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The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.

The Navigator (model: FMNVG15) and Navigator XL (model: FMNVX06) is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, safety belt, pedal, battery box and charger. The device is powered by Li-ion Battery pack (24V 6Ah*2) with 16 Km range, which can be recharged by an off-board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

The provided document, a 510(k) Pre-market Notification for the Navigator and Navigator XL powered wheelchairs, does not describe a study involving an AI/Machine Learning device, expert adjudication, or complex ground truth establishment. Instead, it focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for medical devices like powered wheelchairs.

Therefore, many of the requested details, such as those related to AI/ML performance, human readers, training/test sets, and expert consensus for ground truth, are not applicable to this document.

However, I can extract the acceptance criteria and the "device performance" in terms of meeting those criteria.

Here's a breakdown of the information that is available in the document, formatted to the extent possible according to your request:

Acceptance Criteria and Device Performance (for a Powered Wheelchair)

This section describes the performance evaluation of the Forcemech International LLC Navigator and Navigator XL powered wheelchairs against established international standards for wheelchairs. The study's purpose was to demonstrate substantial equivalence to a predicate device (K232193) by meeting these standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to various parts of the ISO 7176 series of standards and ISO 10993 series for biocompatibility. The reported device performance is that the device meets or complies with these standards.

The document also provides specific performance values for some parameters, as compared to the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "comparison elements" that need to demonstrate substantial equivalence:

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document describes non-clinical testing performed on the device itself. For each standard mentioned (e.g., ISO 7176 series, ISO 10993 series), tests are conducted on a statistically appropriate number of units or materials according to the specific standard's requirements. This is not a patient-based test set but rather a device-based test set. The exact number of units tested for each standard is not specified in this summary but would be detailed in the full test reports.
• Data Provenance: The tests are "non-clinical tests" conducted to verify compliance with design specifications and substantially equivalence. The location of testing is implicitly China, given the applicant's contact person is in Shanghai, China, and the submission correspondent is also from Shanghai, China. The data would be prospective in the sense that the manufacturer specifically conducted these tests on their device models.

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

Not applicable. This is a non-clinical device performance study against engineering and safety standards, not a diagnostic AI/ML study requiring expert radiologists for image interpretation or clinical ground truth. The "ground truth" here is the adherence to the published ISO/IEC standards, which are developed by international expert committees through a consensus process.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical device performance study. The "adjudication" is met by passing the specified tests against the published standard criteria.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done

No. This document explicitly states: "No clinical study is included in this submission." This type of study is for evaluating human performance, typically in diagnostic imaging, and is not relevant for a powered wheelchair's non-clinical safety and performance testing.

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

Not applicable. This is a medical device (powered wheelchair), not an AI/ML algorithm. The performance evaluation is for the physical device and its electrical/mechanical systems.

7. The Type of Ground Truth Used

The ground truth used for this device's acceptance is adherence to well-defined, internationally recognized engineering and safety standards (ISO 7176 series for wheelchairs, ISO 10993 series for biocompatibility, and IEC 60601-1-2 for EMC). These standards dictate specific test methods and acceptance criteria that the device must meet to be considered safe and effective for its intended use.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no AI/ML training set.

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