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The FR-W04 (Luggie Chair) provides transportation for an elderly or disabled person. It can be used in a variety of indoor and outdoor settings.

The FR-W04 (Luggie Chair) is a battery-powered, four-wheeled electric wheelchair intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. The FR-W04 (Luggie Chair) is meant to be used by a single rider weighing up to 360 pounds. The wheelchair is rear-wheel drive and has electric, regenerative electromechanical brakes. The steering and user controls are provided on the armrest for ease of use by the rider. Steering is controlled simply by turning the top controller in the desired direction. There is one lever, and speed knobs on the top controller to control movement speed of the wheel chair. The specification of control method is the same as the predicate device, Freerider FR168-W Power Chair (K033370). The FR-W04 (Luggie Chair) has a controller and one lithium battery. There is also an off-board battery charger, which has also been previously cleared. It has an adjustable seat that has several height adjustments. The specification of battery charger and adjustable seat is the same as the predicate device, Freerider Luggie Super FR-L05 (K151944).

This document is a 510(k) premarket notification for a powered wheelchair, the Luggie Chair (model FR-W04). It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving performance against acceptance criteria for a novel AI or diagnostic device.

Therefore, much of the requested information regarding acceptance criteria, specific study design (MRMC, standalone), expert involvement, and ground truth establishment is not applicable or cannot be extracted from this document, as it pertains to a different type of medical device submission.

However, I can extract the information related to non-clinical testing which serves a similar purpose of demonstrating safety and performance against established standards.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, it lists various national and international standards against which the device was tested and found to comply. Compliance with these standards is the acceptance criterion for this type of device submission.

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

• Sample Size: Not explicitly stated as a number of "samples" in the way a diagnostic device would have patient cases. The testing was performed on the FR-W04 (Luggie Chair) device itself. It's implied that one or a few units were tested to demonstrate compliance.
• Data Provenance: The testing was "non-clinical testing" conducted for regulatory submission. The document doesn't specify the country of origin of the testing data beyond the manufacturer being in Taiwan. It's retrospective in the sense that the testing was completed prior to submission.

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

• Not Applicable: For this type of device (a powered wheelchair), "ground truth" is not established by human experts in the way it is for diagnostic imaging or AI devices. Compliance with engineering and safety standards is determined through objective measurement and testing by qualified test laboratories/personnel.

4. Adjudication Method for the Test Set:

• Not Applicable: As "ground truth" is not established by expert review, there is no adjudication method involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not Applicable: This is a physical medical device (powered wheelchair), not an AI or diagnostic application that would involve human readers.

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

• Not Applicable: This is a physical medical device and does not involve an algorithm working in a standalone capacity without a human user.

7. The Type of Ground Truth Used:

• Technical Specifications and Compliance with Standards: The "ground truth" for this device is its adherence to established engineering, safety, and performance standards (e.g., ISO, IEC, EN standards for powered wheelchairs and electrical safety). Performance metrics like maximum speed, braking distance, weight capacity, and incline ability are objectively measured during testing.

8. The Sample Size for the Training Set:

• Not Applicable: This device does not use an AI algorithm that requires a "training set" of data.

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

• Not Applicable: As there is no AI algorithm or training set, this information is not relevant.

In summary: The provided document is a 510(k) for a physical medical device (a powered wheelchair). Its acceptance criteria are defined by compliance with a comprehensive set of national and international engineering and safety standards, as demonstrated through non-clinical bench testing. The concepts of "AI models," "human readers," "ground truth experts," and "training/test sets" as outlined in your prompt are not applicable to this type of device submission.

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The device provides transportation for an elderly or disabled person. It can be used in a variety of indoor settings.

The Freerider FR1 is a battery-powered, four-wheeled scooter intended to provide mobility for elderly or disabled individuals in indoor and outdoor settings. The FR1 is meant to be used by a single rider weighing up to 400 pounds. The scooter is rear-wheel drive and has electric, regenerative electromechanical brakes. It has an adjustable seat that can be removed for transport or height adjustment.

The steering and user controls are provided on the steering tiller/handlebars for ease of use by the rider. Steering is controlled simply by turning the handlebars in the desired direction. There are two thumb levers, an emergency brake, and buttons on the tiller console to control movement of the scooter.

The FR1 has a controller and 2 batteries. The controller is used on a number of other scooters that have been previously cleared. There is also an off-board battery charger, which has also been previously cleared. The specifications of battery charger is same as a predicate device, Heartway powered mobility S-12(K092650).

The provided document is a 510(k) premarket notification for the Freerider FR1 motorized three-wheeled vehicle. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and clinical study details (like sample size, ground truth, expert opinions, effect size) is not applicable or available in this document.

Here's the information that can be extracted or deduced from the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the way typically seen for diagnostic or AI-driven medical devices. Instead, the "performance" verification for this device is based on compliance with standards and comparison to predicate devices.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not applicable. This device is a mobility scooter, and its testing involves engineering and safety standards, not a "test set" of patient data.
• Data Provenance: Not applicable. The testing is based on engineering and performance standards for the physical device.

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

Not applicable. "Ground truth" in the context of expert consensus is not relevant for a motorized three-wheeled vehicle. Safety and performance are assessed against established engineering standards.

4. Adjudication method for the test set

Not applicable. There is no clinical "test set" requiring adjudication in the context of this device's submission.

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 physical mobility device, not a diagnostic or AI-assisted system that would involve human readers or AI assistance.

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

Not applicable. This device does not involve algorithms or AI in the sense of a standalone diagnostic or assistive system. Its function is direct physical mobility.

7. The type of ground truth used

Not applicable. For this device, "ground truth" is effectively defined by compliance with established national and international safety and performance standards for medical devices and motorized vehicles.

8. The sample size for the training set

Not applicable. This device does not utilize a "training set" in the context of machine learning.

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

Not applicable. As there is no training set, the establishment of its ground truth is irrelevant.

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