TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and non-invasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device.

The monitor should be used exclusively in health institutions by trained medical professionals. The monitor is suitable for use in the presence of electrosurgery. Monitor is not intended to be used in the home environment. The monitor should be used only with a single patient.

Device Description

The device consists of the TOF-Cuff monitor and the TOF-Cuff pressure cuff. The applied part of the device is the TOF-Cuff pressure cuff.

TOF-CUFF monitors the neuromuscular transmission (NMT) using the patented TOF-Cuff® method.

TOF-Cuff® is a new method of monitoring neuromuscular blockade that has several advantages over previous methods. It is based on a modified pressure cuff that incorporates stimulating electrodes. The evoked muscle response is evaluated through the changes in pressure of the cuff generated by the muscular reaction after the electrical stimulus. The modified pressure cuff is also used for NIBP (Non-invasive Blood Pressure) measurement. Thus it is possible to monitor both parameters with only one patient sensor.

NMT can work either in manual or automatic modes. In manual mode the user starts a measurement by touching buttons of main menu. In automatic mode the measurement is performed at reqular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time. The user can stop a NMT measurement at any moment by pressing the NMT Stop key.

TOF-CUFF monitor offers the possibility to start an automatic procedure for Neuromuscular Blockade (NMB) monitoring during the complete surgical process. The Auto-Pilot Program is designed to facilitate the work of the anaesthesiologist and change pattern type and stimulation cycle according to the different blockade phases during surgery, but NMT monitoring requires adequate vigilance and supervision by the anaesthesiologist

TOF-CUFF monitor provides systolic, diastolic and mean arterial pressure values, as well as the pulse rate, in a non-invasive way, by means of an enhanced version of the oscillometric method. The validation has been performed using as reference the intra-arterial pressure measurement

NIBP can work either in manual or automatic modes. In manual mode a measurement is performed only when Start/Stop NIBP key is pressed. In automatic mode, the measurement is performed at regular intervals. The time interval between measurements is selectable by the user. In automatic mode the user can start a measurement at any time by pressing the Start/Stop NIBP key and the next measurement would start once the selected time interval has elapsed. If Start/Stop NIBP key is pressed while a NIBP measurement is in progress, the process is stopped and the cuff deflated. During the measurement a button is also shown in the main menu area that, when pressed, stops the process.

AI/ML Overview

The RGB Medical Devices' TOF-Cuff monitor, intended for monitoring neuromuscular transmission (NMT) and non-invasive blood pressure (NIBP) in adult surgical patients, underwent two clinical studies to demonstrate its performance and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria & Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria or precise reported device performance metrics in a table format for the clinical studies. However, it mentions qualitative outcomes related to the device's functionality.

Acceptance Criteria Category	General Criteria/Goal	Reported Device Performance/Outcome
NIBP Monitoring	Determine capacity to monitor non-invasive arterial pressure.	"The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device the non-invasive arterial pressure..." (Implies successful monitoring capability)
NMT Monitoring	Determine capacity to monitor neuromuscular blockade induced with relaxant drugs. Compare NMB values with a predicate monitor.	"The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device...the level of neuromuscular blockade induced with relaxant drugs." "The main objective of the second study is to compare the values of neuromuscular blockade measured with the TOF-CUFF monitor with neuromuscular blockade values measured with the CARESCAPE B450 monitor...and evaluate the degree of equivalence." (Implies successful monitoring and demonstration of equivalence)
Overall Equivalence	Demonstrate substantial equivalence in terms of indication for use, technology, and performance specifications to predicate devices.	"Both studies showed that the TOF-Cuff monitor supports the determination of substantial equivalence regarding its intended use." "Based on the provided information and performed clinical testing our device the TOF-Cuff monitor is substantially equivalent to the primary predicate device BP100A, the secondary predicate device TwitchView System and to the reference device Carescape B450 in terms of indication for use, technology and performance specifications."

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of patients) used in the two clinical investigations. It vaguely states "Two clinical investigations were performed on the TOF-cuff monitor." The provenance of the data (country of origin, retrospective or prospective) is not explicitly mentioned but clinical investigations typically imply prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

The document describes a comparative study for neuromuscular blockade (the second study) which compares the TOF-CUFF monitor's measurements with those of a CARESCAPE B450 monitor. However, this is not an MRMC study related to human readers or AI assistance. It compares device performance in measuring a physiological parameter. Human reader involvement, AI assistance, or effect sizes related to human improvement are not mentioned.

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

The context of the device (a monitor) implies a standalone performance, meaning the device itself generates the measurements. The studies focus on the device's ability to measure NMT and NIBP and its equivalence to other monitors, rather than human-in-the-loop performance. The term "algorithm only" is not explicitly used, but the device operates to provide measurements.

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

For NIBP: The document states, "The validation has been performed using as reference the intra-arterial pressure measurement." This indicates that intra-arterial pressure, a direct and highly accurate method, was used as the ground truth for NIBP measurements.
For NMT: The second clinical study compared NMB values from the TOF-CUFF monitor with those from the CARESCAPE B450 monitor. Therefore, the measurements from the CARESCAPE B450 monitor served as the reference or comparative ground truth for NMT.

8. The sample size for the training set

The document does not mention the sample size for any training set. As this is a medical device clearance document, it focuses on validation and clinical performance rather than AI model training, which may not be directly applicable in the same way.

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

Since no training set is mentioned in the context of AI model training, the method for establishing its ground truth is not applicable or provided. The document focuses on the clinical validation of the device and its measurements against established reference methods.

Summary

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RGB Medical Devices SA Ricardo Ruiz Regulatory Affairs Manager Calle de Alfonso Gomez 42 Madrid, Spain, 28037

Re: K181894

Trade/Device Name: TOF-Cuff Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, KOI Dated: April 9, 2019 Received: April 12, 2019

Dear Ricardo Ruiz:

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.

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

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801); 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.htm); 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,

ht" Michael Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality 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) K181894

Device Name TOF-CUFF monitor

Indications for Use (Describe)

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for RGB Medical Devices. The logo features the letters "RGB" in a bold, sans-serif font, with the "R" and "B" in blue and the "G" in green. Below the letters, the words "medical devices" are written in a smaller, sans-serif font. The logo is simple and modern, and it conveys a sense of professionalism and expertise.

K181894

VOLUME 006

510(k) Summary

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DATE OF PREPARATION:

APPLICANT:

APRIL 9, 2019

RGB Medical Devices SA Calle de Alfonso Gómez 42 28037 Madrid Spain Tel: + 34 913042011 E-Mail: rgb@rgb-medical.com.

CONTACT PERSON:

Ricardo Ruiz Regulatory Affairs Manager Tel.: + 34 913042011 E-Mail: rruiz@rgb-medical.com

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1 Device Name

Trade Name:	TOF-Cuff monitor
Device Classification Name:	Noninvasive blood pressure measurementsystem
Classification Class:	II
Primary Product Code:	DXN
Regulation:	21 CFR 870.1130
Review Panel:	Cardiovascular

Secondary Product Code 2

RegulationDescription	RegulationMedicalSpecialty	Review Panel	Product Code	RegulationNumber	DeviceClassification
Electrical peripheralnerve stimulator	Anesthesiology	Anesthesiology	KOI	868.2775	II

Predicate Devices / Reference Device 3

Device	Predicate / Reference	510(k)
BP100AShenzhen Combei Technology Co., Ltd.	Primary predicate device	K181104
TwitchView SystemBlink Device Company	Secondary predicate device	K172843
CARESCAPE B450General Electric Finland Oy.	Reference device	K132533

Device Description এ

The device consists of the TOF-Cuff monitor and the TOF-Cuff pressure cuff. The applied part of the device is the TOF-Cuff pressure cuff.

TOF-CUFF monitors the neuromuscular transmission (NMT) using the patented TOF-Cuff® method.

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5 Intended Use

TOF-CUFF monitor is a device intended to monitor neuromuscular transmission and noninvasive blood pressure of adult patients during surgery and issue alarms related with these physiological parameters. It is not a therapeutic device.

The monitor should be used only with a single patient. The monitor is intended for Adult patients.

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Comparison of Technological Characteristics 6

A comparison of technological characteristics of the TOF-Cuff monitor to the predicate and reference device was conducted.

6.1 Device Characteristics Table

Company	RGB Medical Devices(New Device)	BP100A(Predicate Device)K181104	TwitchView System(Predicate Device)K172843	Carescape B450(Reference Device)K132533
Device Name	TOF-Cuff monitor	BP100A	TwitchView System	Carescape B450	Indication for Use	TOF-Cuff monitor is a deviceintended to monitorneuromuscular transmissionand non-invasive bloodpressure of adult patientsduring surgery and issuealarms related with thesephysiological parameters. Itis not a therapeutic device.The monitor should be usedexclusively in healthinstitutions by trainedmedical professionals. Themonitor is suitable for use inthe presence ofelectrosurgery. Monitor is notintended to be used in thehome environment. Themonitor should be used onlywith a single patient.	The subject device intended tomeasure the diastolic, systolicblood pressures and pulse rate ofan adult individual in hospitals,hospital-type facilities and homeenvironments by using a non-invasive oscillometric techniquewith a single upper arm cuff (22-42 cm).The device detects theappearance of irregular heartbeats during measurement andgives a warning signal withreadings.The Subject device is notintended to be diagnostic device.	The TwitchView Systemis used for thequantitative monitoringof neuromusculartransmission by meansof electromyography	The CARESCAPE MonitorB450 is a multi-parameterpatient monitor intended foruse in multiple areas andintrahospital transport withina professional healthcarefacility.The CARESCAPE MonitorB450 is intended for use onadult, pediatric, and neonatalpatients and on one patientat a time.The CARESCAPE MonitorB450 is indicated formonitoring of:• hemodynamic (includingECG, ST segment,arrhythmia detection, ECGdiagnostic analysis andmeasurement, invasivepressure, non-invasiveblood pressure, pulseoximetry, cardiac output(thermodilution and pulsecontour), temperature,mixed venous oxygensaturation and centralvenous oxygensaturation),• respiratory (impedancerespiration, airway gases(CO2, O2, N2O andanesthetic agents), andspirometry)• neurophysiological status(includingelectroencephalography,Entropy, Bispectral Index(BIS) and neuromusculartransmission).The CARESCAPE MonitorB450 also provides alarms
Regulation Number	870.1130	870.1130	868.2775	870.1025
Class	2	2	2	2
Product Code	DXNKOI	DXN	KOI	MHX, BZK, BZL, BZQ, CAP,CBQ, CBR, CBS, CCK, CCL,DPS, DPZ,DQA, DQK, DRT, DSI, DSJ,DSK, DXG, DXN, FLL, GWJ,GWQ,KOI, KRB, MLD, NHO, NHP,NHQ, OLT, OLW, OMC, ORT
510(k) number	K181894	K181104	K172843	K132533

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Image /page/9/Picture/1 description: The image shows the logo for RGB medical devices. The letters RGB are in blue, with a green triangle to the left of the R. Below the letters RGB, the words "medical devices" are written in a smaller font.

Company	RGB Medical Devices(New Device)	BP100A(Predicate Device)K181104	TwitchView System(Predicate Device)K172843	Carescape B450(Reference Device)K132533
				trends, snapshots andevents, and calculations andcan be connected todisplays, printers andrecording devicesThe CARESCAPE Monitor
				B450 is intended for useunder the direct supervisionof a licensed healthcarepractitioner, or by personneltrained in proper use of theequipment in a professionalhealthcare facility.
Pattern Types	ST - Single TwitchTOF - Train of FourPTC - Post-Tetanic Count	---	ST - Single TwitchTOF - Train of FourPTC - Post-Tetanic CountTetanic stimulation	ST - Single TwitchTOF - Train of FourPTC - Post-Tetanic CountDBS - Double BurstStimulationTetanic stimulation
ST cycles [s]	1, 10	---	---	1, 10, 20
TOF cycles	12 s, 30 s, 1 min, 2 min, 5min ,10 min, 15 min, 30 min,60 min	---	---	10 s, 12 s, 15 s, 20 s, 1 min,5 min, 15 min
PTC tetanic period [s]	5	---	5	5
Measurement modes	Automatic and manual	---	Automatic and manual	Automatic and manual
Stimulation current range[mA]	1-60	---	10-80	1-70
Systolic pressure range[mmHg]	30 to 250	30 to 280	---	30 to 260
Diastolic pressure range[mmHg]	10 to 218	30 to 280	---	25 to 220
Mean pressure range[mmHg]	20 to 234	---	---	25 to 260
Company	RGB Medical Devices(New Device)	BP100A(Predicate Device)K181104	TwitchView System(Predicate Device)K172843	Carescape B450(Reference Device)K132533
Physical DimensionsWidth [cm]Height [cm]Depth [cm]Weight [kg]Power Supply	22.220.581.5TOFCUFF is powered from ACmains supply.100 - 240 VAC, 50 / 60 Hz,0.4 - 0.22 ATOFCUFF includes an internalLi-Ion battery as secondarypower supply.11.1 V - 2.60 Ah	9.26.112.80.49 (including battery)4- Type "AA" alkaline batteries	External AC AdaptersLi-Ion battery	30.029.016.05.0100 - 240 VAC, 50 / 60 Hz,1.8 - 0.8 ALi-Ion battery10.8 V - 3.80 Ah(optionally it can include asecond battery
User Interface	TOFCUFF includes a TFT colordisplay with the followingspecifications:Display size: 15.5 cm x 9.3cm Display resolution: 800 x480 pixels User inputs aredone through a resistivetouch panel and it includes amembrane keyboard withfour keys for some functions(Switching on/off the device,Start/Stop NIBPmeasurement, Stop NMTmeasurement and Exit).	BP100A includes a custom designLCD with numerical presentationof data and specific symbolsintegrated.Three specific keys for somefunctions (On/Off, Setting&Time,Memory).	TFT color displayResistive touch paneland one specific key forswitching on/off thedevice	TFT color displayResistive touch panel andone specific key for switchingon/off the device
Sterilization	non-sterile	non-sterile	non-sterile	non-sterile

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6.2 Conclusion of Comparison of Technological Characteristics

Each of the two vital signs monitored by the TOF-Cuff (NIBP, NMT), are also monitored by the selected predicate devices. In addition, the reference device CARESCAPE B450 can monitor several vital signs including neuromuscular transmission (NMT) and non-invasive blood pressure (NIBP), which are the two vital signs monitored by the TOF-Cuff.

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The maximum NIBP measurement time specified for the TOF-CUFF monitor is below the maximum limit allowed by the requirement 201.104 of the IEC 80601-2-30. The device is in compliance with current FDA recognized standard, therefore this difference does not raise any different questions of safety or effectiveness of the device.

The technological characteristics of the TOF-Cuff monitor are substantially equivalent to the technological characteristics of the chosen predicates and reference device. There are no differences between the devices which may raise different questions of safety or effectiveness.

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7 Performance Data

Non-clinical and clinical testing has been performed showing that the device performs as intended and is substantially equivalent to the primary predicate device (K181104), the secondary predicate device (K172843).

7.1 Biocompatibility

An evaluation of biocompatibility according ISO 10993-1 was performed. Furthermore biological tests according ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation) were performed to demonstrate the biocompatibility of the device.

7.2 Electrical Safety and Electromagnetic Compatibility

Electrical safety and EMC testing were conducted. The TOF-Cuff monitor is in compliance with IEC 60601-1, IEC 60601-1-6, IEC 62366, IEC 60601-1-8, IEC 60601-2-10, IEC 80601-2-30 as well as IEC 60601-1-2.

7.3 Software Verification and Validation Testing

Software verification and validation was conducted and the necessary software documentation according to the defined level of concern was provided.

The TOF-Cuff monitor provides different parameters that the user can select to set the operating mode of the device. The right operation of these parameters has been tested during the design & development process.

7.4 Clinical Testing

Two clinical investigations were performed on the TOF-cuff monitor.

The general objective of the first study was to determine the capacity of the TOF-cuff monitor of monitoring with the same device the non-invasive arterial pressure and the level of neuromuscular blockade induced with relaxant drugs.

The main objective of the second study is to compare the values of neuromuscular blockade measured with the TOF-CUFF monitor with neuromuscular blockade values measured with the CARESCAPE B450 monitor during the pharmacologically induced NMB and evaluate the degree of equivalence.

Both studies showed that the TOF-Cuff monitor supports the determination of substantial equivalence regarding its intended use.

ထ Substantial Equivalence Summary / Conclusion

Based on the provided information and performed clinical testing our device the TOF-Cuff monitor is substantially equivalent to the primary predicate device BP100A, the secondary predicate device TwitchView System and to the reference device Carescape B450 in terms of indication for use, technology and performance specifications. There are no differences between the devices which may raise different questions of safety or effectiveness.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).