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Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

The subject device uses infrared probe to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.

The subject device intends to detect the temperature of patients of all ages.

The subject device includes 2 series: ThermoFlash and MyThermo. The ThermoFlash thermometers contain 5 models: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, while MyThermo thermometer contains one model BW-CX10. They all have the following basic functions:

• Sound alarm if temperature is exceeded. -
• LCD back-lighted digital screen. -
• Data displayed in Celsius or Fahrenheit. -
• Automatic stop (energy saver). -
• Small, convenient, easy to use. -

Their differences are in appearance and functions. The LX-26E and LX-360 are same in functions, while LX-260TE and LX-361T contain additional language function, BW-CX10 and PRO LX-261E contain additional rechargeable function, and BW-CX10 contains additional Bluetooth function.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Infrared Thermometer (K160816).

The provided document, a 510(k) summary for the Nexmed Technology Co., Ltd. Infrared Thermometer, focuses on demonstrating substantial equivalence to a predicate device. While it mentions performance standards and "clinical accuracy," it does not present a detailed clinical study with the specific elements requested (test set size, ground truth details, expert qualifications, adjudication, MRMC, or standalone performance metrics for diagnostic tasks), as these are typically applicable to AI/ML or more complex diagnostic devices.

The "clinical tests" section is very brief and refers to meeting a standard rather than providing detailed study results.

Therefore, many of the requested fields cannot be directly extracted from this document because the device (an infrared thermometer) and the regulatory submission type (510(k) for substantial equivalence to a predicate thermometer that also likely met similar standards) do not typically require or provide such detailed clinical study information in the same way as, for example, an AI diagnostic algorithm.

Acceptance Criteria and Reported Device Performance

For an Infrared Thermometer, the primary acceptance criteria revolve around accuracy within a specified range compared to a reference standard.

Study Information (Based on interpretation for a thermometer, not an AI/ML algorithm):

Since this is a submission for an infrared thermometer, the "study" primarily refers to testing against recognized medical device standards rather than a typical clinical trial for a diagnostic algorithm.

1. Sample size used for the test set and the data provenance:

   • Test Set Size: Not explicitly stated as a "test set" in the context of an algorithm. For clinical accuracy, thermometers are typically tested on a cohort of human subjects. The ASTM E1965-98 standard would specify the number of subjects and measurements required. The document states "The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965-98 (2009)."
   • Data Provenance: Not specified, but generally, such tests are conducted at a testing facility or clinical site to meet the standard. The manufacturer is Nexmed Technology Co., Ltd. in China. Likely conducted in a controlled environment.
   • Retrospective or Prospective: Clinical accuracy testing for thermometers against a standard is typically prospective, involving real-time measurements on subjects.

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

   • Ground Truth Experts: Not explicitly stated. For thermometer accuracy, "ground truth" (reference temperature) is typically established using a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measurement device validated against a traceable standard), rather than human expert consensus. The ASTM E1965-98 standard defines the methodology for this.
   • Qualifications of Experts: N/A for this type of "ground truth" establishment.

3. Adjudication method for the test set:

   • N/A. The "ground truth" is typically a direct measurement from a reference device, not an expert interpretation requiring adjudication.

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. This is an infrared thermometer, not an AI diagnostic algorithm for image interpretation or similar tasks. MRMC studies are not applicable.

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

   • Yes, in a sense. The "standalone" performance here refers to the device's accuracy in measuring temperature against a reference standard, which is its intrinsic function without human interpretation of ambiguous outputs (as would be the case for an AI diagnostic aid). The performance is assessed against ASTM E1965-98.

6. The type of ground truth used:

   • Reference Thermometer/Standard Measurement: For clinical accuracy, ground truth is established by simultaneous or near-simultaneous measurements using a highly accurate reference clinical thermometer (e.g., a rectal or oral thermometer), as specified by standards like ASTM E1965-98. This is a direct physical measurement.

7. The sample size for the training set:

   • N/A. Infrared thermometers are not typically "trained" in the machine learning sense. Their design and calibration are based on physics and engineering principles, and their performance is validated against standards.

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

   • N/A, as there is no "training set" in the AI/ML context for this device. Ground truth for calibration and design validation would involve traceable temperature standards and engineering tests.

Summary of Non-Clinical Tests (Table from Document):

The document lists several non-clinical tests that the device passed:

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