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Quickie® and Zippie® power wheelchairs are battery-operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. The Zippie power wheelchairs are specifically for people who are slightly smaller in stature—including children.

Quickie and Zippie wheelchairs are battery-powered, user-controlled, electric wheelchairs. All models of these wheelchairs will be offered with an optional wireless pointer control feature. This option entails adding a Bluetooth Mouse Module (BMM)—a small Bluetooth transmitter—mounted to the chair and wired into its control bus. With BMM in place, the wheelchair's controller can then use the pointer-control feature built into the BMM hardware and software. Pointer control can only be activated when the wheelchair is stationary and not actively performing wheelchair functions. The BMM lets users use the chair's joystick, or other input device, to control the pointer functions of Bluetooth-enabled devices (such as personal or tablet computers) while the chair is not in operation. The wireless pointer control feature will be offered on all models of the Quickie Pulse and Zippie ZM-310 series chairs. Technologically, all of these chair designs are identical. Model designations relate to widths and heights of their seats and various components: such as seating, wheels, and other options available. Quickie Pulse chairs are sized to fit medium to large size individuals Zippie ZM-310 chairs fit individuals of smaller stature—including children. These chairs, along with the BMM, are meant for use in healthcare facilities, in the home, outdoors, and other places of individual activity for the disabled.

The provided text is a 510(k) summary for the Quickie Pulse and Zippie ZM-310 power wheelchairs with an optional wireless pointer control feature (Bluetooth Mouse Module - BMM). It describes the device, its intended use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device.

Regarding your request for "acceptance criteria and the study that proves the device meets the acceptance criteria," it's important to note that this document is for a medical device (powered wheelchair) and not an AI/ML-driven diagnostic tool. Therefore, the questions related to AI/ML performance metrics (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training set) are not applicable in this context.

The "acceptance criteria" for this device are implicitly tied to safety and functional performance, particularly regarding the added Bluetooth Mouse Module (BMM) and its impact on the wheelchair's operation and electromagnetic compatibility. The "study" that proves the device meets these criteria is the non-clinical performance testing.

Here's a breakdown of the relevant information from the document, tailored as much as possible to your request, while acknowledging that it's not an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

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: The document does not specify a numerical sample size for the test set. The performance data section describes types of tests conducted on the device itself (e.g., "chair's electrical braking," "BMM operation," "EMC testing"). This implies testing was done on the physical device, likely prototypes or production samples, rather than a "data set" in the AI/ML sense.
• Data Provenance: Not explicitly stated, but standard practice for medical device testing like this would be in a controlled laboratory or testing facility within the manufacturer's operational region. It is not "retrospective or prospective" data in the clinical study sense; it's non-clinical engineering and functional testing.

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

• Not Applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical reality of the device's function (e.g., brakes holding, wireless signal working without interference). This is typically established by engineers, technicians, and potentially regulatory compliance specialists following established test protocols.

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

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for interpreting medical images or diagnoses where inter-reader variability exists. This document describes non-clinical performance and safety testing.

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

• Not Applicable. An MRMC study is relevant for comparing diagnostic performance, often with AI assistance in clinical settings. This device is a powered wheelchair with an added Bluetooth feature; it is not a diagnostic tool requiring human reader performance evaluation.

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

• Not Applicable. This refers to AI/ML algorithm performance. The "BMM" has software, but its "performance" is evaluated as part of the overall wheelchair system's function and electromagnetic compatibility, not as a standalone diagnostic algorithm.

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

• The "ground truth" for this device is based on engineering standards and physical measurements of performance. For example:
  • Brake holding capability is verified against a specific angle/load (engineering spec).
  • EMC is verified against international standards (e.g., ANSI/RESNA WC2, extended frequency ranges) using proper measurement equipment.
  • Wireless pointer function is verified by observing its actual function with compatible external devices.

8. The sample size for the training set

• Not Applicable. This device does not use machine learning, so there is no concept of a "training set."

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

• Not Applicable. As there is no training set for machine learning, this question is not relevant.

In summary, the provided document describes a medical device in the context of a 510(k) submission, confirming its substantial equivalence to a predicate device. The "acceptance criteria" and "studies" are focused on engineering performance, safety, and electromagnetic compatibility for the physical device system, not on AI/ML diagnostic performance metrics.

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The Sunrise Medical Zippie and Quickie Series Wheelchairs are intended to provide mobility to persons limited to a sitting position.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for various models of wheelchairs, confirming their substantial equivalence to predicate devices and outlining regulatory requirements. It does not include details on performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the request.

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The Sunrise Medical Quickie Rhythm Powered Wheelchairs intended use is to provide mobility to persons limited to a seating position that have the capability of operating a powered wheelchair. The Quickie Rhythm Power Wheelchairs provide an optional means of mobility for physically challenged people.

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This document is a 510(k) clearance letter from the FDA for a powered wheelchair, not a study evaluating a medical device's performance against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

The letter simply states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain any performance data or study results.

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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 Quickie Rhythm & Groove Series Power Wheelchairs with Quickie/Delphi Controls intended use is to empower physically challenged individuals by providing a means of mobility.

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This is a notification from the FDA regarding a 510(k) premarket notification for "QuickieRhythm & Groove Scries Power Wheelchairs with Ouickie/Delphi Controls". This document is a regulatory approval, not a technical study report for an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.

The document confirms that this device is a powered wheelchair, not an AI/ML diagnostic or prognostic device that would typically involve acceptance criteria and a study to prove performance as described in your request. The FDA's determination is based on the device being "substantially equivalent" to legally marketed predicate devices, not on a detailed analysis of performance against specific acceptance criteria for AI algorithms.

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The Quickie Interchange FWD w/ Lift Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.

The Quickie Interchange FWD w/ Lift Power Wheelchair is a High End/Mid-Range Rehabilitation type Power Chair Base design that offers the functionality to be used as a Front Wheel drive or a Rear Wheel drive base without changing major frame parts. The system allows for reassembling parts that will for either front or rear wheel drive function. The design will offer a modular approach within the drive base as intve adopt various seating & wiring elements. The device utilizes components typically found on most wheelchairs, including but not limited to rigid seat frame, backrest, product armrests, cushion, footrests and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen taak holders, IV poles, etc. As a motorized wheelchair, it also contains a controller, joystick, motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a powered wheelchair without having to utilize the services of an attendant. Sunrise Medical makes no claim as to the therapeutic effectiveness of the product. Sunrise Medical's only claim relates to the ability of the product to provide an optional means of mobility for physically challenged people.

The provided text describes a 510(k) premarket notification for a powered wheelchair, not an AI/ML medical device. Therefore, the information typically found for AI/ML device studies (such as diagnostic performance metrics, expert reader studies, and ground truth establishment methods) is not applicable or present in this document.

The document discusses the substantial equivalence of the "Quickie Interchange FWD w/ Lift Power Wheelchair" to a predicate device, focusing on similar technological characteristics and adherence to relevant industry standards for safety and performance.

However, I can extract the closest analogous information based on the 510(k) submission.

Acceptance Criteria and Device Performance (Analogous for a Non-AI Device):

Information Not Applicable or Not Found in the Provided Text (for an AI/ML-focused request):

• Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical testing against engineering standards rather than diagnostic performance on a dataset.
• Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a powered wheelchair's performance is adherence to engineering specifications and safety standards, not expert diagnostic labels.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted diagnostic performance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
• The type of ground truth used: For this device, the "ground truth" is compliance with established engineering and safety standards (e.g., ISO, ANSI/RESNA) and the functional specifications of the device itself.
• 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) submission for a physical medical device (a powered wheelchair), not an AI/ML diagnostic or therapeutic device. Therefore, the specific criteria for evaluating AI/ML models are not relevant to this submission. The "study" described is the non-clinical testing against established physical performance and safety standards.

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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 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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