The proposed device, Wheelchair model HM303, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.

The main frame is made of magnesium alloy frame, which has a seat base with four-wheeled with a back cover. Upon the outside of this framework, and to the rear, are assembled two axle plates, wheels are connected to the stainless steel axle receivers via stainless steel axles. On the front end of the frame are assembled two caster housings. Caster forks are mounted to these housings via steel axles. On the front end of the frame, upon the caster, two footplates are assembled for foot holding. Two armrests are mounted on the frame for user's arm holding. Two grips mounted on the top end of the frame with a brake, and another brake is designed under the seat base. A folden set is on the frame, under the grips, for folding backrest.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of a medical device with an AI component or a comparative effectiveness study.

The document is a 510(k) premarket notification for a Wheelchair, which is a mechanical device, not an AI-powered one. The submission focuses on demonstrating substantial equivalence to a predicate mechanical wheelchair through non-clinical performance and biocompatibility testing against established ISO standards.

Here's why the requested information cannot be extracted from the provided text:

No AI Component: The device described is a "Mechanical Wheelchair" (Model HM303). There is no mention of any artificial intelligence, machine learning, or software algorithm components.
No Clinical Study for Effectiveness: The document explicitly states "No Clinical Test conducted" in Section 8. The evaluation relies solely on non-clinical tests (physical performance and biocompatibility) and comparison to a predicate device.
No Comparative Effectiveness Study: Since there's no AI component and no clinical study, there is no multi-reader multi-case (MRMC) comparative effectiveness study or analysis of human reader improvement with AI assistance.
No Standalone Algorithm Performance: The concept of "standalone (algorithm only without human-in-the-loop performance)" is inapplicable because there is no algorithm or AI involved.
No Ground Truth for AI Models: The establishment of ground truth for training or test sets is relevant for AI/ML models. For a mechanical wheelchair, performance is assessed against physical standards, not against expert labels or pathological outcomes for diagnostic accuracy.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them in the context of AI/ML or comparative effectiveness from the given document.

The document details the following regarding performance and acceptance for a mechanical wheelchair:

1. Table of Acceptance Criteria and Reported Device Performance:

ITEM	Acceptance Criteria (Reference Standard)	Reported Device Performance	Remark
Safety Testing
Static Stability	ISO 7176-1:2014	Complies with ISO 7176-1	SE
Effectiveness of Brakes	ISO 7176-3:2012	Complies with ISO 7176-3	SE
Dimensions, Mass, Maneuvering Space	ISO 7176-5:2008	Complies with ISO 7176-5	SE
Seating and Wheel Dimensions	ISO 7176-7:1998	Complies with ISO 7176-7	SE
Static, Impact, Fatigue Strengths	ISO 7176-8:2014	Complies with ISO 7176-8	SE
Test Dummies	ISO 7176-11:2012	(Implied compliance through ISO 7176-8 tests)	SE
Coefficient of Friction of Test Surfaces	ISO 7176-13:1989	(Implied compliance)	SE
Information Disclosure, Documentation, Labeling	ISO 7176-15:1996	Complies with ISO 7176-15	SE
Resistance to Ignition of Postural Support Device	ISO 7176-16:2012	Complies with ISO 7176-16	SE
Set-up Procedures	ISO 7176-22:2014	Complies with ISO 7176-22	SE
Biocompatibility Performance
Cytotoxicity Test	ISO 10993-5: 2009 (MTT Method, MEM with 10%FBS extract)	Did not show potential toxicity	SE
Skin Sensitization Test	ISO 10993-10: 2010 (Guinea Pig Maximization Test, 0.9% NaCl Injection & Sesame oil Extract)	No significant evidence of causing skin sensitization	SE
Skin Irritation Test	ISO 10993-10: 2010 (0.9% NaCl Injection & Sesame oil Extract)	Negligible	SE
Label and Labeling	FDA Regulatory Requirements	Conforms to FDA Regulatory Requirements	SE

2. Sample size used for the test set and the data provenance: Not applicable. For mechanical device testing against ISO standards, the "sample size" refers to the number of units tested, which is not specified but is typically a small number (e.g., 1-3 units) unless stress testing multiple units. The tests are non-clinical, likely performed in China (country of origin for the manufacturer).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical performance and biocompatibility is established by the specifications of international standards (ISO) and laboratory test results, not by expert interpretation in the medical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading). Mechanical and biocompatibility tests have objective pass/fail criteria based on standards.

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 this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this mechanical device is defined by international standards (ISO) for safety, performance, and biocompatibility, as well as FDA regulatory requirements for labeling.

8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human profiles. The symbol is composed of three interconnected profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2017

Kunshan Hi-Fortune Health Products Co., Ltd. % Ray Wang General Manager Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd. LiYuan Town, TongZhou District, Beijing, 101121 CN

Re: K163352

Trade/Device Name: Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 22, 2017 Received: June 26, 2017

Dear Ray Wang:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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

for

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

Sincerely,

William J. Heetderks -S 2017.07.28 13:46:07 -04'00'

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163552

Device Name Wheelchair

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)

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

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510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K163352

1. Date of Preparation
  06/21/2017
Sponsor 2.

Kunshan Hi-Fortune Health Products Co.,Ltd.

No. 301,Qinhe Road, Zhangpu Town, Kunshan City, Jiangsu Province, China 215300 Establishment Registration Number: Not yet registered or the Number Contact Person: HongFa Zhi Position: General Manager Tel: +86-512-55195100 Fax: +86-512-55199300 Email: lance@hi-fortune.net

1. Submission Correspondent
  Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China Tel: +86-21-50313932 Fax: +86-21-68093116 Email: ray.wang@believe-med.com

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1. Identification of Proposed Device
  Trade Name: Wheelchair Common Name: Mechanical Wheelchair Model(s): HM303

Regulatory Information: Classification Name: Wheelchair, Mechanical Classification: I; Product Code: IOR; Regulation Number: 21 CFR 890.3850; Review Panel: Physical Medicine;

Intended Use Statement:

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

Device Description 5.
The proposed device, Wheelchair model HM303, is traditional manually operated, user propelled, manual, mechanical wheelchairs. The device can be foldable easily for transport.

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6. Identification of Predicate Device

Predicate # 510(k) Number: K153328 Product Name: SUNCO Mechanical Wheelchair Manufacturer: Danyang Sunco Machinery Co., Ltd

Non-Clinical Test Conclusion 7.

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Safety Testing

ISO 7176-1:2014 Wheelchairs - Part 1: Determination of static stability.

ISO 7176-3:2012 Wheelchairs – Part 3: Determination of effectiveness of brakes.

ISO 7176-5:2008 Wheelchairs - Part 5: Determination of dimensions, mass and manoeuvring space.

ISO 7176-7:1998 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 strengths.

ISO 7176-11:2012 Wheelchairs - Part 11 Test Dummies

ISO 7176-13:1989 Wheelchairs - Part 13 Determination of Coefficient of Friction of Test Surfaces.

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

ISO 7176-16:2012 Wheelchairs – Part 16: Resistance to ignition of postural support device. ISO 7176-22:2014 Wheelchairs - Part 22 Set-up Procedures

Biocompatibility Performance

Cytotoxicity Test

Test Method: MTT Method, MEM with 10%FBS extract

Test Standard: ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity.

Test Result: Did not show potential toxicity

Skin Sensitization Test

Test Method: Guinea Pig Maximization Test, 0.9% Sodium Chloride Injection Extract & Sesame oil Extract

Test Standard: ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

Test Result: No significant evidence of causing skin sensitization.

Skin Irritation Test

Test Method: 0.9% Sodium Chloride Injection Extract & Sesame oil Extract

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Test Standard: ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. Test Result: Negligible

1. Clinical Test Conclusion
  No Clinical Test conducted.

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9. Substantially Equivalent (SE) Comparison

Table 1 General Comparison

ITEM	Proposed Device	Predicate Device	Remark
Product Code	IOR	IOR	SE
Regulation No.	21 CFR 890.3850	21 CFR 890.3850	SE
Class	1	1	SE
Intended Use	The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.	The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.	SE
DesignCharacteristic	Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull/Push-to-Lock, Armrest, Backrest, Footpad	Manual Operation, Four-Wheels, Foldable, Cross-Brace, Pull-to-Lock, Armrest, Backrest, Footpad	SE
OperationEnvironment	For Indoor/Outdoor use	For Indoor/Outdoor use	SE

Table 2 Performance Comparison

ITEM	Proposed Device	Predicate Device	Remark
OverallDimensions	Length: 1137 mm (44.8")	Length: 42"
	Width: 680 mm (26.8")	Width:25.2"	Analysis
	Height: 880 mm (34.6")	Height:36"
Rear Wheel	Size: 559 mm (22")	Size: 24"	Analysis
	Tire Type: Rubber	Tire Type: PU Solid Material
	Rim Diameter/Material: 510.7 mm	Rim Diameter/Material: 21"/Steel
	(20.1")/Steel Composite	Composite
Wheel Lock	Pull-to-Lock, Push-to-Lock	Pull-to-Lock	SE
Ground Clearance	64 mm (2.5")	2.3"	SE
Min. TurningDiameter	1915.2 mm (75.4")	31"	Analysis
Armrest	Arm pad: Paded	Arm pad: Padded	SE
	Height-Adjustable: No	Height-Adjustable: No
Seat Dimensions	Depth: 420 mm (16.5")	Depth: 16"
	Height: 470 mm (18.5")	Height: 20"	Analysis
	Width: 410 mm (16.1")	Width: 20"
Casters	Size: 152 mm (6")	Size: 7.9"	Analysis
	Tire Type: PU	Tire Type: PU Solid Material
Weight ofwheelchair	11.07kg	38.6lb/17.5kg	Analysis
Weight Capability	100kg	220lb/100kg	SE

Difference Analysis:

The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

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ITEM	Proposed Device	Predicate Device	Remark
Performance Test	Comply with ISO	Comply with ISO	SE
	7176-1/-3/-5/-7/-8/-15/-16	7176-1/-3/-5/-7/-8/-15/-16
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1	SE
Label andLabeling	Conforms to FDA RegulatoryRequirements	Conforms to FDA RegulatoryRequirements	SE

Table 3Safety Comparison

10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.

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).