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The Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Non-contact Electronic Forehead Infrared Thermometer, Model FT3010 is a hand-held, battery powered IR thermometer. It is intended to measure the temperature of human body from forehead without contact to human body. It is indicated for use by people of all ages in the home.

The work principle of Non-contact Electronic Forehead Infrared Thermometer, Model FT3010, is by using the infrared sensor converts the radiated power into an electrical signal, electrical signal is processed by the ambient temperature compensation circuit and an internal MCU circuit. The electrical signal is displayed in degrees Celsius (or Fahrenheit) on LCD.

The Non-contact Electronic Forehead Infrared Thermometer has the following features:

• Measure the forehead temperature;
• . Provide the prompt tone for high or low body temperature alert;
• . Equip with 32 sets of measurement memories;
• LCD digital displayer with backlight;
• . Display unit of Fahrenheit or Celsius;
• Automatic shutdown feature to save energy;
• . Low battery detection;

The provided document describes the acceptance criteria and the study that proves the performance of the "Non-contact Electronic Forehead Infrared Thermometer. Model: FT3010."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document references conformity with several standards, which implicitly define the acceptance criteria. The performance is reported as meeting these standards.

• $\pm 0.2$ °C for $35.0 \sim 42.0$ °C
• $\pm 0.3$ °C for $34$°C $\sim 34.9$°C and $42.1$°C $\sim 43$°C (based on predicate criteria, assumed similar for subject device based on "does not affect performance and accuracy") | Body temperature: $22.0$ °C ~ $43.0$ °C: $\pm 0.2$ °C
  $71.6$°F ~ $109.4$°F: $\pm 0.4$°F (The document states "The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98.") |
  | Measurement Range | As per ISO 80601-2-56:2017 and ASTM E1965-98. Specifically:
  Body mode: $34.0$ °C -$43.0$ °C ($93.2-109.4$ °F) (Based on predicate criteria) | Body temperature: $22.0 \sim 43.0$ °C ($71.6 \sim 109.4$ °F) (The document states "Wider body temperature measurement range... The difference does not affect the performance and accuracy which was evaluated in the performance testing of ISO 80601-2-56 and ASTM E1965-98.") |
  | Electrical Safety | IEC 60601-1:2005+AMD 1: 2012 | Passed safety testing in accordance to IEC 60601-1:2005+AMD 1: 2012 |
  | Electromagnetic Compatibility | IEC 60601-1-2:2014 | Passed safety testing in accordance to IEC 60601-1-2:2014 |
  | Home Healthcare Environment | IEC 60601-1-11:2015 | Passed safety testing in accordance to IEC 60601-1-11:2015 |
  | Biocompatibility - Cytotoxicity | ISO 10993-5:2009 | Passed biocompatibility tests in accordance to ISO 10993-5:2009 |
  | Biocompatibility - Irritation & Sensitization | ISO 10993-10:2010 | Passed biocompatibility tests in accordance to ISO 10993-10:2010 |
  | Clinical Performance (Bias & Repeatability) | Met the acceptance criteria of the clinical study protocol (as per ASTM E1965-98) | Clinical data, represented by clinical bias and clinical repeatability, met the acceptance criteria of the clinical study protocol. |
  | Software Validation | Consistent with moderate level of concern as per FDA guidance | Software documentation consistent with moderate level of concern was submitted. |

2. Sample size used for the test set and the data provenance

• Sample size: 150 subjects
  • 50 infants (newborn to 1 year)
  • 50 children (1 - 5 years old)
  • 50 subjects (> 5 years old)
• Data provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation." It does not specify if it was retrospective or prospective, but clinical investigations are typically prospective.

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

The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. It mentions a "clinical study" conducted in accordance with ASTM E1965-98 and ISO 80601-2-56, which are standards for clinical thermometers and imply the use of reference thermometers for ground truth.

4. Adjudication method for the test set

The document does not mention an adjudication method. It describes the clinical study as a "randomization, simple blind homologous control, pairing design of clinical investigation."

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 device is a standalone infrared thermometer, not an AI-assisted diagnostic tool that involves human readers.

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

Yes, a standalone study was done. The entire document describes the performance of the device itself (Non-contact Electronic Forehead Infrared Thermometer), which operates as an algorithm-only device without human intervention beyond taking the measurement and reading the display. The clinical study and non-clinical bench tests evaluated the device's performance directly.

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

The ground truth for the clinical study would have been established using reference temperature measurement devices as per the requirements of ASTM E1965-98 and ISO 80601-2-56. These standards typically require comparison against highly accurate clinical reference thermometers to determine bias and repeatability.

8. The sample size for the training set

Not applicable. This device is a traditional electronic thermometer, not an AI/ML-based device that requires a training set in the conventional sense. The "software validation" mentioned refers to traditional software engineering verification and validation steps, not machine learning model training.

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

Not applicable, as there is no traditional "training set" for this type of device.

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