The MaxO2 ME+p is an oxygen monitor with integrated pressure monitoring intended for continuous monitoring of the concentration of oxygen and pressure being delivered to patients ranging from newborns to adults. It can be used in the hospital and sub-acute settings. The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

Device Description

The MaxO2 ME +p is a battery powered oxygen and pressure monitor in a single assembly. The oxygen monitor measures the oxygen concentration from a gas source, displays these measured concentrations, and provides user selectable high and low oxygen alarms. It also the user to monitor pressure simultaneously and provides user selectable high and low pressure alarms.

AI/ML Overview

The MaxO2 ME+p device is an oxygen monitor with integrated pressure monitoring. The acceptance criteria and supporting study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document compares the MaxO2 ME+p (proposed device) to two predicate devices: Maxtec - MaxO2 ME (K153659) for oxygen monitoring and Caradyne - Criterion 40 (K992101) for pressure monitoring.

Attribute	Acceptance Criteria (Predicate MaxO2 ME)	Reported Device Performance (MaxO2 ME+p)	Acceptance Criteria (Predicate Criterion 40)	Reported Device Performance (MaxO2 ME+p)
Oxygen Monitoring
Oxygen % Range	0.0 to 100%	0.0 to 100%	N/A	N/A (for pressure comparison)
Oxygen Resolution	0.1%	0.1%	N/A	N/A
Accuracy and Linearity	±1% of full scale at constant temperature, RH and pressure when calibrated at fill scale	±1% of full scale at constant temperature, RH and pressure when calibrated at fill scale	N/A	N/A
Total Accuracy (Oxygen)	±3% Actual oxygen level over full operating temperature range	±3% Actual oxygen level over full operating temperature range	N/A	N/A
Response Time	90% of final value in approx. 15 seconds at 23°C	90% of final value in approx. 15 seconds at 23°C	N/A	N/A
Low Oxygen Alarm Range	15%-99% (>1% lower than high alarm)	15%-99% (>1% lower than high alarm)	N/A	N/A
High Oxygen Alarm Range	16%-99% (>1% higher than low alarm)	16%-100% (>1% higher than low alarm) (Note: Proposed device allows 100%, predicate 99% - considered acceptable)	N/A	N/A
Pressure Monitoring	N/A (for oxygen comparison)	N/A (for oxygen comparison)
Pressure Measurement Range	N/A	N/A	Up to +99 cmH2O	-15 to +60 cmH2O (Note: Lower maximum range than predicate, but this difference is discussed and deemed acceptable)
Pressure Resolution	N/A	N/A	1 cmH2O	1 cmH2O
Display Resolution (Pressure)	N/A	N/A	0.5 cmH2O	0.5 cmH2O
Total Accuracy (Pressure)	N/A	N/A	± 1 cmH2O	± 1 cmH2O
Low Alarm Range (Pressure)	N/A	N/A	1-20 cmH2O	1 - 30 cmH2O (Note: Adjusted for lower max pressure, deemed acceptable)
High Alarm Range (Pressure)	N/A	N/A	5 - 99 cmH2O	1 – 60 cmH2O (Note: Adjusted for lower max pressure, deemed acceptable)
Alarm Delay (Pressure)	N/A	N/A	1-20 sec	3 seconds (Note: Shorter delay than predicate, deemed acceptable)
Zero Calibration (Pressure)	N/A	N/A	Yes	Yes
General
Indications for Use	Continuous monitoring of O2, newborns to adults, pre-hospital, hospital, sub-acute	Continuous monitoring of O2 and pressure, newborns to adults, hospital, sub-acute	Measurement of airway pressure with positive pressure devices, hospital, sub-acute, home care	Continuous monitoring of O2 and pressure, newborns to adults, hospital, sub-acute
Environments of Use	Pre-hospital, hospital and sub-acute settings	Hospital and sub-acute settings	Hospital, sub-acute institutions, home care	Hospital and sub-acute settings (Note: Not for home care like some predicates, deemed acceptable)
Patient Population	Newborns to adults	Newborns to adults	Not specified (implied similar)	Newborns to adults
Operating Temperature	15°C-40°C	15°C-40°C	15°C-45°C	15°C-40°C (Note: Slightly narrower range than one predicate, deemed acceptable)
Storage Temperature	-15°C-50°C	-15°C-50°C	-40°C-60°C	-15°C-50°C @ 95% RH (Note: Slightly narrower range than one predicate, deemed acceptable)
Atmospheric Pressure	800-1012 mBars	800-1013 mBars	Not specified	800-1013 m Bars
Humidity	0-95% (non-condensing)	0-95% (non-condensing)	15-95%RH	0-95% RH (Note: Slightly wider range for proposed device, deemed acceptable)
Power requirements	4 – AA Alkaline batteries	4 – AA Alkaline batteries	AC / DC	4x - AA alkaline batteries
Battery Life	Approx. 5000 hours	Approx. 5000 hours	Up to 24 hours	5000 hours (Note: Significantly longer battery life for proposed device, deemed acceptable advantage)
Standards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-8, ISO 80601-2-55	ES 60601-1, IEC 60601-1-2, AIM 7351731:2017, IEC 60601-1-8, ISO 80601-2-55	IEC 601-1, IEC 601-1-2	ES 60601-1, IEC 60601-1-2, AIM 7351731:2017, IEC 60601-1-8, ISO 80601-2-55

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

The document does not specify a sample size for a test set in terms of clinical data or patient samples.
The study primarily relies on non-clinical testing (bench testing and adherence to standards) to demonstrate performance.
No human clinical testing or animal testing was performed.
The data provenance is not applicable as it's not a study involving patient data.

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. Given that the testing was non-clinical (adherence to standards and bench testing), the "ground truth" would be established by the requirements of those standards and the accuracy of reference measurement equipment. Experts involved would be in engineering, quality assurance, and regulatory affairs, but specific numbers and qualifications are not detailed.

4. Adjudication method for the test set:

An adjudication method is not applicable as there was no study involving human readers or interpretation of results that would require consensus among experts. The testing involved verifying the device's performance against defined technical specifications and industry 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:

No MRMC comparative effectiveness study was done. This device is an oxygen and pressure monitor, not an AI-powered diagnostic imaging device or a system designed to assist human readers in interpretation. Therefore, this type of study is not relevant to the MaxO2 ME+p.

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

This question is not directly applicable in the context of this device. The MaxO2 ME+p is a standalone physical device (monitor) that measures oxygen concentration and pressure. Its performance is evaluated through non-clinical bench testing against established standards and specifications, not through an "algorithm only" performance study in the way it might be for a diagnostic AI. The device's functioning is its standalone performance without human input beyond its operation.

7. The type of ground truth used:

The "ground truth" for the performance evaluation was established by technical specifications, measurements from calibrated reference equipment, and compliance with recognized industry standards. These include:
- AAMI ANSI ES 60601-1: Medical electrical equipment safety and essential performance.
- IEC 60601-1-2: Electromagnetic Disturbances.
- AIM Standard 7351731: Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers.
- IEC 60601-1-8: Alarm systems.
- ISO 80601-2-55: Respiratory gas monitors.
- ISO 10993-5, -10, -11, -18: Biocompatibility.
- ISO 18562-2, -3: Particulate material and VOCs.

8. The sample size for the training set:

This information is not applicable. This device is a hardware monitor, not a machine learning or AI algorithm that requires a training set of data.

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

This information is not applicable, as there is no training set for this type of device.

Summary

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April 1, 2023

Maxtec, LLC % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704

Re: K221734

Trade/Device Name: Maxtec - MaxO2 ME+p Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: Class II Product Code: CCL, CAP Dated: February 28, 2023 Received: February 28, 2023

Dear Paul Dryden:

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

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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 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-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,

James J. Lee -S

James J. Lee. Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K221734

Device Name

MaxO2 ME+p

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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Date Prepared:	31-Mar-23
Maxtec, Inc.2305 South 1070 WestSalt Lake City, UT 84119Tel - 732-244-0010
Official Contact:	Sidra Hankins - VP of QARA
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:	Maxtec - MaxO2 ME+p
Classification CFR:Classification Code:Classification Name:	21 CFR 868.1720CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
Classification CFR:Classification Code:Classification Name:	21 CFR 868.2600CAPMonitor, Airway Pressure
Primary Predicate Device:Secondary Predicate Device:	Maxtec - MaxO2 ME - K153659Caradyne - Criterion 40 - K992101

Device Description:

The MaxO2ME+p comply with the following standards:

AAMI ANSI ES 60601-1: 2005 + A1: 2012 Medical electrical equipment Part 1: General ● requirements for basic safety and essential performance
IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances Requirements and Tests ●
AIM Standard 7351731 Rev. 2.00 2017-02-23 Medical Electrical Equipment and System ● Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
IEC 60601-1-8 2006+A1 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 80601-2-55 2018 Particular requirements for the basic safety and essential performance of . respiratory gas monitors

Indications for Use:

The MaxO2 ME+p is not intended as a life-supporting device or life sustaining device.

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Patient Population:

Newborns to Adult patients for MaxO2 ME+p.

Environments of use:

MaxO2 ME+p: Hospital and sub-acute settings.

We present the proposed device vs. the predicate and reference in the Tables below.

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Table 1 - Comparison of the proposed device vs. the Primary Predicate MaxO2 ME

Attributes	ProposedMaxO2ME+p	Primary PredicateMaxtec - MaxO2 ME K153659
Indications for Use	The MaxO2 ME+p is an oxygen monitor with integratedpressure monitoring intended for continuous monitoring of theconcentration of oxygen and pressure being delivered topatients ranging from newborns to adults. It can be used in thehospital and sub-acute settings.	The MaxO2ME oxygen monitor is intended for continuousmonitoring of the concentration of oxygen being delivered topatients ranging from newborns to adults. It can be used in thepre-hospital, hospital and sub-acute settings. The MaxO2ME isnot intended as a life supporting device.
New indication	Adding pressure monitoring	N/A
Environments of Use	Hospital and sub-acute settings	Pre-hospital, hospital and sub-acute settings
Patient Population	Newborns to adults	Newborns to adults
Oxygen % Range	0.0 to 100%	0.0 to 100%
Oxygen Resolution	0.1%	0.1%
Accuracy and Linearity	±1% of full scale at constant temperature, RH and pressurewhen calibrated at fill scale	±1% of full scale at constant temperature, RH and pressurewhen calibrated at fill scale
Total Accuracy	±3% Actual oxygen level over full operating temperaturerange	±3% Actual oxygen level over full operating temperature range
Response Time	90% of final value in approx. 15 seconds at 23°C	90% of final value in approx. 15 seconds at 23°C
Warm-up Time	None required	None required
Operating Temperature	15°C-40°C (59°F-104°F)	15°C-40°C (59°F-104°F)
Storage Temperature	-15°C-50°C (5°F-122°F)	-15°C-50°C (5°F-122°F)
Atmospheric Pressure	800-1013 mBars	800-1012 mBars
Humidity	0-95% (non-condensing)	0-95% (non-condensing)
Power requirements	4 – AA Alkaline batteries	4 – AA Alkaline batteries
Battery Life	Approx. 5000 hours, typical use	Approx. 5000 hours, typical use
Low Battery Indications	Battery indicator on LCD display	"LOWBAT" icon on LCD display
Sensor Type	Maxtec MAX-550E galvanic fuel cell	Maxtec MAX-550E galvanic fuel cell
Expected Sensor Life	> 1,500,000 %O2 Hours, over 2 years typical application	> 1,500,000 %O2 Hours, over 2 years typical application
Alarm Systems	High/Low alarms, flashing yellow LEDsNominal 975 Hz audio buzzer (IEC 60601-1-8)	High/Low alarms, flashing yellow LEDsNominal 975 Hz audio buzzer (IEC 60601-1-8)
Low Oxygen Alarm Range	15%-99% (>1% lower than high alarm)	15%-99% (>1% lower than high alarm)
High Oxygen Alarm Range	16%-100% (>1% higher than low alarm)	16%-99% (>1% higher than low alarm)
Attributes	ProposedMaxO2ME+p	Primary PredicateMaxtec - MaxO2 ME K153659
Accuracy	Exact to display alarm value	Exact to display alarm value
Dimensions	3.6"(W) x 5.8"(H)x1.2"(D)	3.6"(W) x 5.8"(H)x1.2"(D)
Weight	Approx. 1.01 lbs.	Approx. 0.89 lbs.
Accessories	DiverterTee adapter (15 mmm x 22 mm fittings)Pressure monitoring lineMounting bracketsDC power adapter	DiverterTee adapter (15 mmm x 22 mm fittings)Mounting bracketsDC power adapter
Standards	ES 60601-1IEC 60601-1-2IEC 60601-1-8ISO 80601-2-55	ES 60601-1IEC 60601-1-2IEC 60601-1-8ISO 80601-2-55
	Features related to pressure monitoring discussed in Table 2

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Table 2 - Comparison of the proposed device vs. the predicate.

Attributes	ProposedMaxO2ME+p	Secondary PredicateCaradyne Criterion 40K992101
New indication	Pressure monitoring	Pressure monitoring
Indications for Use	The MaxO2 ME+p is an oxygen monitor with integrated pressuremonitoring intended for continuous monitoring of theconcentration of oxygen and pressure being delivered to patientsranging from newborns to adults. It can be used in the hospital andsub-acute settings.	Intended to measure airway pressure when used with positivepressure devices. The device alarms when the airwaypressure falls outside the user selected high and low alarmlimits and displays peak pressure and real-time airwaypressures. It may be used with positive pressure deviceswhich do not include pressure measurement capabilities, e.g.,resuscitation bags or basic ventilators, or as an independentbackup pressure monitor for devices with pressuremeasurement capabilities. The device has been designed forstationary and intra-institution transport only.
Environments of Use	Hospital and sub-acute settings	Hospital, sub-acute institutions, home care
Patient Population	Newborns to adults	Not specified
Technology	Microprocessor controlled device	Microprocessor controlled device
Pressure sensor type	Solid-state pressure transducer	Solid-state pressure transducer
Displayed information
	Low pressure a larm settingHigh pressure a larm settingAlarm silence indicatorPower supply indicatorAverage (mean) pressureAudible and visual alarm	Low pressure a larm settingHigh pressure a larm settingStatus of alarm silence and time remainingPeak pressureReal-time pressurePower source and statusAudible and visual alarm
Attributes	ProposedMaxO2ME+p	Secondary PredicateCaradyne Criterion 40K992101
PressureMeasurement Range	-15 to +60 cmH2O	Up to +99 cmH2O
Pressure Resolution	1 cmH2O	1 cmH2O
Display resolution	0.5 cmH2O	0.5 cmH2O
Total Accuracy	$\pm$ 1 cmH2O	$\pm$ 1 cmH2O
Low alarm range	1 - 30 cmH2O	1-20 cmH2O
High alarm range	1 – 60 cmH2O	5 - 99 cmH2O
Alarm delay	3 seconds (pressure only)	1-20 sec
Zero calibration	Yes	Yes
System interface	Disposable tubing with filter and with or without Nafion connectsto in-line tee or face mask	Disposable tubing with filter connects to in-line tee or facemask
OperatingTemperature	15°C-40°C, 0-95% RH	15°C-45°C, 15-95%RH
Storage Temperature	-15°C-50°C @ 95% RH	-40°C-60°C@95%RH
Atmospheric Pressure	800-1013 m Bars	No specified
Power requirements	4x - AA alkaline batteries	AC / DC
Battery Life	5000 hours	Up to 24 hours
Biocompatibility	Externally communicating, tissue, permanent	Externally communicating, tissue, permanent
Standards	ES 60601-1IEC 60601-1-2AIM Standard 7351731:2017IEC 60601-1-8ISO 80601-2-55	IEC 601-1IEC 601-1-2

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510(k) Summary Page 5 of 7

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Substantial Equivalence Discussion and Conclusion

As discussed the only new feature is the addition of the pressure monitoring feature. As all other features and performance are identical to the reference, we will only discuss the new pressure monitoring feature.

Indications for Use

The subject device, MaxO2 ME+p, have added the feature of measuring and monitoring pressure. The indications are similar to the primary predicate K152659 Maxtec – MaxO2 ME for measuring oxygen concentration and the secondary predicate K992101, Caradyne - Criterion 40 for measuring and monitoring pressure.

Environment of Use

The subject device, MaxO2 ME+p, has similar environments of use when compared to the primary predicate K152659 Maxtec - MaxO2 ME and the secondary predicate K992101. Caradyne - Criterion 40. However, the subject device is not intended for the home care setting like the secondary predicate. This difference does not raise different concerns of safety or effectiveness.

Population

The subject device, MaxO2 ME+p, has similar patient population as the primary predicate K152659 Maxtec - MaxO2 ME and the secondary predicate K992101, Caradyne - Criterion 40. The K992101, Caradyne - Criterion 40 did not specify a patient population, but measurement of pressure would have included the same population as the subject device.

While it is not specified in the predicates, the population does not raise different concerns of safety or effectiveness.

Performance Specifications

The subject device, MaxO2 ME+p, has similar performance specifications when compared to the secondary predicate K992101, Caradyne - Criterion 40.

There are differences in the pressure measurement range between the devices with the subject device limited to a maximum of 60 cmH2O and the predicate measures up to 99 cmH2O. The alarm setting ranges are also adjusted for this lower maximum pressure.

The alarm delay for the subject device is 3 seconds as compared to the predicate which can be up to 20 seconds. This difference does not raise different concerns of safety or effectiveness.

Non-clinical Testing

We performed a number of tests to demonstrate that the proposed device performed as intended. Testing includes:

AAMI ANSI ES 60601-1: 2005 +A1: 2012 Medical electrical equipment Part 1: General requirements ● for basic safety and essential performance
IEC 60601-1-2: 2014 Collateral standard: Electromagnetic Disturbances Requirements and Tests .
AIM Standard 7351731: 2017 Electromagnetic Immunity Test for Exposure to Radio Frequency ● Identification Readers
IEC 60601-1-8: 2012 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 80601-2-55: 2018 Particular requirements for the basic safety and essential performance of ● respiratory gas monitors

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Biocompatibility

Patient contacting materials were evaluated per:

ISO 10993-5:2009 - Cytotoxicity
ISO 10993-10:2010 Sensitization and Irritation ●
ISO 10993-11:2017 - Material Mediated Pyrogenicity
ISO 10993-18:2020 Chemical Characterization with a Toxicological Risk Assessment ●
ISO 18562-2:2017 Particulate Material ●
ISO 18562-3:2017 VOC with Toxicological Risk Assessment .

Animal

No animal testing was performed.

Clinical

No human clinical testing was performed.

Conclusion

We have performed a comparison of specifications in the above table and found the proposed model to be substantially equivalent.

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).