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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 Bariatric Power Positioning System is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant.

The Bariatric Power Positioning System (BPPS) is a seating system which is added to a power wheelchair base to provide two basic functions: power tilt, and power recline including shear reduction. Note the BPPS in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc.

The power Tilt function causes the position of the occupant to change by tilting the whole seat, including the seat pan, backrest, foot supports, and arm supports. The range of tilt is 0° to 50°.

The power Recline function causes the position of the occupant's back to 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 latter is accomplished by using a linkage that slides the backrest down on the back posts as the back recline function is also useful for the redistribution of pressure and providing improved body position for certain user activities. The range of Recline is 90° to 150°.

The maximum occupant weight for the Bariatric Power Positioning System is up to 400 lb depending on the wheelchair powerbase and seating features selected. The BPPS is assembled using primarily laser-cut steel parts, steel tube, machined aluminum, and mounting hardware.

The power positioning modules may be activated via two options: using separate switches or through the wheelchair base manufacturer's joystick control.

Safety features include a drive lock-out which prevents the power chair while tilted or reclined beyond a certain pre-set limit. Electrical components are maximum 24 volts and include a current limiter in the relay box. Stability of the Bariatic Power Positioning System was tested on wheelchair powerbases commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the Bariatric Power Positioning System.

The provided text describes the Bariatric Power Positioning System (BPPS), a seating system for power wheelchairs, and its substantial equivalence to a predicate device (Modular Power Positioning System - MPPS). The focus of the provided document is regulatory clearance (510(k)) and not a comprehensive clinical study report for a diagnostic AI device. Therefore, much of the requested information about AI model performance, sample sizes for test/training sets, expert adjudication methods, and MRMC studies is not applicable or available in this document.

However, I can extract information related to the device's acceptance criteria and the non-clinical studies proving its performance against established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the BPPS largely revolve around meeting relevant ANSI/RESNA standards for powered wheelchairs, biocompatibility, electrical safety, and functional performance comparable to the predicate device.

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 as this is a mechanical medical device, not a diagnostic AI device requiring a test set of data. The testing involved physical devices and materials, not data.

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 this is a mechanical medical device. The "ground truth" for this device is based on compliance with established engineering and safety standards (e.g., ANSI/RESNA, ISO) and functional verification, not on expert interpretations of data.

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

This information is not applicable as this is a mechanical medical device. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic imaging, which is not relevant here.

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

A multi-reader multi-case (MRMC) study is not applicable/was not done for this device. This type of study is relevant for AI-assisted diagnostic tools, not for mechanical power positioning systems. The device is a physical product that provides repositioning, not an AI model enhancing human interpretation.

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

This information is not applicable as the BPPS is a mechanical medical device, not an AI algorithm.

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

The "ground truth" for the BPPS's performance and safety is based on compliance with established international and national standards for wheelchairs and medical devices (e.g., ANSI/RESNA, ISO), physical testing results from mechanical, electrical, and biocompatibility evaluations, and demonstration of functional equivalence to a predicate device. This is a conformance-based assessment rather than interpretation of diagnostic data.

8. The sample size for the training set

This information is not applicable as this is a mechanical medical device, not an AI algorithm requiring a training set.

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

This information is not applicable as this is a mechanical medical device, not an AI algorithm.

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The Modular Power Positioning system is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

• All positioning benefits associated with the tilt/recline product:
  Comfort: As with any individual, able-bodied or disabled, changes in position are necessary to maintain a state of comfort.
  Positioning: Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction: Individuals who wish, from time to time, to redistribute pressure from one area of the body to another, can do so by tilting and/or reclining, By changing the individual's orientation in space, pressures caused by gravity will shift.
• Positioning/Versatility: Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.
  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 Positioning System is a seating system which is added to a power wheelchair base to provide three basic functions, power recline including shear reduction, and power elevate (or lift). Note the Modular power positioning system in itself does not include any wheelchair base components such as wheelchair frame, drive train, drive controls, wheels, brakes, batteries, suspension etc.
The Tilt unit utilizes a center of gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances the stability since the center of gravity is kept substantially in place while the user is tilting. The Tilt unit may be one of two similarly designed systems, one designed for 50° tilt, and one for 45° tilt which is integrated with the 12 inch linkage style lift.
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 latter is accomplished by using a linkage that slides the backrest down on the back posts as the back reclines. The range of Recline is 90° to 168°.
The Elevating seat (or Lift) module allows the user to elevate the entire seat by up to 12 inches. It consists of a standard linkage style mechanism.
The maximum occupant weight for the system is up to 300 lb depending on the features of the wheelchair base and system modules selected. The Modular Power Positioning System is assembled using primarily laser-cut steel tube, machined aluminum, and mounting hardware.
The various power positioning modules may be activated via two options: using switches or through the wheelchair manufacturer's controller. Switches consist of either push button or toggle style.
Safety features include a drive lock-out which prevents the user from driving the power chair while tilted, reclined, or elevated beyond a certain pre-set limit. Electrical components are maximum 24 volts, and include a current limiter in the relay box. Stability of the Modular Power Positioning System was tested on various wheelchairs commonly used for power positioning applications. These tests were conducted to ensure the safety of the power wheelchair was not compromised by the addition of the power positioning system.

The provided document is a 510(k) premarket notification for a medical device called the "Modular Power Positioning System," which is a component added to power wheelchairs. This document focuses on demonstrating substantial equivalence to a predicate device and includes performance data from various types of testing, but it does not describe an AI/ML powered device or a study involving human readers or ground truth established by experts in the context of diagnostic performance. Therefore, many of the requested categories in your prompt are not applicable to the information contained in this document.

However, I can extract the information that is available regarding the device's acceptance criteria and the studies performed.

Here's a breakdown based on the information provided:

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

The document does not explicitly state "acceptance criteria" in a quantitative format as would be typical for diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, it lists various tests performed and implies that compliance with relevant standards and successful completion of these tests constitute meeting the acceptance criteria for safety and effectiveness.

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 does not specify sample sizes for any of the performance tests. The testing appears to be primarily bench testing (mechanical, electrical, software) and material biocompatibility, rather than human clinical data. The device manufacturer, Motion Concepts, is based in Concord, Ontario, Canada, suggesting the testing was likely conducted in Canada or by labs associated with the manufacturer. These would be considered prospective tests performed on the physical device components.

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

Not Applicable. This device is a mechanical/electrical system, not a diagnostic AI/ML system requiring expert interpretation of medical data to establish ground truth.

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

Not Applicable. No human adjudication of results is mentioned or relevant for the types of tests performed.

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-powered diagnostic device, and no MRMC study was conducted.

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

Not Applicable. This device does not have an AI algorithm with standalone performance to evaluate in this context. While it has software, its V&V is focused on functional safety rather than diagnostic accuracy.

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

The "ground truth" for this device's performance would be the physical and electrical properties of the device components and system as measured against engineering specifications and industry standards (e.g., ANSI/RESNA, ISO). For example:

• Biocompatibility: In vitro cytotoxicity results as per ISO 10993.
• Electrical Safety/EMC: Compliance with RESNA Section 21.
• Mechanical Performance: Functionality according to relevant ANSI/RESNA standards (e.g., static stability, dynamic stability, impact, fatigue strengths).
• Software Safety: Verification against documented requirements and risk analysis.

8. The sample size for the training set

Not Applicable. This device uses conventional engineering design, not a machine learning model that requires a training set.

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

Not Applicable. No training set for an AI model is involved.

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The TRX Vertical Positioner is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

• All positioning benefits associated with the tilt/recline product -
  • Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
  • Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
  • Pressure relief Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting, reclining or vertical positioning. By changing the individual's orientation in space, pressures caused by gravity will shift.
• Positioning/Versatility Individuals are able to reach higher elevations, increasing their range of motion and accessibility.

The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline, and elevating functions already available in with the TRX Power Positioning System defined in K021264.

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. TRX Vertical Positioners are to be installed ONLY by qualified Dealers.

The above indications for use are identical to those of the Levo Mobile LCM defined in K963817 to which we are claiming substantial equivalence.

The TRX Vertical Positioner is used to add the vertical positioning function to the tilt, recline. and elevating functions already available in with the TRX Power Positioning System defined in K021264. The Vertical Positioner functions by coordinating the elevating and reclining motion with an anterior tilt motion to change the user from an upright seated position to a vertical position and back again.

The TRX Vertical Positioner is assembled using primarily steel and aluminum, powder coated parts.

The vertical positioning is be activated using TRx switches consisting of either push buttons or togale switches, or through the wheelchair joystick.

Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond 1/2". The system also includes extensions for the existing front anti-tipper wheels to provide additional front stability, and a lockout for the active track suspension in the vertical positioning mode. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX Vertical Positioner was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the system.

The provided text describes a 510(k) premarket notification for a medical device called the "TRX Vertical Positioner." This document establishes substantial equivalence to a predicate device, the Levo Mobile LCM (K963817), rather than presenting a study to prove acceptance criteria with specific performance metrics.

Therefore, the requested information elements related to detailed study methodologies, sample sizes, expert involvement, and statistical results (such as effect size for MRMC studies or specific performance metrics for standalone algorithms) are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted and inferred regarding the acceptance criteria and the "study" (in this context, primarily the safety and similarity testing):

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

The document does not provide a quantitative table of acceptance criteria and reported device performance in the manner typically found in a clinical study report. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and by asserting that safety was tested.

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 does not specify a "test set" in the context of a clinical trial or AI model validation. The "testing" mentioned ("Stability of the TRX Vertical Positioner was tested in our facility") refers to in-house engineering and functional testing of the device itself.

• Sample Size: Not specified. It likely refers to testing performed on a limited number of prototype or production units.
• Data Provenance: "in our facility" (Motion Concepts, Canada). These are likely engineering test results, not patient data.
• Retrospective or Prospective: Not applicable in the context of this description, as it's not a study involving patient data.

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

Not applicable. This device is a mechanical accessory; its "ground truth" is based on engineering specifications, safety standards, and functional equivalence to a predicate device, rather than expert judgment on complex medical interpretations. Safety testing would be evaluated against established engineering parameters and regulatory standards by qualified engineers.

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

Not applicable. There is no information about expert adjudication as it relates to a "test set" in a diagnostic or interpretive context.

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 a medical device accessory for wheelchairs, not an AI software intended for diagnostic or interpretive tasks requiring human readers.

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

Not applicable. This is a mechanical/electrical device, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness determination is essentially:

• Compliance with engineering specifications and safety standards.
• Functional equivalence to the legally marketed predicate device (Levo Mobile LCM K963817) with respect to its mechanism of action and intended use.
• Internal stability testing results validating the mechanical integrity and safe operation of the system when added to a power wheelchair.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI device.

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

Not applicable.

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The TRx-CG is appropriate for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

• All positioning benefits associated with the tilt/recline product -

Comfort As with any individual -- able-bodied or disabled -- changes in position are necessary to maintain a state of comfort.
Repositioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
Pressure relief Individuals who wish, from time to time, to redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.

• Positioning/Versatility Individuals are able to reach higher elevations in a seated position, increasing their range of motion and accessibility.

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. TRx-CG Power Positioning Systems are to be installed ONLY by qualified Dealers.

The above indications for use are identical to those of the Permobil Tit/Recline/Elevating Seat System to which we are claiming substantial equivalence.

The TRX-CG Power Positioning System consists of a power tilt unit with optional power recline module, shear reduction module and power elevating seat module. The TRX-CG tilt system utilizes a center-of-gravity shift linkage, which causes the seat frame to shift progressively forward throughout the range of tilt. This enhances stability since the center of gravity is kept substantially in place while the user is tilting. The tilt system may be one of two similarly designed systems, one adapted for front wheel drive chairs and one adapted for rear wheel drive chairs. The tilt range of the power positioning system is 55°.

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 module works in conjunction with recline to reduce the shear movement between the user and the backrest. This is accomplished using a linkage that slides the backrest down on the back posts as the back reclines. The range of recline of the TRX-CG is 168°.

The elevating seat module allows the user to elevate the entire system by up to 7 in. It consists of a 24 V ball drive pedestal actuator with a maximum capacity of 500 Ibs and a maximum stroke of 7 in.

The maximum occupant weight for the TRX-CG system is up to 400 lbs depending on the features of the base and system modules selected. The minimum seat-to-floor height is 18 ½ in. The TRX-CG is assembled using laser-cut steel parts, steel tube, machined aluminum, delrin blocks and mounting hardware.

The power positioning modules may be activated via two options: using TRx switches or through the wheelchair manufacturer's controller. TRx switches consist of either push button switches or toggle switches.

Additional safety features include a drive lock-out which prevents the user from driving the power chair while tilted beyond a pre-set limit of 20° from the vertical or elevated beyond ½ in. Tilt limit is also available. Electrical components are a maximum of 24 volts with a fuse between the batteries and the relay box and current limiter built into the relay box. Stability of the TRX-CG was tested in our facility to ensure that the safety of the power wheelchair was not compromised by the addition of the power positioning system.

This 510(k) summary does not contain the requested information regarding acceptance criteria, device performance, study designs, or ground truth establishment.

The document is a 510(k) summary for a "TRx-CG Power Positioning System" and focuses on:

• Device Description: What the device is and its features (power tilt, recline, elevating seat).
• Predicate Device Identification: The Permobil Powered Wheelchair 1280 (K991658) is identified as the predicate.
• Indications for Use: How the device is intended to be used (e.g., comfort, repositioning, pressure relief, versatility for wheelchair users).
• Safety Features: Mentions of drive lock-out and electrical components, and that stability was tested to ensure safety.
• Regulatory Clearance: The FDA's decision of substantial equivalence.

There is no mention of:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets, data provenance, or retrospective/prospective study design.
3. Number of experts, their qualifications, or how ground truth was established for a test set.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human readers with/without AI.
6. Standalone algorithm performance.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

This is a mechanical device (a power wheelchair positioning system), not a diagnostic or AI-driven device. Therefore, the types of studies and criteria typically associated with AI/diagnostic devices (e.g., ground truth, expert consensus, MRMC studies) are not applicable and are not present in this document. The "study" mentioned is limited to internal stability testing.

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The TRx-CG is appropriate for use by any individual who drives a Quickie G-424, S-525, or an S-626 power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

• Comfort As with any individual able-bodied or disabled changes in position are necessary to maintain a state of comfort.
• Positioning -- Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
• Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.

TRx-CG Power Tilt and Recline System

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a power tilt and recline system for wheelchairs, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and indications for use, but no specific performance metrics or study details are provided.

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The TRx-CG system is appropriate for use by any individual who drives an Invacare Storm Power Base wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include: Comfort - As with any individual - able-bodied or disabled - changes in position are necessary to maintain a state of comfort. Positioning - Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position. Pressure Relief or Reduction - Individuals, who wish to, from time to time, redistribute pressure from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift. 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. TRx-CG Tilt and Recline Systems are to be installed ONLY by qualified Dealers. The above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.

TRx-CG Power Tilt and Recline System

This document is a 510(k) clearance letter from the FDA for a medical device called the "TRx-CG Power Tilt and Recline System." It is not a study report or a technical document describing a clinical study. Therefore, the information required to answer your questions about acceptance criteria and study details is not present in the provided text.

The document primarily focuses on:

• Substantial Equivalence Determination: The FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Regulatory Classification: The device is classified as Class II.
• Indications for Use: The document clearly states the intended uses of the device.

There is no mention of:

• Acceptance criteria for device performance.
• Any specific study conducted to prove the device meets performance criteria.
• Sample sizes, data provenance, ground truth establishment, expert involvement, or any other details related to a clinical or performance study.

In summary, the provided document does not contain the information requested to populate the table or answer the questions regarding acceptance criteria and study details.

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Statement of Indications For Use: Otatement of manoutiente for use by any individual who drives a power wheelchair and who desires or requires a change of position without having to utilize the services of an attendant. Needs for position changes include:

• 6. Comfort -- As with any individual -- able-bodied -- changes in position are necessary to maintain a state of comfort.
• 7. Positioning Individuals without adequate upper-body stability can be tilted to allow gravity to hold them in position.
• 8. Pressure Relief or Reduction Individuals who wish to, from time to time, redistribute pressures from one area of the body to another, can do so by tilting and/or reclining. By changing the individual's orientation in space, pressures caused by gravity will shift.

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 above indications for use are identical to those of the Tarsys Tilt and Recline System to which we are claiming substantial equivalence.

TRx-CG Power Tilt and Recline System

This document is an FDA 510(k) clearance letter for a medical device called the "TRx-CG Center-of-Gravity Shifting Power Tilt and Recline Systems." It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

• Acceptance criteria
• Study that proves the device meets acceptance criteria
• Device performance
• Sample sizes (test or training sets)
• Data provenance
• Number of experts or their qualifications for ground truth establishment
• Adjudication method
• MRMC comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for training set was established

The document is a regulatory clearance and not a performance study report. Therefore, I cannot extract the requested information from the provided text.

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