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The Invacare AVIVA Storm RX Power Wheelchair is indicated to provide mobility and positioning to persons limited to a sitting position.

The subject device is a rearward drive wheel version substantially equivalent to the previously cleared forward drive wheel Invacare® AVIVA FX Power Wheelchair (K192216) with LiNX Electronics and Ultra Low Maxx Seating System. The subject device version consists of the following changes:

• . Rearward drive wheel placement
• . Modification to suspension system
• . Modification to battery box design and seat interface brackets
• Minor changes to mechanical components such as new rims and colors .
  The Invacare® AVIVA Storm RX Power Wheelchair is a 24V DC system, motor-driven wheelchair, utilizing the predicate device LiNX® control system. The subject device consists of a rigid or "non-folding" type power wheelchair base with rearward drive wheel placement with two (2) casters in the front and two anti-tippers in the rear. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.

The provided text describes a 510(k) premarket notification for a powered wheelchair, the Invacare AVIVA Storm RX Power Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device (Invacare AVIVA FX Power Wheelchair) through non-clinical testing against various international standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by compliance with a comprehensive set of international (ISO), American National Standards Institute (ANSI), and European (EN) standards. The reported device performance is that the "subject device components met the performance requirements."

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

The document does not specify a "test set" in terms of a patient cohort or a specific number of devices tested individually. Instead, it refers to "non-clinical test reports" and "design verification test reports" that support the finding of substantial equivalence. The testing is based on compliance with established international standards for wheelchairs. Therefore:

• Sample size: Not explicitly stated as a numerical sample of devices or patients. The assumption is that sufficiently representative samples were used to conduct the required tests under each standard.
• Data provenance: Not explicitly stated, as the focus is on compliance with standards rather than clinical data from a specific geographical region or retrospective/prospective study. The testing is implied to be laboratory-based non-clinical testing.

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

This document does not describe the use of human experts to establish "ground truth" for a performance test set. The evaluation is based on objective, standardized non-clinical engineering and performance tests carried out by the manufacturer to demonstrate compliance with recognized standards.

4. Adjudication Method

There is no mention of an adjudication method as the evaluation relies on compliance with technical standards and objective measurements, not subjective expert reviews.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic devices where human reader performance is a key metric. This submission is for a physical medical device (power wheelchair) where performance is evaluated against engineering standards.

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

This question is not applicable. The device is a power wheelchair, not an algorithm, and its performance is evaluated against engineering and safety standards, not an algorithm's diagnostic output.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly defined by the pass/fail criteria of the various international and national standards (ISO, IEC, ANSI) listed in the document. These standards define objective performance thresholds and test methods for aspects like stability, braking, speed, safety, and electromagnetic compatibility.

8. The Sample Size for the Training Set

This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning algorithm.

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

This question is not applicable.

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