The intended use of the Solax Powered Wheelchair is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair.

Device Description

The Solax Powered Wheelchair (Model S7102) is to provide mobility to adults, limited to a seated position that have capability to operate a few simple controls and the ability to control a powered wheelchair. The Solax Powered Wheelchair (Model S7102) is with 100 kg (220 lbs) weight capacity. It is basic conventional rear wheels drive, rigid frame vehicle that are battery powered. It consists primarily of a foldable welded-aluminum frames, two sealed transaxle motors drive system, electromagnetic braking system, electric motor controller and two Li-ion batteries with an off-board battery charger. It is powered by rechargable batteries with 27.65 km which maximum speed upto 6.2 km/hr. The controller with a joystick attaches to either armrest and allows the rider to control the movement and velocity of the powered wheelchair. When the joystick is released, the electromagnetic brake will be actuated and the power wheelchair is slow to stop.

lt consists of four parts which are chair part, control part, folding part and drive part. Overall it mainly has a basic aluminum alloy frame, two front wheels, two anti-tip wheels, a seat, a footrest, an controller, an electric motor, an electromagnetic brake, a remote for folding the device and a Lithium battery with an off-board charger.

AI/ML Overview

The provided document is a 510(k) summary for the Solax Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device based on performance standards, rather than presenting a study of diagnostic or clinical effectiveness with specific acceptance criteria in the way a medical AI/ML device would.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. The document describes engineering and manufacturing specifications and adherence to international standards for wheelchairs.

However, I can extract the relevant information from the document regarding its "performance summary" which serves as the fulfillment of its acceptance criteria in the context of a powered wheelchair.

Here's the closest interpretation of your request based on the provided document:

Acceptance Criteria and Device Performance for Solax Powered Wheelchair (K182576)

The "acceptance criteria" for the Solax Powered Wheelchair are considered met by demonstrating compliance with various parts of the ISO 7176 standard series (Wheelchairs) and IEC standards for medical devices and software. The "study" proving this is the successful completion of these tests as reported by the manufacturer.

1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance

Acceptance Criteria (ISO/IEC Standard)	Reported Device Performance (Compliance Statement)
ISO 7176-1: 2014 (Static stability)	Conducted with Solax Powered Wheelchair
ISO 7176-2:2001 (Dynamic stability)	Conducted with Solax Powered Wheelchair
ISO 7176-3: 2012 (Effectiveness of brakes)	Conducted with Solax Powered Wheelchair
ISO 7176-4: 2008 (Energy consumption/theoretical distance range)	27.65 km range (complies with ISO 7176-4 Requirement as per Note 2)
ISO 7176-5: 2008 (Overall dimensions, mass and manoeuvring space)	Conducted with Solax Powered Wheelchair (Size and Base Weight comply with ISO 7176-5 Requirement as per Note 1)
ISO 7176-6: 2001 (Maximum speed, acceleration and deceleration)	Max speed: 6.2 km/h (complies with ISO 7176-6 Requirement as per Note 2)
ISO 7176-7: 1998 (Measurement of seating and wheel dimensions)	Conducted with Solax Powered Wheelchair (Tires comply with ISO 7176-7 Requirement as per Note 1)
ISO 7176-8:2014 (Static, impact and fatigue strengths)	Conducted with Solax Powered Wheelchair
ISO 7176-9:2009 (Climatic tests)	Conducted with Solax Powered Wheelchair
ISO 7176-10:2008 (Obstacle-climbing ability)	50mm obstacle climbing ability (conducted with Solax Powered Wheelchair)
ISO 7176-11: 2012 (Test dummies)	Conducted with Solax Powered Wheelchair
ISO 7176-13: 1989 (Coefficient of friction of test surfaces)	Conducted with Solax Powered Wheelchair
ISO 7176-14:2008 (Power and control systems)	Conducted with Solax Powered Wheelchair (Drive System complies with ISO 7176-14 Requirement as per Note 2)
ISO 7176-15:1996 (Information disclosure, documentation and labeling)	Conducted with Solax Powered Wheelchair
ISO 7176-16: 2012 (Resistance to ignition of postural support devices)	Conducted with Solax Powered Wheelchair
ISO 7176-21: 2009 (Electromagnetic compatibility)	Conducted with Solax Powered Wheelchair
ISO 7176-22: 2014 (Set-Up Procedures)	Conducted with Solax Powered Wheelchair
IEC 62304: 2006 (Medical device software, Software life-cycle processes)	Conducted with Solax Powered Wheelchair
IEC 60601-1-6: 2010 (Usability)	Conducted with Solax Powered Wheelchair
IEC 62366: 2007 (Application of usability engineering)	Conducted with Solax Powered Wheelchair

Note: For specific parameters like "Maximum speed forward," "Energy consumption," "Minimum braking distance," "Base weight," "Maximum capacity," and "Obstacle Climbing Ability," the document provides specific values for the subject device and states that these comply with the relevant ISO 7176 requirements, even if different from the predicate device. For "Battery" and "Battery Charger," it states they comply with "ISO 7176 Requirement" (general reference).

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

Sample Size for Test Set: Not explicitly stated as a number of devices. "Solax Powered Wheelchair" (singular) is referred to, implying at least one physical device was tested against these standards.
Data Provenance: The tests were "conducted with Solax Powered Wheelchair," implying these are prospective tests performed on the manufactured device. The manufacturer is "Dongguan Prestige Sporting Goods Co., Ltd." in Guangdong province, China, suggesting the testing was likely conducted in China or by a certified body on behalf of the manufacturer.

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

Not applicable. This isn't an AI/ML clinical study that requires expert adjudication for ground truth. Compliance with engineering standards is typically verified through standardized testing protocols executed by engineers or technicians in certified labs.

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

Not applicable. See point 3.

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 pertains to a powered wheelchair, not an AI/ML diagnostic or assistive device.

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

Not applicable. See point 5.

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

Not applicable. The "ground truth" equivalent here is the set of established performance criteria defined by the ISO 7176 and IEC standards for powered wheelchairs. The device performance is measured against these objective engineering and safety standards.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm.

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

Not applicable. See point 8.

Summary

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May 21, 2019

Dongguan Prestige Sporting Goods Co., Ltd % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, 510663 Cn

Re: K182576

Trade/Device Name: Solax Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: Class II Product Code: ITI Dated: April 21, 2019 Received: April 26, 2019

Dear Cassie Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182576

Device Name Solax Powered Wheelchair, model: S7102

Indications for Use (Describe)

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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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Submitter's Information 1.

Company Name: Dongguan Prestige Sporting Goods Co., Ltd. �
Establishment Registration Number: 3008841035 �
Address: 3rd industrial, Qiaotou Area, Houjie Town, Dongquan City, Guangdong province, China, � 523950
� Phone: 13763128800
� Fax: 86-769-85922505
Contact Person (including title): Zhang Zhao (General Manager) �
E-mail: leon@wisefame.com �

Application Correspondent 2.

� Contact Person: Ms. Cassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. �
� Tel: +86-20-61099984
� Email: requlatory@glomed-info.com

3. Subject Device Information

Type of 510(k) submission: Traditional �
Device Common or Usual Name: Powered Wheelchair �
� Trade Name: Solax Powered Wheelchair, model: S7102
� Regulation Name / Classification Name: Wheelchair, Powered
Medical specialty (Panel): Physical Medicine Device �
� Regulatory Class: II
Classification Product Code: ITI �
Regulation Number: 890.3860 �

Predicate Device Information 4.

� Sponsor: MERITS Health Products, Inc.
Device Trade name: MP3C Power Base Chair, Model: MP3C �
� Common name: Powered Wheelchair
Classification name: Wheelchair, Powered �
� 510K Number: K011687
Medical specialty (Panel): Physical Medicine �
Regulation number: 890.3860 �
Product Code: ITI �
Classification: Class II �

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5. Device Description

Intended Use / Indications for Use 6.

Performance Summary 7.

The following performance and safety tests were conducted with Solax Powered Wheelchair:

· ISO 7176-1: 2014, Wheelchairs Part 1: Determination of static stability
ISO 7176-2:2001, Wheelchairs Part 2: Determination of dynamic stability of Powered Wheelchairs
ISO 7176-3: 2012, Wheelchairs Part 3: Determination of effectiveness of brakes
· ISO 7176-4, Third edition 2008-10-01, Wheelchairs Part 4: Energy consumption of electric

wheelchairs and scooters for determination of theoretical distance range

· ISO 7176-5, Second edition 2008-06-01, Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space

• ISO 7176-6: 2001, Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of Powered Wheelchairs

• ISO 7176-7, First Edition 1998-05-15, Wheelchairs - Part 7: Measurement of seating and wheel dimensions

• ISO 7176-8:2014, Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strenaths

• ISO 7176-9:2009, Wheelchairs - Part 9: Climatic tests for Powered Wheelchairs

• ISO 7176-10:2008, Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs

• ISO 7176-11, Second edition 2012-12-01, Wheelchairs - Part 11: Test dummies

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· ISO 7176-13, First edition 1989-08-01, Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces

• ISO 7176-14:2008, Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods

• ISO 7176-15:1996, Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling

• ISO 7176-16, Second edition 2012-12-01, Wheelchairs - Part 16: Resistance to ignition of postural support devices

ISO 7176-21 Second edition 2009-04-01 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and battery chargers

• ISO 7176-22 Second Edition 2014-09-01 Wheelchairs - Part 22: Set-Up Procedures

IEC 62304: 2006 (First Edition), Medical device software, Software life- cycle processes
• IEC 60601-1-6 Medical electrical equipment- Part1-6: General requirements for safety-Collateral Standard: Usability Edition 3.0, 2010

• IEC 62366 Medical devices – Application of usability engineering to medical devices Edition 1.0, 2007

8. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Solax Powered Wheelchair is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device	Remark
Submitter	Dongguan Prestige SportingGoods Co., Ltd.	MERITS Health Products, Inc.	--
Proprietary name	Solax Powered Wheelchair	MP3C Power Base Chair	--
Model	S7102	MP3C	--
510K Number	K182576	K011687	--
Common orUsual name	Powered Wheelchair	Powered Wheelchair	SE
Intended use	The intended use of the SolaxPowered Wheelchair is to providemobility to adults, limited to aseated position that havecapability to operate a few simplecontrols and the ability to controla powered wheelchair.	The intended use of the MP3C isto provide mobility to adults,limited to a seated position thathave capability to operate a fewsimple controls and the ability tocontrol a powered wheelchair.	SE
Intended Use	Over-the-counter	Over-the-counter	SE
Size (unfold)	690mm x 600mm x 910mm	960 x 610 x 1040mm	SENote1
Tires	6 inches for front wheel (solidwheel)9 inches for rear wheel (solidwheel)	8 inches for front wheel (foamwheel)10 inches for rear wheel (foamwheel)	SENote1

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Maximum speedforward	6.2 km/h	8 km/h	SENote2
Energyconsumption	27.65 km	~ 32 km	SENote2
Minimum brakingdistance frommax speed	0.8 m	0.53m	SENote1
Base weight (notincluding battery)	52kg	54kg	SENote1
Brake	Electromagnetic	Electromagnetic	SE
Drive system	PG VR2 60A / Rear wheel drive	PG VR2 50A / Rear wheel drive	SENote2
Maximumcapacity	100 kg Approx.	135 kg Approx.	SENote2
ObstacleClimbing Ability	50mm	50mm	SE
Battery	Lithium 25.9V30AH	12V/U1*2 PCS	SENote3
Motor	24V 200W	24V 200W	SE
Battery charger	DC24V/2A off-board	5 Amp off-board	SENote3

Comparison Discussion:

Note1:

Although the "Size", "Base Wight" and "Turning Circle" are a little different from the predicative device, they all comply with ISO 7176-5 Requirement. Although the "Tires" is a little different from the predicative device, they all comply with ISO 7176-7 Requirement. So the differences will not raise any safety or effectiveness issues.

Note2:

Although the "Maximum speed forward" is a little different from the predicative device, they all comply with ISO 7176-6 Requirement. Although the "Energy consumption" and "Maximum capacity" are a little different from the predicative device, they all comply with ISO 7176-4 Requirement. Although the "Drive System" is a little different from the predicative device, they all comply with ISO 7176-14 Requirement. So the differences will not raise any safety or effectiveness issues.

Note3:

Although the "Battery" and "Battery Charger" are a little different from the predicative device, they all comply with ISO 7176 Requirement. So the differences will not raise any safety or effectiveness issues.

Final Conclusion

The subjective device "Solax Powered Wheelchairs, model S7102" are Substantially Equivalent to the predicate device as described herein.

8. Date of the summary prepared: 2019-05-16

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).