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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 Jazzy Frontie is to provide mobility to disabled persons having limited walking capabilities. The intended use of the Jazzy Frontie is to provide mobility to those who are limited to a seated position that have the capability of operating a Powered Wheelchair.

The Jazzy Frontie is a Powered Wheelchair having a digital controller, electrical 140 outly motors, batteries, seating, and frame. The Jazzy Frontie is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, front anti-tip wheels, and rear caster wheels. The Jazzy Frontie has a depth adjustable fold flat seat that provides fast, simple adjustment for enhanced, personalized comfort that is removable.

The provided text is a 510(k) summary for a powered wheelchair, the Jazzy Frontie. It details the device's description, intended use, and comparison to a predicate device, as well as non-clinical testing performed. However, it explicitly states "N/A" for "Discussion of Clinical Testing Performed."

Therefore, based on the provided document, the following points regarding acceptance criteria and a study proving the device meets them cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on regulatory compliance through non-clinical testing and substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical study was performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical study was performed.
4. Adjudication method for the test set: Not applicable as no clinical study was performed.
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 as no clinical study was performed, and the device is a powered wheelchair, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a powered wheelchair, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical study was performed.
8. The sample size for the training set: Not applicable as no clinical study that would require a training set was performed.
9. How the ground truth for the training set was established: Not applicable as no clinical study that would require a training set was performed.

The document primarily relies on non-clinical testing and substantial equivalence to a predicate device (Pride Mobility Jet 1, K001970) to demonstrate safety and effectiveness.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing and Substantial Equivalence):

Study Proving Acceptance Criteria Met:

The study proving the device meets the acceptance criteria is non-clinical testing in conjunction with a substantial equivalence comparison to a predicate device.

• Non-Clinical Testing: The device underwent testing to comply with various standards including:

  • RESNA WC Vol.1 2008 DRAFT
  • RESNA WC Vol. 2 2008 DRAFT
  • ANSI/RESNA WC Vol. 2-1998 Section 21
  • IEC 601-1-1
  • CAL 117
    The document states the device "passed all the necessary testing."

• Substantial Equivalence Study: A comparison was made to the predicate device, Pride Mobility Jet 1 (K001970), demonstrating that the Jazzy Frontie

  • Has the same intended use.
  • Has similar technological characteristics.
  • Does not raise new questions of safety or effectiveness due to any differences in technological characteristics.

In summary, no clinical study was performed or required for the 510(k) clearance of the Jazzy Frontie powered wheelchair. The evidence supporting its safety and effectiveness is based on adherence to recognized non-clinical performance standards and a demonstration of substantial equivalence to an already legally marketed device.

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The intended use of the Pride Mobility Products Corp. Jazzy 600 Powered Wheelchair is to provide mobility to persons limited to a seated position.

The intended use of the Pride Mobility Products Corp. Jazzy 600 Power Wheelchair is to provide mobility to persons limited to a seated position, that have the capability of operating a powered wheelchair.

The Jazzy 600 is a battery-operated power wheelchair featuring Mid-Wheel Drive technology, rear casters, front anti-tip casters, and a standard 75 amp Pride Flight controller. The Jazzy 600 is designed for, but not limited to Pride Mobility Products Corp. providers / retailers and their consumers.

The Jazzy 600 Power Wheelchair consists of the same basic components found on the Jazzy (K945936), such as a rigid steel frame, upholstered seat, amrests, football drive wheels, rear caster wheels and front anti-tip devices. As a motorized wheelshair substantially equivalent to the Jazzy (K945936) it also offers 2 motors for operational purposes, electronic regenerative disc brakes, suspension, onboard hattery charger, a fully programmable controller, and requires two batteries. Accessories include lap bett, rear basket, cane or crutch holder, oxygen holder, walker holder, flag holder, cup holder, saddle bag, and dust cover.

The Jazzy 600 is designed with ultimate safety, stability, and performance in mind. It features rear casters, and front anti-tip casters which allow for surface contact all times and prevents pitching on sloped terrain.

The provided document is a 510(k) premarket notification for a powered wheelchair, the Jazzy 600. It focuses on demonstrating substantial equivalence to a predicate device and includes information on non-clinical testing. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a clinical study for an AI/algorithm-based medical device would.

Therefore, I cannot fulfill your request for the specific acceptance criteria and study details as they are not present in the provided text. The document refers to "Non-Clinical Testing" which details compliance to various ANSI/RESNA WC standards. These are likely performance and safety standards for wheelchairs, not clinical efficacy metrics for an AI.

Here's a breakdown of why each numbered point of your request cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document lists "Compliance to applicable Testing Standards" for non-clinical aspects like static stability, dynamic stability, brakes, dimensions, etc., but it doesn't provide specific numerical acceptance criteria or performance metrics in a table format. For example, it lists "ANSI/RESNA WC/01 Determination of Static Stability" but doesn't state what the acceptable static stability angle is or what the Jazzy 600 achieved.
2. Sample sized used for the test set and the data provenance: Not applicable. The testing described is non-clinical, likely involving physical prototypes and testing equipment, not human subjects or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/algorithm performance is not relevant here.
4. Adjudication method for the test set: Not applicable.
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 is a powered wheelchair; it does not involve human readers or AI assistance in data interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical powered wheelchair.
7. The type of ground truth used: Not applicable. The "ground truth" for a physical device like a wheelchair is compliance with engineering and safety standards, determined by physical measurements and tests.
8. The sample size for the training set: Not applicable. This device is not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The provided document describes the non-clinical testing performed for the Jazzy 600 Powered Wheelchair to demonstrate substantial equivalence to a predicate device for its physical and mechanical performance and safety. It is not a document describing the validation of an AI or algorithm.

The non-clinical testing focuses on compliance with the following ANSI/RESNA WC standards:

• ANSI/RESNA WC/01 Determination of Static Stability
• ANSI/RESNA WC/02 Determination of Dynamic Stability
• ANSI/RESNA WC/03 Effectiveness of Brakes
• ANSI/RESNA WC/05 Overall Dimensions, Mass & Turning Space
• ANSI/RESNA WC/08 Test methods for Static, Impact and Fatigue Strengths
• ANSI/RESNA WC/09 Climatic Tests
• ANSI/RESNA WC/10 Obstacle Climbing
• ANSI/RESNA WC/15 Documentation and Labeling
• ANSI/RESNA WC Vol. 2-1998 Section 21 - Requirements and Test Methods for Electromagnetic Compatibility.
• ANSI/RESNA WC/93 Maximum overall Dimensions
• CAL 117 - Flammability Testing

The conclusion states that the Jazzy 600 "has passed all the necessary testing procedures and is considered to be safe for user operation." This implies that the device met the requirements of these standards, but the document does not further elaborate on specific numerical acceptance criteria or performance results within these standards.

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