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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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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 TWIST and TWIST R are add-on drive accessories for wheelchairs. The main parts of the drive unit include a drive wheel with a brushless motor and tire, an Electronic Control Unit (ECU), a removable lithium ion battery pack, an On/Off button and indicators, a carrying and release handle, a battery charger, front and rear lights, and locking pins. The controller includes a wireless interface, On/Off button, battery level LEDs, speed selection lever and brake button, integrated Li-ION battery cell, and a USB-C socket. The handlebar unit includes a wireless interface, On/Off button, battery level LEDs, accelerator, brake levers, integrated Li-ION battery cell, and a USB-C socket.

The provided text focuses on the K240267 510(k) Summary for the Klaxon TWIST and TWIST R add-on drive accessories for wheelchairs. While it details numerous technical specifications and non-clinical testing standards, it does not include acceptance criteria, performance data against those criteria, or information about a study that proves the device meets specific performance targets in the way typically required for AI/ML medical devices.

Instead, the document asserts substantial equivalence to a predicate device (SMOOV O10) based on similar indications for use, intended use, and demonstration of safety and performance through adherence to recognized standards.

Therefore, I cannot populate the table or answer most of the questions using only the provided text as it pertains to AI/ML device performance and acceptance criteria. The device described is a physical powered wheelchair accessory, not an AI/ML diagnostic or prognostic tool.

Here's a breakdown of what can be extracted and why other parts cannot be answered:

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

This information is not present in the document in the context of acceptance criteria and performance results for an AI/ML device. The document lists numerous technical specifications for the device (e.g., max speed, motor power, battery capacity, weight), and declares compliance with various ISO and other standards (listed in section 4). However, it does not provide specific acceptance criteria (e.g., "The device must achieve an accuracy of X% for Y task") nor reported performance against such criteria for an AI/ML algorithm.

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

This information is not applicable/not provided as the device is a physical powered wheelchair accessory, not an AI/ML device that requires a test set of data for algorithm performance evaluation. The "testing" referred to is non-clinical, related to physical and electrical safety and performance standards of the hardware.

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

This information is not applicable/not provided for the same reason as point 2.

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

This information is not applicable/not provided for the same reason as point 2.

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 information is not applicable/not provided as the device is not an AI-assisted diagnostic or prognostic tool used by human readers.

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

This information is not applicable/not provided for the same reason as point 2 and 5.

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

This information is not applicable/not provided for the same reason as point 2. The "ground truth" for this type of device would be mechanical, electrical, and safety standards verified through engineering tests.

8. The sample size for the training set:

This information is not applicable/not provided as the device is a physical product and does not have a "training set" in the context of AI/ML.

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

This information is not applicable/not provided for the same reason as point 8.

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KLICK is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a KLICK device.

KLICK devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement.

The KLICK 2021 device is a "TRACTION UNIT" (also called DRIVE UNIT or HUB) which is connected to the wheelchair (via a LINK SYSTEM) to provide electric propulsion to the three wheels resultant vehicle. The motor is in the front wheel (traction unit).

The handlebar contains all the interfaces with which the user can drive the vehicle.

The front castors rise off the ground and a single wheel, in the "traction unit", is used for steering.

Klick can be used both with rigid or foldable wheelchairs.

The main parts of the drive unit are as follows:

• HUB (drive or traction unit): is the aluminium frame with brushless motor, steering set and aluminium fork, for both the steering and the traction functions
• Motor: is a brushless unit with 250W nominal power for the Power variant and 1000W power for the Race and Monster variants
• Wheel: aluminium rim, 14inch diameter for Power and Race, 20inch for Monster
• Removable battery (available in 3 capacity versions: 11.6Ah, 5.8Ah, 2.9Ah)
• Handlebar with user interfaces:
  • i. Throttle
  • ii. Cruise control, front/reverse selection switch
  • iii. Electronic brake
  • iv. Left hand mechanical brake
  • v. Right hand mechanical brake
  • vi. Display command for ON/OFF, level selection, on/off lights (optional), on/off usb charger
• Display with driving informations, main parameters adjust.
• Stand for support the device when disconnected from the vehicle
• Battery charger is an external carriable unit (54,6V 2A) supplied by Klaxon-Mobility GmbH.

The main parts of the connection system are:

• Clamps: are always connected to the wheelchair, assembled by a Klaxon's trained specialist
• Crossbeam: is connected to the clamps and supports the connector; the crossbeam is removable for installation on foldable wheelchairs. The connector is adjusted for each application by a Klaxon's trained specialist
• Connector: it includes the front hook and connects the HUB to the crossbeam

I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/ML powered medical device. The document is an FDA 510(k) premarket notification for a powered wheelchair attachment (Klick) and focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the document discusses:

• The trade name, regulation, and classification of the Klick device.
• Comparison of the Klick device with a predicate device (SMOOV O10) based on intended use, technology, and performance specifications.
• Details about the Klick device's components (drive unit, motor, wheel, battery, handlebar controls, connection system).
• A conclusion that the Klick device is as safe and effective as the predicate device despite some differences.

It does not mention:

• Acceptance criteria for an AI/ML powered medical device.
• Any study proving an AI/ML powered device meets acceptance criteria.
• Sample sizes for test or training sets related to AI/ML.
• Data provenance for AI/ML studies.
• Number or qualifications of experts for AI/ML ground truth.
• Adjudication methods for AI/ML ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance for an AI/ML algorithm.
• Types of ground truth used for AI/ML.
• How ground truth for a training set was established for an AI/ML device.

Therefore, I cannot extract the requested information from this document.

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