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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 XT2 power wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair. The XT4 power wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

The XT Series Power Wheelchair has two configurations: XT2 and XT4. They are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position. The XT Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips). The XT Series Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.

The provided document is an FDA 510(k) clearance letter and summary for a Magic Mobility XT Series Power Wheelchair. It details the device's technical specifications, indications for use, and a comparison to predicate devices, along with the non-clinical testing performed to establish substantial equivalence.

However, the document does not contain any information about an AI/ML-based medical device, nor does it include details about a study conducted to demonstrate its performance against specific acceptance criteria for such a device. The device described, a powered wheelchair, is a physical medical device, not a software or AI-driven diagnostic or therapeutic tool that would typically have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance improvement.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, a sample size, expert qualifications, ground truth establishment, or MRMC studies, as these concepts are not applicable to the content of the provided document.

The document focuses on non-clinical bench testing to demonstrate the safety and effectiveness of the physical wheelchair in comparison to existing predicate devices, primarily through adherence to ISO standards for wheelchairs.

To directly answer your prompt, based on the provided text:

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

• This document does not present acceptance criteria or reported performance for an AI/ML device. It lists various ISO standards that the physical wheelchair was tested against. The "reported device performance" is essentially that it met these standards, thus demonstrating substantial equivalence to predicate devices. For example, for "Static stability," the acceptance criterion is compliance with ISO 7176-1, and the reported performance is implicit compliance as it contributed to the substantial equivalence determination.

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

• Not applicable/Not provided for an AI/ML device. The "test set" here refers to the physical wheelchairs undergoing bench testing. The sample size for such physical product testing is not specified, but typically involves a small number of units. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of medical device testing.

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

• Not applicable. "Ground truth" in the context of an AI/ML device's performance (e.g., disease detection) is not established for a physical powered wheelchair. The "truth" for this device is its adherence to engineering standards.

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

• Not applicable. This is a concept for reconciling disagreements among human readers in a diagnostic AI/ML study, not for physical product testing.

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:

• No, an MRMC study was not done as this is a physical wheelchair, not an AI/ML diagnostic or assistive device.

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

• Not applicable. There is no AI algorithm being submitted for standalone performance evaluation in this document.

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

• Not applicable in the context of AI/ML. The "ground truth" for this device's performance is adherence to established international engineering and safety standards (e.g., ISO, IEC).

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML device, so there is no training set for an algorithm.

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

• Not applicable for the same reason as above.

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The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair and are capable of operating a powered wheelchair.

Action Trackchair Hawk

My apologies, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Action Trackchair Hawk." This document primarily addresses regulatory aspects, such as substantial equivalence to predicate devices, and outlines general controls and regulations.

It does not contain any information regarding:

• Acceptance criteria for device performance.
• Details of a study proving the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in a separate study report, clinical trial summary, or a more detailed device description submitted as part of the 510(k) application, which is not included here.

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• Any individual who needs a power wheelchair and can not stand up on their own such as people with paraplegia, spina bifida, cerebral paresis, multiple sclerosis, muscular dystrophy and polio
• any individual to take part in sports activities requiring an upright position

The ParaMotion is an all-terrain electric wheelchair with an integrated standing function. All functions are controlled via the joystick control panel. Strong electric motors on the front wheels with wide terrain tires ensure safe handling, and obstacles are overcome easily. The ParaMotion is steered by targeted control of the drive wheels with appropriate operation of the joystick. The dual rear wheel is freely mounted on a steering shaft and thus has a 360° turning radius. This ensures excellent manoeuvrability of the ParaMotion. The joystick control panel also manages the standing function to the driving functions. An electric motor ensures adjustment of the seat from the horizontal position to the upright position. At the same time, the angle of the backrest and the hinges of the leg support are adjusted so that the operator assumes an upright position in the end position. Thanks to the infinitely variable linear motor, any position between the seated position and the standing position can be assumed. All control functions are carried out by means of an R-Net wheelchair control. Thanks to the easy programmability of the R-Net system, the driving functions can be adapted to suit the user's needs.

The ParaMotion device is a stand-up wheelchair. Since this is not an AI/ML device, the typical acceptance criteria related to accuracy metrics are not applicable. Instead, the device's performance is demonstrated through its compliance with various recognized standards for wheelchairs.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." Therefore, there is no mention of a "test set" in the context of clinical or performance data from human subjects. The device's performance is assessed against recognized engineering and safety standards using nonclinical (laboratory and bench) testing. The document does not specify the sample sizes (e.g., number of wheelchairs tested) for each specific nonclinical test conducted to ensure 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:

Not applicable, as no clinical test set using human data was required, and the evaluation was based on compliance with established technical and safety standards.

4. Adjudication method for the test set:

Not applicable, as no clinical test set was used.

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, as this device is a physical medical device (stand-up wheelchair), not an AI/ML diagnostic or assistive technology for human readers.

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

Not applicable, as this is a physical medical device.

7. The type of ground truth used:

For this device, the "ground truth" refers to the established requirements and specifications outlined in the FDA-recognized and non-FDA-recognized international and national standards for wheelchairs. Compliance with these standards (e.g., for stability, braking, speed, safety, risk management, and electromagnetic compatibility) serves as the basis for demonstrating the device's safety and effectiveness.

8. The sample size for the training set:

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

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

Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.

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The Frontier Series Power Wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

The Frontier Series Power Wheelchairs have four configurations: V4 RWD, V4 FWD, V6, and C73. The Frontier Series Power Wheelchairs are designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject devices are intended to provide mobility to persons who are restricted or limited to a sitting position. The Frontier Series Power Wheelchairs are battery powered, electric motor driven devices that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).

This is a 510(k) premarket notification for the "Frontier Series Power Wheelchairs". This document is a submission to the FDA to demonstrate that the new device is "substantially equivalent" to already legally marketed predicate devices. Therefore, the "acceptance criteria" here refers to the performance of the device relative to established standards and the predicate devices, rather than strict statistical thresholds for an AI algorithm.

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

The acceptance criteria are established by adherence to recognized international standards and comparison to predicate devices, showing that any differences do not affect safety or effectiveness. The reported device performance is demonstrated by meeting these standards and having similar or identical characteristics to the predicate devices.

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

This submission describes non-clinical performance and engineering testing on the device prototypes, not a clinical study on human subjects with a test set of data in the traditional sense of an AI/imaging device. The "test set" would be the physical Frontier Series Power Wheelchairs themselves, subjected to various standardized tests. No specific numerical sample size (e.g., how many wheelchairs were tested for each test) is provided in the document, other than implying the testing of "the subject devices." The provenance is manufacturing in Australia. The testing is presumably prospective for the purpose of this 510(k) submission.

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 is not applicable to this type of device submission. Ground truth, in the context of this 510(k), refers to the established standards (e.g., ISO 7176 series, ISO 10993 series, IEC 62304) and the performance characteristics of the predicate devices. The "experts" are the creators of these standards, and the engineers/testers who conduct measurements and compare the device's performance against these benchmarks and the predicate devices' specifications. No specific number or qualifications of such 'experts' are provided in this document beyond the general statement of "testing performed."

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

This is not applicable. The evaluation is based on objective measurements against engineering standards and comparison of technical specifications to predicate devices, not subjective assessments requiring adjudication by multiple readers.

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 as the device is a power wheelchair, not an AI-assisted diagnostic or therapeutic tool that involves human readers or interpretation of medical cases.

6. 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 (power wheelchair), not an algorithm or AI system.

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

The "ground truth" for this submission is established by:

• International Standards: Complying with numerous ISO and IEC standards for wheelchairs (e.g., ISO 7176-1 for static stability, ISO 10993-1 for biocompatibility, IEC 62304 for software life cycle).
• Predicate Device Performance: Demonstrating that the subject device's technological characteristics and performance are similar or identical to legally marketed predicate devices, or that any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

This is not applicable as the device is a physical power wheelchair, not an AI algorithm trained on a dataset. The design and manufacturing process would involve engineering iterations and testing, but not a "training set" in the context of machine learning.

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

Not applicable. As described above, this is about adherence to engineering standards and comparison to predicate devices, not machine learning ground truth.

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The Extreme X8 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

The Extreme X8 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons who are restricted or limited to a sitting position. The Extreme X8 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e., concrete, asphalt, indoor flooring such as carpet, gravel, grass, and bark/woodchips).The Extreme X8 Power Wheelchair offers two basic seating options: MPS and Rehab. The MPS option is more static and does not allow for additional aftermarket cushions. The Rehab option is more adjustable to adhere to recommendations from the user's physician or physical therapist.

The provided text is a 510(k) summary for a powered wheelchair, not an AI/ML medical device. Therefore, the information requested in the prompt, which is specific to AI/ML device studies (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set sample size), is not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the "Extreme X8 Power Wheelchair" to a predicate device, focusing on non-clinical testing for performance, EMC and electrical safety, biocompatibility, and software in the context of general medical device safety and effectiveness.

Here's a breakdown of the relevant information provided, tailored to the context of a non-AI/ML medical device for which the prompt's questions are not appropriate:

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by compliance with various ISO standards for wheelchairs. The reported device performance is that the "Extreme X8 Power Wheelchair has undergone testing to ensure that any differences in technological characteristics (i.e., battery, castor wheels, and no anti-pitch mechanism) do not affect safety and effectiveness when compared to the predicate device."

The study proving the device meets these criteria is the non-clinical testing summarized in the "Summary of Non-Clinical Testing" section. This testing demonstrated that the Extreme X8 Power Wheelchair does not raise new issues of safety or effectiveness compared to the predicate device, leading to a conclusion of substantial equivalence.

The following numbered points from the prompt cannot be answered as they pertain to AI/ML device studies, and this document is for a physical medical device (powered wheelchair):

2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The Magic 360 Power Wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position who have the capability of operating a power wheelchair.

The Magic 360 Power Wheelchair is designed for everyday use for both indoor and outdoor environments including care facilities and private residences. The subject device is intended to provide mobility to persons that are restricted or limited to a sitting position.

The Magic 360 Power Wheelchair is a battery powered, electric motor driven device that can be used on both indoor and outdoor surfaces (i.e. concrete, asphalt, indoor flooring, gravel, grass, and bark). The subject device has two seat options: MPS and rehab. The rehab seat option has more built-in adjustments (i.e., width and depth adjustments) and allows for aftermarket cushions. All the wheelchairs include the same power seating options including lift, tilt, recline, and leg elevation to ensure the user to find a position that is comfortable.

The Magic 360 Power Wheelchair includes the following accessories:

• Extra spreader bar
• Slide in table
• Lights
• Luggage rack
• Accessory charger ●
• Posture belt
• Roho cushion
• Jay cushion
• MPS push rail
• MPS peg push handle
• Scooter stopper ●
• Retractable docking pin
• Fold forward kit

Please note, the fold forward kit is an accessory which allows the user to fold the wheelchair and put the wheelchair in a car. To fold the wheelchair the user pulls the red release handle located at the back of the Magic 360 Power Wheelchair. To unfold the wheelchair the user pulls the frame back into place using the armrests.

The provided text is a 510(k) summary for the Magic 360 Power Wheelchair. This document is a regulatory submission to the FDA for medical device clearance, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria and a study proving device meets acceptance criteria is not directly applicable in the AI/ML context.

However, I can extract the closest analogous information from the document as it pertains to a traditional medical device (power wheelchair).

Here's an interpretation based on the provided text:

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

The document does not present a table of specific acceptance criteria with quantitative performance metrics for the Magic 360 Power Wheelchair in the way one would for an AI algorithm (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by adherence to recognized ISO standards for wheelchairs and demonstrating substantial equivalence to predicate devices. The "reported device performance" is inferred from the successful completion of these tests.

The comparison table provided in the document (pages 6-7) highlights the characteristics of the Magic 360 Power Wheelchair against predicate devices. The "Statement of Equivalence" column implicitly indicates that the device's performance characteristics are either identical or substantially equivalent to the predicate devices, thus meeting regulatory expectations.

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 provided because this is a submission for a physical medical device (power wheelchair) and not an AI/ML algorithm. The "test set" in this context refers to physical units of the wheelchair undergoing standardized engineering and performance tests, not a dataset for an algorithm. There is no mention of "data provenance" in the sense of patient data. The manufacturer is based in Australia ("3 International Court, Scoresby, VIC, 3179 Australia").

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 is not applicable to this type of device submission. "Ground truth" in this context would implicitly be the established engineering specifications and performance requirements defined by ISO standards and regulatory guidelines, confirmed through physical testing by qualified engineers or technicians.

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

Not applicable. This concept relates to human review of data, which is not described for the performance testing of this physical device. The testing described (e.g., Static stability, Dynamic stability, EMC testing) are objective engineering measurements against defined 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 not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this medical device's performance is established by international consensus standards (ISO standards) for wheelchairs regarding functionality, safety, and durability, as well as the performance characteristics of legally marketed predicate devices. The testing verifies that the device performs according to these objective standards and is comparable to equivalent devices already on the market.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set." The device is designed, manufactured, and tested to engineering specifications.

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

Not applicable, as there is no training set mentioned in the context of an AI/ML algorithm.

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The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander and brings the user from a seated position to a passive standing position.

Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) Models: TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD06, TEKRMD06, TEKRMD07, TEKRMD08

The provided text is a 510(k) premarket notification letter from the FDA regarding the Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE). This document does not contain any information about acceptance criteria, device performance, clinical study design, or ground truth establishment relevant to an AI/ML medical device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval, product codes, and general controls, rather than a performance evaluation of the device based on specific criteria.

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The Explorer Mini is a pediatric powered wheelchair with the intention to provide mobility to pediatric users weighing up to 35 pounds and maximum length of up to 39 inches tall, between 12-36 months of age, who position themselves in a sitting position in the wheelchair and have the capacity to operate a joy stick hand control.

The Explorer Mini includes a base to which the wheels and casters are attached. An adjustable height, vertical column is attached to the base. The driver control (joystick) is integrated at the top of the column and the seating system is attached to the column. The Explorer Mini speed and direction are controlled via a control system comprising a power module and joystick. The Explorer Mini has the appearance of a "ride on toy" and weighs between 60% and 90% less than typical power chairs available to this population today. Explorer Mini seat is configured with a permanent 360degree support assembly positioned around the upper torso for added user safety and stability. This assembly supports both sitting and standing. An adjustable-position saddle shaped seat is used for sitting. The saddle shape allows for 'straddle' standing or alternately the seat can be removed to open the area for full active standing. The 360degree support assembly adjusts to accommodate and support standing while driving. The Explorer Mini is powered by two 5 Amp. batteries providing an approximate driving range up to 4.6 miles. The base provides the propulsion which is derived from two (left and right) front mounted gear-motor wheel assemblies supported by two rear mounted 360degree swiveling casters. Also incorporated in the base are the batteries and control module. When the user activates the joystick, the controller receives a signal to move the device in the direction the joystick is pointed. Simultaneously, the controller directs the gear-motors to respond appropriately. When the user releases the joystick, the chair decelerates to a stop. The inherent gear ratio holds the device in place like a park brake.

Please note that the provided text is a 510(k) summary for a medical device (Explorer Mini, a pediatric powered wheelchair). It describes the device, its intended use, comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, this document does NOT describe the acceptance criteria and study for an AI/ML-based medical device. It details the regulatory clearance process for a powered wheelchair, which involves proving its safety and effectiveness through engineering and human factors testing, not through AI performance metrics like sensitivity, specificity, or reader studies common for AI/ML devices.

Therefore, many of the requested points regarding AI/ML device testing (e.g., ground truth establishment, sample size for training data, MRMC studies, standalone performance) are not applicable to the information contained in this 510(k) summary.

However, I can extract the information relevant to the acceptance criteria and the studies that were performed for this specific device.

Here's a breakdown based on the provided document, addressing the applicable points and explaining why others are not relevant:

Acceptance Criteria and Device Performance (Based on "Non-Clinical Testing" Section)

The acceptance criteria for the Explorer Mini are primarily defined by successful passage of various ISO 7176 standards, which evaluate the physical and functional characteristics of wheelchairs.

Study Details:

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

   • Non-Clinical Testing: The document refers to "the Explorer Mini" being tested according to the ISO standards. This implies testing of the device itself, likely multiple units for robustness, rather than a "test set" in the sense of patient data for an AI algorithm. The provenance is implied to be from the manufacturer's testing facilities based on compliance with international standards. Details like number of devices tested or specific test runs are not provided.
   • Clinical Testing (Usability Study): 33 children with mobility impairments were included. This was a usability study, not a clinical trial to prove efficacy in the traditional sense, but focused on how users interact with the device.
   • Clinical Testing (Label Comprehension Study): 15 physiotherapists/occupational therapists and 15 parents participated.
   • Data Provenance: Not explicitly stated (e.g., country of origin for the usability study participants), but the studies were conducted by the manufacturer Permobil AB (Sweden). The studies appear to be
     • Usability Study: Prospective, as it involved real children interacting with the device.
     • Label Comprehension Study: Prospective, as it involved participants reviewing the user manual.

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

   • Not Applicable in the traditional AI sense. For a physical device like a wheelchair, "ground truth" is established by direct measurement against engineering standards and specifications (e.g., speed, dimensions, stability tests). The experts involved would be engineers, technicians, and potentially clinical professionals ensuring the device meets the needs of pediatric users.
   • For the Usability Study, the "ground truth" would be observed user behavior and feedback, assessed by human factors engineers/clinicians.
   • For the Label Comprehension Study, the "ground truth" was whether participants could correctly understand the label, assessed by the study design and interpretation of responses from "physiotherapists/occupational therapists and parents." Their qualifications are stated by their profession.

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

   • Not Applicable. This is an AI/ML specific term for resolving discrepancies in expert labeling. For physical device performance tests (ISO standards), the results are typically objectively measured and don't require expert adjudication in the same way. For the usability/label comprehension studies, detailed adjudication methods are not provided, but such studies typically involve qualitative and quantitative analysis of user interactions and feedback.

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:

   • Not Applicable. This is specific to AI/ML devices where AI assists human interpretation (e.g., radiologists reading images). This product is a physical mobility device and does not involve AI assistance for human readers.

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

   • Not Applicable. As above, this is an AI/ML specific concept. The device's performance is inherently tied to its physical interaction with a user ("human-in-the-loop" is a given for a wheelchair).

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

   • Non-Clinical Testing: Engineering specifications and standardized test methods (ISO 7176 series). The "ground truth" is adherence to these defined performance benchmarks.
   • Clinical Testing (Usability/Label Comprehension): User behavior, performance, and understanding as observed and measured through structured studies.

7. The sample size for the training set:

   • Not Applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.

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

   • Not Applicable. (See point 7).

In summary, the provided document outlines the process for clearance of a physical medical device (a pediatric powered wheelchair) by demonstrating its safety and effectiveness through compliance with recognized international standards for wheelchairs and human factors studies. It does not pertain to the development or validation of an AI/ML diagnostic or assistive algorithm.

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The F5 Corpus VS powered 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.

F5 Corpus VS Powered Wheelchair is battery powered, front wheel motor driven and is controlled by the R-net 120 amp controller. The user interface is a joystick. The F5 Corpus VS is powered by two 12VDC, Group M24, approximate driving range on fully charged batteries is up to 25km (15.5 miles), depending on use and the terrain the chair is driven on. The chair frame is a steel construction and includes two front drive units (motor, gear and brake), two batteries and two rear pivoting casters. Depending on the user's needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user to stop by letting go of the joystick. F5 Corpus VS will enable the user to stand up, completely or partially, to facilitate reaching, working eye to eye with colleagues. The standing sequence is controlled by the joystick and gives the user the possibility to come to a standing position. The seating, chest support and knee stop stabilize the user during the stand-up or sitdown operation.

This document (K191874) is a 510(k) premarket notification for a powered wheelchair, the F5 Corpus VS. It compares the device to two predicates: the Quickie® Q700-UP M (K172384) and the F5 (K143014).

Based on the provided text, here is an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally demonstrated by compliance with various ISO and RESNA standards for wheelchairs. The document does not present a single table explicitly listing "acceptance criteria" against "reported device performance" in a quantitative manner for all aspects. Instead, it states compliance with standards and provides some performance specifications when comparing the device to its predicates.

Here's an attempt to compile relevant information, though a direct "acceptance criteria" column is not explicitly defined in the document for each performance characteristic:

The document emphasizes that the F5 Corpus VS passes the requirements in ISO 7176 and RESNA WC-1:2009 Section 20.

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 refers to "Non-Clinical Testing" which involves compliance with a long list of ISO standards and RESNA WC-1. These are physical performance tests for the device itself (e.g., stability, brake effectiveness, strength).

• Sample size for the test set: Not explicitly stated as a number of devices or units. Typically, for device performance testing against standards, a representative sample (e.g., a few units or prototypes) is tested. The nature of these tests does not involve patient data or human subjects for the "test set" in the context of an AI/algorithm study.
• Data provenance: Not applicable in the context of patient data for an algorithm. The tests are for the physical wheelchair device. The Permobil AB company is based in Sweden. The tests were conducted to international standards.

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 as the device is a physical powered wheelchair, not an AI/algorithm that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the physical performance of the device as measured by standardized engineering and safety tests.

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

This information is not applicable as the device is a physical powered wheelchair, not an AI/algorithm study involving adjudication of clinical findings. Compliance with standards is typically measured objectively through specified test procedures.

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. The device is a physical powered wheelchair. There is no AI component or human reader in the context of medical image interpretation that would warrant an MRMC study.

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

This information is not applicable. The device is a physical powered wheelchair, not a standalone algorithm.

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

The "ground truth" for the F5 Corpus VS device is its physical performance, safety, and functional characteristics as measured and validated against established international standards (ISO 7176 series and RESNA WC-1:2009 Section 20). These standards define objective test methods and acceptable performance limits.

8. The sample size for the training set

This information is not applicable. The device is a physical powered wheelchair. There is no AI/algorithm being trained on a dataset. The design and manufacturing process would involve engineering principles and testing, not machine learning training.

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

This information is not applicable for the same reasons as in point 8.

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