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The Sunrise Medical Quickie QX Manual Folding Mechanical Wheelchair's intended use is to provide mobility to persons restricted to a sitting position. The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels that is intended for medical purposes which provides an optional means of mobility for physically challenged people. The mechanical wheelchair is indicated for physically challenged individuals and can provide a means of mobility.

The Quickie QX Manual Folding Wheelchair is a mechanical wheelchair that is a manually operated device with wheels.

This document is a 510(k) premarket notification decision letter from the FDA for a manual folding wheelchair. It does not contain information about acceptance criteria, device performance tables, or a study demonstrating that the device meets acceptance criteria as described in your request.

The provided text only contains:

• A decision letter from the FDA indicating that the Sunrise Medical Quickie QX Manual Folding Wheelchair has been found substantially equivalent to a legally marketed predicate device.
• Indications for Use Statement for the Quickie QX Manual Folding Wheelchair.

Therefore, I cannot extract the requested information points (1-9) from this document. This typically falls under a different section of a 510(k) submission, such as a "Summary of Non-Clinical Tests" or "Performance Testing" section, which is not present in the provided text.

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The Quickie MWD Series II Power Wheelchair's intended use is to empower physically challenged individual by providing a means of mobility.

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The provided text is related to a 510(k) premarket notification for a powered wheelchair (Quickie MWD Series II Power Wheelchair). This type of document, particularly from 2006, focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, expert ground truth, or AI-related metrics like those listed in the prompt.

Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, and training set ground truth) is not available in the given document.

The document primarily states:

• Device Name: Quickie MWD Series II Power Wheelchair
• Intended Use: To empower physically challenged individuals by providing a means of mobility.
• Regulatory Status: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

The FDA's review in 2006 for this type of device would have focused on engineering specifications, safety testing (e.g., electrical safety, mechanical stability, durability), and performance characteristics compared to a predicate device, rather than the kind of clinical performance study with AI-specific metrics that your prompt asks for.

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The Center Drive Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.

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I am sorry, but the provided text from the FDA 510(k) summary for the "Center Drive Power Wheelchair" (K031289) does not contain information about acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth establishment, expert involvement, or training sets.

This document is a letter from the FDA confirming the substantial equivalence of the device to legally marketed predicate devices, and an "Indications for Use Statement." It does not include the detailed technical and performance data that would typically be found in a study report.

Therefore, I cannot provide the requested information based on the text you provided.

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Sunrise scooters empower physically challenged persons by providing a means of mobility.

The Three Wheeled mid Range Scooter is a medium duty, conventional, rear whech drive, rigid frame power Vehicle. The armrests of the sear are adjustable. The seat may be repositioned from from to back and chair height can be adjusted up and down. There are many kinds of accessories that are commonly sold after market. These accessories include canopies, crutch holders, cup holders, baskers etc.

Like most scooters, the tiller and throttle controls are the user interface. They transfer the rider's intentions to command the device. When the control is activated, or moved out of neutral position, the motor brake is energized and released, allowing the scooter to move in the appropriate direction. When the activation device is released, the scooter slows to a stop and the motor brake is automatically reengaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device.

If the scooter looses power, the motor brake is automatically engaged and the scooter comes to a stop. To prevent the rider from becoming stranded, the scooter may be pushed. The design incorporates a "free wheel" device motor lock disengagement device. This device allows the drive train to be manually disengaged, enabling the scooter to be pushed. It should be noted that the scooter would not have electronic brakes when in the "free wheel" mode.

The controller is microprocessor based and program-able. It is pro-programmed at the manufacturer to meet Sunrise specifications. This controller is currently used on selected models of the Sunrise scooters under K880425. Drive characteristics that are pre set are:

forward/reverse acceleration forward speed

forward/reverse deceleration reverse speed

The controller also has manual reset circuit breakers. These adjustments and features are similar to all standard scooter controllers.

The provided text describes a 510(k) submission for a medical device, specifically a mobility scooter. However, it does not include the typical information one would expect for demonstrating the acceptance criteria and performance of an AI/ML device in a clinical study.

The document is a K981885 submission for a "Sunrise 3 Wheel Scooter" in 1998, which is a physical device, not an AI/ML software device. The "testing" section refers to engineering standards like ISO 7176 and RESNA for wheelchairs, covering aspects like stability, brakes, energy consumption, and EMC. The "efficacy" section refers to articles about power wheelchairs in general, not specific studies on this particular device's clinical efficacy in a statistical sense.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets those criteria, as the provided input does not contain information relevant to an AI/ML device's clinical performance assessment.

Here's a breakdown of why each requested point cannot be addressed with the given document:

1. A table of acceptance criteria and the reported device performance: The document lists engineering tests (e.g., Static Stability, Dynamic Stability, Effectiveness of Brakes) and states that the device was tested to these standards. It doesn't present specific acceptance criteria values (e.g., "must stop within X feet at Y speed") and then reported performance values against them in a table format. These are design and safety standards, not clinical performance metrics for an AI/ML diagnosis/prediction.
2. Sample sized used for the test set and the data provenance: Not applicable. This refers to engineering tests, not a clinical study on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth is established for patient data.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory submission for a physical medical device (a scooter) and focuses on engineering safety standards and comparisons to predicate devices, not on the clinical performance validation of an AI/ML algorithm.

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Sunrise powered wheelchairs empower physically challenged persons by providing a means of mobility.

The Quickie P190 R (or S525) is a medium duty, conventional, rear wheel drive, and rigid frame power wheelchair. The Quickie P190R Power Wheelchair consists of typical components found on most wheelchairs, such as push handles, armrests, backrest, seat frame, cushion, footrest and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As a motorized wheelchair, it also controller, a joystick, a motor, brakes, a drive wheel and 2 batteries. Like most power wheelchairs, the joystick is the user interface. It transfers intentions to command the chair. When the control is activated, or moved out of the center position, the motor brake is energized and released, allowing the chair to move in the direction of the activation. When the activation device (joystick or afternate input device) is released, the chair slows to a stop and the motor brake is automatically re-engaged. These dynamic "on command" brakes allow the user to stop by letting go of the activation device. If the chair loses power, the motor brake is automatically engaged and the chair comes to a stop. To prevent the rider from becoming stranded, the chair may be pushed. The chair incorporates a "free wheel" device motor lock disengagement option. This option allows the drive train to be manually disengaged, enabling the chair to be more easily pushed by an assistant. It should be noted that the chair would not have electronic brakes when in the "free wheel" mode. However, the manual wheel locks (also optional) will still function if engaged.

This 510(k) premarket notification for the Sunrise Medical S-525 Power Wheelchair is primarily focused on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and adherence to recognized performance standards. Itdoes not describe a study involving an AI/Machine Learning device or a diagnostic/screening medical device in the way typically expected by your request. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

However, I will extract and present the information available that aligns with your request, interpreting "acceptance criteria" as the standards the device was tested against and "device performance" as its successful adherence to those standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: This document does not specify a separate "test set" in the context of device performance data generation for a diagnostic/screening algorithm. The testing described refers to the physical device itself. It's implied that at least one S-525 Power Wheelchair was tested against the listed standards.
• Data Provenance: The testing was conducted internally by Sunrise Medical. The country of origin of the data is the United States, as Sunrise Medical is a US-based company, and the submission is to the FDA. The testing conducted is for prospective validation of the device's adherence to safety and performance standards.

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

• This section is not applicable. The "ground truth" for a physical product like a power wheelchair is defined by its engineering specifications and its adherence to the published performance standards. There is no mention of human experts establishing ground truth for a diagnostic output.

4. Adjudication Method for the Test Set

• This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of data, typically in diagnostic studies. Here, the device's performance is objectively measured against technical 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

• This section is not applicable. This document describes a physical medical device (power wheelchair), not an AI/ML-driven diagnostic tool that would involve human readers.

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

• This section is not applicable. The S-525 Power Wheelchair is a physical product operated by a user, not an algorithm. The performance described is of the complete physical device.

7. The type of ground truth used

• The ground truth for the S-525 Power Wheelchair's performance is established by conformance to internationally recognized and national engineering/performance standards (ISO 7176 and ANSI/RESNA). This is an objective, measurable "ground truth" based on predefined specifications and safety thresholds. It is not expert consensus, pathology, or outcomes data in the context of a diagnostic test.

8. The sample size for the training set

• This section is not applicable. This device is a physical product, not an AI/ML system that requires a "training set."

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

• This section is not applicable, as there is no training set for this type of device.

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Alternate input devices are designed to provide those with sever physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit from a single actuating device.

Alternate actuators (input devices) are designed to provide those with severe physical disabilities the independence to operate a power wheelchair, a power seating system, and an environmental control unit using a device other than the standard joystick. A variety of alternate input actuators are currently available on the market as many power wheelchair users require some form of input control other than a joystick.

In prior submissions, several alternate input devices (specialty controls) and their interface modules were employed in addition to the main wheelchair controller. These included the breath tube interface, which contained a pressure transducer, a single switch scanner module and a display. Other specialty control functions also required independent display boxes and / or displays. However Quickie's new controllers, that are intended to interface with specialty input devices, have incorporated these functions into the Controller/ USCM (Universal Specialty Control Module). This greatly simplifies the wheelchair's configuration as it eliminates the need for additional dedicated interface boxes and displays to be mounted on the chair.

As with the devices currently marketed by Quickie, the alternate actuator is used to signal both the speed and direction of the power chair, as well as the selection of various operating modes which are then controlled by the wheelchair controller/USCM. Examples of the various modes that can be controlled are: maximum speed, drive profile (e.g. indoor/outdoor), latched driving, powered seating systems and environmental controls systems.

The method of selection for both drive control and mode is dependent upon the type of alternate input actuator. Two basic types of input actuators exist: proportional and switched. Both types are compatible with Quickie's controller/USCM. When using alternate input actuators, the wheelchair controller will enter a sleep state if the actuator has not sent a signal for a specified period of time. This helps to extend the life of the chair batteries, and reduces the likelihood of unintentional movement.

The primary change being addressed is the modification of one of the standard connectors used to interface with the Quickie Controllers that have a Universal Specialty Control Unit (USCM). Two of the three connections that were made to the old Multi-mode remain the same. Some devices used a breath tube that activated a pressure transducer that translated the air pressure to electrical signals. This connection remains unchanged. Some devices used a single jack connector to transfer signal. This connection also remains unchanged. The third type of connector employed by the prior Multi-mode device was a DB15 connector. The Controller/ USCM, which replaces the Multi-mode, translates the same signals using a DB9 connector. The DB9 was selected for the Controller/USCM because it has developed across the specialty input device industry as the standard connector. The DB-9 is used by many companies making specialty input devices including Switch-it, Tash, and ASL.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided document describes a 510(k) premarket notification for "QUICKIE SPECIALTY INPUT DEVICE" and its various models. However, it does not contain a formal study designed to prove the device meets specific acceptance criteria in the way one might expect for a typical medical device with measurable performance metrics (e.g., diagnostic accuracy, precision).

Instead, this submission is focused on demonstrating substantial equivalence to predicate devices. The "study" here is primarily a comparison to predicate devices and basic engineering testing, not a clinical trial or performance study against predefined targets.

Here's a breakdown based on your requested information, with explanations for what is present and what is absent:

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

Explanation: The "acceptance criteria" are not explicitly stated with quantitative targets. Instead, the document argues for substantial equivalence by asserting that the device's characteristics and performance are "the same" as the predicate devices. The mechanical tests (pull out strength, insertion force, pin activity compatibility) are the only truly explicit performance tests mentioned, and their "acceptance criteria" appear to be simply "Pass."

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

• Test Set Sample Size: Not applicable in the traditional sense of a clinical or performance study.
  • For the mechanical tests (Pull Out Strength, Insertion Force, Pin Activity Compatibility), the sample size is not specified. It would typically be a small number of connectors tested in a lab setting.
  • For the safety analysis, the "sample" was the complaints against Quickie chairs and a literature review of general wheelchair complaints/MDRs/recalls. The size of these datasets is not specified.
• Data Provenance: Not explicitly stated. Given it's a US 510(k) submission, it's likely primarily related to the US market, but this is not confirmed.
• Retrospective or Prospective:
  • The mechanical tests would be prospective (conducted specifically for this submission).
  • The safety analysis based on complaints/MDRs/recalls is inherently retrospective.
  • The efficacy articles provided would be retrospective literature.

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 is not a study that requires expert adjudication of ground truth for device output. The substantial equivalence argument relies on comparing the device's features to those of predicate devices and general knowledge of wheelchair safety and efficacy.

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

Not applicable. No expert adjudication of a test set was 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 device is a physical input device for wheelchairs, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical input device, not an algorithm. Its function is to convert user input into signals for a wheelchair controller. Human-in-the-loop is fundamental to its operation.

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

Not applicable. This submission relies on:

• Engineering test results for mechanical properties ("Pass" indicates meeting an engineering specification).
• Comparison of features and intended use to legally marketed predicate devices.
• Analysis of existing safety data (complaints, MDRs, recalls) related to wheelchairs in general.
• Existing literature on wheelchair efficacy.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set. It's a hardware input device.

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

Not applicable. As above, this device does not utilize a training set in the AI/ML sense.

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Sunrise Medical powered wheelchairs empower physically challenged persons by providing a means of mobility. This includes conditions in all ages such as: Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric Conditions, And other immobilizing or debilitating conditions. A wheel chair with Bus Transport option may be used for motor vehicle transportation, with the use of wheelchair tie down and occupant restraint system (WTORS) that meet the requirements of SAE J 2249.

The G-424 is a mid-wheel drive, moderate duty chair that comes in one basic configuration. It is available with the Pilot controller. The Quickie G-424 Power Wheelchair consists of the same basic components found on the P200, such as a frame with suspension, seat, armrests, footrest, cushion, casters and drive wheels. Accessories include items such as positioning belts, backpacks, seat pouches, oxygen tank holders, IV poles, etc. As motorized wheelchairs, they also contain controllers, joysticks, motors, brakes, drive wheels and batteries. Key changes between the P200 and the G-424 are the replacement of anti-tip wheels with anti-tip casters, change from aluminum to steel frame construction, revised suspension, revised modular seat and use of the Pilot controller from Penny & Giles. Aesthetics have been improved by adding a plastic thermoformed molded cover.

Here's an analysis of the provided text regarding the acceptance criteria and study for the G-424 Power Wheelchair:

Description of Device: The G-424 is a mid-wheel drive, moderate-duty power wheelchair. Key changes from its predicate device (Quickie P200) include:

• Replacement of anti-tip wheels with anti-tip casters.
• Change from aluminum to steel frame construction.
• Revised suspension.
• Revised modular seat.
• Use of the Pilot controller from Penny & Giles.
• Improved aesthetics with a plastic thermoformed molded cover.

Intended Use: To provide mobility for physically challenged persons of all ages, including those with conditions such as Arthritis, Amputee, Paraplegic, Cerebral Palsy, Hemiplegic, Tetraplegic (Quadraplegic), Spina Bifida, Head Injury or Trauma, Muscular Dystrophy, Multiple Sclerosis, Polio, Geriatric conditions, and other immobilizing or debilitating conditions.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of wheelchairs or test units) used for the testing. It also does not specify the country of origin of the data or whether the tests were retrospective or prospective. The testing was conducted to "ISO7176 and ANSI/RESNA Wheelchair Standards," which are international and American standards, respectively.

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

This document describes performance testing of a physical medical device (power wheelchair) against established engineering and safety standards (ISO7176 and ANSI/RESNA). The "ground truth" here is objective measurement and observation of the device's adherence to these standards. Therefore, "experts" in the context of establishing ground truth for image interpretation or clinical outcomes (like radiologists) are not applicable. The implicit experts would be the qualified engineers and technicians performing the standard tests and interpreting the results according to the specified criteria. The number and specific qualifications of these individuals are not provided.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for clinical studies involving subjective assessments (e.g., image interpretation by multiple readers). This document pertains to objective engineering and performance testing against predefined standards. There is no mention of an adjudication method in this context, as the results are likely determined by quantitative measurements and pass/fail criteria from the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study assesses human reader performance, often with and without AI assistance, which is not relevant for the performance testing of a physical device like a power wheelchair.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done. This concept is applicable to software algorithms, particularly in AI/ML, not for the physical performance of a power wheelchair. The "performance" discussed here refers to the device's physical capabilities and safety features.

7. Type of Ground Truth Used

The ground truth used for this study is based on objective measurements and pass/fail criteria defined within the ISO7176 and ANSI/RESNA Wheelchair Standards. These standards would specify the methodologies, parameters, and acceptable ranges for each test (e.g., maximum allowable dynamic tilt, braking distance, fatigue cycles).

8. Sample Size for the Training Set

This document describes the testing of a physical medical device. There is no "training set" in the context of machine learning algorithms. The tests performed are to validate the final product's conformance to established engineering standards. Engineering design and development (which could involve iterative testing and refinement, analogous in some ways to training) would precede this final validation testing, but a distinct "training set" as understood in AI/ML is not applicable.

9. How the Ground Truth for the Training Set Was Established

As noted in point 8, the concept of a "training set" is not applicable here. The device's design and manufacturing processes are validated against engineering specifications, which themselves are derived from safety and performance standards. The "ground truth" for the device's performance is ultimately defined by its ability to meet these established engineering and regulatory standards.

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