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The Infrared Non-Contact Thermometers, ACT8100, is non-sterile, reusable clinical thermometers intended for the intermittent determination of human body temperature measured at the center of the forehead without contact. The device is intended for use on people of all ages, except pre-term babies or very small (small for gestational age). The device is intended for use in clinical and home use environments.

The Infrared Non-Contact Thermometer, ACT8100 is a hand-held device powered by batteries and designed to measure human body temperature without contacting patients. This thermometer can switch modes between forehead and ambient temperatures. The ambient temperature mode is DIRECT MODE and the forehead temperature mode is ADJUSTED MODE. The forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an oral equivalent temperature without contacting the patient's forehead. Infrared Non-Contact Thermometer, ACT8100 uses a thermopile integrated with a thermistor, a thermistor mounted on the head of the thermometer for ambient temperature readings, and an optoelectronic mechanism that focuses the infrared energy emitted from the user s forehead for the detection of noncontact use and calibration of temperature reading.

Here's a breakdown of the acceptance criteria and study information for the Infrared Non-Contact Thermometer, Model ACT8100, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the ACT8100's accuracy and measuring range "All meet ASTM E 1965-98:2009". The specific criteria for ASTM E1965-98:2009 for the full range are a bit more detailed, but the provided table summarizes the reported performance against the specified ranges.

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

The document states:

• "The three groups of subjects being tested were: (1) Infants of under 1 year old, (2) Children between 1 to 5 years old, (3) Adults"
• However, the specific number of subjects (sample size) within each group or the total sample size for the clinical study is not provided.
• Data Provenance: The country of origin for the data is not explicitly stated in the provided text. The submission is from TAIWAN (Easywell Biomedicals, Inc.), so it's likely the study was conducted there, but this is not confirmed. The study was prospective in nature, as it involved taking measurements from subjects using the device.

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

• The document does not specify the number of experts used to establish the ground truth or their qualifications.
• The ground truth was established by a "reference thermometer, Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group." While this is a reference device, it doesn't involve "experts" in the sense of human readers adjudicating images; rather, it's a direct measurement.

4. Adjudication Method for the Test Set

• An adjudication method (like 2+1, 3+1) is not applicable here as the ground truth was established by direct temperature measurements from a reference thermometer, not by human interpretation that requires consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the context of human readers improving with AI vs. without AI assistance. This device is a standalone non-contact thermometer, not an AI-assisted diagnostic tool that humans would interpret.
• The study did compare the ACT8100's measurements to a predicate device (NTF 3000) and a reference standard (ACT 2130), demonstrating similar clinical biases and repeatability, but this is not an MRMC study.

6. Standalone Performance (Algorithm Only)

• Yes, a standalone performance study was done. The entire clinical evaluation detailed in Section X ("Clinical Testing") is a standalone performance assessment of the ACT8100. It directly measures the device's accuracy and repeatability against a reference standard and compares it to a predicate device without human interpretation of the device's output.

7. Type of Ground Truth Used

• The type of ground truth used was measurements from a reference standard device, specifically the "Actherm Digital Clinical Thermometer ACT 2130 (K031905), either at the rectal, oral, or axillary site depending on their age group." This is clinical measurement-based ground truth.

8. Sample Size for the Training Set

• The document does not provide information on a "training set" or its sample size. This type of non-AI, hardware-based medical device typically does not involve machine learning training sets in the same way an AI-powered diagnostic algorithm would. The device's calibration and algorithm for converting infrared readings to oral equivalent temperatures would have been developed during its R&D phase, but a distinct "training set sample size" with associated ground truth for a retrospective ML model is not applicable here.

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

• As there's no mention of a distinct "training set" in the context of machine learning, the question of how its ground truth was established is not applicable based on the provided information. The device's internal algorithms would have been developed and validated through engineering and laboratory testing, likely using controlled temperature sources and potentially clinical data, but not typically referred to as a "training set" in this context.

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The CliniCloud Non-Contact Thermometer is an infrared thermometer intended for the periodic measurement of human body temperature for persons of all ages, to be used in conjunction with the CliniCloud app.

The CliniCloud Non-Contact Thermometer Model SPL1024 (abbreviated 'CliniCloud Non-Contact Thermometer') is a battery powered Bluetooth Low Energy (BLE) enabled portable infrared thermometer intended for the measurement of human body temperature for persons of all ages. It features no physical buttons or a display and must be used in conjunction with the CliniCloud App on a compatible BLE enabled smartphone. The CliniCloud App is free to download.

When power is applied to the device via 2 AAA batteries, the CliniCloud Non-Contact Thermometer starts to advertise via BLE, and can establish a BLE connection with BLE enabled smart phones with the CliniCloud app. The user could then request the CliniCloud non-contact thermometer to take temperature readings from within the CliniCloud app. The measured temperatures are sent back to the smart phone via the established Bluetooth link and displayed on the smartphone's display in the CliniCloud app. The CliniCloud Non-Contact Thermometer uses a medical grade MLX90614ESF-DCC thermopile sensor supplied by Melexis to passively measure object surface temperature using infrared radiation emitted by patients. The sensor also measures the ambient temperature with a built-in thermistor. The sensor is factory calibrated to meet consensus standard ASTM E1965-98. Upon receiving a request from the CliniCloud APP over the established BLE connection the onboard Nordic Semiconductor NRF51822 BLE SOC microcontroller communicates with the thermopile (MLX90614ESF-DCC) over the 12C bus and sends the received temperature readings including the object surface temperature and the ambient temperature to the CliniCloud app via the established BLE connection. On the smartphone app, the well-known heat loss equation is used to perform conversion of forehead surface temperature to oral equivalent temperature.

Here's a breakdown of the acceptance criteria and study information for the CliniCloud Non-Contact Thermometer, Model SPL1024, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ASTM E1965-98 standard for infrared thermometers.

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The Non-contact Thermometer is intended to measure the human body temperature for children and adults without contact to human body. It can be used by consumers in household environment and doctor in clinics as reference.

The Non-contact Thermometer is a compact, small and light-weight device, which is powered by a battery and can be connected to a smartphone through headphone jack, for detecting body temperature without contact to human body. The measured temperature will be displayed on the screen of a smartphone.

The provided document describes a 510(k) premarket notification for a Non-contact Thermometer (K120711). The primary method for proving the device meets acceptance criteria is through demonstrating substantial equivalence to a predicate device (K102947) and compliance with recognized standards.

Here's an analysis of the acceptance criteria and the study (or lack thereof) that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the predicate device's performance specifications and industry standards.

Detailed Study Information (Based on provided text)

The document primarily relies on design validation and compliance with established standards rather than a specific clinical study with human subjects for novel performance claims.

1. Sample size used for the test set and data provenance:
   This information is not provided in the document. The filing states the device "complies" and is "verified and validated," but it does not detail the specific test set size (e.g., number of temperature measurements, number of subjects) or the provenance (e.g., country of origin, retrospective/prospective) of any data collected to demonstrate compliance with ASTM E1965-98, which would typically involve testing on physical samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The document does not describe a clinical study relying on expert-established ground truth. Compliance with ASTM E1965-98 would typically involve metrology experts and calibrated reference devices, but specific details are absent.

3. Adjudication method for the test set:
   This information is not provided. As there's no mention of a clinical study with multiple observers, adjudication methods like 2+1 or 3+1 are not applicable here.

4. 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 device is a standalone thermometer, not an AI-assisted diagnostic tool for human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   The entire premise of this submission is for a standalone device (a thermometer). The "performance" described is the standalone performance of the device itself (its accuracy, operating range, etc.) in meeting established standards. There's no separate "algorithm only" component vs. "human-in-the-loop," as the human interacts directly with the device to take a measurement. The "study" (or validation) conducted would have been to verify the device's accuracy against a known reference temperature source during testing, as per ASTM E1965-98.

6. The type of ground truth used:
   The ground truth for performance (specifically temperature accuracy) would have been established through calibrated reference standards and laboratory testing in accordance with ASTM E1965-98. For safety and EMC, the ground truth is adherence to the technical specifications and test methodologies defined in the respective IEC/ANSI/AAMI standards.

7. The sample size for the training set:
   This information is not applicable/not provided. This device is a hardware product with embedded firmware/sensors for a direct physical measurement. It is not an AI/machine learning device that requires a "training set" in the conventional sense.

8. How the ground truth for the training set was established:
   This information is not applicable/not provided, as there is no "training set" for this type of device.

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