The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Device Description

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:

The device is intended to be reusable for home use and clinical use.
The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, LCD display.
Switching of temperature unit between °C and °F.
The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
Buzzer on or off to set the prompt tone on or off.
Prompt tone function and backlights function.
The prompt limit setting function.
Low battery indication, and auto power-off.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text for the Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603):

Device: Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (Reported for JZK-601, JZK-602, JZK-603)	Standard Met?
Measurement Range	32 - 42.9°C (89.6 - 109.2°F)	Yes (Performance testing confirms compliance with ISO 80601-2-56 and ASTM E1965-98)
Accuracy	±0.3°C (0.5°F) within 32 - 34.9°C (89.6~~94.8°F) ±0.2°C (0.4°F) within 35 - 42°C (95.0~~107.6°F) ±0.3°C (0.5°F) within 42.1 - 42.9°C (107.8~109.2°F)	Yes (Performance testing confirms compliance with ISO 80601-2-56 and ASTM E1965-98)
Display Resolution	0.1°C /0.1°F	Yes
Response Time	≤3 seconds	Yes (Validated against ISO 80601-2-56 & ASTM E1965-98 during performance & clinical testing)
Electrical Safety	Complies with AAMI/IEC 60601-1:2005+AMD 1: 2012, IEC 60601-1-11:2015	Yes
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2:2014	Yes
Biocompatibility	Complies with ISO 10993-5:2009 (in vitro cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization)	Yes
Software Validation	Documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" (May 11, 2005). Software function for memory verified.	Yes
Clinical Performance	Complies with ASTM E1965-98 (Reapproved 2016) requirements. Demonstrated through a clinical study.	Yes
Measurement Distance	1-5cm (performance testing confirms compliance with ISO 80601-2-56 & ASTM E1965-98)	Yes
Operation Environment	10 - 40°C (50 - 104°F), Humidity: ≤95% (measurement accuracy demonstrated to comply with IEC 60601-1 & ISO 80601-2-56)	Yes
Storage Environment	-20 - 60°C (-4 - 140°F), Humidity: ≤95% (demonstrated to comply with IEC 60601-1 & ISO 80601-2-56)	Yes

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: 200 subjects were evaluated in the clinical study.
- 50 newborns (0 to 3 months)
- 50 infants (older than 3 months up to 1 year)
- 50 children (older than 1 year and younger than 5 years)
- 50 adults (older than 5 years old)
Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It merely describes the study design and its findings. It was a clinical investigation, implying a prospective data collection, rather than retrospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study. It refers to a "randomization, simple blind homologous control, pairing design of clinical investigation" that evaluated the device against the requirements of ASTM E1965-98 (Reapproved 2016). This standard itself defines the acceptable reference methods for temperature measurement (e.g., oral, rectal, axillary, tympanic) and their accuracy, which would serve as the defacto "ground truth" rather than direct expert consensus reading of the device's output.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method in the traditional sense of multiple reviewers resolving discrepancies, as might be found in imaging studies. Given it's a thermometer study comparing to a reference method, the "ground truth" is likely established by the reference thermometer measurements as per ASTM E1965-98, negating the need for complex expert adjudication of device readings. The study design is described as "randomization, simple blind homologous control, pairing design."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic AI tools where human readers interpret medical images with and without AI assistance to measure improvement in diagnostic performance. For a temperature measurement device, the objective is to accurately measure temperature against a reference standard, not to assist human interpretation of complex data. Therefore, an MRMC study is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the primary performance evaluation appears to be a standalone (algorithm only) assessment. The device's accuracy and performance criteria (measurement range, accuracy, response time) are tested directly against performance standards (ISO 80601-2-56, ASTM E1965-98) and in a clinical study where its readings are compared to a reference method, without explicit human interpretation being part of the primary performance metric beyond using the device as intended. The "human-in-the-loop" here is the user taking the temperature, but the device's measurement itself is the standalone output being validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was based on reference temperature measurements as required by the ASTM E1965-98 (Reapproved 2016) standard. This typically involves using highly accurate reference thermometers (e.g., direct contact electronic thermometers, mercury-in-glass thermometers at a core body site) as the "true" temperature against which the infrared forehead thermometer's readings are compared.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This is a medical device, not an AI/ML diagnostic algorithm in the sense of requiring separate training datasets. While internal calibration or factory data might be used in manufacturing, it's not a "training set" in the context of deep learning models.

9. How the Ground Truth for the Training Set Was Established

As this is a physical measurement device (infrared thermometer) and not a machine learning model requiring a distinct training phase with annotated data, the concept of a "training set" and its ground truth establishment in the AI/ML sense does not apply. The device's internal algorithms are likely based on physical principles of infrared detection and calibrated during manufacturing, rather than "trained" on a dataset of patient temperatures.

Summary

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March 12, 2021

ShenZhen ZhengKang Technology Co., Ltd. % Iris Wang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China

Re: K203707

Trade/Device Name: Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: December 8, 2020 Received: December 18, 2020

Dear Iris Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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,

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203707

Device Name

Infrared Forehead Thermometer, Model JZK601, JZK602, JZK603

Indications for Use (Describe)

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

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1. Administrative Information

Date Prepared	March 10, 2021
Manufacturer	ShenZhen ZhengKang Technology Co., Ltd.Address:2&3/F, Building A, No.3 FuXing Yi Lane, HeHua Community,PingHu Street, LongGang District, ShenZhen, GuangDong,China.Contact person: Huayong YangTEL: +86 -0755-83260864E-Mail: 893488645@qq.com
SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.1713A, 17th Floor, Block A, Zhongguan Times Square, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, China.Contact person: Ms. Iris Wang; Mr. Field FuE-Mail: iris@cefda.com; field@cefda.comImage: [logo]
Establishmentregistration number	3015697152

2. Device Information

Device Name:	Infrared Forehead Thermometer
Model:	JZK-601, JZK-602, JZK-603
Classification Name:	Thermometer, Electronic, Clinical
Review Panel:	General Hospital
Device Class:	2
Regulation Number:	880.2910
Product Code:	FLL

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3. Predicate Device

Manufacturer:	Shenzhen Calibeur Industries Co., Ltd.
Device Name:	Infrared Thermometer
Model:	DT-8836T, DT-8836P
510(k) Number:	K191251
Regulation Number:	880.2910
Product Code:	FLL

4. Device Description

The device is intended to be reusable for home use and clinical use. 1)
The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, 2) LCD display.
1. Switching of temperature unit between °C and °F.
The latest 32 sets of memory for measuring human body and object; the user can view or delete 4) the previous measurement results.
1. Buzzer on or off to set the prompt tone on or off.
1. Prompt tone function and backlights function.
1. The prompt limit setting function.
Low battery indication, and auto power-off. 8)

5. Intended Use/ Indications for Use

The Infrared forehead thermometer is a non-contact infrared thermometer (Models JZK-601, JZK-602, JZK-603) intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

6. Comparison with Predicate Device

The subject device infrared forehead thermometer, Model: JZK-602, JZK-603 is substantially equivalent to the predicate device (K191251). This conclusion is based upon comparison on intended use, technological characteristics, materials and applicable safety standards. The difference between the subject device and predicate device do not raise any issues on the device safety and effectiveness.

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Items	Subject Device (K203707)(Model: JZK-601, JZK-602,JZK-603)	Predicate Device (K191251)	Comparison
Regulation number	880.2910	880.2910	Same
Product code	FLL	FLL	Same
Intended Use/Indications for use	The Infrared foreheadthermometer (Models JZK-601, JZK-602, JZK-603) is anon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperature fromforehead at a distance of 1-5cm for people of all ages.The device is reusable forhome use and clinical use.	The Infrared thermometer is anon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperature fromforehead for people of allages. The device is reusablefor home use and clinical use.	Comparable(1) See below
Measurement Method	Infrared radiation detection	Infrared radiation detection	Same
Measurement Range	32 - 42.9°C (89.6 - 109.2°F)	32.0 - 42.5°C (89.6 - 108.5°F)	Comparable(2) See below
Accuracy	±0.3°C(0.5°F) within 32 -34.9°C (89.6~~94.8°F)±0.2°C (0.4°F) within 35 -42°C (95.0~~107.6°F)±0.3°C(0.5°F) within 42.1 -42.9°C (107.8~109.2°F)	±0.2°C (0.4°F) within 35.0°C -42.0°C (95.0°F ~ 107.6°F),±0.3°C(0.5°F) other range	Same
Display	0.1°C /0.1°F	0.1°C(0.1°F)	Same
Measurementdistance	1-5cm	≤3cm	Comparable(3) See below
Measurement place	Forehead	Forehead	Same
Response time	≤3 seconds	1s	Comparable(4) See below
Sensor type	Thermopile	Thermopile	Same
Scale Selection	°C /°F	°C /°F	Same
Memory	32 sets	60 sets	Comparable(5) See below
Buzzer	Yes	Yes	Same
Shelf Life	5 years	Not Available	Acceptable (6)See below
IP classification	IP22	Not Available	Acceptable (6)See below
Auto power-off whileno operation	Yes	Yes	Same
Power supply	JZK-601 and JZK-603: DC 3V(2× AA 1.5V Alkalinebatteries)JZK-602: DC 3V (2× AAA)	2 * 1.5V AAA	Comparable(7) See below
	1.5V Alkaline batteries)
Display screen	LCD	LCD	Same
Contact materials	ABS	ABS	Same
Backlight	JZK-601 and JZK-603:Three color backlight (green,yellow, and red)JZK-602: two color backlight(green and red)	Not Available	Acceptable (6)See below
OperationEnvironment	10 - 40°C (50 - 104°F)Humidity:≤95%	10 - 40°C (50 - 104 °F)RH 15 - 95%	Comparable(8) See below
Storage Environment	-20 - 60°C (-4 - 140°F)Humidity: ≤95%	-25 - 55°C (-13 - 131°F)RH:15 - 95%	Comparable(9) See below
Dimension	JZK-601 and JZK-603:154 x 96 x 42mmJZK-602: 143 x 81 x 36mm	153.8 x 62.4 x 62.4 mm	Comparable(10) See below
Weight	JZK-601 and JZK-603: 93gJZK-602: 86g	96g	Comparable(10) See below
Conformancestandard	ISO80601-2-56 (performance)IEC60601-1(Safety),IEC60601-1-2(EMC)ASTM E1965-98	ISO80601-2-56 (performance)IEC60601-1(Safety),IEC60601-1-2(EMC)ASTM E1965-98	Same
Patient contactmaterials	ABS	ABS	Same
Biocompatibility	ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10	Same

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Discussion of Comparable Items:

(1) Indications for Use

The subject device indications for use includes the models and measurement distance. Therefore, this difference does not affect the performance and accuracy

(2) Measurement Range

The measurement range of subject device is different from the predicate device. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56 and ASTM E1965-98. Therefore, this difference does not affect the performance and accuracy.

(3) Measurement distance

The measurement distance of subject device is a little different from the predicate device. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56 and ASTM E1965-98. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

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(4) Response time

The response time of subject device is different from the predicate device. However, the software has been validated according to FDA's software guidance. The performance testing shows that the subject device complies with performance standard during performance testing ISO 80601-2-56 and ASTM E1965-98 and clinical testing. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

(5) Memory

The memory of subject device is different from predicate device. The software function of memory of subject device has been verified during software verification according to FDA's software guidance, and the performance testing shows that the subject device complies with performance standard ISO 80601-2-56 and ASTM E1965-98performance and clinical testing. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

(6) Shelf Life, IP Classification, Backlight

The shelf life, ingress protection, and backlight of the predicate were not available. However, the device is comparable to other devices on the market. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness of the subject device.

(7) Power supply

The power supply of subject device for model: JZK-602 is the same with the predicate device, but the power supply of subject device for model: JZK-601/JZK-603 is different from the predicate device. However, the both of the subject device has been demonstrated to comply with the requirements of electrical safety IEC 60601-1 and Electromagnetic Compatibility IEC 60601-1-2. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

(8) Operation Environment

The operation environment of subject device is different from the predicate device, but the measurement accuracy of subject device has been demonstrated to comply with the requirements of standards IEC 60601-1 and ISO 80601-2-56 in operation environment. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

(9) Storage Environment

The operation and storage environment of subject device is different from the predicate device, but the subject device has been demonstrated to comply with the requirements of standards IEC Page 5 of 7

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60601-1 and ISO 80601-2-56. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

(10) Dimension, Weight

The dimension and weight of subject device is different from the subject device. The difference is caused by their different appearance and construction, but the electrical safety, electromagnetic compatibility, performance of subject device has been evaluated to meet the requirements of the standards IECS60601-1, IEC 60601-1-2, ASTM E1965-98 and ISO 80601-2-56. Therefore, we considered that the difference does not raise any issues on the device safety and effectiveness.

7. Non-Clinical Test Summary

7.1. Electromaqnetic Compatibility and Electrical Safety Test

The subject device has been tested in compliance with the following standards: 1) AAMI/IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

7.2. Biocompatibility Test

The subject device has been tested in compliance with the following standards:

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

1. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

7.3. Performance Test-Bench

The subject device has been tested in compliance with the following standards:

ISO 80601-2-56:2017+AMD2018 Medical electrical equipment - Part 2-56: Particular

requirements for basic safety and essential performance of clinical thermometers for

body temperature measurement

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ASTM E1965-98 (Reapproved 2016) Standard Specification for InfraredThermometers for Intermittent Determination of Patient Temperature

7.4. Software Verification

The software documentation of the subject device was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005.

8. Clinical Study

The clinical study is conducted as the requirement of ASTM E1965-98 (Reapproved 2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98(Reapproved 2016).

The clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation. The clinical study evaluated 200 subjects, and the infrared forehead thermometer was evaluated in all age groups. All subjects were divided into three age groups, including (1)Infants newborn to one year, (2)Children - greater than one to five years; (3)Adults - greater than five years old. 50 newborns 0 up to 3 months, 50 infants older than 3 months up to 1 year, 50 children older than 1 year and younger than 5 years, and 50 people older than 5 years are selected. The clinical test report showed the clinical performance of the subject devices complied with the requirement of ASTM E1965-98(Reapproved 2016).

9. Conclusion

The subject device Infrared Forehead Thermometer (Model: JZK-601, JZK-602, JZK-603) is substantially equivalent to the predicate device (K191251). This conclusion is based upon comparison on intended use, technological characteristics and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.