The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.

Device Description

The Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD and can also be transmitted to a non-device APP to record and display through Bluetooth.
There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an Infrared Thermometer (AOJ-20A; AOJ-20Y). It details the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

However, the document does not contain the level of detail typically found in a clinical study report or a more comprehensive validation plan. Specifically, it lacks:

Explicit acceptance criteria in a tabular format with corresponding performance results.
Specific sample sizes for test sets beyond general statements of testing being conducted.
Data provenance (country, retrospective/prospective) for clinical data.
Number and qualifications of experts for ground truth.
Adjudication methods.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance details.
Specific details on the type of ground truth (e.g., pathology, outcomes data) beyond "performance effectiveness."
Training set sample size and ground truth establishment for training.

The document primarily focuses on non-clinical performance data to support the substantial equivalence claim, rather than a clinical study demonstrating acceptance criteria met in a real-world setting with human subjects. The tests mentioned are:

Biocompatibility testing: Cytotoxicity, Skin Sensitization, Skin Irritation per ISO 10993-1.
Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-11, and IEC 60601-1-2.
Bench Testing: Compliance with ISO 80601-2-56 for performance effectiveness.
Software Verification and Validation Testing: Conducted as per FDA's "Content of Premarket Submissions for Device Software" guidance, with the device considered "Basic" documentation level.

Given these limitations in the provided text, I can only extract the general types of tests and the standards they comply with, rather than specific acceptance criteria values and the device's measured performance against them. The information on "study that proves the device meets the acceptance criteria" is limited to the types of non-clinical tests conducted.

Therefore, direct answers to many of your questions cannot be provided from the given document as it does not contain clinical study data or a detailed validation report with specific performance metrics against acceptance thresholds.

Based on the provided text, here is what can be inferred and what is explicitly stated:

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

The document references compliance with ISO 80601-2-56 for "performance effectiveness" in bench testing. This standard likely specifies accuracy and precision requirements for clinical thermometers. However, the specific numerical acceptance criteria (e.g., ±0.2°C) and the actual measured performance values of the device against these criteria are not provided in this summary.

Inferred/General:

Acceptance Criteria (Standard)	Reported Device Performance
Performance Effectiveness	Complies with ISO 80601-2-56 (details not provided)
Biocompatibility	Passes Cytotoxicity, Skin Sensitization, Skin Irritation per ISO 10993-1
Electrical Safety & EMC	Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2
Software V&V	Testing conducted, documentation provided per FDA guidance for "Basic" level device software

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for test set: Not specified. The document states "Bench testing was conducted on the thermometer device, consisting of all the system." This suggests testing of the physical devices, but no numerical sample count (e.g., number of thermometers tested, number of measurements taken) is given.
Data provenance: Not specified. The tests are non-clinical bench and lab tests, not clinical human subject data.

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

Not applicable as the testing described is non-clinical/bench testing, not involving human expert interpretation for ground truth.

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

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (thermometer), not an AI imaging or diagnostic algorithm used by human readers.

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

The document describes the performance of the device itself (sensor, electronics, software) in a standalone manner via bench testing, but not an "algorithm only" in the sense of a standalone AI model. The device's function is temperature measurement.

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

For "performance effectiveness," the ground truth (or reference standard) would typically be calibrated reference thermometers or temperature sources compliant with the ISO standard used for test and measurement, not clinical outcomes or expert consensus.
For biocompatibility, the ground truth is the chemical and biological assays.
For electrical safety and EMC, the ground truth is the measurement against standard limits using appropriate test equipment.

8. The sample size for the training set

Not applicable, as this is a traditional medical device (thermometer), not an AI/machine learning model requiring a training set for its core function. The "software verification and validation testing" refers to standard software engineering practices, not machine learning model training.

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

Not applicable for the same reasons as point 8.

Summary

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October 14, 2023

Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan District Shenzhen, Guangdong 518126 China

Re: K232128

Trade/Device Name: Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 13, 2023 Received: July 17, 2023

Dear Jack 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 (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/cdrb/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.

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"

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(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 OS regulation requires device manufacturers to review and approve changes to device design and production (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 mediation-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,

Daniel Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors

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OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K232128

Device Name

Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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		510(k) Summary	Prepared on: 2023-07-17
Contact Details			21 CFR 807.92(a)(1)
Applicant Name	Shenzhen AOJ Medical Technology Co., Ltd
Applicant Address	Room 301&4F, Block A, Building A, Jingfa Intelligent Manufacturing Park,Xiaweiyuan, Gushu Community, Xixiang Street, Bao'an District, ShenzhenGuangdong 518126 China
Applicant Contact Telephone	86 755-27786026
Applicant Contact	Mr. Jack Wang
Applicant Contact Email	regulation@aojmedical.com
Device Name21 CFR 807.92(a)(2)
Device Trade Name	Infrared Thermometer (AOJ-20A);Infrared Thermometer (AOJ-20Y)
Common Name	Clinical electronic thermometer
Classification Name	Thermometer, Electronic, Clinical
Regulation Number	880.2910
Product Code	FLL
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #		Predicate Trade Name (Primary Predicate is listed first)	Product Code

K221039		Infrared Thermometer, models AOJ-20A, AOJ-20Y	FLL
K220276		Infrared Thermometer TET-351 (Reference Device)	FLL
Device Description Summary			21 CFR 807.92(a)(4)
		The Infrared thermometer is a handheld device, which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD and can also be transmitted to a non-device APP to record and display through Bluetooth.There are two models AOJ-20A and AOJ-20Y. Both models share the same construction except differences on product enclosure,PCB layout and button designs.
Intended Use/Indications for Use			21 CFR 807.92(a)(5)
		The Infrared thermometer is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
Indications for Use Comparison			21 CFR 807.92(a)(5)
		The indication for use of the subject device is the same as the predicate devices.
Technological Comparison			21 CFR 807.92(a)(6)

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The subject device is a modification device to the device cleared by K221039.The only modification is software change to allow Bluetooth communication to a non-device APP. K220276 was used as a reference device to support the evaluation of the Bluetooth feature.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following performance data were referenced in support of the substantial equivalence determination. Biocompatibility testing

The biocompatibility evaluation for the thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is contacting, limited exposure (-less than 24 hours). And the evaluation of testing includes the following tests:

· Cytotoxicity
· Skin Sensitization
· Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the thermometer device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 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, and the IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC. Bench Testing

Bench testing was conducted on the themometer device, consisting of all the system. The system complies with the 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 for performance effectiveness.

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, "Content of Premarket Submissions for Device Software for this device was considered as a "Basic" Documentation level.

Not Applicable.

Based on the non-clinical performance data as document, the subject devices were found to be as safe, as effective, and perform as well as the legally marketed devices identified above.

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.