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The intended use of the Adventure scooters is to provide mobility to persons limited to a seated position.

The Invacare Adventure Series of Scooters are motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to persons limited to a seated position. The scooters are basic conventional rear wheel drive, rigid frame vehicles that are battery powered. Various options and accessories are available depending upon user needs and preferences. They consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They also include a tiller handle for steering and a throttle control to engage and disengage the scooter motion in both the forward and reverse directions. The scooters can also be disassembled for ease of transport, are powered by two (2) 12 volt DC batteries, and utilize an on-board charger. The scooters have a status indicator located on the face of the control panel that provides diagnostic information. The status LED will flash a certain number of times, separated by a pause when a fault is detected in the controller or in the wiring. This feature is for diagnostic information only and does not control the operation of the scooter. The Adventure SX-3 is a compact version of the scooter with a 250 lb. weight capacity while the Adventure LX-3 scooter is a mid-size version of the scooter with a 350 lb. weight capacity.

This document describes a 510(k) premarket notification for the Invacare Adventure Motorized Scooters. This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials or extensive performance studies for regulatory approval. As such, the structure of the data provided is different from what would be expected for a novel AI/medical imaging device.

Here's an analysis based on the provided text, addressing your questions where applicable, and noting when the information is not present due to the nature of a 510(k) submission for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (motorized scooter), performance is typically assessed against established industry standards for safety and functionality, rather than specific diagnostic accuracy metrics.

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

This information is not applicable in the context of this 510(k) submission for a motorized scooter. There isn't a "test set" of patient data in the way one would analyze for an AI diagnostic device. The performance data refers to the scooter itself meeting engineering and safety standards, likely through bench testing, materials testing, and mechanical evaluations of the physical product.

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

This information is not applicable. Ground truth, in the sense of expert consensus on diagnostic findings, is not relevant for the regulatory approval of a motorized scooter. The "truth" here is whether the physical product adheres to engineering standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or experts when establishing ground truth for diagnostic studies. This is not performed for mechanical device evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

This information is not applicable. This submission is for a physical medical device (motorized scooter), not an AI diagnostic tool. Therefore, no MRMC study or analysis of human reader improvement with AI assistance was conducted or would be relevant.

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

This information is not applicable. This device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is adherence to established, published engineering and safety standards:

• ANSI/RESNA WC/14 (1991) for wheelchairs.
• ISO 7176: 1993 (E) for power and control systems of electric wheelchairs.
• California 116 and 117 specifications for upholstery fire retardancy.

The device itself (scooter) is the object of evaluation against these standards, through physical testing, material analysis, and design verification.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of a physical medical device submission like this one. Training sets are used for machine learning algorithms.

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

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is a series of engineering evaluations, material tests, and design reviews that demonstrate the Invacare Adventure Scooters (and their components) meet the requirements of specific, recognized industry standards: ANSI/RESNA WC/14 (1991), ISO 7176: 1993 (E), and California 116 and 117. The primary method of demonstrating regulatory compliance under a 510(k) is to show substantial equivalence to existing legally marketed predicate devices (Invacare Lynx SX-3, Lynx LX-3, and Lynx LX-3P06 scooters, K010135). The submission states that "minor differences in performance specifications... do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness," which is the core argument for substantial equivalence. The FDA, by granting clearance, concurred with this assessment.

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