Search Results

The device measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital 1.CD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.

The 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X, and ST8B30X/ST8B40X, are the electronic thermometers by using a thermistor 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, a reference resistor for comparison 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 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 5 Sec Digital Thermometer, models ST8630X/ST8640X, ST8730X/ST8740X, ST8930X/ST8940X, ST8030X/ST8040X and ST8B30X/ST8B40X it was designed and verified according to the US standard ASTM E 1112-00.

The provided text describes the 510(k) summary for the Mesure 5 Sec Digital Thermometer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with a novel AI algorithm. Therefore, many of the requested details related to AI-specific studies (e.g., multi-reader multi-case studies, standalone algorithm performance, AI training/test set details) are not applicable or findable in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data in the typical sense of a clinical trial for an AI-powered device. Instead, it states that the device was designed and verified according to the US standard ASTM E 1112-00. This standard defines performance requirements for electronic thermometers.

Acceptance Criteria (from ASTM E 1112-00, as implied by compliance):

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is referred to as "verification and validation tests" conducted according to the US standard ASTM E 1112-00 and other relevant safety standards (EN 60601-1 series). These are typically non-clinical laboratory tests to ensure accuracy, precision, and safety parameters.

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

• Sample Size for Test Set: Not specified. For a digital thermometer conforming to ASTM E 1112-00, the "test set" would typically refer to the number of individual thermometer units tested, the number of temperature measurements taken under controlled conditions (e.g., water bath), and potentially a small number of human subjects for limited clinical validation (though in-depth clinical trials are not usually required for substantial equivalence of such devices). The document does not provide these numbers.
• Data Provenance: Not specified. However, the company is based in Taiwan (Mesure Technology Co., Ltd., Taipei Hsien, Taiwan, R.O.C.), suggesting testing likely occurred in Taiwan or through certified labs. The submission is to the FDA for the US market. The term "retrospective or prospective" is not applicable as this concerns a medical device's physical performance, not an AI model's data.

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

This query is typically relevant for AI/imaging devices where ground truth is established by expert consensus (e.g., radiologists). For a digital thermometer, the "ground truth" for temperature measurement is established by reference standards (e.g., highly accurate temperature baths traceable to national standards or calibration standards). Experts involved would be metrology engineers, technicians, and quality control personnel within the manufacturing and testing facilities, ensuring compliance with standards like ASTM E 1112-00. The document does not specify the number or qualifications of such experts.

4. Adjudication Method for the Test Set

Not applicable in the context of a digital thermometer's performance testing. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies among human readers interpreting medical images or data. For a thermometer, performance is objectively measured against a reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for AI systems assisting human readers in interpreting medical data (e.g., radiology). This is a simple digital thermometer, not an AI-powered diagnostic device.

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

Yes, in essence. The "device" (thermometer) itself is a standalone measurement tool. Its performance is evaluated intrinsically through laboratory testing against metrological standards, not in conjunction with human interpretation in the way an AI algorithm might be. However, this is not an "algorithm" in the sense of a complex AI model. The "algorithm" here is simply the ASIC (Application Specific IC) controlling the circuit to calculate and display the temperature. Its standalone performance is what's verified against ASTM E 1112-00.

7. The Type of Ground Truth Used

The ground truth for a digital thermometer's accuracy and precision testing is established using calibrated reference standards, such as highly stable and accurate temperature-controlled water baths, whose temperatures are known with high certainty and are traceable to national/international measurement standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm that undergoes a "training phase." Its function is determined by its hardware design (thermistor, ASIC circuit) which translates a physical measurement into a digital reading based on fundamental physics and electronics, not machine learning from a training set.

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

Not applicable, as explained in point 8.

Ask a specific question about this device