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To provide improved mobility, both indoors and outdoors, for persons who have adequate upper body strength suitable for manual steering, and who have a medical condition that impairs their ability to stand for periods of time or to walk.

Navigator I was designed to assist individuals with limited mobility to maintain an active lifestyle. Its manual steering, high-torque four brush motor with rear wheel drive, large diameter (16") front wheels, high ground clearance (5.4"), full circle turning radius (27.5"), side to side anti-tip resistance, and curb climbing (5.5") ability make it a versatile vehicle equally adept in the shopping mall, on firm surface wilderness trails, or in the close quarters of a restaurant or home kitchen. Navigator I is a blended hybrid drawine elements from both scooters and wheelchairs, to meet desired features requested by long term scooter users. It does this while still maintaining the three-wheel scooter configuration with manual steering and anti-tip wheels adjacent to the single steering wheel. Navigator I is an clectronically controlled motorized 3-wheeled vehicle employing a rear single wheel remotely steerable motor drive system (11.5" tire). It employs a 24 Volt DC permanent magnet motor powered by two 12 Volt scaled lead acid deep cycle batteries. The rigid Front Frame Assembly holds the two batteries, mounts the two front 16" diameter wheels, the two front hand controlled parking brakes, the swing up front foot rests, the electronic motor controller, and the steering arm with handle incorporating the 6-position variable speed-control. The Rear Frame Assembly is made up of the rear motor drive, the swing out Anti-tip wheels, the rear bearing block assembly and pivot wheel assembly. The Front and Rear Frame Assemblies are connected together by two semi-rigid Torsional Elements™ (relatively rigid to a vertical load, but allowing limited rotation), which also support the scat block mounting assembly. The Torsional Elements™ allow limited twist (similar to the Articulation Beam in the Pride Jazzy, K945936) to occur between the Front and Rear Frame Assemblics up to 5° of rotation, at which point one Anti-tip wheel with the ground. This greatly enhances side to side stability when driving Navigator I over rough terrain, since Navigator I is smothly transformed from three wheels to four wheels with ground contact on all four wheels.

The provided text is a 510(k) summary for the "Navigator I Powered Scooter." It describes the device, its intended use, and argues for its substantial equivalence to predicate devices, particularly focusing on safety and effectiveness.

However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as one would expect for a diagnostic or AI-driven medical device. This is a mobility device, and the evaluation relies on a comparison of features to legally marketed predicate devices, rather than statistical performance metrics from a study with a test set, ground truth, or expert review.

Therefore, many of the requested sections (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Here's a breakdown of what can be extracted and what cannot:

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

No explicit quantitative acceptance criteria or corresponding reported performance values (e.g., sensitivity, specificity, accuracy) are presented in this document. The "acceptance" is based on demonstrating substantial equivalence to predicate devices in terms of functionality and safety, rather than meeting specific performance thresholds derived from a clinical trial in the way an AI diagnostic would.

The document highlights the following features as improvements for safety and effectiveness, effectively acting as "performance claims" without quantitative metrics:

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

Not applicable. The document refers to "testing" regarding improved occupant safety due to anti-tip features and Torsional Elements™, but provides no details on the study design, sample size, or data provenance. This is 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 (e.g. radiologist with 10 years of experience)

Not applicable. There is no concept of a "test set" or "ground truth" derived from expert consensus in this 510(k) submission for a mobility device.

4. Adjudication method (e.g. 2+1, 3+1, none) 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. This is not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a motorized scooter, not an algorithm.

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

Not applicable. "Ground truth" in the context of this device would relate to its physical performance characteristics (e.g., turning radius, curb climbing ability, stability angle) which are inherent design attributes or measured engineering specifications. The document states "testing to significantly improve occupant safety" but does not detail the nature of this testing or how a "ground truth" was established.

8. The sample size for the training set

Not applicable. There is no machine learning or AI algorithm development described.

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

Not applicable.

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