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The intended use of the Pride Mobility Products Corporation device is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

The Jazzy Elite 6 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Jazzy Elite 6 is equipped with electronic regenerative disc brakes, 3A off-board battery charger, removable 12 volt batteries, drive wheels, and front and rear caster wheels.

The Jazzy Elite 6 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.

The provided document describes the Jazzy Elite 6 Powered Wheelchair and its substantial equivalence to a predicate device, the Jazzy Frontie (K092961). The information focuses on non-clinical testing and comparison rather than a study involving human readers or a standalone algorithm.

Here's a breakdown based on your request, highlighting what is and isn't available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

This document describes non-clinical testing of a powered wheelchair, not a test set for an AI/algorithm-based device. Therefore, the concept of "sample size for the test set" and "data provenance" in the context of clinical data is not applicable. The testing involves physical tests on the device itself.

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

This information is not applicable as the document describes physical testing and compliance with engineering standards, not a study requiring expert-established ground truth for an algorithm.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

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 is not applicable. The device is a powered wheelchair, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This is not applicable. The device itself is a physical product (a powered wheelchair), not a standalone algorithm.

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

The "ground truth" for the Jazzy Elite 6 is established through compliance with recognized industry standards and regulatory requirements (e.g., RESNA, ANSI/RESNA, CAL 117, ISO 10993). This involves objective measurements and evaluations against specified criteria for safety, performance, and functionality of the physical device. It is not based on expert consensus for a diagnostic outcome or pathology.

8. The sample size for the training set:

This is not applicable as the document does not describe the development or testing of an AI algorithm that would require a training set.

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

This is not applicable for the reasons stated above.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is referred to as "Non-Clinical Testing" and the "Comparison to Predicate Devices."

The document states:

• "Compliance to applicable Testing Standards is as follows (See 7F for FDA-3654 forms):" followed by a list of RESNA, ANSI/RESNA, CAL 117, and ISO 10993 standards.
• "The Jazzy Elite 6 Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy Frontie (K092961), moreover, the non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the Jazzy Elite 6 is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation."

In essence, the "study" is a series of engineering and safety tests conducted on the physical device to ensure compliance with established standards, and a direct comparison of its design and performance against a previously cleared predicate device (Jazzy Frontie K092961). The specific details of these tests (e.g., how many units tested, exact results for each parameter within the standards) are not provided in this summary but are referenced as having been performed and demonstrating compliance.

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The intended use of the Pride Mobility Products Corporation Quantum Bariatric 451 is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

The Quantum Bariatric 451 is a Powered Wheelchair having a digital controller, electrical system, motors, batteries, seating, and frame. The Quantum Bariatric 451 is equipped with electronic regenerative disc brakes, 8A off-board battery charger, removable 12 volt batteries, front anti-tip wheels, and rear caster wheels.

The Quantum Bariatric 451 is designed with ultimate safety, stability, and performance in mind. The Powered Wheelchair is designed for, but not limited to Pride Mobility Products Corporation, providers/retailers and their consumers.

This document primarily details the substantial equivalence of the Quantum Bariatric 451 powered wheelchair to a predicate device and its compliance with relevant testing standards, rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy.

Therefore, many of the requested elements for describing an acceptance criteria study, particularly those related to diagnostic performance or AI model validation, are not applicable or cannot be extracted from this document.

However, I can provide information based on the document's content:

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

Based on the document, the "acceptance criteria" are compliance with established testing standards and demonstrating substantial equivalence to a predicate device. The "device performance" in this context refers to successfully meeting these standards and exhibiting similar characteristics to the predicate device.

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

• Sample Size: The document does not specify a "sample size" in the context of a test set for performance metrics the way one would for an AI or diagnostic device. The testing refers to engineering and safety standards applied to the device itself.
• Data Provenance: Not applicable in the context of clinical or AI data. The "data" refers to the results of non-clinical engineering and safety tests.

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

Not applicable. The ground truth for this type of device (powered wheelchair) is established by adherence to recognized engineering, safety, and flammability standards, and comparison to existing legally marketed predicate devices, rather than expert interpretation of a test set.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for discrepancies in expert opinion on ground truth. This document concerns engineering and safety compliance.

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 document is about a powered wheelchair, not an AI or diagnostic device that would involve human readers.

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

This concept is not applicable to a powered wheelchair. The device itself is a "standalone" product in the sense that it operates, but not in the context of an algorithm's performance without human interaction.

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

The "ground truth" here is compliance with established international and national standards for medical devices and wheelchairs, along with the mechanical and functional characteristics of the predicate device (Jazzy Frontie K092961). It's essentially engineering standards compliance and predicate device comparison.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as no training set (for AI) is involved.

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