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

The Invacare Models Lynx and Panther scooters are motor driven indoor and outdoor transportation vehicles. The Lynx series of scooters are three-wheeled vehicles while the Panther Series of scooters are four-wheeled vehicles.

All of the scooters products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They all consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. Like most scooters, they include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions. They are all powered by two (2) 12 volt DC batteries, and they all include a variety of options and accessories in order to meet the needs and preferences of various users.

This document describes a 510(k) premarket notification for the Invacare Models Lynx and Panther Motorized Scooters. It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as it is for a low-risk physical device (motorized scooter) and not a diagnostic AI/ML device.

The study that proves the device meets acceptance criteria is primarily through demonstrating substantial equivalence to predicate devices and adherence to established industry standards for motorized wheelchairs/scooters.

Here's a breakdown of the available information based on your request:

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

The document does not provide a table of specific acceptance criteria with corresponding device performance metrics in the format requested for AI/ML devices. Instead, it states that the devices meet existing standards.

• Acceptance Criteria/Standards Met:

  • Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991)
  • ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs

• Reported Device Performance:
  The document asserts that the Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the above standards. It also states their "performance specifications for speed, acceleration, deceleration, turning radius and braking" are similar to predicate devices, but without providing specific numerical values.

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

This information is not applicable/provided as the device is a physical motorized scooter, not an AI/ML diagnostic software. The "test set" in this context refers to physical testing performed against engineering standards, not a dataset for an AI model.

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)

This information is not applicable/provided for a physical device. Ground truth, in the context of AI/ML, refers to annotated data. For a scooter, compliance with standards is assessed through engineering testing, not expert consensus on ground truth data.

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

This information is not applicable/provided for a physical device. Adjudication methods are typically relevant for resolving discrepancies in expert labeling of ground truth data for AI/ML.

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

This information is not applicable/provided. This type of study is specific to AI/ML diagnostic devices where human "readers" (e.g., radiologists) interact with or without AI assistance. The device in question is a motorized scooter for mobility.

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

This information is not applicable/provided. "Standalone performance" in this context refers to an AI algorithm operating independently, which is not relevant for a motorized scooter.

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

The "ground truth" for this device's performance is adherence to established engineering and performance standards (RESNA and ISO). This is validated through physical testing and engineering assessment against those standards, not through expert consensus on qualitative data, pathology, or outcomes data in the sense used for AI/ML devices.

8. The sample size for the training set
Not applicable/provided. This document is for a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable/provided. This document is for a physical device, and therefore the concept of a training set and its ground truth establishment is not relevant.

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