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

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lead-acid 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 Electric 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 Electric Wheelchair has 7 inch front wheel and 12 inch rear tire.

Max. distance of travel on the fully charged battery is 13.3 km and Max. speed forward is 5.76 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.

The provided FDA 510(k) clearance letter and summary are for an Electric Wheelchair (HG-630). This document specifies performance criteria based on engineering and safety standards (ISO 7176 series), not on AI/algorithm performance. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance, are not applicable to this device.

The study proves the device meets acceptance criteria through a comparison to a predicate device and adherence to established international standards for wheelchairs.

Here's a breakdown of the acceptance criteria and proof of performance based on the provided text:

Acceptance Criteria and Device Performance for the Electric Wheelchair (HG-630)

The acceptance criteria for the Electric Wheelchair (HG-630) are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K240913) and compliance with relevant international performance and safety standards, specifically the ISO 7176 series and ISO 10993 series. The "performance" of the device is assessed against a set of engineering and safety specifications that ensure it functions safely and effectively as a powered wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the adherence to a comprehensive set of ISO standards for wheelchairs and by demonstrating that the device's technical specifications are comparable to or meet the safety requirements outlined by the predicate device and those standards.

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

• Sample Size: Not explicitly stated as a "test set" in the context of a dataset for AI/algorithm validation, as this is an electro-mechanical device. The performance is based on physical testing of the device itself.
• Data Provenance: The tests are conducted according to international standards (ISO series) which specify the methodologies. The manufacturer is Zhejiang Automwheel Tech Co., Ltd. from China. The testing would have been conducted in a laboratory environment, likely by the manufacturer or a third-party testing facility, to certify compliance with the stated ISO standards. This is akin to prospective testing on a manufactured unit.

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

• Not Applicable. For an electric wheelchair, "ground truth" is established by adherence to engineering performance metrics and safety standards defined by organizations like ISO. There are no human "experts" establishing subjective "ground truth" in the way one would for diagnostic AI. The performance metrics are objective and measurable (e.g., braking distance, stability angles, dimensions).

4. Adjudication Method for the Test Set

• Not Applicable. As objective engineering parameters and safety standards are being met, there is no need for adjudication in the context of multiple human interpretations as there would be in, for example, medical image analysis. The tests either pass or fail the defined criteria.

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

• Not Applicable. This is not an AI/algorithm-assisted diagnostic device. Therefore, a comparative effectiveness study involving human readers' improvement with or without AI assistance is irrelevant.

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

• Not Applicable. This device is an electro-mechanical product. It does not have a "standalone algorithm" in the typical sense of AI/ML. Its performance is inherent to its design and functionality, which is then tested against industry standards.

7. The Type of Ground Truth Used

• Engineering and Safety Standard Compliance: The "ground truth" for this device's performance relies on objective, measurable physical parameters and functionalities as defined by established international standards (ISO 7176 series for performance, ISO 10993 series for biocompatibility, etc.). These standards set the benchmarks for what constitutes safe and effective operation for a powered wheelchair.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires machine learning training data.

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

• Not Applicable. No training set for AI/ML was used. The "ground truth" (i.e., compliance with performance and safety standards) is established through established test procedures defined by the ISO standards themselves.

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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.

This product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design.The wheelchair can easily fold and unfold for transportation or storage.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 QDWP-A01 uses lithium batteries as its power source, The QDWP-B02 uses lead acid batteries as its power source.The controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of QDWP-A01 is aluminum,the frame of QDWP-B02 is steel. 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. When in use, the operator drives the motor of the rear wheel by operating the joystick to achieve the rear wheels movement.

The motor and brake system are fixed on the rear wheels.

The max loading of the device is 120KG. Only for one person sit.

This document is a 510(k) clearance letter for an electric wheelchair, not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and study designs for AI/ML devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not available or applicable in this context.

The 510(k) letter focuses on demonstrating substantial equivalence to a predicate device based on:

1. Indications for Use: The current device has the same intended use as the predicate (to provide mobility to disabled or elderly individuals).
2. Technological Characteristics: Comparison of physical and operational specifications (e.g., motor, battery, dimensions, speed, braking).
3. Performance Benchmarking: Validation through adherence to widely accepted international standards for wheelchairs (ISO 7176 series) and biocompatibility (ISO 10993 series), rather than a clinical study comparing human performance with and without AI assistance.

Here's an attempt to structure the available information, acknowledging that many requested fields are not relevant for this type of device clearance:

Device: Electric Wheelchair (QDWP-A01, QDWP-B02)

Study Purpose (Implied from 510(k) clearance): To demonstrate substantial equivalence of the proposed device to legally marketed predicate devices, ensuring it meets established safety and performance standards for powered wheelchairs.

1. Table of Acceptance Criteria and Reported Device Performance

For an electric wheelchair, acceptance criteria are typically compliance with relevant ISO standards and specific performance thresholds based on comparative data with predicate devices. The document highlights "Analysis" remarks for minor differences and states that numerous ISO standards were met.

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

• Test Set Sample Size: Not specified in terms of a "sample size" of individual devices, as this is typically based on testing a representative number of units to demonstrate compliance with standards. Testing would involve a few prototypes/production units.
• Data Provenance: The device manufacturer is Jinhua Qidian Vehicle Co. Ltd. in China. The testing would have been conducted by the manufacturer or accredited testing laboratories, likely in China, to the specified ISO standards. The data is prospective in the sense that it's generated for the clearance submission.

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

• Not applicable. For a physical medical device like an electric wheelchair, "ground truth" is established by direct physical measurements, engineering tests, and adherence to objective performance standards (e.g., braking distance, speed, stability under load). It does not involve expert interpretation of medical images or clinical outcomes that require medical experts to establish a "ground truth."

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, particularly in image interpretation or clinical diagnosis. This device's performance is objectively measured against engineering and safety standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human-in-the-loop clinical study comparing human performance with and without AI assistance would be conducted for this product.

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

• Not applicable. There is no "algorithm only" performance for an electric wheelchair in the sense of an AI/ML model. The device operates mechanically and electronically, with its "performance" being its ability to move, brake, and maintain stability.

7. The Type of Ground Truth Used

• Engineering Standards and Objective Measurements: The "ground truth" for this device's performance is established by recognized international engineering, safety, and quality standards (e.g., ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility). Performance is measured directly against these benchmarks and compared to a predicate device. This includes physical measurements (dimensions, speed), mechanical tests (strength, stability, braking), electrical tests (battery, motor, EMC), and material tests (biocompatibility, flammability).

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device, not an AI/ML system that requires training data. The "training" for the device would be its design and manufacturing processes.

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

• Not applicable. As above, there is no AI/ML training set for this device. The design specifications and performance objectives are based on engineering principles and regulatory requirements for powered wheelchairs.

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This Electric 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 product is intended only carry one person and used as a means of transportation for the old and infirm who have difficulty in moving.

The maximum occupant mass is 100kg.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists one Lithium battery with an off-board battery charger, frame, controller, motors, seat, back support, control device (including the battery power indicator, ON/OFF button, horn button, speed indicator, speed control button, joystick, Battery charger socket), arm supports, two rear wheels, two casters(front wheels), Foot support, anti-tip devices.

The wheelchair can easily fold and unfold for transportation or storage.

The provided text describes the FDA 510(k) clearance for an Electric Wheelchair. However, it does not include information about acceptance criteria for a device performance study in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy.

Instead, the "acceptance criteria" for this device are demonstrated through adherence to a comprehensive set of international standards for wheelchairs. The study that proves the device meets these criteria is a series of non-clinical tests conducted against these standards.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Electric Wheelchair are largely defined by compliance with a comprehensive set of ISO and IEC standards related to wheelchairs. The reported device performance is demonstrated by its successful adherence to these standards.

Study Details:

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

   • The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." This typically implies testing of a representative sample of the manufactured device models. Specific numbers for each test (e.g., how many units were tested for static stability) are not provided.
   • Data provenance: The tests were performed by the manufacturer, Ningbo Baichen Medical Devices Co., Ltd., which is located in China. The data would be considered retrospective in the sense that the testing was completed prior to the 510(k) submission, but it's prospective in relation to the design validation process.

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

   • This question is not applicable in the context of this device and study type. The "ground truth" for non-clinical performance (e.g., static stability, brake effectiveness) is defined by the technical specifications and limits set forth in the international standards (ISO, IEC). The testing involves objective measurements rather than expert interpretation of data like in an image-based diagnostic study.

3. Adjudication method for the test set:

   • This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations (e.g., 2+1 means 2 out of 3 experts agree, 3+1 means 3 out of 4 agree, with a fourth to resolve ties). Since these are objective physical performance tests against established numerical standards, there is no expert adjudication process. The results are either within the standard's limits or they are not.

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:

   • This is not applicable. This is an Electric Wheelchair, a physical medical device, not an AI software intended for interpretation by human readers. Therefore, an MRMC study is not relevant.

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

   • This is not applicable. This is a physical medical device. While it contains an "Electronic controller" (SYC-PM30), the performance described (e.g., speeds, stability, braking) is a property of the integrated physical device, not a standalone algorithm. Software validation was performed for the control system, as mentioned under the difference D#11, but this is part of the overall device's non-clinical testing, not a standalone algorithm performance study in the context of diagnostic AI.

6. The type of ground truth used:

   • The "ground truth" for this device's performance is established by international consensus standards (ISO and IEC). These standards define the acceptable performance parameters and test methods for electric wheelchairs to ensure their safety and effectiveness.

7. The sample size for the training set:

   • This question is not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this type of device. The design and validation are based on engineering principles and compliance with established standards.

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

   • This question is not applicable, as there is no training set for this device.

In summary, the provided document details a non-clinical performance study demonstrating substantial equivalence through rigorous adherence to internationally recognized safety and performance standards for electric wheelchairs. The specific metrics are defined by these standards, and the device's performance met these criteria through objective physical testing.

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This Electric 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 product is intended only carry one person and used as a means of transportation for the disabled, and sick.

The electric wheelchair is classified as class B and the maximum occupant mass is 120kg.

The Electric Wheelchair is a battery powered four wheeled vehicle.

It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle.

The wheelchair can easily fold and unfold for transportation or storage.

The provided FDA 510(k) clearance letter for the Electric Wheelchair (F309) does not describe a study involving AI or human-in-the-loop performance measurement. This document pertains to a physical medical device (an electric wheelchair) and focuses on demonstrating its substantial equivalence to a predicate device through non-clinical performance and safety testing against established ISO standards.

Therefore, many of the requested points regarding acceptance criteria and study design for AI/human-in-the-loop performance cannot be extracted from this document, as they are not relevant to the clearance of this type of device.

However, I can extract information related to the non-clinical tests that were conducted to prove the device meets its design specifications and safety requirements.

Here's a breakdown based on the provided document, addressing the extractable information:

Acceptance Criteria and Device Performance for Electric Wheelchair (F309)

The acceptance criteria for the Electric Wheelchair (F309) are based on demonstrating compliance with a comprehensive set of ISO 7176 series standards for wheelchairs, as well as biocompatibility and electromagnetic compatibility (EMC) standards. The device performance is deemed acceptable if it meets the requirements outlined in these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and that "The test results demonstrated that the proposed device complies with the following standards." For each standard, the acceptance criterion is implicitly "meets the requirements of the standard," and the reported performance is that the device did meet those requirements.

Note: Specific quantitative thresholds for "acceptance criteria" are generally detailed within the referenced ISO standards themselves, not typically in a 510(k) summary (unless there's a deviation or specific performance claim being made). The document generally confirms compliance.

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

• Sample Size: Not explicitly stated as a number of devices. For physical device testing against standards, it's typically one or a few representative units of the device that undergo the specified tests. The document implies that the "proposed device" (singular) was tested.
• Data Provenance: The tests are non-clinical (laboratory/engineering tests) performed to verify design specifications. The company, Changshu Pingfang Wheelchair Co., Ltd, is located in China. The tests would have been performed by or on behalf of the manufacturer, likely at a certified testing facility. The data is prospective in the sense that it's generated specifically for this submission to verify safety and performance.

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

Not applicable. For non-clinical device performance testing against ISO standards, "ground truth" is established by the test methodology and the physical properties of the device as measured by calibrated equipment and verified according to the standard protocols. There are no human experts establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images).

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

Not applicable. This is not a clinical study involving human interpretation or adjudication. The assessment is based on objective measurements against 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 for an electric wheelchair, not an AI-assisted diagnostic or therapeutic device. No human reader study (MRMC) was performed or required.

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

Not applicable. This device does not involve an algorithm for standalone performance evaluation in the medical imaging sense. Its performance is physical and mechanical.

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

The "ground truth" for this medical device is the adherence to the requirements and specifications outlined in the referenced international standards (primarily ISO 7176 series, ISO 10993-1, IEC 60601 series). This is verified through physical and electrical measurements and tests conducted in a laboratory setting. It is a technical/engineering standard conformance ground truth, not a clinical ground truth.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

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

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The "eFOLDi Navigator Powerchair STPC-A" 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 eFOLDi Navigator Powerchair STPC-A 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 wheelchair has two front wheels, two rear wheels, two electric motors with electromagnetic brake, and one rechargeable Lithium-Ion batteries with an off-board charger. The movement of the wheelchair is controlled by the joystick controller or attendant control. When attendant control is in use, the wheelchair no longer responds to the joystick controller. The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The wheelchair only can be operated on the flat road for both outdoor and indoor use, hospital, senior center, family or similar circumstances use only. The Powerchair only can be operated on the flat road or slopes less than 6 degrees. The Powerchair is foldable.

The Powerchair has a physical dimension of 108 (depth) x 59 (width) x 89 (height) cm, with the seat itself has a dimension of 35 (depth) x 45 (width) x 50 (height) cm. The footrest is 10 cm in height. The Powerchair is foldable, and the folded dimension is 34 (Long) x 59 (width) x 89 (height) cm.

The device has a weight capacity of 120 kilograms, and weighs 14 kilograms with battery (12 kilograms without battery). The color is black.

The Powerchair consists of four wheels, a magnesium alloy mechanical main frame, seat, handle, and 100% polyester flame retardant cloth for upholstery that is ignition resistant.

The Powerchair uses solid Polyurethane wheels and the front wheel has a diameter of 20 cm (8 inch) and the back wheel has a diameter of 30 cm (11.5 inch). Both front wheel and back wheels use solid tires.

The Powerchair has two motors of 24V and 180 Watt, which allows a maximum speed of 5.6 kilometers per hour, and maximum travel range of 13 kilometers. It brakes in the form of electromagnetic force to apply mechanical resistance to the back wheels to force stop.

The wheelchair is equipped with anti-tipper device.

This FDA 510(k) clearance letter is for a physical medical device (eFOLDi Navigator Powerchair), not an AI/software as a medical device (SaMD). Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement for AI performance is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and compliance with relevant ISO and IEC standards for wheelchairs.

However, I can extract the acceptance criteria and study information related to the device's physical performance as detailed in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size (number of units) used for each non-clinical performance test. It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is from non-clinical tests performed by the manufacturer (SunTech UK Ltd.) likely in a controlled laboratory or testing facility setting, rather than human data. There is no mention of country of origin for the data or whether it's retrospective or prospective in the context of data acquisition, as it's not human data.

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

Not applicable. For a physical device like a powerchair, "ground truth" as it relates to expert consensus for diagnostic accuracy or similar AI contexts is not relevant. Performance is determined by objective physical tests against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI studies (e.g., medical image interpretation). For physical device testing, the outcome is determined by whether the device passes or fails the specified standard criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/SaMD device, so MRMC studies involving human readers or AI assistance are irrelevant.

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

Not applicable, as this is not an AI/SaMD device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by compliance with internationally recognized engineering and safety standards for wheelchairs and their components (ISO 7176 series, ISO 10993-1, ISO 16840-10, IEC 62133-2). These standards define objective, measurable criteria that the device must meet.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/SaMD device. There is no "training set" in the context of a physical powerchair's mechanical and electrical performance.

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

Not applicable, as this is not an AI/SaMD device and has no training set.

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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 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 controller controls the drive left/right motor to realize the wheelchair forward, backward and turn functions. The frame's material of model ZH-W001 and ZH-W002 is aluminium alloy,the model ZH-W003 is carbon steel. 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 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 motor and brake system are fixed on the rear wheels. The max loading of the device is 120KG. Only for one person sit.

The provided FDA 510(k) clearance letter and summary discuss the substantial equivalence of an Electric Wheelchair to a predicate device. This document is for a physical medical device, not an AI/ML-driven device. As such, many of the requested criteria related to AI/ML model performance evaluation (e.g., sample size for AI test sets, expert adjudication, MRMC studies, standalone algorithm performance, training set details) are not applicable to this submission.

The acceptance criteria provided focus on fundamental safety and performance attributes typical of medical devices that are not AI-driven, and the "study" referred to is a series of non-clinical laboratory tests adhering to established ISO standards.

Here's the information that can be extracted and a clear statement about the inapplicable sections:

Acceptance Criteria and Device Performance for Electric Wheelchair (K250158)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of ISO 7176 series standards and FDA guidance for Power Wheelchairs. The "reported device performance" refers to the results of non-clinical laboratory tests showing compliance with these standards.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a series of non-clinical laboratory tests conducted on the proposed device models (ZH-W001, ZH-W002, ZH-W003) in accordance with the specified international standards (ISO 7176 series, IEC 60601-1-2, and ISO 10993 series for biocompatibility). The 510(k) summary explicitly states: "The non-clinical laboratory data support the safety and performance of the subject device and demonstrate that the subject device should perform as intended in the specified use conditions."

AI/ML Specific Questions (Not Applicable to this Device):

The following questions are not applicable to this 510(k) submission as the device is an Electric Wheelchair, a physical medical device, and not an AI/ML software or system. Therefore, there is no AI/ML model being evaluated.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, no AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, no AI test set requiring adjudication.
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, no AI component or human reader study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, ground truth related to AI/ML is not relevant here. The "ground truth" for this device's performance is objective measurements against engineering and safety standards.
8. The sample size for the training set: Not applicable, no AI training set.
9. How the ground truth for the training set was established: Not applicable, no AI training set.

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The TWIST and TWIST R are add-on drive accessories for wheelchairs.

The TWIST and TWIST R devices are intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users.

TWIST and TWIST R devices are designed to provide support to active wheelchair users who are physically and mentally able to safely control a manual wheelchair in typical situations, including inclines, even manually.

The device is an add on accessory for manual wheelchairs.

1. TWIST

TWIST device is meant to be added to the wheelchair in 5 different combinations of position and control:

1. Front mounted without handlebar, driven by the wheelchair occupant
2. Front mounted without handlebar, driven by the attendant
3. Front mounted position with handlebar, driven by the wheelchair occupant
4. Rear mounted without handlebar, driven by the wheelchair occupant
5. Rear mounted without handlebar, driven by the attendant

Coupling the TWIST device in front position to the wheelchair raises the front castors off the ground. The single wheel of the "traction unit" is then used for steering.

2. VARIATION TWIST R

VARIATION TWIST R device is meant to be added to the wheelchair in 1 only position (rear) and 2 ways of control

1. Rear mounted without handlebar, driven by the wheelchair occupant
2. Rear mounted without handlebar, driven by the attendant

The provided FDA 510(k) clearance letter pertains to a powered wheelchair accessory (Klaxon TWIST/TWIST R), which is a physical device, not an AI/software as a medical device (SaMD).

Therefore, many of the requested criteria related to AI/SaMD performance evaluation (such as multi-reader multi-case studies, expert consensus for ground truth establishment, training set details, or standalone algorithm performance) are not applicable to this submission.

The acceptance criteria and supporting study described in the document relate to the physical and mechanical properties and safety of the device, specifically addressing changes in maximum speed and maximum user weight.

Here's an analysis based on the provided document, addressing the applicable criteria for a physical medical device:

Acceptance Criteria and Device Performance Study for KLAXON (TWIST); KLAXON (TWIST R)

The submission describes changes made to a previously cleared device (K240267) and the non-clinical tests performed to demonstrate that these changes maintain the device's safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the safety and performance requirements outlined in the referenced ISO consensus standards. The "performance" is the demonstration of compliance with these standards.

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

• Sample Size: Not explicitly stated in terms of a "sample size" as one might see for a diagnostic study. For mechanical and performance testing of a physical device, testing typically involves a representative number of units (e.g., a few prototypes or production units) to demonstrate compliance with standards. The document states "Both the TWIST, and variation TWIST R, devices... have been subjected to the same testing requirements." This implies physical testing of the devices.
• Data Provenance: The tests were conducted by the manufacturer, KLAXON-MOBILITY GmbH, in Austria (their listed address). The data is implicitly "prospective" in that it was generated for this specific 510(k) submission to validate the design changes.

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

N/A. For mechanical and physical performance testing of a medical device like a powered wheelchair accessory, "ground truth" is established by the specifications and performance metrics within recognized consensus standards (e.g., ISO 7176 series). There aren't "experts" in the sense of clinicians establishing a diagnostic ground truth, but rather engineers and technicians performing standardized tests.

4. Adjudication Method for the Test Set

N/A. Mechanical and performance tests typically involve objective measurements against predefined criteria/tolerances specified in the standards, rather than subjective interpretation requiring an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a physical powered wheelchair accessory, not an AI/SaMD diagnostic tool.

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

N/A. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" or "reference standard" is the compliance with recognized international consensus standards for wheelchairs, specifically:

• ISO 7176-1:2014 (Static stability)
• ISO 7176-2:2017 (Dynamic stability)
• ISO 7176-3:2012 (Braking effectiveness)
• ISO 7176-8:2014 (Static, impact, and fatigue strengths)

These standards define the test methodologies and acceptable performance limits.

8. The Sample Size for the Training Set

N/A. There is no "training set" as this is a physical device, not an AI/machine learning model.

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

N/A. Not applicable for a physical device.

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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 Electric Wheelchair, model: LW01301A07, 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 17.6 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, 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.

This document is an FDA 510(k) clearance letter for an Electric Wheelchair, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria and study proving the device meets the criteria in the context of AI/ML performance (e.g., sample size for test set, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this document.

The acceptance criteria mentioned in this document refer to the device's compliance with established performance standards for electric wheelchairs, such as various ISO 7176 series standards, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted against these standards.

Here's a breakdown of what can be extracted from the provided document, framed as close as possible to your request, but acknowledging the difference in device type:

Device: Electric Wheelchair (LW01301A07)

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

The document doesn't provide specific numerical acceptance criteria alongside reported performance values in a direct table format for all parameters. Instead, it states that the device "complies with" or "meets the requirements of" various ISO standards. Where numerical comparisons are made to the predicate, it highlights differences and then asserts that these differences do not cause new safety concerns because the device still meets the relevant standards.

Here's an attempt to synthesize the information into a table, focusing on the comparisons and the implicit acceptance of compliance with the listed ISO standards:

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

• Sample Size: The document does not specify a numerical sample size for the devices tested. Typically, for non-AI/ML devices undergoing performance testing against standards, a small number of devices (e.g., 1-5 units) are tested, often following specific sampling plans outlined in the test standards themselves.
• Data Provenance: The testing was "non-clinical laboratory data," implying the tests were conducted in a controlled lab environment. The manufacturer is Anhui Longway Medical Technology Co., LTD in China. The data would therefore be prospective, generated specifically for this submission.

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

• This is not applicable to a non-AI/ML device. "Ground truth" in this context is established by the performance standards themselves (e.g., a wheelchair must not tip at a certain angle) and measured by calibrated equipment and documented test procedures, not expert interpretation of outputs.

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

• Not applicable. Adjudication methods are typically relevant for human interpretation tasks in AI/ML studies where there might be inter-reader variability. For engineering performance tests, the results are objectively measured.

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 an electric wheelchair, not an AI-assisted diagnostic or therapeutic device.

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

• Not applicable. This device is not an algorithm. Its "performance" is its physical function.

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

• The "ground truth" used for this device is compliance with established international engineering standards (ISO 7176 series, ISO 10993 series), electrical safety standards (IEC 60601 series), and FDA regulatory guidance. This is determined through physical testing, measurement, and validation against the specified requirements of these standards.

8. The sample size for the training set

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

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

• Not applicable. As above, there is no AI/ML model or training set.

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