The intended use of the Pride Mobility Products Corporation Q6 Edge EM is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Device Description

The Q6 Edge EM is a Powered Wheelchair having a digital controller, electrical system, motors, encoders, batteries, seating, actuator driven stability system, and frame. The Q6 Edge EM is equipped with electronic, regenerative disc brakes, off-board battery charger, removable 12 Volt U1 batteries, and front and rear caster wheels.

The Q6 Edge EM 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 Q6 Edge EM will incorporate all of the same features as current devices with elevation, but will utilize a secondary power actuator assembly in the base to lock the casters for additional stability. The actuator will be controlled through the current control system. The addition of the actuator assembly is the reason for this change.

The Q6 Edge EM utilizes a digital controller with a Class 1 Bluetooth®. The actual power output of the Bluetooth® device is 10 dBm (which is 10 mW) maximum output power at 50 Ohm impedance, and the maximum range is 40 m. The specific RF wireless technology type for this Bluetooth® is a Co-existence with IEEE 802.11 (AWMA, AFH). The Bluetooth® has 128-bit encryption security. The Bluetooth® allows clients to connect to a computer, smartphone, and tablet. The Bluetooth® is not active during driving or seating operation.

AI/ML Overview

The provided document is a 510(k) premarket notification for a powered wheelchair, the Q6 Edge EM. It does not contain information about studies related to AI, machine learning, or complex algorithms that would typically have acceptance criteria focusing on performance metrics like sensitivity, specificity, or AUC.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Pride Mobility Jazzy 600, K042612) by adhering to established performance and safety standards for powered wheelchairs.

Therefore, many of the requested points regarding AI/ML device studies (such as sample size for test set/training set, expert qualifications, adjudication methods, MRMC studies, standalone performance with specific performance metrics, and detailed ground truth establishment for AI models) are not applicable to this type of medical device submission.

Here's a breakdown of the available information based on your request, with an emphasis on what is present in the document:

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

The document does not present a formal table of acceptance criteria with specific numerical performance targets and reported results as one would typically see for an AI/ML diagnostic or prognostic device. Instead, acceptance is implied by compliance with recognized standards for powered wheelchairs.

Acceptance Criteria (Implied)	Reported Device Performance (Implied by Compliance)
Compliance with RESNA WC-1:2009 (Requirements and Test Methods for Wheelchairs)	Device passed non-clinical testing.
Compliance with RESNA WC-2:2009 (Additional Requirements for Wheelchairs with Electrical Systems)	Device passed non-clinical testing.
Compliance with California Technical Bulletin 117 (Flammability Test Requirements for Upholstered Furniture)	Device passed non-clinical testing.
Compliance with ISO 8191-1:1987 (Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition source: smouldering cigarette)	Device passed non-clinical testing.
Compliance with ISO 8191-1:1988 (Furniture - Assessment of ignitability of upholstered furniture -Part 2: Ignition source: match-flame equivalent)	Device passed non-clinical testing.
Compliance with AAMI / ANSI / ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	Device passed non-clinical testing.
Compliance with AAMI / ANSI / ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)	Device passed non-clinical testing.
Compliance with ANSI/AAMI/ISO 10993-12:2007 (Biological evaluation of medical devices - Part 12: Sample preparation and reference materials)	Device passed non-clinical testing.
Substantial Equivalence to Predicate Device (Pride Mobility Jazzy 600, K042612) in performance, maneuverability, stability, and structure	Claimed to be substantially equivalent.

The study proving the device meets these criteria is the "Non-Clinical Testing" detailed in the document, which involved demonstrating compliance with the listed standards.

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

This information is not provided in the document as it pertains to non-clinical testing against standards for wheelchair safety and performance, not a clinical study on a population. The testing involves specific units of the device under controlled lab conditions rather than patient data.

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 and therefore not provided. "Ground truth" in the context of AI/ML usually refers to labels or outcomes derived from expert review or clinical data. For this device, "ground truth" equates to mechanical and electrical engineering principles and compliance with established performance standards. The expertise would be in mechanical, electrical, and biomechanical engineering, and regulatory compliance, but not in medical image interpretation or clinical diagnosis.

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

This information is not applicable and therefore not provided. Such methods are used for resolving discrepancies in expert labeling during AI/ML model development.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or decision-support systems which is not the nature of this device.

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

This information is not applicable. The Q6 Edge EM is a powered wheelchair; it is a physical device operated by a human user, not a standalone algorithm. While it has a digital controller and Bluetooth, there is no "standalone algorithm performance" in the sense of an AI/ML model being evaluated.

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

As described in point 3, the "ground truth" for this device's non-clinical testing is based on compliance with established international and national standards (e.g., RESNA, ISO, California Technical Bulletin). This involves measurement of physical properties, electrical safety, flammability, and biocompatibility in a laboratory setting, not clinical outcomes or pathology.

8. The sample size for the training set

This information is not applicable and therefore not provided. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 23, 2015

Pride Mobility Product Corporation Kimberly Elmes Verification Manager, Quality Management Systems 182 Susquehanna Avenue Exeter, PA 18643

Re: K143383

Trade/Device Name: 06 Edge EM Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 25, 2015 Received: June 25, 2015

Dear Kimberly Elmes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena 🇿丛

Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143383

Device Name Q6 Edge EM

Indications for Use (Describe)

The intended use of the Pride Mobility Products Corporation Q6 Edge EM is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Exhibit 1 510(k) Summary Pride Mobility Products Corporation Q6 Edge EM

Submitter's Name & Address:

Pride Mobility Products Corporation 182 Susquehanna Avenue Exeter, PA 18643 Phone: (570) 655-5574 Facsimile: (570) 602-4056

Contact Person:

Kimberly Elmes

Date Prepared:

7/14/2015

Name of Device and Proprietary Name:

Q6 Edge EM

Common or Usual Name:

Powered wheelchair

Classification Name:

Physical Medicine / Powered Wheelchair

Product Code:

ITI

Comparison to Predicate Devices:

The Q6 Edge EM is substantially equivalent to the Pride Mobility Jazzy 600 (K042612), when comparing performance, maneuverability, stability, and structure. The performance characteristics and the position of the electronics and drive mechanisms are similar to achieve the same intended use function that enables the user to maintain optimum stability without hindering performance.

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The major differences between the Q6 Edge EM and the Jazzy 600 (K042612) are as follows:

· The Q6 Edge EM has a lower weight capacity of 200 lbs versus 300 lbs for the Jazzy 600.
. The Q6 Edge EM is slightly larger dimensionally (47.5" L and 27.5" W) versus the Jazzv 600 (35,25" L and 23,5" W).
. The Q6 Edge EM utilizes Curtis electronics (previously utilized on K112815 submission) versus Flight electronics on the Jazzy 600.
. The Q6 Edge EM will utilize a secondary power actuator assembly in the base to lock the casters for additional stability.

Device Description:

Intended Use:

The intended use of the Pride Mobility Products Corporation Q6 Edge EM is to provide mobility to persons limited to a seated position that have the capability of operating a Powered Wheelchair.

Non-Clinical Testing:

Compliance to applicable Testing Standards is as follows (Refer to 7F for FDA-3654):

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RESNA WC-1:2009 Requirements and Test Methods for Wheelchairs (Including ● Scooters).
RESNA WC-2:2009 - Additional Requirements for Wheelchairs (Including Scooters) with Electrical Systems
California Technical Bulletin 117 - Flammability Test Requirements for Upholstered Furniture
ISO 8191- 1:1987 Furniture -- Assessment of the ignitability of upholstered ● furniture -- Part 1: Ignition source: smouldering cigarette
. ISO 8191-1:1988 Furniture -- Assessment of ignitability of upholstered furniture --Part 2: Ignition source: match-flame equivalent
. AAMI / ANSI / ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity. (Biocompatibility)
AAMI / ANSI / ISO 10993-10:2010 Biological evaluation of medical devices Part ● 10: Tests for irritation and skin sensitization. (Biocompatibility)
ANSI/AAMI/ISO 10993-12:2007 Biological evaluation of medical devices Part ● 12: Sample preparation and reference materials.

Discussion of Clinical Testing Performed:

N/A

Conclusions:

The Q6 Edge EM Powered Wheelchair has the same intended use and similar technological characteristics as the Jazzy 600 (K042612), 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 Q6 Edge EM is substantially equivalent to the predicate device, has passed all the necessary testing, and is considered to be safe for user operation

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).