(132 days)
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
| Standard/Requirement | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| ZSDT-XXX Digital Thermometer | ||
| ASTM E 1112-00 | Compliance with all requirements for electronic thermometers for intermittent determination of patient temperature. | "designed and verified according to the US standard ASTM E 1112-00." |
| ZSET-XXX Infrared Thermometer | ||
| ASTM E 1965-2002 | Compliance with all requirements for infrared thermometers for intermittent determination of patient temperature. | "designed and verified according to the US standard ASTM E 1965-2002." |
| General | ||
| EN 60601-1 | Compliance with general requirements for basic safety and essential performance of medical electrical equipment. | "Compliance to applicable voluntary standards includes... EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement." |
| EN 60601-1-1 | Compliance with collateral standard for safety requirements for medical electrical systems. | "Compliance to applicable voluntary standards includes... EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement." |
| EN 60601-1-2 | Compliance with collateral standard for electromagnetic compatibility - requirements and tests. | "Compliance to applicable voluntary standards includes... EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement." |
Study Information
The document describes non-clinical tests and refers to a clinical report for one of the devices.
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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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.
§ 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.