MA012 Aluminum wheelchair and MS019 Steel wheelchair are mechanical wheelchairs which is a manually operated, attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. The wheelchair is controlled, steered and operated completely by a trained caregiver. The wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. There are two models of the wheelchair, MA012 and MS019. The MA012 Aluminum wheelchair has an aluminum frame, fixed armrest and a foldable back, while the MS019 Steel wheelchair has a steel frame, fixed back and a detachable, flip-back armrest. The wheelchair can support users of up to115 kg.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a mechanical wheelchair (MA012 Aluminum wheelchair, MS019 Steel wheelchair) and its substantial equivalence to a predicate device.

Crucially, this document is for a medical device (a wheelchair), not an AI/ML-driven device. Therefore, the standard questions related to acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and training sets for AI/ML performance are not applicable to the information provided.

The "acceptance criteria" for this device are its compliance with various ISO standards related to wheelchair performance and biocompatibility with materials. The "study that proves the device meets the acceptance criteria" refers to the non-clinical tests conducted to demonstrate compliance with these standards.

Here's an attempt to answer the questions based on the provided document, highlighting why many AI-specific questions are irrelevant:

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

The document defines "acceptance criteria" as compliance with specific ISO standards and biocompatibility requirements. The "reported device performance" is a statement that the test results meet these standards.

Acceptance Criteria Category	Specific Standard / Requirement	Reported Device Performance
Biocompatibility	ISO 10993-5: 2009 (In Vitro Cytotoxicity)	All user directly contacting materials are compliant.
	ISO 10993-10: 2010 (Irritation and Skin Sensitization)	All user directly contacting materials are compliant.
	ISO 10993-23: 2021 (Irritation)	All user directly contacting materials are compliant.
Performance (Mechanical Wheelchair)	ISO 7176-1: 2014 (Static Stability)	Test results meet design specification.
	ISO 7176-3: 2012 (Effectiveness of Brakes)	Test results meet design specification.
	ISO 7176-5: 2008 (Dimensions, Mass & Maneuvering Space)	Dimensions and mass determined.
	ISO 7176-7: 1998 (Seating and Wheel Dimensions)	Seating and wheel dimensions determined.
	ISO 7176-8: 2014 (Static, Impact & Fatigue Strength)	All test results meet requirements in Clause 4.
	ISO 7176-11: 2012 (Test Dummies)	Test dummies used meet requirements.
	ISO 7176-13: 1989 (Coefficient of Friction of Test Surfaces)	Coefficient of friction determined.
	ISO 7176-15: 1996 (Information Disclosure, Documentation & Labeling)	Information disclosure, documentation, and labeling meet requirements.
	ISO 7176-16: 2012 (Resistance to Ignition of Postural Support Devices)	Performance meets requirements.
Labeling	FDA Regulatory requirements	Conforms to FDA Regulatory.

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

This document details tests on physical products, not data. The sample size for the non-clinical tests (e.g., how many wheelchairs were tested for each ISO standard) is not specified in this submission. The origin of the testing data is implied to be from the manufacturer (Sichuan AST Medical Equipment Co., Ltd. in China), as they submitted the test results. These tests are conducted on the newly manufactured devices to demonstrate compliance, so it's akin to a prospective test of the product's design.

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. The "ground truth" for a mechanical wheelchair is based on objective measurements and established engineering standards (ISO standards) rather than expert consensus on subjective interpretations (like medical images). The tests are conducted by qualified personnel following the ISO standards, but their specific "qualifications" are not detailed in this submission in the way they would be for medical image interpretation.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in scenarios where human interpretation or consensus is needed for establishing ground truth (e.g., in medical image reading trials). For mechanical device testing, the results are determined by objective physical measurements against predefined limits outlined in the ISO 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

This is not applicable. This is a submission for a mechanical wheelchair, not an AI/ML-driven device. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

This is not applicable. This device is a mechanical wheelchair, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

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

The "ground truth" for this device is based on objective measurement against engineering standards (ISO standards). For biocompatibility, it's compliance with established biological safety requirements. For mechanical performance, it's about meeting specified physical parameters (e.g., static stability, brake effectiveness, strength) as defined and tested according to the ISO 7176 series.

8. The sample size for the training set

This is not applicable. The device is a mechanical product, not an AI/ML model that requires a training set.

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

This is not applicable. The device is a mechanical product, not an AI/ML model; therefore, no training set or its associated ground truth establishment is relevant.

Summary

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August 15, 2023

Sichuan AST Medical Equipment Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K231750

Trade/Device Name: MA012 Aluminum wheelchair, MS019 steel wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I, reserved Product Code: IOR Dated: June 15, 2023 Received: June 15, 2023

Dear Ivy 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. 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 (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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tushar Bansal -S

for Heather Dean, 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) K231750

Device Name

MA012 Aluminum wheelchair, MS019 steel wheelchair

Indications for Use (Describe)

MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited 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)

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510(k) Summary

K231750

l. Applicant

Name: Sichuan AST Medical Equipment Co., Ltd.

Address: No.58 JinPeng Road, Area C, West Industrial Park, Luxian County, Luzhou, Sichuan,

646100 CN

Name of contact person: Ms. Mae Tse

Telephone: +86 830 8130333

Email: sales01@ast168.cn

Date prepared: 2023-08-11

II. Submission Correspondent

Ms. Ivy Wang

Shanghai SUNGO Management Consulting Co., Ltd.

Tel: +86-21-5881 7802

Email: zxfdaf@sungoglobal.com

III. Device

Device trade name: MA012 Aluminum wheelchair, MS019 Steel wheelchair

Common name: Manual Wheelchair

Regulatory Information:

Classification name: Mechanical Wheelchair

Regulation class: 1

Regulation number: 21CFR 890.3850

Panel: Physical Medicine

Product code: IOR

IV. Predicate device

Primary - K181795

AST Model MA012 and MS019 Rehab Wheelchair

Sichuan AST Medical Equipment Co., Ltd

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V. Device description

The wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. There are two models of the wheelchair, MA012 and MS019. The MA012 Aluminum wheelchair has an aluminum frame, fixed armrest and a foldable back, while the MS019 Steel wheelchair has a steel frame, fixed back and a detachable, flip-back armrest. The wheelchair can support users of up to115 kg.

VI. Indication for use

MA012 Aluminum wheelchair and MS019 steel wheelchair are intended for medical purpose to provide mobility to persons limited to a sitting position.

VII. Non-Clinical Test Conclusion

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:

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
ISO 10993-23: 2021 Biological evaluation of medical devices - Part 23: Tests for irritation
. 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

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maneuvering 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 strength
. 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 Second edition 2012-12-01 Wheelchairs - Part 16: Resistance to ignition of postural support devices

VIII. Comparison with the predicate device

Attribute	Subject device	Predicate device	Results
Manufacturer	Sichuan AST MedicalEquipment Co., Ltd.	Sichuan AST Medical EquipmentCo., Ltd.	/
Proprietary name,model	MA012 Aluminum wheelchair,MS019 Steel wheelchair	AST Model MA012 and MS019Rehab Wheelchair	/
510(k) number	K231750	K181795	/
Device classificationname	Class I	Class I	Same
Classificationregulations	21 CFR 890. 3850	21 CFR 890. 3850	Same
Product code	IOR	IOR	Same
Indication for use	MA012 Aluminum wheelchairand MS019 steel wheelchairare intended for medicalpurpose to provide mobility topersons limited to a sittingposition.	The AST Model MA012 andMS019 Rehab Wheelchairs areto provide mobility to personslimited to a sitting position.	Same
Dimension (Length xWidth x Height)	Model MA012:950x610x970mmModel MS019:916x574x896mm	Model MA012:1173x645x892mm (±1mm)Model MS019:1196x775x894mm (±1mm)	SimilarThe two physicaldimensions aredifferent. Thedifference does
Attribute	Subject device	Predicate device	Results
Total weight	Model MA012: 11.5kg/25 lbsModel MS019: 18.7kg/41 lbs	Model MA012: 17.2kg/38 lbsModel MS019: 20kg/ 46 lbs	not affecteffectiveness andsafety.SimilarDifferent weight ofthe device do notraise the safetyand effectivenessof the device.
Weight Capacity	115 kg/250lbs	Model MS019: 200 kg/450 lbs,Model MA012: 136kg/ 300 lbs	SimilarDifference onloading weight willnot causedifferentperformance.Lower weightprovide lesspressure to thechair and easy forthe transportation.
Seat depth	Model MA012: 390mmModel MS019: 420mm	Model MA012:16"-20" (406mm-508mm)Model MS019:18"-20" (457mm-508mm)	SimilarDifferent seat sizedo not raise thesafety and
Seat width	Model MA012: 420mmModel MS019: 450mm	Model MA012: 16" (406mm); 18"(457mm); 20" (508mm)Model MS019: 18" (457mm);20" (508mm); 22" (558mm); 24"(609mm)	effectiveness ofthe device.
Seat height	Model MA012: 520mmModel MS019: 596mm	Model MA012: 19.7" (500mm)Model MS019: 19.8" (503mm)
Frame type	Foldable	Foldable	Same
Frame material	Model MA012: AluminumModel MS019: Steel	Model MA012: AluminumModel MS019: Steel	Same
Back style	Model MS019: FixedModel MA012: foldable	Model MS019: FixedModel MA012: Adjustable	SimilarThe slightdifference on backstyle do not raisethe safety andeffectiveness ofthe device.
Armrest	Flip back armrest	Model MA012: Height Adjustabledesk length armrest. Flip back	SimilarThe height of
Attribute	Subject device	Predicate device	Results
		Model MS019: Fixed or adjustable height; desk or full length; removable	armrest of proposed device can not be adjustable.
Footrest	Optional/ swing away	Optional/ swing away	Same
Rear Axle Position	Single	Multiple	SimilarThe rear axle of proposed device has only one size.
Tires	Front: 200mm (8")Rear: 315mm (12.5")	Front: 6",7",8"Rear: 20",22",24"	SimilarMinor difference on dimension of driven wheel will not cause different performance.

Table 1 General Comparison

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Substantial equivalence Analysis:

The design and technological characteristics of the subject device is basically similar to the predicate device chosen. There are some minor differences with the predicate device don't affect the safety or effectiveness of the subject device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness.

Therefore, the subject device is substantially equivalent to the predicate device.

Attribute	Subject device	Predicate device	Results
Biocompatibility	All user directly contactingmaterials are compliance withISO10993-5,ISO10993-10, ISO 10993-23requirements.	All user directly contactingmaterials are compliance withISO10993-5 andISO10993-10 requirements.	S.E.
Performance	ISO7176 series	ISO7176 series	S.E.
Label and labeling	Conforms to FDA Regulatory	Conforms to FDA Regulatory	S.E.

Table 2 Safety comparison

Table 3 Safety comparison

Attribute	Subject device	Predicate device	Results
ISO7176-1	The Static stability has beendetermined after the testingaccording to the ISO 7176-1, andtest results meet its designspecification.	The Static stability has beendetermined after the testingaccording to the ISO 7176-1,and test results meet its designspecification.	S.E.
Attribute	Subject device	Predicate device	Results
ISO7176-3	The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification.	The effectiveness of brakes has been determined after the testing according to the ISO 7176-3, and test results meet its design specification.	S.E.
ISO7176-5	The dimensions, mass has been determined after the testing according to the ISO 7176-5.	The dimensions, mass has been determined after the testing according to the ISO 7176-5.	S.E.
ISO7176-7	The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7	The seating and wheel dimensions has been determined after the testing according to the ISO 7176-7	S.E.
ISO7176-8	All test results meet the requirements in Clause 4 of ISO 7176-8	All test results meet the requirements in Clause 4 of ISO 7176-8	S.E.
ISO7176-11	The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11.	The test dummies used in the testing of ISO 7176 series are meet the requirements of ISO 7176-11.	S.E.
ISO7176-13	The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved	The coefficient of friction of test surfaces has been determined, which could be used in other 7176 series tests involved	S.E.
ISO7176-15	The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15	The test results shown that information disclosure, documentation and labelling of device meet the requirements of ISO 7176-15	S.E.
ISO 7176-16	The performance of resistance to ignition meets the requirements of ISO 7176-16	The performance of resistance to ignition meets the requirements of ISO 7176-16.	S.E.

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IX. Summary of clinical testing

No clinical study is included in this submission.

Conclusions X.

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well the legally marketed predicate device K181795.

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).