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Its intended function and use is to aid in the pressure relief to persons confined to a powered wheelchair, by way of posterior tilt and reclining seat back.

It is intended use is to aid in the pressure relief of persons confined to a power wheelchair, by providing a method of tilting the seat and reclining the seat back.

The Invacare Model 2G Power Tilt/Recliner Seating System for Power Wheelchairs is a battery powered, motorized seating system designed for use with power wheelchairs. Its intended function and use is to aid in the pressure relief of persons confined to a wheelchair, by providing a method of tilting the seat and reclining the seat back.

The tilting and reclining systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline system, or as a separate tilt system or reclining system depending upon the users' needs. The reclining system also includes a movable leg rest feature.

The system includes an upper and lower frame assembly both of which are fabricated from welded steel. The lower assembly mounts directly to the wheelchair base using standard mounting screws. It includes the recline drive actuator as well as other mechanical components used to either tilt or recline the seating system.

The upper frame includes the wheelchair seat and back, as well as the tilt drive The seat and back are constructed of aluminum plates without actuator. upholstery. This allows the wheelchair user to decide the type of seat cushion that best meets their individual needs as determine by the health care provider.

The provided text describes a 510(k) premarket notification for a medical device, the Invacare Model 2G Tilt/Recliner for Powered Wheelchairs. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical trials with detailed acceptance criteria and performance metrics. Therefore, much of the requested information regarding specific acceptance criteria related to statistical performance, sample sizes for test sets, expert involvement, and ground truth establishment, which are typical for AI/ML device studies, is not applicable to this submission.

However, I can extract the information that is present and indicate where the requested details are not available in this type of regulatory document.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The submission refers to meeting engineering standards (RESNA and ISO) which typically involve device testing on a limited number of units to ensure compliance with mechanical, electrical, and performance specifications. It does not refer to a "test set" in the context of data for an AI/ML algorithm.
• Data Provenance: Not applicable. The study involved engineering tests and verification against established standards for wheelchairs, not data collection from human subjects.

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

• Number of Experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert labels on images) is not relevant to this type of device submission.
• Qualifications of Experts: Not applicable. The "ground truth" for this device is compliance with engineering standards established by organizations like RESNA and ISO, which are developed by committees of engineers, clinicians, and other relevant stakeholders in the field of rehabilitation technology.

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

• Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the context of human expert review for data labeling. The compliance is assessed through objective engineering tests according to the specified standards.

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

• MRMC Study: No. This is not an AI/ML device; it is a mechanical/electrical medical device.
• Effect size of human readers: Not applicable.

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

• Standalone Performance: Not applicable. This is not an algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance is adherence to the technical specifications and test methods outlined in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs." These standards define acceptable ranges for parameters like stability, durability, electrical safety, and functional performance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not use an AI/ML training set.

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

• Ground Truth Establishment for Training Set: Not applicable. This device does not use an AI/ML training set.

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