The AST Model MA012 and MS019 Rehab Wheelchair are manual wheelchairs. They have adjustable armrests, and multiple axle position. The casters are 6"/7"/8" PU wheels with height adjustable forks and the rear wheels are 20"/22"/24″*1-3/8″ polyurethane(MA012 and MS019). The wheelchair also has a shear reduction system: by carefully aligning the pivot points of the user, to minimize the sliding down of the user and also minimize the shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable. The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel; The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices. The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (AST Model MA012 and MS019 Rehab Wheelchair). It describes the process of demonstrating substantial equivalence to a predicate device, not the development and validation of an AI/ML powered device. As such, most of the requested information regarding acceptance criteria, study design for AI, expert involvement, and ground truth establishment is not applicable to this document.

However, I can provide information based on what is available in the document regarding the device's performance against non-clinical test standards, which serves as a form of acceptance criteria for this type of medical device submission.

Here's the breakdown of the information provided in the document:

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

For a traditional medical device like a manual wheelchair, "acceptance criteria" are tied to compliance with recognized consensus standards. The performance is reported as meeting these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 7176-1:2014: Determination of Static Stability	Meets specifications
ISO 7176-3:2012: Determination of effectiveness of brakes	Meets specifications
ISO 7176-5:2008: Determination of overall dimensions, mass and maneuvering space	Meets specifications
ISO 7176-7:1998: Method of Measurement of Seating and Wheel Dimensions	Meets specifications
ISO 7176-8:2014: Requirements and test methods for static, impact and fatigue strengths	Meets specifications
ISO 7176-11:2012: Test dummies	Meets specifications (refers to test methodology)
ISO 7176-13:1989: Determination of coefficient of friction of test surfaces	Meets specifications (refers to test methodology)
ISO 7176-15:1996: Requirements for Information Disclosure, Documentation and Labeling	Meets specifications
ISO 7176-16:2012: Resistance to ignition of postural support devices	Meets specifications
ISO 14971:2007: Medical devices -- Application of risk management to medical devices	Meets specifications
ISO 10993-5:2009: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	Meets specifications
ISO 10993-10:2010: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Meets specifications

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 provided in the document. The document describes compliance with international standards for wheelchair testing, which implies internal testing by the manufacturer. The country of origin of the manufacturer is China (Sichuan AST Medical Equipment Co., Ltd., Luzhou City, Sichuan, China). The type of testing (e.g., retrospective or prospective) is not applicable in the context of these device performance tests; they are typically conducted on manufactured units.

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 to a non-AI/ML device submission like this. The "ground truth" for a mechanical wheelchair's performance is determined by established engineering and medical device standards and test methods, not by expert consensus in a clinical diagnostic sense. The experts involved would be engineers and technical specialists responsible for conducting the ISO standard tests.

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

Not applicable. Adjudication methods are relevant for clinical studies or expert review processes, which are not described here. Device performance is determined by passing predefined test criteria 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

Not applicable. This is not an AI-powered device, and no MRMC comparative effectiveness study was performed or is relevant for this type of device.

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

Not applicable. This is not an AI-powered device.

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

For this medical device, the "ground truth" is defined by the objective performance criteria specified within the referenced ISO standards (e.g., static stability limits, brake effectiveness, dimensions within tolerance, strength requirements). Compliance with these standards confirms the device's fundamental safety and performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2018

Sichuan AST Medical Equipment Co., Ltd. Johnson Van Technical Sales Associate No.58, Jin-Peng Road, C Area, Luxian Industrial Park Luzhou City, Sichuan 646100 China

Re: K181795

Trade/Device Name: AST Model MA012 and MS019 Rehab Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: July 3, 2018 Received: July 5, 2018

Dear Johnson Van:

We have reviewed vour 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 and Part 809); 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.html; 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 J. Pinto -S

for Carlos 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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Indications for Use

510(k) Number (if known) K181795

Device Name

AST Model MA012 and MS019 Rehab Wheelchair

Indications for Use (Describe)

The AST Model MA012 and MS019 Rehab Wheelchairs are 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

Sichuan AST medical Equipment Co., Ltd. 510(k) Premarket Notification

Submitter:

Sichuan AST Medical Equipment Co., Ltd.

No.58, Jin-Peng Road, C Area, Luxian Industrial Park, Luzhou City, Sichuan, China, 646100

Contact Person:

Johnson Van

Sichuan AST Medical Equipment Co., Ltd. No.58, Jin-Peng Road, C Area, Luxian Industrial Park, Luzhou City, Sichuan, China, 646100 Phone: +86-830-8130286 Fax: +86-830-8130262

Date Prepared:

June 2nd, 2018

Proprietary Name:

AST Model MA012 and MS019 Rehab Wheelchair

Common name:

Manual Wheelchair

Classification name:

Mechanical Wheelchair, Class 1

Product Code:

IOR

Regulation Number:

21 CFR 890.3850

Indications for Use

The AST Model MA012 and MS019 Rehab Wheelchairs are to provide mobility to persons limited to a sitting position.

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The Predicate Device:

This submission indicates the Substantial Equivalence of the AST Model MA012 and MS019 Rehab Wheelchair, with the predicate Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621). MA012 and MS019 have the same intended uses and similar indications, technological characteristics and principles of operation with predicate device.

Device Description

shear force and pressure against the back. The armrest height can be adjusted from 8" to 12" and it is detachable.

The wheel for MA012 is quick release rear wheel. The AST MS019 Rehab Wheelchair has NO quick release rear wheel;

The upholstery of the device complies with ISO 7176-16:2012 Resistance to ignition of postural support devices.

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

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Discussions of Non-clinical Tests Performed for Determinations of Substantial equivalence are as follows:

ISO 7176-1:2014	Determination of Static Stability
ISO 7176-3:2012	Determination of effectiveness of brakes
ISO 7176-5:2008	Determination of overall dimensions, mass and maneuveringspace
ISO 7176-7:1998	Method of Measurement of Seating and Wheel Dimensions
ISO 7176-8:2014	Requirements and test methods for static, impact and fatiguestrengths
ISO 7176-11:2012	Test dummies
ISO 7176-13:1989	Determination of coefficient of friction of test surfaces
ISO 7176-15:1996	Requirements for Information Disclosure, Documentation andLabeling
ISO 7176-16:2012	Resistance to ignition of postural support devices
ISO 14971:2007	Medical devices -- Application of risk management to medicaldevices
ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization

The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.

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Comparison of the Technological Characteristics:

The AST Model MA012 and MS019 Rehab Wheelchair, is substantially equivalent to the Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 350lbs) mechanical wheelchair (K162621). Both products are mechanical designed for use as personal manual mobility aids. Performance characteristics and drive mechanisms are similar and all have the same intended function and use which is to provide mobility to persons limited to a sitting position. Additional, they are all constructed from the same basic materials, have the same basic operational principles or operated by others. The comparison table is as follow:

Characteristics		The AST ModelMS019 RehabWheelchair(K181795)	The AST ModelMA012 RehabWheelchair(K181795)	Invacare Tracer SX5Manual Wheelchairmechanicalwheelchair (K162621)
Indications for Use		To provide mobility topersons limited to asitting position.	To provide mobility topersons limited to asitting position.	To provide mobility topersons limited to asitting position.
Dimension	Length	1196mm(±1mm)	1173mm(±1mm)	828mm(±1mm)
	Width	775mm (±1mm)	645mm (±1mm)	762mm(±1mm)
	Height	894mm (±1mm)	892mm (±1mm)	889mm(±1mm)
Weight	Total	46 lbs	38 lbs	40 lbs
Weight Capacity		450 lbs	300 lbs	250/300 lbs
Seat width		18"/20"/22"/24"	16"/18"/20"	14"-22"
Seat height		19.8"	19.7"	17.5"-19.5"
Seat depth		18"-20"	16"-20"	18"-20"
Frame type		foldable	foldable	foldable
Cross-braceconfiguration		14 · , 16 · , 18 · , 20 · or22 ·	14 · , 16 · , 18 · , 20 · or22 ·	14 · , 16 · , 18 · , 20 · or22 ·
Back Style		Fixed	Adjustable	Fixed
Anti-tippers		Optional	Optional	Optional
Wheelconstruction		Fixed	Quick release	Fixed
Tires		Front: 6",7",8"Rear: 20",22",24"	Front: 6",7",8"Rear: 20",22",24"	Front: 6",7",8"Rear: 20",22",24"
Armrest		Fixed oradjustableheight; deskor full length;removable	Height Adjustabledesk lengtharmrest	Fixed oradjustableheight; desk orfull length;removable
Foot rest		Optional/ swing away	Optional/ swing away	Optional/ swing away
Rear Axle Position		Multiple	Multiple	Multiple
Frame Construction		Foldableframe	Foldableframe	Fixed Frame(Or foldable)
Frame Material		Steel	Auminum	Steel
Safety Feature		Manual Wheel Lock	Manual Wheel Lock	Manual Wheel Lock

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The comparison of the technical details between MA012 and MS019 and its predicate device are summarized in the following:

a. Dimension: The dimensions of our device and the predicate are similar. And our device conforms to the specific ISO test and that the results are disclosed to the user appropriately, as documented in the ISO standards for disclosure. So there is no deleterious affection of safety and effectiveness about the differences from the dimensions with the predicate device.
b. Weight: Although the total weight bearing capacity of MA012 and MS019 is heavier than Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 350lbs) mechanical wheelchair (K162621). The device conforms to the specific ISO test and that the results are disclosed to the user appropriately, as documented in the ISO standards for disclosure (Requirements and test methods for static, impact and fatique strengths) test. So there is no deleterious affection of safety and effectiveness about the difference on weight bearing capacity with predicate device.
ﻥ Both of our devices and the predicate are equipped with PU foam Seat/Backrest Pad, adjustable Headrest and Armrest. Our MA012 AND MS019 is supplied with a standard Elevating Legrest/Footrest, while the predicate device is provided it as an option. The Elevating Legrest/Footrest can provide better strain-relief for legs.
d. Multiple Rear Axle Position: Both our MA012 AND MS019 and the predicate device are provided with Multiple Rear Axle Positions to allow users to change its seat height to a best fitting position.
Frame Construction and material: Our MS019 and MA012 devices and the e. predicated device are the same foldable frames.
Safety Feature: Both of our devices and the predicated device are equipped f. with Manual Wheel Locks to prevent unexpected movement while parking.

The minor differences between MA012 and MS019 and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the MA012 and MS019 is substantially equivalent to the predicate device.

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Conclusions

According to comparison table, the differences on weight capacity, adjustable back angle and dimensions do not deleteriously affect the safety and effectiveness of the device.

The non-clinical testing and the predicate comparisons demonstrate that any differences in their technological characteristics do no raise any new questions of safety or effectiveness.

So based on the design, performance specifications and testing and intended use, The AST Model MA012 and MS019 Rehab Wheelchair, is substantially equivalent to the Invacare Tracer SX5 Manual Wheelchair (Heavy Duty 450lbs) mechanical wheelchair (K162621).

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).