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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 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 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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The UPnRIDE™ stand-up power wheelchair is intended for medical purposes to provide mobility to persons restricted to a sitting position. The product changes position from Sitting to Standing and Standing to Sitting but also any position in between. The product provides indoor and outdoor mobility.

The UPnRIDE™ device enables disabled and elderly individuals to be mobile in a sitting or standing position indoors and outdoors. The device design is based on the following principles: 1. Using motorized jointed braces and harnessing to safely support the user while sitting, shifting to standing, standing and returning to sitting - 2. Center of gravity (COG) is maintained substantially at the center of the device in all positions, thus maximizing stability and safety. - 3. Balancing the platform which supports the user so that the user always remains vertical even on skewed surfaces. - 4. Implementing an operation and safety algorithms to minimize risks and hazards to the user, even beyond the provisions of standard wheelchairs. The product is comprised of the following modules: - Driving module: a motorized driving chassis that 1. includes two front motorized wheels, two high capacity Li-Ion batteries 21.6VDC / 29.7Ah and a steel frame which is installed as a chassis for the device's components. - Inertial Measurement Unit ("IMU") for measuring 2. ground slopes (pitch and roll) and user's tilt angles (pitch and roll). - Standing and sitting module: a motor-based lifting 3. mechanism for shifting between standing and sitting positions. - 4. Balancing module: a platform that balances the user while sitting or standing, relative to earth. - 5. User interface module: a unit through which the user controls the UPnRIDE™. This module has an "R-NET" controller that contains a Joystick, commanding buttons and a display for viewing indications and status and a switching box for controlling the various modes of operation. - Actuator drivers: five units that control the lifting 6. motors. - 7. Main Controller: a unit which reads all sensors and user inputs, performs the balancing and safety algorithms, and controls all the chairs function.

The provided text is a 510(k) summary for the UPnRIDE stand-up power wheelchair. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Levo Comfort II and Quickie Q700-UP M) by comparing intended use, technical characteristics, and adherence to performance standards.

Here's how the requested information relates to the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not present for an AI/ML component. The text lists voluntary standards (ISO series, ANSI/RESNA WC-1) that the UPnRIDE complies with, which are performance standards for wheelchairs in general, not specific acceptance criteria for an AI/ML algorithm's output.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as there's no AI/ML test set discussed. The document mentions "performance tests" and a "usability study" but provides no details on sample size, data provenance, or methodology for these.
• 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.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical wheelchair with an "operation and safety algorithms" and a "Main Controller" that "performs the balancing and safety algorithms," but these are embedded control systems, not a standalone AI/ML diagnostic or predictive algorithm being evaluated for performance against a ground truth dataset in the way typically discussed in AI/ML reviews.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for an AI/ML component. The mention of "balancing operation was validated by multitude performance tests and a usability study" suggests physical performance and user experience were evaluated, not AI/ML output.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) premarket notification for a stand-up power wheelchair and does not include the type of detailed information about acceptance criteria and studies for an AI/ML device as requested. It focuses on demonstrating substantial equivalence to existing medical devices through technical comparison and compliance with relevant industry standards for wheelchairs.

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The Modular Power Standing System is appropriate for use by individuals who drive a power wheelchair and cannot stand up on their own. The Modular Power Standing System allows such users to change position including from seating to standing, standing to seating, or any position in between. The device is appropriate for indoor and outdoor use. Motion Concepts makes no claims as to the therapeutic effectiveness of the products. Our only claims relate to the ability of the products to provide safe and reliable powered repositioning on the equipment onto which they are installed.

The Modular Power Standing System (MPSS) is a seating system which is added to a wheelchair powerbase to provide four basic functions: power stand-up, power tilt, power recline including shear reduction, and power elevate. It can be operated in private residences, chronic care facilities, indoor and outdoors. Note the MPSS in itself does not include any wheelchair base components such as wheelchair frame, drive controls, wheels, brakes, batteries, suspension etc.

The Stand function is used to orient the user in an upright position. The mechanism consists of linkages driven by linear actuators. The system includes both a knee support to help stabilize the user in the standing position.

The Tilt function is used to change the seating inclination angle of user. The mechanisms consist of linkages driven by linear actuators. The range of tilt is 0° to 45°.

The Recline function causes the position of the occupant's back to change by changing the position of the backrest with respect to the seat pan. The Shear Reduction works in conjunction with Recline to reduce the shear movement between the user and the backrest. The mechanisms consist of linkages driven by linear actuators. The range of Recline is 90° to 178°.

The Elevating seat module allows the user to elevate the entire seat. The mechanisms consist of linkages driven by linear actuators. The range of elevation is 6.5 inches.

The maximum occupant weight for the system is 250 lb. The Modular Power Standing System is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.

The various power positioning modules may be activated via two options: using switches or through the powerbase manufacturer supplied joystick.

Safety features include a drive lock-out and reduced drive mode which are activated when any of the power functions are activated beyond pre-set limits. The system also includes front castor locks to provide additional front stability when in stand mode. Electrical components are maximum 24 volts and include current limiting within the seat control box. Stability of the Modular Power Standing System was tested on the powerbase selected for this application. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Modular Power Standing System.

The Modula Power Standing System (MPSS) aims to add standing (and other features) to a power wheelchair. The relevant information from the provided text has been extracted for your request. It should be noted that this is a 510(k) summary, and as such, detailed study information like sample sizes for test sets, the number and qualifications of experts, adjudication methods, and explicit effect sizes for human improvement with AI assistance are typically not part of such submissions, particularly for mechanical devices without AI components.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria (Performance Data) and Reported Device Performance

The acceptance criteria for the Modular Power Standing System (MPSS) are demonstrated by adherence to various ISO standards and by exhibiting similar technological characteristics to the predicate device (Levo C3) and a reference device (Motion Concepts Modular Power Positioning System). The 'Reported Device Performance' columns below reflect the characteristics of the Subject Device (MPSS) as provided in the comparison table.

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

• Sample Size: The document does not specify a "sample size" in terms of subject count for clinical testing. Instead, the performance data refers to various engineering and materials testing (biocompatibility, software, electrical, mechanical). For mechanical and electrical tests, it's typically performed on a limited number of device units rather than a "sample size" of users.
• Data Provenance: The testing appears to be internal verification and validation testing performed by Motion Concepts. There is no mention of country of origin for data or whether it was retrospective or prospective in the context of user studies.

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

• This information is not provided in the document. The testing described is primarily engineering-based, not clinical trials requiring human expert ground truth for interpretation.

4. Adjudication Method for the Test Set

• This information is not applicable/provided as the testing is not based on expert review or adjudication of clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the subject device." The device is a mechanical system, not an AI or imaging device that would typically undergo such a study.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as this is a mechanical device and does not involve AI assistance 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 mechanical device; there is no "algorithm only" performance study in the context of AI or diagnostic interpretation. The device's performance is its direct mechanical functionality.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through objective engineering measurements and adherence to recognized international technical standards (ISO). For example, static stability (ISO 7176-1) is a directly measurable property against a standard, not subject to expert consensus or pathology. Biocompatibility is verified against ISO 10993 standards using laboratory tests.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical product; there is no "training set" in the context of machine learning or AI algorithms.

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 Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.

This submission covers the Q700-UP M which includes the following new components to the Sunrise Medical Quickie® Pulse 6SC:

• 1. Requires a knee block that was a previous option
• 2. Adds a stand-up actuator (PG Drives Technology) to power the stand-up feature
• 3. Requires a different version of the power center leg-rest to support the patient's weight when standing.
• 4. Adds a CSXM power seating control module (PG Drives Technology) to control the seating during standing
• 5. A caster / suspension lock-out system to stabilize the base when stand-up is actuated.

The Sunrise Medical Quickie® Q700-UP M power wheelchairs are battery operated devices, that are indicated for medical purposes to provide mobility and repositioning of the user, including a stand-up feature.

The Sunrise Medical Quickie® Q700-UP M power wheelchairs provide seating and standing function for patients who cannot stand on their own.

The document does not describe a study involving a medical device with "acceptance criteria" and "reported device performance" in the typical sense of diagnostic test performance (e.g., sensitivity, specificity, accuracy).

Instead, the document is a 510(k) summary for a medical device called the Quickie® Q700-UP M (a stand-up wheelchair). The "acceptance criteria" and "reported device performance" are presented as compliance with various recognized industry standards and a comparison of technical features to predicate devices to demonstrate substantial equivalence.

Here's the information extracted and formatted according to your request, with clarifications where the terms need to be adapted to the context of a wheelchair 510(k) submission:

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

In the context of this 510(k) submission for a stand-up wheelchair, "acceptance criteria" refers to compliance with recognized consensus standards (primarily ISO 7176 series and RESNA WC-1) and demonstrating substantial equivalence to predicate devices based on technical features. The "reported device performance" is the outcome of testing against these standards and the listed technical specifications.

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

• Sample Size for Test Set: The document does not specify a "sample size" in terms of many individual devices tested for each standard. Instead, it states that "All verification and validation testing conducted demonstrate that the Quickie® Q700-UP M is substantially equivalent..." This implies that at least one device (or a representative number of units) was tested to each listed standard. Standard compliance testing typically involves a small number of units (e.g., 1-3 units) unless otherwise specified by the standard or regulatory body.
• Data Provenance: The document does not explicitly state the country of origin of the test data or whether it was retrospective or prospective. However, given that Sunrise Medical (US) LLC is listed with a Fresno, California address, and the submission is to the U.S. FDA, it is implied that the testing was conducted to meet U.S. regulatory requirements. It is a premarket notification (510(k)), so the testing would have been conducted as part of the development and validation process before market entry, making it prospective testing in anticipation of regulatory 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 section is Not Applicable to this submission. The "ground truth" for a medical device like a wheelchair is not established by expert consensus in the same way as an AI diagnostic tool. Instead, the "ground truth" or acceptable performance is defined by adherence to internationally recognized performance standards for wheelchairs (ISO, RESNA). The experts involved would be engineers and technical specialists performing the tests and verifying compliance with these standards, not clinicians establishing a "diagnosis."

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

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in reading medical images for AI ground truth). For physical device testing against standards, the results are typically objectively measured and either pass or fail the specified criteria.

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

This section is Not Applicable. This is a physical medical device (wheelchair), not an AI diagnostic tool involving human "readers" or AI assistance. No MRMC study would be relevant here.

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

This section is Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is established by compliance with recognized international and national consensus standards (listed in Table 4) for wheelchair safety, performance, and functionality. These standards define the acceptable range of physical, mechanical, and electrical performance characteristics. The comparison to predicate devices also serves as a benchmark for demonstrating substantial equivalence based on established features of legally marketed devices.

8. The sample size for the training set

This section is Not Applicable. This is a physical medical device, not an AI model requiring a training set.

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

This section is Not Applicable. As it's not an AI model, there is no "training set" or corresponding ground truth to establish.

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The Action Trackstander all-terrain power wheelchair with the integrated stand-up position function provides mobility to individuals who need a power wheelchair, that are capable of operating a powered wheelchair and cannot stand up on their own. The Action Trackstander does not require a doctor's prescription.

Action Trackstander models Tr1816. Tr1820. Tr2016. and Tr2020

The provided document is an FDA 510(k) clearance letter for Action Manufacturing Inc.'s Action Trackstander power wheelchairs. It primarily concerns regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set details. This document is a regulatory communication, not a scientific or clinical study report.

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

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