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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.

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.

Ask a specific question about this device

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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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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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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Walking rehabilitation training electric wheelchair is to provide indoor mobility, including stand-up feature, to persons limited to a seating position that are capable of operating a powered wheelchair.

Walking rehabilitation training electric wheelchair (ZW518)

This FDA 510(k) clearance letter for the "Walking rehabilitation training electric wheelchair (ZW518)" does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a regulatory clearance letter, confirming that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory compliance, labeling, quality systems, and other administrative requirements for marketing the device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for the test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing training set ground truth.

This document pertains to the regulatory pathway for market clearance, not the detailed technical and performance validation studies.

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The 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 Electric wheelchair, YE200, is a powered wheelchair that is designed to fold when not in use so it can be more easily transported in a car trunk or similar space. It uses rechargeable lithium batteries, and is controlled by a joystick and a few other simple controls which are located on the end of the armrest. The joystick assembly may be installed on either side of the chair to accommodate both right-handed and left-handed users. The Electric wheelchair consists of two armrests, a back rest, a seat cushion, a foldable frame, two rear drive wheels with hub motor and electromagnetic brake assemblies, two pivoting casters, two Li-ion battery pack, an off-board battery charger, a control panel (joystick) with connect cables and an electric motor controller. The device is powered by Li-ion battery pack, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet 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 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) summary for an electric wheelchair (Model YE200). It details the device, its intended use, a comparison to a predicate device, and a summary of non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

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

The document does not present a formal "acceptance criteria" table with specific pass/fail values. Instead, it provides a comparison table between the subject device (YE200) and the predicate device (DC01), highlighting similarities and differences. The "Discussion/Conclusion" column in this table serves as the performance assessment against the predicate. The underlying "acceptance criteria" appear to be the successful execution and passing of specific ISO standards relevant to electric wheelchairs.

Here's a re-imagined table focusing on key performance attributes where differences exist, and the stated conclusion regarding compliance with standards. It's important to note that the document states "all passed" or "will not affect safety/performance," implying that the measured performance met the unseen criteria of the referenced standards.

Study Proving Device Meets Acceptance Criteria:

The study to prove the device meets the acceptance criteria is primarily a non-clinical performance evaluation through testing against recognized international standards (ISO and IEC), and a comparison to a legally marketed predicate device.

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

• Sample Size: The document does not specify a numerical "sample size" in terms of number of devices tested. It refers to "the subject device" (singular), implying that at least one physical unit of the YE200 electric wheelchair was subjected to the various performance, strength, climatic, and EMC tests. For biocompatibility, individual material samples would have been tested.
• Data Provenance: The document does not explicitly state the country of origin of the data collection or whether it was retrospective or prospective. However, given that Shenzhen Yattll Industry Co., Ltd is based in China and the submission is to the FDA, it is highly likely that the testing was performed by a certified lab, possibly in China or a mutually recognized testing facility. Since it's for a 510(k) submission for a new device model, the testing data would be prospective relative to the submission date, generated specifically for this application.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for an electric wheelchair's performance is established by objective, measurable outputs against defined engineering and safety standards (e.g., maximum speed, braking distance, stability angles, EMC limits, biocompatibility results), not by expert consensus or interpretation of complex medical images. The testing labs would have qualified technicians and engineers performing these measurements according to ISO/IEC protocols.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in medical imaging studies where there's subjective interpretation by multiple readers/experts that needs to be reconciled to establish a "ground truth" for diagnosis. For engineering performance tests like those for an electric wheelchair, the tests yield objective, quantifiable results, not subjective interpretations 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:

This is not applicable. This document is for an electric wheelchair, which is a physical mobility device, not an AI-powered diagnostic or assistive tool for human readers/clinicians interpreting data. Therefore, an MRMC study is not relevant to demonstrating its safety and effectiveness.

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

This is not applicable. This device is an electric wheelchair, which does not have an AI algorithm that functions in a standalone capacity. It is a user-controlled device with embedded electronic controls. While software validation was performed, it's for the control system of the wheelchair, not for an AI algorithm for diagnostic purposes.

7. The type of ground truth used:

The "ground truth" for the performance of the electric wheelchair is objective, measurable performance criteria defined by internationally recognized standards (ISO 7176 series, ISO 10993 series, IEC 60601-1-2) and engineering specifications. For example:

• Static stability: Measured in degrees.
• Braking distance: Measured in meters.
• EMC: Measured against specific radiated/conducted emission and immunity limits.
• Biocompatibility: Results of specific biological tests (cytotoxicity, sensitization, irritation) against defined pass/fail criteria.
• Strength/Fatigue: Ability to withstand specified forces for a given number of cycles.

The predicate device's performance also serves as a crucial point of comparison, establishing substantial equivalence rather than a medical "ground truth" in the diagnostic sense.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's functionality is based on established engineering principles and pre-programmed controls, not learned patterns from data.

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

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

Ask a specific question about this device

The 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.

Electric Wheelchair (MODEL H)

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that an "Electric Wheelchair (MODEL H)" meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device, which indicates that the device is substantially equivalent to a legally marketed predicate device.

The letter outlines:

• The device name and classification.
• The FDA's determination of substantial equivalence.
• General controls and other regulations the device is subject to (e.g., Quality System regulation, UDI rule).
• Contact information for various FDA departments.
• The "Indications for Use" statement for the Electric Wheelchair (MODEL H).

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, or study design for testing.
3. Information on expert involvement, ground truth establishment, or adjudication methods for any test set.
4. Any mention of an MRMC comparative effectiveness study or standalone algorithm performance.
5. Details about training sets or how ground truth for training data was established.

Therefore, I cannot fulfill your request for this specific information based on the provided text.

Ask a specific question about this device