The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-A WI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.

Device Description

The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.

The device utilizes the pneumatically controlled chambers actuated by an electronically controlled air pump and air valve. The pump, air valve and other components are protectively housed within the ABS plastic enclosure of the control unit.

The device consists of a control unit, two RecoveryLeg (air boot with attached hose connector), two RecoveryArm (air arm sleeve with attached hose connector) and one RecoveryPants (air pants with two attached hoses and hose connectors). The RecoveryLeg, RecoveryArm and RecoveryPants work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the boots, sleeves or pants to compress body.

The device is categorized to have long-term skin contact of greater than 30 days.

Environment of use of the device: Clinics, hospital, athlete training, and home environments.

AI/ML Overview

The provided text is a 510(k) summary for the "Air Compression Therapy Recovery System." It outlines the device's characteristics and its comparison to predicate devices to establish substantial equivalence. However, this document does not contain the specific information required to describe acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML medical device performance evaluation.

The document describes a physical medical device (a massager) and focuses on its electrical safety, EMC, biocompatibility, and software verification as part of non-clinical performance testing. It explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device from this specific document. The questions you posed, such as "Sample sized used for the test set," "Number of experts used," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," and "Type of ground truth," are typically relevant for evaluating the performance of AI/ML algorithms in diagnostic or prognostic applications, which is not the subject of this 510(k) submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

October 26, 2023

Jiangsu MaxF Electric Appliance Co., Ltd % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd No. 1919-1920, Building D3, Minjie Plaza Shuixi Road, Huangpu District Guangzhou, Guangdong 510000 China

Re: K230500

Trade/Device Name: Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: August 10, 2023 Received: August 11, 2023

Dear Cassie Lee:

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 (the 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 available 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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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.

Heather L. Dean -S

Heather Dean, PhD

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Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K230500

Device Name

Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801. MF-AWI.LED.B-801. MF-AWI.OLED.A-601. MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)

Indications for Use (Describe)

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 K230500

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Name: Jiangsu MaxF Electric Appliance Co., Ltd Establishment Registration Number: 3017153262 Address: NO.12, West Park Road, Rulin Town, Jintan District, Changzhou, China

Contact name: ZHANG JIANFANG Tel: +86-15961228139 E-mail: 372601574@qq.com Postal Code: 213200

Application Correspondent:

Name: Share Info (Guangzhou) Medical Consultant Ltd. Contact Person: Ms. Cassie Lee Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com

2. Date of the summary prepared: October 25, 2023

3. Subject Device Information

Classification Name: Massager, powered inflatable tube Trade Name: Air Compression Therapy Recovery System Model Name: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulatory Class: II

4. Predicate Device Information

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Predicate Device 1 Information

Sponsor: Rapid Reboot Recovery Products, LLC Trade Name: Rapid Reboot Compression Therapy System Classification Name: Massager, powered inflatable tube 510(K) Number: K182668 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulation Class: II

Predicate Device 2 Information

Sponsor: FOSHAN HONGFENG CO.,LTD. Trade Name: Air compression therapy system Classification Name: Massager, powered inflatable tube 510(K) Number: K201982 Review Panel: Physical Medicine Product Code: IRP Regulation Number: 890.5650 Regulation Class: II

5. Device Description

The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is a portable inflatable tube massage system which simulates kneading and stroking of leg, arm and hip by the use of inflatable air compression techniques. The device can be used to temporarily increase blood circulation and temporarily relieve minor muscle aches and pains. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.

The device is categorized to have long-term skin contact of greater than 30 days.

Environment of use of the device: Clinics, hospital, athlete training, and home environments.

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6. Intended Use / Indications for Use

The Air Compression Therapy Recovery System (model: MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas. The Air Compression Therapy Recovery System simulates kneading and stroking of tissues by using an inflatable garment. This device is Over-The-Counter (OTC). It is intended for use by healthy adults who are over 21 years old.

7. Comparison to predicate device and conclusion

As compared to the predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.

Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)	Remark
Company	Jiangsu MaxF ElectricAppliance Co., Ltd	Rapid RebootRecoveryProducts, LLC	FOSHAN HONGFENGCO.,LTD.	--
Trade Name	Air Compression TherapyRecovery System (model:MF-AWI, MF-AWI.LED.A-801,MF-AWI.LED.B-801,MF-AWI.OLED.A-601,MF-AWI.LED.A-601,MF-AWI.LED.B-601, MF-AWI.OLED.A-401,MF-AWI.LED.A-401,MF-AWI.LED.B-401)	Rapid RebootCompressionTherapy System	Air compressiontherapy system: FO-3001	--
ClassificationName	Massager, Poweredinflatable tube	Massager, poweredinflatable tube	Massager, poweredinflatable tube	Same
510(k)Number	K230500	K182668	K201982	--
Product Code	IRP	IRP	IRP	--
RegulationNumber	890.5650	890.5650	890.5650	Same
FDA DeviceClassification	II	II	II	Same
Review Panel	Physical Medicine	Physical Medicine	Physical Medicine	Same
Rx or OTC	OTC	OTC	OTC	Same
Intended Use /Indications for	The Air CompressionTherapy Recovery	The Rapid RebootCompression	Intended for home totemporarily relieve	Same
Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)	Remark
Use	System (model: MF-AWI,MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) isindicated for thetemporary relief of minormuscle aches and painsand for temporaryincrease in circulation tothe treated areas. The AirCompression TherapyRecovery Systemsimulates kneading andstroking of tissues byusing an inflatablegarment. This device isOver-The-Counter (OTC).It is intended for use byhealthy adults who areover 21 years old.	Therapy System isintended for thetemporary relief ofminor muscleaches and painsand for thetemporary increasein circulation to thetreated areas inpeople who are ingood health. TheRapid RebootCompressionTherapy Systemsimulates kneadingand stroking oftissues by using aninflatable garment.	minor muscle achesand/or pains, promoteblood circulation intreated areas.
Treatmenttime	0-50mins	User determinestherapy time.Choose from 10,20, or 30 minutesession time, withoption to addadditional 10minutes to anytherapy time.	1-60mins	SimilarNote 1
Treatmentarea	Leg (including of foot, calf,knee, upper leg)Hip (including of upperleg, glutes, hips, lowerback)Arm (including of entirearm, shoulder, upperchest and back)	Leg (including offoot, calf, knee,upper leg)Hip (including ofupper leg, glutes,hips, lower back)Arm (including ofentire arm,shoulder, upperchest and back)	Leg	Same
Environment	Clinics, hospital, athlete	Clinics, hospital,	Not provided in the	Same

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Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)	Remark
	chambers one and twoare fully inflated, the thirdand the fourth chamberbegin to inflate while thefirst and the secondchambers begin todeflate. The cycle repeatsthrough the 8 chambers.Image: chambers		for chamber ③④ tillchamber ⑤⑥, pausefor 3 seconds. Thenrepeat. D (WholeSqueeze Mode):chamber ①②③④⑤⑥inflating at the sametime till setup pressureor for 90 seconds, thendeflating in the sametime for 3 seconds.Then repeat. E(Combined B + C):sequential squeeze +double wave F(Combined A + C + D):normal + double wave+ whole squeeze. 4and 8 chambers sameas 6 chambers above.
	Mode D: Pressure fillstwo chambers at a timeuntil all 8 are filled. Thefirst and the secondchambers inflate to theselected pressure. Oncefully inflated, the third andthe fourth chambers beginto inflate until all 8chambers are fullyinflated. Then, all the 8chambers deflate togetherand the cycle repeats.Image: chambers		Image: chambers
	Mode E: Pressure fillsone chamber at a timeand that chamberdeflates while nextchamber fills. When thefirst chamber inflates tothe selected pressure, thethird chamber begins toinflate and the firstchamber deflates. Whenthe third chamber fullyinflates, the fifth chamberbegins to inflate and thethird chamber deflates.Then the seventh,second, fourth, sixth andeighth inflate and deflateone by one

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Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)	Remark
	Image: [Subject Device Image]For MF-AWI.OLED.A-601and MF-AWI.OLED.A-401using 6 chambers and 4chambers, the mode isthe same as mode of MF-AWI as demonstratedabove.ForMF-AWI.LED.B-801,MF-AWI.OLED.A-601,MF-AWI.LED.A-601,MF-AWI.LED.B-601, MF-AWI.LED.A-401,MF-AWI.LED.B-401They only has one mode(mode B).
Outputpressurerange	0-40-80-120-160-200mmHg(Tolerance: -10% ~+20%)	0-200 mmHg	30-110mmHg	SimilarNote 1
Power source	100-240V, 50/60Hz	110VAC, 60Hz	100-127V/220-240V,50/60Hz	SimilarNote 3
Power	30W	30W	65 W	Same
Number ofChamber	4, 6, 8	4	4, 6, 8	Same
Photo/size ofthe controlunit	Image: [Subject Device Photo]	Image: [Predicate Device (Primary) Photo]10" x 6.5" x 5"	Image: [Predicate Device (Secondary) Photo]220190113mm	SimilarNote 4

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Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)	Remark
	Image: Subject Device TopImage: Subject Device Bottom140mm x 87mm x 280mm
Housingmaterials	Molded ABS enclosure	Molded ABS enclosure	Molded ABS enclosure	Same
CompressionApplicatorGarmentsBoots/Sleeves/pantsMaterial	TPU Nylon Composite	Nylon with aPolyurethanelaminate	Not mentioned in the510k summary	SimilarNote 5
Photo/size ofthe boots	Image: Subject Device Boots1060mm x 345mm	Image: Predicate Device Primary BootsX-Short: 14" x 41"Short: 14" x 43"Medium: 14" x 45"Long: 14" x 48"X-Long: 14" x 52"Image: Predicate Device Primary Boot Size	Image: Predicate Device Secondary BootsM:9165cmL:10074cmXL:110*70cm(Overlapping)	SimilarNote 4

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Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)	Remark
Photo/size ofthe armsleeves	Image: Subject Device arm sleeves974mm x 325mm	Image: Predicate Device (Primary) arm sleevesRegular: 18" x 38"Long: 18" x 44"	No arm sleeves	SimilarNote 4
Photo/size ofthe pants	Image: Subject Device pants530mm x 730mm	Image: Predicate Device (Primary) pantsRegular:26" x 32"Large: 26"35"	No pants	SimilarNote 4
Safety feature	Button on control unitallow users to stop orpause therapy session atany time.	Button on displayallows users to stopor pause therapysession at any time.	Power button on mainunit allows user to stoptherapy session at anytime	Same
Mode ofcompression	Sequential	Sequential	Sequential	Same
Software/firmware/microprocess or control	Microprocessor	Microprocessor	Microprocessor	Same
Technology	Compressor and valvesystem which sequentiallyinflates cells of appliance.	Compressor andvalvesystem whichsequentiallyinflates cells ofappliance.	Compressor and valvesystem whichsequentially inflatesinflatable chambers	Same
Electrical	ANSI-AAMI ES 60601-1	ANSI-AAMI ES	IEC 60601-1	Same

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Elements ofComparison	Subject Device	Predicate Device(Primary)	Predicate Device(Secondary)
safety, EMC,Bio-compatibility	IEC 60601-1-2	60601-1	IEC 60601-1-2
	IEC 60601-1-11	IEC 60601-1-2	IEC 60601-1-11
	ISO 10993-5	IEC 60601-1-11	ISO 10993-10
	ISO 10993-10	ISO 10993-5	ISO 10993-5
	ISO 10993-23	ISO 10993-10	ISO 10993-12

Comparison in Detail(s):

Note 1:

Though there is a little difference of "treatment time" and "output pressure range" between the subject device and predicate devices, but treatment time is within the time range of predicate device 2, and output pressure range is within the predicate device 1. So, this slight difference will not raise any safety and effectiveness issue.

Note 2:

The mode A, B, C of subject device is similar to the Normal Mode, Sequential Squeeze Mode and Double Wave mode of predicate device 1 respectively. The inflating and deflating order of mode D, and E is different from predicate devices, but will not raise any safety and effectiveness issue.

Note 3:

Though there is difference of "power source" between the subject device and predicate device, but the subject device has been tested per ANSI/AAMI ES60601-1, IEC 60601-1-11. So, the difference of modes would not adversely impact safety and effectiveness.

Note 4:

Though there is difference of "Photo/size of the control unit", "Photo/size of the boots", "Photo/size of the arm sleeves", "Photo/size of the pants sleeves" between subject device and predicate devices 1, but the difference would not adversely impact safety and effectiveness.

Note 5:

Though there is difference in material of boots/sleeves/pants does not contact with skin during the massage, and the TPU Nylon Composite has been tested per ISO 10993-10 and ISO 10993-23, so the difference would not adversely impact safety and effectiveness.

8. Test Summary

8.1 Summary of Non-Clinical Performance Testing

1) Performance Testing Summary

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Title of the test	DeviceDescription/SampleSize	TestMethod/ApplicableStandards	Acceptancecriteria	UnexpectedResults/SignificantDeviations	Testresults
Generalrequirements forbasic safety andessentialperformance	The testsample isthe final,finishedproduct.	IEC 60601-1:2005/AMD1:2012/AMD2:2020	The test iscarried outunder the testmethodspecified in thestandard, andthe test result iswithin the testacceptancerange of thestandard.	NA	Pass
Electromagneticdisturbances	Thetestsampleisthefinal,finishedproduct.	IEC 60601-1-2:2014+A1:2020	No degradationof performancewasfoundduringtest orLowerthanlimitsofmeasurement	NA	Pass
Requirementsfor medicalelectricalequipment andmedicalelectricalsystems used inthe homehealthcareenvironment.	Thetestsampleisthefinal,finishedproduct.	IEC 60601-1-11:2015/AMD1:2020	Thedeviceoperatesnormally, andcanprovidebasicsafetyandessentialperformance.	NA	Pass

Biocompatibility testing 2)

. ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
. ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
. ISO 10993-10:2021Biological Evaluation of Medical Devices - Part 10: Tests skin sensitization
. ISO 10993-23: 2021 Biological Evaluation of Medical Devices - Part 23: Test for irritation

3) Software verification and validation testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as

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a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

4) Cybersecurity

The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.

8.2 Clinical Performance

Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.

9. Final Conclusion:

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K182668 and K201982.

Regulation Number and Section

§ 890.5650 Powered inflatable tube massager.

(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).