The Shengguang Manual Wheelchair is an indoor/outdoor wheelchair that has a base with four-wheels with a seat. The device can be disassembled for transport and it is foldable easily. Both the back and seat upholstery material is the same resistanceignitability fabric.

AI/ML Overview

The provided text is a 510(k) summary for a manual wheelchair, which is a Class I medical device. For such devices, the regulatory pathway relies on demonstrating "substantial equivalence" to a predicate device already on the market, rather than extensive clinical studies that measure specific performance metrics against acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and ground truth establishment is typically not part of a 510(k) submission for a manual wheelchair.

However, based on the provided text, I can infer the acceptance criteria are adherence to recognized standards for wheelchair performance and safety, along with demonstrating similarity to predicate devices. The "study" that proves the device meets these criteria is the non-clinical testing described in the submission, along with the substantial equivalence comparison.

Here's an attempt to answer your questions based on the available information, noting where specific details are not provided due to the nature of the device and regulatory submission:

1. Table of acceptance criteria and the reported device performance

Given the nature of a manual wheelchair and a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily established by conformity to recognized industry standards and direct comparison of features and performance to legally marketed predicate devices. The device "performance" is implicitly demonstrated by passing these tests and showing equivalence.

Acceptance Criteria Category	Specific Criteria / Standard Applied	Reported Device Performance	Comments / Context
Safety & Performance Standards	ANSI/RESNA WC-1:2009 Section 1: Determination of static stability	Compliance demonstrated.	Device passed this standard.
	ANSI/RESNA WC-1:2009 Section 3: Determination of effectiveness of brakes	Compliance demonstrated.	Device passed this standard.
	ANSI/RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space	Compliance demonstrated.	Device passed this standard.
	ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions	Compliance demonstrated.	Device passed this standard.
	ANSI/RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strengths	Compliance demonstrated.	Device passed this standard.
	ANSI/RESNA WC-1:2009 Section 11: Test dummies	Compliance demonstrated.	This section likely refers to the use of standardized test dummies during testing.
	ANSI/RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces	Compliance demonstrated.	Device passed this standard.
	ANSI/RESNA WC-1:2009 Section 15: Requirements for information disclosure, documentation and labeling	Compliance demonstrated.	Device passed this standard.
Material Flammability	California Technical Bulletin 117 Section E Part 1 (Upholstery material)	Shown to be Class 1 - normal flammability.	Applies to SG-LY-001001/ SG-LY-001016 and SG-LY-001017/SG-LY-001018 series.
	California Technical Bulletin 117 Section A Part 1 and Section D Part 2 (Seat cushion foam material)	Shown to meet performance standards.	Demonstrated compliance with flammability standards for foam.
Biocompatibility	FDA Guidance G95-1	Meets biocompatibility requirements.	Based on using same materials, chemical composition, and manufacturing processes as predicate devices for patient-contacting components.
Substantial Equivalence to Predicate Devices	Same intended use, similar specifications, functions, and performance as predicate devices.	The Shengguang Manual Wheelchair is substantially equivalent.	Differences in weight of wheelchair, style of backrest height, and armrest did not affect safety and effectiveness.

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 applicable in the context of a 510(k) for a basic manual wheelchair. The "test set" here refers to the actual physical device models manufactured by Shengguang. The standards (ANSI/RESNA WC-1:2009) define the specific number of test pieces required (e.g., how many chairs are subjected to durability tests), but this detail isn't explicitly stated in the summary.
Data Provenance: The testing was "Non-clinical testing performed on the Shengguang Manual Wheelchair." The country of origin for the testing is not explicitly stated, but it would have been conducted by or for Pingdingshan Shenxing Healthcare Technology Co., Ltd. in China. The data is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

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 question is not applicable to this type of device and submission. "Ground truth" and expert consensus are concepts typically relevant to diagnostic or AI-driven devices where human interpretation or expert labeling is needed. For a manual wheelchair, compliance with engineering standards and material properties is objectively measured, not subjectively interpreted by experts for ground truth.

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

Not applicable. Adjudication methods (like 2+1 or 3+1) are used in clinical trials or studies where subjective assessments (e.g., lesion detection, disease staging) require resolution of discrepancies among multiple reviewers. For mechanical device testing against standards, the results are typically objective measurements.

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 device is a manual wheelchair, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies and concepts of human readers or AI assistance are irrelevant to this submission.

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

Not applicable. This question pertains to AI/algorithm performance. The Shengguang Manual Wheelchair is a mechanical device and does not involve any algorithms or AI.

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

As explained in point 3, the concept of "ground truth" as typically defined for diagnostic or AI devices does not apply here. The "truth" for this device's performance is established by objective measurements and adherence to recognized international and national consensus standards (ANSI/RESNA WC-1:2009) for mechanical properties, safety, and flammability. Material properties are verified against specifications and predicate device equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" for a manual wheelchair. This term refers to data used to train machine learning models.

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

Not applicable. As there is no training set (see point 8), there's no ground truth to establish for it.

In summary: The K131529 submission for the Shengguang Manual Wheelchair demonstrates substantial equivalence primarily through adherence to established performance and safety standards for wheelchairs and direct comparison of its design and components to previously cleared predicate devices. The specific types of studies, ground truth, and expert involvement described in your prompt are characteristic of submissions for more complex, often software-driven or diagnostic, medical devices, and do not apply to this Class I manual wheelchair.

Summary

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K131529

510(K) SUMMARY

This 510(k) summary of safety and effectiveness for Shengguang Manual Wheelchair is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Applicant:	Pingdingshan Shenxing Healthcare Technology Co., Ltd.
Address:	Xinxing Road South of industrial Park, Lushan County,Pingdingshan City Henan P.R. China
Contact Person:	Wang Qing
Telephone:	(86 0375)- 5620005
Email:	kenwqing@gmail.com
Date of Preparation:	Aug. 28, 2013
Device Name:	SHENGGUANG MANUAL WHEELCHAIR
Classification Name:	Manual Wheelchair
Device Class:	Class I
Regulation Number	890.3850
Product Code:	IOR
Classification Panel	Physical Medicine
Type of submission	Traditional 510K

Table 1 General Information

Intended use:

The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position.

Indications for Use:

The Shengguang Manual Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position. Shengguang Manual Wheelchair is not designed, sold, or intended for use except as indicated.

Device Description

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All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in Predicate Devices.

Predicate Devices:

Universal Wheelchair by Graham-Field Health Products, Inc. (Formerly Everest & Jennings), 510(k) # K930411.
7000 Series Lightweight Wheelchairs by Nova Ortho-Med, Inc., 510(k) # K061273.

Substantial Equivalence Discussion

Shenxing Healthcare Technology Co. believes that its Shengguang Manual Wheelchair is substantially equivalent to the Predicate Devices for the following reasons.

The Shengguang Manual Wheelchair has the same indication as the predicate device that it is intended for medical purposes to provide mobility to persons restricted to a seated position.

There are no significant differences between the specifications, functions and performance of Shengguang Manual Wheelchair and legally marketed predicate devices to which it is claimed to be substantially equivalent.

Summary of Substantial Equivalence Comparison

Table 2: Descriptive Comparison of Shengguang Manual Wheelchair to Predict Devices

ITEMS	SUBJECT DEVICE				PREDICATEDEVICE	PREDICATEDEVICE
BRAND NAME	SHENGGUANG	SHENGGUANG	SHENGGUANG	SHENGGUANG	Everest&Jennings	Nova
MANUFACTURER	Pingdingshan Shenxing HealthcareTechnology Co., Ltd				Graham-FieldHealthProducts	NovaOrtho-med Inc.
MODEL NO	SG-LY-001001(Fixedarmrest)	SG-LY-001016(detachable shortarmrest)	SG-LY-001017	SG-LY-001018	Metro IC4(3D020120)(UniversalWheelchair)	Nova7160L/7180L
510K NO					K930411	K061273
INTENDED USE	Same	Same	Same	Same	The device isintended formedical	To providemobility to adultpersons with
						purposes toprovidemobility topersonsrestricted to aseated position	limited mobilityor adult personslimited to aseated position.(Over-The-Counter Use)
	PrimaryMaterial	Same	Same	Same	Same	Welded steeltube	Welded steeltube
	width	16"/18"(406mm/457mm/)	Same	Same	Same	16"/18"/20"(406mm/457mm/508mm)	16"/18"/20"(406mm/457mm/508mm)
	Cross brace	Same	Same	Same	Same	Yes	Yes
	Depth	895mm	895mm	895mm	Same	915mm	915mm
frame	Seat	Same	Same	Same	Same	Width:16"/18"/20"(406mm/457mm/508mm)	Width:16"/18"/20"(406mm/457mm/508mm)
		Same	Same	Same	Same	Depth16"(406mm)	Depth16"(406mm)
	Backrestheight	Fixed	Fixed	Fixed	Same	adjustable	adjustable
	Recliningbackrest	Same	Same	Same	Same	Fixed	Fixed
	Seat sling	Same	Same	Same	Same	Padded nylon	Padded nylon
	Frame colors	Same	Same	Same	Same	Black	Black
	Arm pad	Same	Same	Same	Same	Padded	Padded
Armrest	Flip back	Fixed	Detachable	Detach-able	Same	Flip back	Flip back
	Height-adjustable	Same	Same	Same	Same	No	No
	Swing-away	Same	Same	Same	Same	Yes	Yes
HANGERS	Elevating legrest	Same	Same	Same	Same	Yes	Yes
	Articulatingleg rest	Same	Same	Same	Same	No	No
	Footplate style	Same	Same	Same	Same	PA	PA
	Heel loop	Same	Same	Same	Same	No	No
	Footrest angle	Same	Same	Same	Same	20°	20°
	Offset axle	Same	Same	Same	Same	No	No
REAR
AXLE	Quick-releaseaxle	Same	Same	Same	Same	No	No
	Whorl	Same	Same	Same	Same	Yes	Yes
REARWHEEL	Size		Same	Same	Same	24"	24"
	Tire type	Same	Same	Same	Same	Solidnylon	SolidNylon
	Handrimmaterial	Same	Same	Same	Same

CASTERS	Size	Same	Same	Same	Same		8"
	Tire type	Same	Same	Same	Same		Solid
WHEEL LOCK		Same	Same	Same	Same	Manual	Manual
Upholstery Material		PVC(Same asGF Vista)	PVC(Same asGF Vista)	Same	Same	.Nylon	Nylon
WEIGHT CAPACITY		250lbs	250lbs	Same	Same	300lbs/136kg	300lbs/136kg
WEIGHT OF CHAIR		17.3kg(38lb)	18.6kg(41lb)	17.3kg(38lb)	Same	15.5kg(34lb)	15.5kg(34lb)
WARRANTY		Same	Same	Same	Same	5 years onframe	5 years on frame
OPTIONALACCESSORIES	Anti-tipper	No	No	No	Same	Yes	Yes

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・

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The Shengguang Manual Wheelchair and the predicate devices employ the same technology and are similar in design, dimensions and other technological features. As seen in Table 2, the only differences in features between the Shengguang Manual Wheelchair and the predicate Devices are small differences in the weight of the wheelchair, style of the backrest height and armrest. These differences do not affect the safety and effectiveness of the Shengguang Manual Wheelchair compared to the predicate device.

Technological/Safety Characteristics and Performance Testing

The Shengguang Manual Wheelchair's technological and safety characteristics are identical to those described in the Predicate Devices.

Non-clinical testing has been performed on the Shengguang Manual Wheelchair and the results demonstrate compliance with the following standards:

ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability

ANSI/RESNA WC-1:2009 Section3: Determination of effectiveness of brakes

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ANSI/RESNA WC-1:2009 Section 5: Determination of dimensions, mass and maneuvering space

ANSI/RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions

ANSI/RESNA WC-1:2009 Section 8: Requirements and test methods for static, impact and fatigue strengths

ANSI/RESNA WC-1:2009 Section 11: Test dummies

ANSI/RESNA WC-1:2009 Section 13: Determination of coefficient of friction of test surfaces

ANSI/RESNA WC-1:2009 Section 15: Requirements for information disclosure, documentation and labeling

The upholstery material for the SG-LY-001001/ SG-LY-001016 and SG-LY-001017/SG-LY-001018 series is the same as those used for the Graham Field Vista model and the Graham Field Metro IC4 model, respectively. It was tested in accordance with the California Technical Bulletin 117 Section E Part 1 and was shown to be Class 1 - normal flammability.

The foam material for the seat cushion was tested for flammability in accordance with the California Technical Bulletin 117 Section A Part 1 and Section D Part 2, and was shown to meet the performance standards.

Biocompatibility

The patient contacting components of the Shengguang Manual Wheelchair use the same materials, have the same chemical composition, and are manufactured using the same process by the same suppliers, as those of the Predicate Devices. Therefore, the Shengguang Manual Wheelchair meets the biocompatibility requirements in accordance with FDA Guidance G95-1. The comparison is shown in Table 3a and Table 3b.

Model	Parts	Material	Comparison Device	510(k) NO.
ShengguangManualWheelchairSeries	Handgrip	PVC	YUYUE K2Wheelchair	K120526
	Armrest shell	ABS	YUYUE K2Wheelchair	K120526
	Handrim	Nylon	YUYUE K2Wheelchair	K120526
	Brake handle	Rubber	YUYUE K2Wheelchair	K120526

Table 3a. Comparison with Predicate Device Parts:

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		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The first and the last and the been the desires of the first and the	89.77neelchair3	STATUTE AND INCOME OF CHARACT AND THE PERSONAL PROPERTY------------------
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	10-40-440

Table 3b. Comparison with Predicate Device Parts:

Model	Parts	Material	Comparison Device	510(k) NO.
ShengguangManualWheelchairSeries	Upholstery ofseat and back	Oxfordcloth, PVC	YUYUE K2, K4Wheelchair	K120526
			JUMAO MANUALWHEELCHAIR	K082784

Conclusion:

The data submitted in this 510(K) Premarket Notification supports the finding that this device is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Devices. Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 24, 2013

Pingdingshan Shenxing Healthcare Technology Co., LTD c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K131529

Trade/Device Name: Shengguang Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 11, 2013 Received: September 12, 2013

Dear Mr. Job:

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

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Page 2 - Mark Job

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance 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,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting 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):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use ___ X (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

Page 1 of _1

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).