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The e-motion M25 DuoDrive is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

The e-motion-M25 DuoDrive is a medical device for active wheelchair users who are reliant on a wheelchair as a result of their disability. The subject device e-motion is an additional drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven and thus significantly increasing the wheelchair user's mobility and flexibility. To extend functionality an optional remote control (ECS) a smartphone app and a detachable control unit is available. The user interacts with the e-motion M25 DuoDrive via two push-rims that trigger the assistive power drive. The main parts of the drive unit are as follows: Pushrim-wheels including a brushless DC-motor. Control electronic for the motor and wireless interface for communication with ECS remote control and smartphone app. Integrated lithium ion battery pack with battery management system. Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery charger. Quick-release axle for attaching and detaching the drive unit to wheelchair-frame. The main function of the APP are as follows: Status information (battery, speed). Live display of error messages. Recording of tours. Selection of preset driving profiles. ECS functionality (extra charge, details see below). Wheelchair navigation (extra charge). Enhance maximum speed (extra charge). Cruise mode (extra charge). Activation flight mode. System information. Error logfile (password protected). Setting auto shut-off time (password protected). Individual adjustment of driving parameters (password protected). The main function of the ECS remote control are as follows: Switch between 2 assist level for indooir and outdoor. Selection of learner mode (formerly also called Training mode). Activation of rollback delay (hill holder). Switch the wheels on and off (standby mode). The main parts of the control unit are as follows: Wireless interface for communicating with the drive wheels. Rotary wheel to start and change the cruise speed. Rotary wheel to stop cruise mode (short push on the side). Rotary wheel to switch the drive wheels on and off/standy mode (long push on the side). Integrated Li-ion battery cell including battery management system. USB-C socket for charging via drive unit or other external USB-C charger. Display for operating status and remaining capacity of drive wheels and control unit. To charge the battery of the drive unit a battery charger is available. Main attributes: Multi-range charger 100-240 VAC, 50-60 Hz. Automatic charging and switch-off mechanism. Indicating status and mains.

This document describes the premarket notification (510(k)) for the e-motion M25 DuoDrive, a power assist wheelchair conversion kit. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

The information provided does not outline specific acceptance criteria or a detailed study proving the device meets those criteria in the typical sense of a clinical or analytical performance study for an AI/ML-driven medical device. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices (e-motion M25 (K192618) and SMOOV O10 (K192016)) by comparing technical specifications, intended use, and addressing potential changes (like the addition of a control unit).

Therefore, I cannot directly provide the requested table of acceptance criteria and reported device performance related to an AI/ML model's output metrics (e.g., sensitivity, specificity, AUC). This device is a mechanical/electronic medical device, not an AI/ML diagnostic or prognostic tool.

However, I can extract the relevant information regarding the device's functional and safety characteristics, which serve as its "performance" and "acceptance criteria" in the context of this 510(k):

Acceptance Criteria and Device Performance (Based on Device Specifications and Safety Considerations)

Since this is a mechanical/electronic device, "acceptance criteria" here refer to its technical specifications and demonstration of safety/effectiveness compared to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, which is more applicable to AI/ML software as a medical device (SaMD) performance studies:

This 510(k) pertains to a mechanical/electronic power assist device, not an AI/ML algorithm that requires a test set, ground truth experts, or MRMC studies for its core function. Therefore, the following points are not applicable to this specific submission.

2. Sample sized used for the test set and the data provenance: Not applicable for this type of device. Testing would involve engineering performance tests (e.g., battery life, speed, durability) and safety testing for electrical and mechanical hazards, not a "test set" of data for an AI algorithm.

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 this device would be established through engineering specifications, standards compliance, and physical testing, not expert interpretation of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device does not involve "human readers" or AI assistance in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no standalone AI algorithm in the context of device performance outlined here. The device itself is a "human-in-the-loop" system, assisting a human wheelchair user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on engineering specifications, international performance and safety standards (e.g., ISO 7176-4, ISO 7176-21), and physical testing (e.g., speed, range, weight capacity, electrical safety, EMC). The "change information" notes that the changes were made under their "design control process," which would involve verifying that the updated design still meets these established specifications and safety requirements.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the computational sense.

9. How the ground truth for the training set was established: Not applicable.

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The e-motion M25 is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

The e-motion-M25 is a medical device for active wheelchair users who are reliant on a wheelchair as a result of their disability. The subject device e-motion is an additional drive for wheelchairs that is attached to a manual wheelchair, converting it into an electrically driven and thus significantly increasing the wheelchair user's mobility and flexibility.

To extend functionality an optional remote control (ECS) and a Smartphone App is available.

The user interacts with the e-motion M25 via push-rim that triggers the assistive power drive.

The main parts of the drive unit are as follows:

• Pushrim-wheels including a brushless DC-motor .
• Control Electronic for the motor and wireless interface for communication with ECS and . smartphone App
• . Integrated lithium ion battery pack with battery management system
• Magnetic charger socket for the integrated battery (Easy Connect) for connecting the battery charger
• Quick-release axle for attaching and detaching the drive unit to wheelchair-frame .

The main function of the APP are as follows:

• Status information (Battery, Speed)
• Live display of error messages ●
• Recording of tours
• Selection of preset driving profiles ●
• ECS-Funtionality (extra charge , details see below) ●
• Wheelchair navigation (extra charge)
• Enhance maximum speed (extra charge) ●
• . Cruise Mode (extra charge)
• Activation flight mode ●
• System information ●
• Error logfile (password protected)
• Setting auto shut-off time (password protected) ●
• Inidivial adjustment of driving parameters (password protected) ●

The main function of the ECS are as follows:

• Drive-Mode
• Settings ●
• Diagnostics ●

To charge the battery of the drive unit a battery charger is available. Main attributes:

• . Multi-range charger 100-240 VAC, 50-60 Hz
• . Automatic charging and switch-off mechanism
• Indicating status and mains ●

The provided text is a 510(k) Summary for the e-motion M25, a power assist wheelchair conversion kit. It describes the device, its intended use, comparison to predicate devices, and conformity with recognized standards. However, it explicitly states:

"Clinical tests were not conducted."

This means that the document does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance. The focus of this 510(k) submission is on demonstrating substantial equivalence to predicate devices through non-clinical testing and adherence to recognized standards.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This would be based on clinical study outcomes, which are absent.
2. Sample size used for the test set and the data provenance: No clinical test set data is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set with ground truth was established from expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a medical imaging-specific study type and not relevant to a powered wheelchair accessory.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable, as this is hardware, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document emphasizes non-clinical tests to demonstrate safety and efficiency, including mechanical, electrical, and biological safety, as well as performance aspects, all in conformity with recognized standards (e.g., ISO 7176 series for wheelchairs). The "acceptance criteria" here would be meeting the specifications outlined in those standards and demonstrating substantial equivalence to the predicate devices.

In summary, the provided document does not describe a clinical study or a study directly proving the device meets acceptance criteria through clinical performance data.

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The SMOOV O10 add-on drive for wheelchairs is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users. It is 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 SMOOV O10 drive unit is attached and detached to rigid wheelchairs via a bracket or alternatively to a foldable wheelchair with an optional adapter. The SMOOV 010 converts the user´s manual wheelchair, when needed, in a partly motorized wheelchair to extend the mobility and flexibility of the wheelchair user. To extend functionality an optional Smartphone App is available. The user interacts with the SMOOV 010 via control unit mounted to the wheelchair for wireless interfacing with the drive unit. The control unit is used to switch on and off the power assistance and adjust the speed of the drive unit via the turnwheel.

This document describes the 510(k) Summary for the SMOOV O10 add-on drive for wheelchairs (K192016). This is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on comparative performance and compliance with relevant standards, rather than a standalone clinical study with acceptance criteria and reported device performance in the format typically seen for novel diagnostics or treatments.

Here's an attempt to structure the available information based on your request, acknowledging the limitations of a 510(k) summary in providing all requested details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial for a diagnostic device. Instead, substantial equivalence is demonstrated by comparing the subject device (SMOOV O10) to a predicate device (SmartDrive MX2+ K151199) across various technical specifications and intended uses, and by demonstrating conformity to recognized international standards for safety and performance in powered wheelchairs.

The "acceptance criteria" are implied by compliance with these standards and comparable specifications to the predicate device. The "reported device performance" is largely presented through these specifications and the claim of meeting the standards.

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

The document does not describe a "test set" in the context of a clinical performance study with human subjects. The evaluation for this 510(k) relies on:

• Comparison to a predicate device: MaxMobility GmbH SmartDrive (MX2+) (K151199).
• Conformity to recognized international standards: A comprehensive list of ISO and IEC standards related to wheelchairs, batteries, biological evaluation, electromagnetic compatibility, and risk management is provided.
• Engineering bench testing: Implied by conformity to standards, but specific sample sizes for these tests are not detailed in this summary.

Data Provenance: Not applicable in the context of a "test set" from a clinical study. The data is largely derived from the technical specifications, design documents, and test reports supporting compliance with the listed standards.

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

This is not applicable as there was no "test set" requiring expert ground truth in the clinical sense. The "ground truth" for the device's acceptable performance is established by its adherence to internationally recognized consensus standards and its substantial equivalence to a legally marketed predicate device, as assessed by the manufacturer and reviewed by the FDA.

4. Adjudication method for the test set

Not applicable, as no external clinical test set requiring expert adjudication is described in this 510(k) summary.

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. The SMOOV O10 is an assistive powered wheelchair attachment, not a diagnostic or AI-assisted image analysis tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant to this device.

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

Not applicable. The SMOOV O10 is a physical medical device (an add-on drive for wheelchairs) with a human user always "in-the-loop" for control and operation. It is not an algorithm-only device.

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

The "ground truth" for demonstrating the safety and effectiveness of the SMOOV O10 for this 510(k) is primarily established through:

• Compliance with recognized international standards: These standards define measurable performance and safety criteria accepted by experts in the field of medical devices and assistive technology.
• Comparison to a legally marketed predicate device: Demonstrating that the subject device's design, materials, intended use, and performance are substantially equivalent to a device already deemed safe and effective.

8. The sample size for the training set

Not applicable. The SMOOV O10 is a physical device, not an AI/ML algorithm that requires a "training set" of data.

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

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

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The e-fix is an add-on drive for wheelchairs. The e-fix E35/E36 turns a manually propelled wheelchair into a powered wheelchair. It is intended for medical purposes to provide a means for a disabled person to take over the propulsion of the wheelchair and increase mobility and flexibility.

The subject device e-fix E35/E36 is an add-on drive, which converts a manual wheelchair into an electrical wheelchair.

The drive system e-fix E35/E36 includes two power wheels, a battery mount, a battery pack, a control unit, a power supply and optional devices. The wheelchair is not part of the drive system and is provided by the customer. For initial use mounting brackets are required. If the mounting brackets are fitted to the wheelchair, the power wheels, the control unit and the battery pack can be adapted. The main principle of the power wheel is that the motor unit is fixed against turning and the wheel hub is rotating. The fixing of the motor unit to the mounting brackets is realized with the wheel receiver. The wheel receiver supports the torque which the motor applies and is the interface to the wheel chair.

There are different variants of the e-fix E35 is the conventional version of the e-fix. The e-fix E36 provides a more robust drive with a higher torque. The battery pack has more capacity than the normal one. The e-fix E36 is mainly intended for heavy-weighted persons. The e-fix E35 and E36 are available with 22" or 24" wheels. The control unit is the steering device of the system. It allows a safe and comfortable ride with the wheelchair.The battery pack is easily removable and rechargeable.

The provided document is a 510(k) summary for a medical device called e-fix E35/E36, which is an add-on drive for wheelchairs. It outlines the device's technical specifications, indications for use, comparison to a predicate device, and conformity with standards.

However, the document does not contain the specific information requested regarding the acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies. This device is a powered wheelchair accessory, and the FDA submission focuses on its mechanical, electrical, and performance characteristics as a physical medical device, not an AI/ML-driven diagnostic or analytical tool.

Therefore, I cannot extract the requested information from the provided text. The document describes conformity to ISO standards for wheelchair performance and safety, but these are not the "acceptance criteria" in the sense of accuracy, sensitivity, specificity, etc., typically associated with AI/ML device evaluations. There is no mention of a "study" in the context of evaluating an AI algorithm's performance against a ground truth.

If you have a document pertaining to an AI/ML medical device, please provide that.

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The twion is a Power Assist Wheelchair Conversion Kit and suitable for the manual wheelchair users who are limited in their field of activities because of their physical conditions. The device can expand their field of activities by assisting their wheelchair operating force.

The twion is a power assist drive system. Its basic functionality can be compared to a power steering of a car. By pushing the push rim attached to the wheel, a motor assists in turning the wheel - like a power steering does when turning the steering wheel.

The intent of the twion device is to expand the field of activities for those wheelchair drivers who are limited in their physical condition.

The twion is designed to fit most standard manual wheelchairs available on the market. It is lightweight and with motors and batteries designed inside the wheelhubs it does not compromise the usability and safety of such wheelchairs. The twion can be driven without power assist very close to a manual wheelchair.

Each hub motor is equipped with a DC motor and an integrated battery. A push rim sensor detects the force applied by the wheelchair driver. An integrated microcontroller converts this signal into a proportional motor output which generates an additional torque to the wheel. This torque by itself is very low but enables the driver to drive the wheelchair manually.

The benefit for the wheelchair driver is such that he can keep driving in his manual wheelchair. Without a device like the twion, the patient would have to use a fully electrical wheelchair (with joystick).

The provided text is related to a 510(k) premarket notification for a medical device called "twion," a power-assist wheelchair conversion kit. Based on the document, this device is a mechanical one and performs its functions through mechanical means rather than artificial intelligence or an algorithm. Therefore, the questions related to AI/algorithm performance, such as acceptance criteria for AI, sample sizes for test and training sets for algorithms, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable here.

The document focuses on demonstrating substantial equivalence to a predicate device (Yamaha JWX-2) through a comparison of physical characteristics and adherence to performance standards for wheelchairs.

However, I can extract information related to the device's performance based on the established safety and performance standards it was tested against.

Here's a breakdown of the relevant information:

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

The document does not explicitly present a table of "acceptance criteria" in terms of specific performance metrics with target values that the device must achieve and then reports the device's measured performance against those targets. Instead, it states that the device was tested against a series of national and international performance standards. The "acceptance criteria" are implied to be compliance with these standards, and the "reported device performance" is that it met all relevant requirements of these standards.

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

The document mentions "testing" and "non-clinical tests" but does not specify a "sample size" in the context of a test set of data. The testing refers to the device itself being subjected to various physical and electrical tests according to the listed standards. There is no mention of "data" in the sense of patient data or clinical images. The data provenance is also not applicable in this context; the tests were performed on the device by the manufacturer (Alber GmbH, based in Germany).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a mechanical device subject to engineering and performance standards, not an AI/algorithmic device requiring expert review of generated outputs or interpretations.

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

Not applicable, for the same reasons as above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic or interpretive tool that would involve human "readers."

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

Not applicable. The "twion" is a power-assist conversion kit for manual wheelchairs, a mechanical device. It is not an algorithm or AI system.

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

Not applicable. The "ground truth" for this device's performance is its direct compliance with established international and national engineering, safety, and performance standards for wheelchairs and electrical components.

8. The sample size for the training set

Not applicable, as there is no mention of a training set for an algorithm.

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

Not applicable, as there is no mention of a training set for an algorithm.

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