The SUNCO Mechanical Wheelchair, model SKW-9003 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, and the upholstery fabric meets the EN 1021-1:2006 Furniture --Assessment of ignitability of upholstered furniture - Part 1: Ignition source smouldering cigarette & EN 1021-2:2006 Furniture -- Assessment of ignitability of upholstered furniture - Part 2: Ignition source match flame equivalent. The back upholstery material is resistance-ignitability fabric. The removable desk-length armrest and swing-away detachable footrest.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the SUNCO Mechanical Wheelchair, model SKW-9003. This type of document is a regulatory approval, not a clinical study report. Therefore, it does not describe an AI/ML device or its performance criteria in the way envisioned by the posed questions.

The device in question is a mechanical wheelchair, which is a physical medical device, not a software or AI/ML-driven diagnostic or therapeutic device. The document focuses on demonstrating substantial equivalence to a predicate mechanical wheelchair based on design, materials, and performance against established safety standards.

Consequently, most of the requested information regarding acceptance criteria and a study proving an AI/ML device meets them cannot be extracted from this document. Specifically:

No AI/ML device: The document pertains to a mechanical wheelchair, not an AI/ML device.
No performance criteria for AI/ML: The acceptance criteria and performance data are related to the physical and mechanical aspects of the wheelchair (e.g., static stability, brake effectiveness, material ignitability), not AI/ML metrics like sensitivity, specificity, AUC, etc.
No clinical study for AI/ML effectiveness: The "performance data" refers to non-clinical bench testing against ISO standards for biocompatibility and safety of the wheelchair, not a clinical study involving human readers or AI assistance.

Therefore, I will provide the information that is present in the document related to the wheelchair's acceptance criteria and testing, and explicitly state when the requested AI/ML specific information is not available.

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

The document does not present acceptance criteria in a quantitative table with specific target values and achievement against those targets. Instead, it states that the device was tested against recognized ISO standards and "complied with" them, which implies meeting the requirements of each standard. The predicate device's characteristics are used for comparison to establish substantial equivalence.

Acceptance Criteria Category (implied by standards)	Reported Device Performance (implied by compliance)
Biocompatibility
Cytotoxicity (ISO 10993-5:2009)	Complied with standard
Sensitization (ISO 10993-10:2009)	Complied with standard
Irritation (ISO 10993-10:2009)	Complied with standard
Safety Testing (ISO 7176 series)
Static Stability (ISO 7176-1:2014)	Complied with standard
Effectiveness of Brakes (ISO 7176-3:2012)	Complied with standard
Overall Dimensions (ISO 7176-5:2008)	Complied with standard
Seating Dimensions (ISO 7176-7:1998)	Complied with standard
Static, impact and fatigue strength (ISO 7176-8:2014)	Complied with standard
Test Dummies (ISO 7176-11:2012)	Complied with standard
Coefficient of friction of test surfaces (ISO 7176-13:1989)	Complied with standard
Information disclosure, documentation, labeling (ISO 7176-15:1996)	Complied with standard
Resistance to ignition of upholstered parts (ISO 7176-16:2012)	Complied with standard (material meets EN 1021-1:2006 & EN 1021-2:2006)
Set-up procedures (ISO 7176-22:2014)	Complied with standard
Functional/Design Characteristics	(Compared to predicate, differences deemed not to raise safety/effectiveness concerns)
Overall dimensions (Length, Width, Height)	42", 25.2", 36" (similar to predicate)
Frame (Cross brace, Backrest, Seat sling)	YES, Fixed, Fixed, Padded Nylon (similar)
Weight of wheelchair	38.6 lb / 17.5 kg (similar to predicate)
Weight Capacity	220 lb / 100 kg (lower than predicate, but documented)

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 applicable in the context of an AI/ML device or a clinical study. The performance data presented refers to bench testing of the physical wheelchair and its components. Specific sample sizes for these engineering tests (e.g., how many wheelchairs were tested for static stability) are not detailed, but the testing was done by the manufacturer (Danyang Sunco Machinery Co., Ltd.) in China. This is not a human subject-based test set.

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 is not applicable as the device is a mechanical wheelchair and no ground truth by human experts interpreting data (as in AI/ML performance evaluation) was established. The "ground truth" for the wheelchair's safety and performance is defined by the technical specifications and test methods within the cited ISO standards.

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

Not applicable. There was no human interpretation or adjudication involved in evaluating the performance of this mechanical device against standard engineering tests.

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 mechanical wheelchair, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

Not applicable. This is a mechanical wheelchair, not an AI algorithm.

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

For the mechanical wheelchair, the "ground truth" or reference for evaluating its performance is based on predefined engineering and safety standards (ISO standards) and the characteristics of a legally marketed predicate device. There is no "ground truth" in the sense of clinical pathology, expert consensus, or outcomes data as would be used for an AI/ML device.

8. The sample size for the training set

Not applicable. This device is a mechanical wheelchair and does not involve AI/ML models that require a training set.

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

Not applicable. This device is a mechanical wheelchair and does not involve AI/ML models that require a training set or ground truth for such a set.

Summary

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

July 20, 2016

Danyang Sunco Machinery Co., Ltd Jen Ke-Min Official Correspondent Taojing Road, Optics Industrial Park, Situ Town Danyang City, 212300 CN

Re: K153328

Trade/Device Name: SUNCO Mechanical Wheelchair, model SKW-9003 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: March 4. 2016 Received: July 11, 2016

Dear Jen Ke-Min:

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

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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 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. 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 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,

Michael J. Hoffmann -A

Carlos L. Peña, PhD, MS for 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) K153328

Device Name

SUNCO Mechanical Wheelchair, model SKW-9003

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Taojing Road, Optics Industrial Park, Situ Town, Danyang City, Jiangsu, China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116

SECTION D

510(k) Summary of Safety and Effectiveness

(per 21 CFR 807.92)

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Taojing Road, Optics Industrial Park, Situ Town, Danvang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116

I. SUBMITTER

Danyang Sunco Machinery Co., Ltd. Taojing Road, Optics Industrial Park, Situ Town, Danyang City, Jiangsu, China 212300

Phone: +86-511-86733686 Fax: +86-511-86733116 Contact Person: Jen, Ke-Min, ceirs.jen(@msa.hinet.net Date Prepared: July 20, 2016

DEVICE II.

Name of Device:	SUNCO Mechanical Wheelchair, model SKW-9003
Common or Usual Name:	Mechanical Wheelchair
Classification Name:	Wheelchair, Mechanical (21 CFR 890.3850)
Regulatory Class:	Class I
Product Code:	IOR

III. PREDICATE DEVICE

Valentine International Ltd. Valentine Steel Wheelchair, model 1000, K130017

IV. DEVICE DESCRIPTION

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Taojing Road, Optics Industrial Park, Situ Town,

Danyang Citv. Jiangsu. China 212300

Tel: +86-511-86733686 Fax:+86-511-86733116

The features of the subject device include

The back upholstery material is resistance-ignitability fabric.
�� The removable desk-length armrest and swing-away detachable footrest..

Due to the device design of the body structure the following surfaces are recommended NOT to operate on:

. Sand surface
. 1Wet or icy surface
. Road maintenance hole metal cover
. Avoid going up multiple steps.
. Avoid using escalators. Use the elevator.
. Too steep incline over 10 degrees.
. Turning Diameter 31"
Ground clearance: 2.3" .
. Curb climbing ability: 0.8"

v. INDICATIONS FOR USE

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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Comparison table

ITEMS	Predicate device	Subject device
Manufacturer	Valentine International Ltd.	DANYANG SUNCOMachinery Co., Ltd.
Brand name	Valentine	SUNCO
Device name	Steel Wheelchair,model 1000	Mechanical Wheelchair,model SKW-9003
510(k) Number	K130017	K153328

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Taojing Road, Optics Industrial Park, Situ Town,

Similarities
Indications for use	The device is intended formedical purposes to providemobility to personsrestricted to a sittingposition.	Same indications for use
Operating environments	For Indoor / Outdoor use	Same operating environments
Technologicalcharacteristics	Testing per ISO7176-1/-3/-5/-7/-8/-11/-13/-15/-16 series standards	Same technological standards
Overall dimensionsLengthWidthHeight	42"25.2"36.2"	42"25.2"36"
FRAMECross braceBackrest heightReclining backrestSeat slingFrame color	YESFixedFixedPadded NylonBlue Powder Coating	YESFixedFixedPadded NylonSilver hammer tone
HANGERSSwing-awayElevating leg restArticulating leg restFootplate styleHeel loopFootrest angle	YESYESYESPaddedNo10~15°	Same hangers
REAR AXLEOffset axleQuick-release axle	YESYES	Same rear axle
REAR WHEELSizeTire typeHandrim Diameter /material	24"*1"PU Solid Material21" / Steel Composite	Same rear wheel
Wheel Lock	Pull-to-Lock	Same wheel lock
Ground Clearance	2.3"	Same ground clearance
Climbing Angle	10 degrees	Same climbing angel
Curb climbing ability	0.8"	Same curb climbing ability
Minimum turningdiameter	31"	Same minimum turning radius
Curb Stepper	YES	YES
ARMREST
Arm pad	Padded	Padded
Flip back	YES	YES
Height-adjustable	NO	NO
Optional accessory
Anti-tipper	YES	YES
Seat belt	YES	YES
Differences
Seat dimensions
Depth	16"	16"
Height	20"	20"
Width	18"	20"
Casters
Size	8"*1"	7.9"*1"
Tire type	PU solid material	PVC solid material
Weight of wheelchair	40 lb / 18.1 kg	38.6 lb / 17.5 kg
Weight Capacity	250 lb / 113.4 kg	220 lb / 100 kg
Warranty	12 months for the main parts(footrest, wheel locks, armrest,cross braces, backrest canes,front fork, fork stem house)The chair side frames areguaranteed for 5 years from thedate of purchase.	12 months for the main parts(chair side frames, footrest, wheellocks, armrest, cross braces,backrest canes/Push handle tube,front fork, fork stem house)

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Taojing Road, Optics Industrial Park, Situ Town, Danyang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116

● Discussion

From the above comparison table, we knew that the indications for use of both devices are the same. Both mainframes of two devices are foldable. The castor tires are PU 8" solid tires for predicate device and PVC 7.9" solid tires for subject device. The PU tires can absorb more vibrational impact from the unsmooth ground than PVC tires. The difference is not much as to raise any safety and effectiveness concerns. The weights of wheelchairs (40 lb vs. 38.6 lb) differ not so much to raise any safety and effectiveness concerns. This difference means the user needs less power to move the wheelchair for the subject device. The front/rear tire sizes PVC solid 7.9"*1"/ PU solid 24"*1" and weight capacity (220 lbs.) are indicated on the product durable label and user manual for the

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Taojing Road, Optics Industrial Park, Situ Town. Danvang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116

subject device. The users can be informed of those limitations. The chair side frames are guaranteed for 5 years for predicate device and 1 year for the subject device. The difference in the chair side frames warranty periods just involves the more cost paid by the users of the subject device, and it does not raise any safety and effectiveness concerns. Overall dimensions are the same, and seat width has the difference of 2". No safety and effectiveness concerns are raised about this. The other safety and effectiveness concerns of the subject device have been considered and mitigated by complying with the ISO 7176 series standards.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the SUNCO Mechanical Wheelchair SKW-9003 was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The testing included the following tests:

Cytotoxicity: ISO 10993-5:2009
Sensitization: ISO 10993-10: 2009
Irritation .: ISO 10993-10:2009

Safety testing

To ensure the safety and effectiveness of the device, the following ISO 7176 series standards were complied with:

1. ISO 7176-1 Wheelchairs Part 1: Determination of static stability, 2014. (FDA
  Recognition Number: 16-158 )
1. ISO 7176-3 Wheelchairs Part 3: Determination of effectiveness of brakes, 2012.
  (FDA Recognition Number: 16-192)

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Taojing Road, Optics Industrial Park, Situ Town, Danvang Citv. Jiangsu. China 212300 Tel: +86-511-86733686 Fax:+86-511-86733116

1. ISO 7176-5 Wheelchairs Part 5: Determination of overall dimensions, mass and maneuvering space, 2008. (FDA Recognition Number: 16-163)
1. ISO 7176-7 Wheelchairs Part 7: Determination of seating dimensions Definitions and measuring method, 1998. (FDA Recognition Number: NA)
1. ISO 7176-8 Wheelchairs Part 8: Static, impact and fatigue strength for manual wheelchairs, 2014. (FDA Recognition Number: NA)
1. ISO 7176-11 Wheelchairs Wheelchairs Part 11: Test dummies, 2012. (FDA Recognition Number: 16-190)
1. ISO 7176-13 Wheelchairs Part 13: Determination of coefficient of friction of test surfaces, 1989. (FDA Recognition Number: 16-25)
1. ISO 7176-15 Wheelchairs Part 15: Requirements for information disclosure, documentation and labelling, 1996. (FDA Recognition Number: 16-27)
1. ISO 7176-16 Wheelchairs Part 16 Requirements and test methods for resistance to ignition of upholstered parts, 2012. (FDA Recognition Number: 16-191)
1. ISO 7176-22 Wheelchairs Part 22 Set-up procedures, 2014 (FDA Recognition Number: NA)

VIII. CONCLUSIONS

The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph III of this section. They are substantially equivalent.

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).