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The Infrared Ear Thermometer, models IR-04MT are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.

The Infrared Ear Thermometer, models IR-04MT is a handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) – controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.

This system uses a 3.0 V DC battery(2xAAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of IR-04MT, they were designed and verified according to the US standard ASTM E 1965-2003.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Ear Thermometer, models IR-04MT:

1. Table of Acceptance Criteria and Reported Device Performance

Despite multiple references to performance and compliance with ASTM E1965-2003, the document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., a specific deviation tolerance) or the exact reported performance metrics from the clinical study in an easily quantifiable format. It broadly states the device "was designed and verified according to the US standard ASTM E 1965-2003" and that "The results of the Clinical Test Report could positively support the claim of Substantial Equivalence."

To fulfill this section accurately, I can only infer the acceptance criteria are met by compliance with the referenced standard.

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

• Test Set Sample Size: Not explicitly stated. The document mentions "A Clinical Test Report conducted according to ASTM E1965:2003" but does not provide the number of subjects or measurements included in this test.
• Data Provenance: The study was conducted by the "manufacturer," which is DONGGUAN DALANG VIGOR ELECTRONICS MFY in China. Therefore, the data provenance is China. It is a prospective study, as it was a "Clinical Test Report conducted... performed by the manufacturer" as part of the device's validation.

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

• The document does not provide information on the number or qualifications of experts used to establish ground truth. The nature of an ear thermometer's ground truth (e.g., a reference rectal or oral temperature measured by a calibrated clinical thermometer) typically doesn't involve "experts" in the sense of radiologists or pathologists. Instead, it relies on the accuracy of the reference device and the methodology for its use.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method. For a device like an ear thermometer, "adjudication" in the traditional sense of multiple reviewers resolving discrepancies is not typically applicable. The ground truth is generally a single, objectively measured value from a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images, sometimes with AI assistance. The Infrared Ear Thermometer is a direct measurement device, not an interpretative one, and does not involve AI assistance for human readers.

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

• Yes, this is effectively a standalone performance study. The device itself is an "algorithm only" (ASIC-controlled circuit) device that measures and displays temperature. Human involvement is limited to operating the device (placing it in the ear canal and reading the display), not interpreting complex output that would require a "human-in-the-loop" interaction in the typical sense of AI-assisted diagnostics. The clinical test measured the device's accuracy against a recognized standard without a human interpretation component that would require comparison to human-in-the-loop scenarios.

7. The Type of Ground Truth Used

• The ground truth used would be a reference temperature measurement obtained by a calibrated clinical thermometer following the guidelines of ASTM E1965:2003. This standard details how to conduct clinical performance evaluations for infrared thermometers. It implies a direct comparison to a known accurate temperature measurement from a standard clinical method (e.g., a rectal thermometer) under controlled conditions.

8. The Sample Size for the Training Set

• The document does not mention a specific training set or its sample size. This device is described as having an "ASIC (Application Specific IC) – controlled circuit," which is a "hard-wire control instead of programmable control." This implies a fixed, hardware-based algorithm rather than a software algorithm that would undergo a separate "training" phase with a dataset. Therefore, the concept of a "training set" as understood in machine learning/AI (which wasn't the focus of this device) does not apply here.

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

• As there is no indicated "training set" in the context of an ASIC-controlled, hard-wired device that is not an AI/machine learning product, this question is not applicable. The device's fundamental function is governed by its hardware design and integrated circuit, which are designed to comply with physical principles of thermometry.

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The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages.

The clinical thermometer / model ZSET-XXX infrared thermometer are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use on people at all ages.

A> ZSDT-XXX Digital thermometer.
The digital clinical thermometer, models ZSDT-XXX Series, are the electronic thermometers by using a themistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, measuring circuit for the measurement of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts.

This system uses a 1.5V/DC AG3 or SG3 Alkaline battery for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically. and displays 'Low battery' in LCD display. Regarding the performance of ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00.

B> ZSET-XXX Infrared thermometer.
The infrared thermometer, models ZSET-XXX, are the handheld electronic thermometers that measures the temperature through the opening of the auditory canal by using a thermopile as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control.

From the construction point of view, the ear thermometer comprises of a thermopile for the measuring sensor, a reference thermistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermopile sensor detect the ear canal temperature through the infrared.

This system uses a 3.0 V DC battery(2xAAA batteries) for operation of complete system whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002.

Here's the breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The submission refers to compliance with specific ASTM standards rather than explicit "acceptance criteria" presented as thresholds. The device performance is implicitly demonstrated by meeting the requirements of these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Information

The document describes non-clinical tests and refers to a clinical report for one of the devices.

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

   • ZSDT-XXX Digital Thermometer: Not explicitly mentioned beyond compliance with ASTM E 1112-00. The specific test set size or data provenance for the digital thermometer is not provided in detail.
   • ZSET-XXX Infrared Thermometer: "The clinical report for the measurement accuracy comparison as required by ASTM E1965: 2002 is provided for ZSET-XXX and ST613C." The sample size, country of origin, or whether it was retrospective or prospective is not explicitly stated in this summary. ASTM E1965-2002 requires specific clinical study design, including subjects (usually febrile and non-febrile) to establish accuracy, but the details are not included here.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • This information is not provided in the summary. For clinical thermometers, ground truth typically involves a highly accurate reference thermometer (e.g., a rectal or oral mercury-in-glass thermometer or a highly calibrated electronic thermometer) used by trained personnel in a controlled setting, rather than "experts" in the sense of medical specialists interpreting images.

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

   • Given the nature of a clinical thermometer's accuracy testing, an adjudication method like 2+1 or 3+1 is not applicable or mentioned. The ground truth for temperature measurement would typically be established by a single, highly accurate reference measurement.

4. 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 type of study is relevant for imaging devices where human interpretation is involved. Clinical thermometers are direct measurement devices.

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

   • The devices themselves are standalone. Their performance is assessed directly against a reference, not in a human-in-the-loop context. The summary states, "Regarding the performance of ZSDT-XXX, it was designed and verified according to the US standard ASTM E 1112-00," and "Regarding the performance of ZSET-XXX, they were designed and verified according to the US standard ASTM E 1965-2002." These standards define standalone performance requirements.

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

   • For clinical thermometers, the ground truth would be based on highly accurate reference temperature measurements (e.g., from a calibrated laboratory standard thermometer or a well-established clinical standard like a rectal mercury thermometer, as specified in the ASTM standards). The document refers to "measurement accuracy comparison as required by ASTM E1965: 2002," implying adherence to the ground truth methodologies prescribed by that standard.

7. The sample size for the training set

   • Not applicable / Not provided. These are hardware devices, not AI/machine learning algorithms that require a "training set."

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

   • Not applicable / Not provided. As mentioned above, these are not AI/machine learning algorithms requiring a training set with established ground truth in that context. The "design and verification" according to the ASTM standards implies that the engineering and calibration processes ensured the device's accuracy.

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