document describes a Class II medical device (Powered Wheelchair, Product Code: ITI) undergoing a 510(k) premarket notification process. This process focuses on demonstrating substantial equivalence to a predicate device rather than proving clinical efficacy or superiority through extensive clinical trials. Therefore, the "study that proves the device meets the acceptance criteria" primarily refers to non-clinical performance testing against established international standards for wheelchairs, rather than AI/software performance metrics often seen in other medical device clearances.

Crucially, this document is for a physical medical device (power wheelchair), NOT a software/AI medical device. Many of the points you requested (e.g., number of experts, adjudication method, MRMC study, standalone AI performance, ground truth for training) are not applicable to this type of device clearance. The "performance" being evaluated here is mechanical, electrical, and safety performance of the wheelchair itself.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this power wheelchair are derived from international ISO standards for wheelchairs. The "reported device performance" is essentially a statement of compliance with these standards, indicating that various tests were conducted and the device met the specifications within those standards.

Table of Acceptance Criteria and Reported Device Performance:

Inapplicable/Not Provided Information for a Physical Wheelchair 510(k):

The following points are standard for AI/ML device submissions but are not applicable and therefore not provided in this traditional medical device 510(k) for a power wheelchair:

2. Sample sizes used for the test set and the data provenance: Not relevant for physical device performance testing against engineering standards. The "samples" would be the manufactured wheelchairs tested. Data provenance typically refers to patient/clinical data, which isn't used for this type of device's "performance" evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance (e.g., brake effectiveness, stability) is established by physical measurement against engineering standards, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for human interpretation of data, typically medical images or clinical outcomes.
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 for AI/software devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/software devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" is defined by the technical specifications and testing methods outlined in the ISO 7176 series and IEC 60601-1-2 standards, confirmed by laboratory testing.
8. The sample size for the training set: Not applicable. There is no AI/ML model for this device that requires training data.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for an AI/ML model.

Summary of the "Study" Proving Substantial Equivalence and Meeting Criteria:

The "study" proving the Vive Health LLC Power Wheelchair (MOB1107) meets acceptance criteria and is substantially equivalent to its predicate device (K242791) is based entirely on non-clinical laboratory performance testing and technical comparisons.

• Study Design: The manufacturer performed a series of tests on the subject device according to the rigorous requirements of various international ISO 7176 series standards (for wheelchairs) and IEC 60601-1-2 (for electromagnetic compatibility/electrical safety).
• Measurement: These tests involve direct physical measurements of parameters like static stability, dynamic stability, brake effectiveness, theoretical distance range, dimensions, weight, maximum speed, obstacle-climbing ability, as well as evaluating material biocompatibility and electrical safety.
• Assessment of Compliance: The results of these tests were expected to "meet its design specification" or "meet the requirements" of the respective ISO standards. The submission asserts that the subject device's performance did meet these requirements.
• Substantial Equivalence Argument: The core of the 510(k) submission is that because the subject device demonstrates comparable technical characteristics and achieves equivalent performance (as verified by these standard tests) to a legally marketed predicate device, it is considered "substantially equivalent" in terms of safety and effectiveness. The document explicitly states: "All these tests have corresponding requirements/ acceptance criteria following above mentioned standards. And the test results show that the subject device is within acceptable performance specifications and thus substantially equivalent to the predicate device in performance."
• No Clinical Studies: The document explicitly states, "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device." This reinforces that the safety and performance were established through non-clinical, engineering-based testing.

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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.

The power wheelchair, model name:D26, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-Ion battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion.

The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop.

The power wheelchair, model name: D26, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design.

The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

This document is a 510(k) clearance letter for a Power Wheelchair (D26), not a software or AI-enabled medical device. Therefore, the provided information does not contain the details typically sought in an acceptance criteria and study report for AI/ML devices.

The 510(k) process for a physical device like a power wheelchair focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering and performance testing against recognized standards, rather than clinical studies with human subjects in the same way an AI-driven diagnostic tool would be evaluated.

Here's why the AI/ML-specific questions cannot be answered from this document:

• No AI/ML Component: The device description clearly indicates it's a "motor driven, indoor and outdoor transportation vehicle" with components like motors, brakes, joystick control, and Bluetooth remote control. There is no mention of artificial intelligence, machine learning, or algorithms that perform diagnostic or interpretative functions.
• Performance Evaluation Type: The "study that proves the device meets the acceptance criteria" in this context refers to various engineering and safety tests outlined in the ISO 7176 series and IEC 60601-1-2 standards (e.g., static ability, dynamic stability, brake performance, biocompatibility, EMC). These are objective, quantitative tests of the device's physical properties and functionality.

Therefore, it is not possible to fill out the table and answer the questions about AI/ML device performance, ground truth, expert adjudication, or MRMC studies based on the provided FDA 510(k) document.

This document demonstrates substantial equivalence for a physical medical device by comparing its technical specifications and performance against international standards for wheelchairs.

However, if you're looking for an example of how a 510(k) for a non-AI/ML device does define acceptance criteria and demonstrates compliance, here's an interpretation based on the provided text:

Acceptance Criteria and Study for Power Wheelchair (D26)

The device, a Power Wheelchair (D26), is primarily evaluated based on its adherence to established international standards for wheelchairs and its substantial equivalence to a predicate device (K242448, Power Wheelchair, D26 from the same manufacturer). The "acceptance criteria" are derived from these standards and the comparative analysis with the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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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, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. The power wheelchair is a battery powered four wheel t consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheels. The operation of the scooter: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will deternine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the wheelchair uns. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric / manual model the seat will allow for the brakes to engage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.

The provided text is a 510(k) premarket notification letter from the FDA regarding a power wheelchair. It discusses the regulatory classification, general controls, and compliance with regulations.

However, the document does not contain any information about acceptance criteria or a study that proves a device meets those criteria for an AI/ML medical device. The product is a "Power Wheelchair," which is a physical medical device, not a software or AI/ML device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section lists various ISO standards that the power wheelchair complies with, such as tests for static stability, dynamic stability, effectiveness of brakes, energy consumption, etc. These are engineering standards for mechanical and electrical safety and performance, not AI/ML performance metrics.

Therefore, I cannot extract the requested information as it is not present in the provided document.

To fulfill your request, I would need a document that describes the development and validation of an AI/ML medical device, which would typically include:

• Details on the algorithm's functionality.
• Specific performance metrics (e.g., sensitivity, specificity, AUC, F1-score for classification tasks; RMSE, MAE for regression during inference).
• Test set characteristics (size, provenance).
• Ground truth establishment methods (expert consensus, pathology, follow-up outcomes).
• Details of any human-in-the-loop studies (MRMC).
• Training data characteristics.

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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.

The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, is an indoor/outdoor, foldable, battery-operated 2-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D03, D05, D06, D09, D11, D16, D22, D23, D26, D36, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange.

Here's a breakdown of the acceptance criteria and study information for the Power Wheelchair, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Power Wheelchair (models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) are implicitly defined by compliance with a comprehensive set of ISO standards. The reported device performance is indicated by the statement that the device met all design specifications and passed all tests.

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

• Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or images. Instead, the testing refers to physical devices (the specific models D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) and their components. The tests performed are bench tests conducted on these physical devices to verify their performance against engineering standards.
• Data Provenance: Not applicable as the testing involves physical device performance, not data from human subjects. The testing is prospective in the sense that the manufacturer tested their newly designed device models to confirm compliance. The manufacturing location is Anhui, China.

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

Not applicable. This is a technical performance study of a physical device against engineering standards. Ground truth as typically defined for AI/diagnostic studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" is defined by the technical specifications and requirements of the referenced ISO standards.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or consensus required for the test results; the tests involve quantifiable measurements (e.g., stability angles, braking distances, electrical properties) that either meet or do not meet the specified criteria in the standards.

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

No. An MRMC study is not relevant for this type of device (a power wheelchair). It's typically used for evaluating diagnostic or screening tools where human readers interpret patient data (e.g., radiology images).

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

Yes, in essence, the entire suite of non-clinical bench testing constitutes a "standalone" evaluation of the device's physical and electrical performance without human operation as a variable beyond what is required to execute the test protocols. The Bluetooth remote control functionality (a form of "algorithm") was also tested in a standalone manner for effectiveness and cybersecurity.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) for these tests is the quantitative and qualitative requirements set forth in the extensive list of ISO and IEC engineering standards (e.g., ISO 7176 series, IEC 62133-2, IEC 60601-1-2, ANSI C63.27, ISO 14971, ISO 10993 series). These standards define the acceptable performance limits and test methodologies for power wheelchairs.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device where a "training set" of data is used for model development. The development process would involve engineering design and iterative prototyping, not data-driven model training.

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

Not applicable, as there is no training set for an AI/ML model.

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

The power wheelchair, model name: D10, D12, D15, D17, D20, D37, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D10, D12, D15, D17, D20, D37, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair (Model D10, D12, D15, D17, D20, D37) can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange. The D17 power wheelchair has an additional headrest and its seat unit can be adjusted by a remote control key to a largest angle of 30°.

The provided text is a 510(k) Premarket Notification from the FDA for a Power Wheelchair. It describes the device, compares it to predicate devices, and outlines the non-clinical testing performed to establish substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or expert ground truth establishment for medical imaging or similar AI applications.

The document explicitly states:

• "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device." (Page 17, Section IX)
• The comparison tables (Table 1, Table 2, Table 3) detail physical, mechanical, and electrical characteristics, and safety standards met (ISO, IEC, EMC, biocompatibility). These are engineering and safety performance criteria for a wheelchair, not AI/ML performance.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and a study that proves the device meets those criteria, as the provided text pertains to a power wheelchair and not a medical device involving AI/ML for diagnostic or therapeutic purposes.

If you have a document describing an AI/ML medical device and its validation study, please provide that, and I will be able to answer your questions.

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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.

The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.

The provided text describes a 510(k) submission for a power wheelchair and does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device.

The document is a letter from the FDA regarding a premarket notification for a Power Wheelchair. It focuses on the substantial equivalence of the proposed device to legally marketed predicate devices based on non-clinical performance testing (bench testing), adherence to ISO standards for wheelchairs, and material biocompatibility.

Therefore, I cannot extract the requested information (such as AI/ML performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) because the document does not pertain to an AI/ML device study.

The closest information available is related to non-clinical performance testing for the physical safety and performance of a wheelchair, not an AI/ML algorithm.

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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.

This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding. The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device. The wheelchair uses lithium batteries as its power source. The controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame of the device is carbon fiber. The front wheels are driven wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels. The rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels. The max loading of the device is 136KG. Only for one person sit.

This document is an FDA 510(k) Premarket Notification for a Power Wheelchair (Model N6102). It aims to demonstrate substantial equivalence to a predicate device (K230964). Since this is a submission for a physical medical device (a power wheelchair) and not a software/AI-driven diagnostic or therapeutic device, the concepts of acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and separate training/test sets are not applicable in the context of typical AI/ML device evaluations.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for a power wheelchair primarily revolve around compliance with recognized performance and safety standards (ISO 7176 series, IEC 60601-1-2, ISO 10993 series) and demonstrating that any differences from a predicate device do not raise new safety or effectiveness concerns.

Here's how to interpret the provided information in the context of device acceptance, organized to address your prompt's structure where applicable, but noting the non-applicability of certain AI/ML-specific terms:

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

The document provides a comparison of the proposed device against a predicate device, largely referencing compliance with international standards. The "acceptance criteria" are implied by these standards and the "reported device performance" is the statement of compliance or comparison to the predicate.

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

This information is not provided as it's not relevant for a direct testing of a physical device against standards (e.g., you test a specific number of manufactured units or prototypes for compliance, not a "data set"). The provenance isn't applicable in the same way either; the tests are performed on the device.

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 context of device performance is established by the specified ISO standards and validated test methods (e.g., a test rig for stability or braking) and direct measurements. It doesn't rely on expert consensus in the same way an AI diagnostic image reading might.

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

Not applicable. As above, the "truth" is determined by objective measurements against engineering standards, not through a consensus of human interpretative results.

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 study is for a physical power wheelchair, not an AI software. There are no "human readers" or "AI assistance" in its intended function or evaluation.

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

Not applicable. This device does not contain an algorithm in this context. Its "performance" is mechanical and electrical, not computational.

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

The "ground truth" for this device's performance is derived from:

• International Standards: Primarily the ISO 7176 series, IEC 60601-1-2, and ISO 10993 series, which define objective test methods and acceptable performance limits for wheelchairs.
• Engineering Specifications: The design specifications for the device itself (e.g., max speed, loading weight, dimensions).
• Physical Testing: Direct physical measurements and tests on the device (e.g., dynamic stability tests, braking distance tests, obstacle climbing tests).

8. The sample size for the training set

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

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

Not applicable. See point 8.

In summary, the "study" proving the device meets the "acceptance criteria" is a series of engineering tests and analyses demonstrating compliance with relevant international performance and safety standards for power wheelchairs, and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. The differences noted (e.g., slightly different dimensions, braking distance, max loading weight, travel distance, obstacle climbing) are all deemed not to raise new safety or effectiveness concerns, with testing conducted to confirm compliance with the applicable standards even with these differences (e.g., "All safety and performance have been validated with the maximum rated weight dummy").

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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 marketing authorization for a power wheelchair, not a study evaluating an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and performance metrics related to AI/ML device evaluation cannot be extracted from this text.

The document discusses regulatory compliance for a power wheelchair, including:

• Trade/Device Name: Power wheelchair
• Regulation Number/Name: 21 CFR 890.3860, Powered Wheelchair
• Regulatory Class: Class II
• Product Code: ITI
• 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."
• Type of Use: Over-The-Counter Use

It does not contain any information about:

1. Acceptance criteria or reported device performance in the context of AI/ML.
2. Sample sizes, data provenance, or details about a test set.
3. Number or qualifications of experts.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes of AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

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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.

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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.

This Power Wheelchair, model: JJW-6001, is a motor driven, indoor and outdoor 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, armrest, backrest, seat cushion, seatbelt, pedal, battery box and charger. The device is powered by Li-ion Battery pack with 16 Km 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 patient 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 text is a 510(k) Premarket Notification from the U.S. FDA for a Power Wheelchair (JJW-6001). It outlines the device's characteristics, comparison to a predicate device, and the non-clinical tests performed.

This document pertains to the physical performance and safety of a medical device (a power wheelchair), not the performance of an AI/ML algorithm or software. Therefore, the questions related to AI/ML specific criteria (such as MRMC studies, ground truth for AI, training/test set sample sizes for AI, number of experts for AI ground truth, or adjudication methods for AI performance) are not applicable to the information contained in this document.

The document describes non-clinical tests conducted to confirm the device's safety and effectiveness compared to a predicate device, adhering to various ISO standards relevant to wheelchairs and electrical medical equipment.

Here's the relevant information based on the provided text, addressing the applicable questions:

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

The acceptance criteria are generally implied by demonstrating compliance with various ISO standards. The reported device performance is that it met the design specifications by passing these tests. Specific numerical acceptance criteria and reported values for each performance metric are not explicitly presented in a single table as distinct "acceptance criteria" vs. "reported performance" for each individual test, but rather as statements of compliance.

However, a comparison table (Table 1) provides some performance specifications for both the subject device and the predicate device.

Table of Device Performance (from Table 1, "General Comparison")

Implied Acceptance Criteria for Safety and Performance:
The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:" followed by a list of ISO and IEC standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, IEC 60601-1-2 for electromagnetic compatibility). The acceptance criteria for these tests are the requirements specified within these standards. The device's reported performance is that it met these standards.

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

The document does not specify a "sample size" in terms of number of patients or data records, as it refers to engineering and non-clinical performance testing of a physical medical device. The "test set" would be the physical JJW-6001 device itself. The data provenance is from non-clinical laboratory testing performed to demonstrate compliance with international standards. The origin of the testing data is implied to be in China, as the manufacturer and submission correspondent are based there. The tests are "non-clinical," meaning they are not performed on human subjects and thus do not have retrospective or prospective patient data provenance.

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

Not applicable. This is a physical device submission, not an AI/ML or diagnostic imaging submission. Ground truth for device performance is established by standardized test procedures (e.g., ISO 7176, ISO 10993).

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

Not applicable, as this is a physical device and not an AI/ML algorithm requiring human expert adjudication of output. Performance is determined by compliance with standard measurements and 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 a physical device, not an AI-assisted diagnostic tool. No human reader study information is provided.

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

Not applicable. This is a physical non-AI device.

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

The "ground truth" for the device's performance is compliance with established international standards (e.g., ISO 7176 series for wheelchair performance, ISO 10993 series for biocompatibility). These standards define the test procedures and acceptance criteria for various physical and safety aspects of the device.

8. The sample size for the training set

Not applicable. This is a non-AI physical device. No training set is described.

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

Not applicable. No training set or associated ground truth establishment is described for this physical device.

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