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The device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral , armpit , and rectal in neonatal , pediatric and adult population used in the clinical and home testing .

The OSTI Temp-Teller High Speed Digital Thermometer(Model DT-302 DT-312 , DT-412 , DT-502) is an electronic thermometer using a thermistor as the temperature sensor . The sensor's electric signal is calculated and displayed by an ASIC (Application Specific IC)
The High Speed digital thermometer comprises: a thermistor for temperature sensing , a reference resistor for comparing the resistance of the thermistor , a buzzer for sounding effect , an ASIC and a LCD display for calculating and displaying the target temperature digitally . The system uses a 1.55 V battery for the power supply and the battery power is automatically check by the ASIC and displayed in LCD if the battery is exhausted .
The OSTI Temp-Teller High Speed Digital Thermometer (Model DT-302 , DT-312 . DT-412 . DT-502) can makes temperature taking faster , its temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+1-2°C .
DT-312 ,DT-412 is high speed digital thermometers, with flexible front tip and with power /measuring button set aside with LCD display and with water resistant function .
DT502 is high speed digital thermometers, with rigid front tip and with power /measuring button set aside with LCD display and with water resistant function .
DT302 is high speed digital thermometers, with rigid front tip and with power /measuring button on top end and with water resistant function .
The DT-302 , DT-312 , DT-412 , DT-502 is identical in functionality and performance .
The essential change include 1)Metal cap / Thermistor mechanical structure change to improve thermal transmission 2)Firm ware 3)Material 4)Shape layout and dimension .
The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

The provided document K042202 is a 510(k) Pre-Market Notification for the TempTeller-High Speed Digital Thermometer, Models DT302, DT312, DT412, DT502. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than a detailed report of a study proving the device meets specific acceptance criteria in a standalone performance study.

However, based on the information provided, we can infer some details regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states compliance with relevant standards and guidelines, which inherently define the acceptance criteria for a digital thermometer.

• Acceptance Criteria (Implied from Standards and Description):

  • Accuracy: Temperature measurement accuracy as defined by ASTM E 1112-2000.
  • Response Time: Temperature stabilize reading within 10 seconds.
  • Safety: Compliance with IEC 601-1-1 and IEC 601-1-2.
  • Performance (General): Maintenance of original safety and effectiveness after modifications.
  • Functionality: Identical functionality between models and with predicate devices.

• Reported Device Performance:

  • Response Time: "temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+/-2°C."
  • Functionality: "The DT-302, DT-312, DT-412, DT-502 is identical in functionality and performance."
  • Safety/Effectiveness: "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness."

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

• Sample Size: The document states that "Controlled human clinical studies were conducted," but does not specify the sample size (number of participants or measurements) for these studies.
• Data Provenance: The studies were "Controlled human clinical studies," suggesting prospective data collected specifically for this submission. The country of origin of the data is not explicitly stated, though the manufacturer is based in Taiwan.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: This information is not provided in the document.
• Qualifications of Experts: The document mentions "readings representing a conventional /currently accepted reading by oral or rectal temperature," implying comparison to standard clinical practice, but the personnel establishing the "ground truth" are not specified, nor are their qualifications.

4. Adjudication Method:

• The document does not specify any adjudication method for the test set.

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

• No, a "multi reader multi case (MRMC) comparative effectiveness study" focusing on human readers' improvement with AI vs. without AI assistance was not mentioned or implied. This device is a digital thermometer, not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance Study (Algorithm Only):

• Yes, a standalone performance assessment was conducted for the device. The document states, "Controlled human clinical studies were conducted using the OSTI Temp Teller Thermometer," and that "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness." This implies the device was tested on its own to confirm its temperature measurement capabilities.
• Specifically, the performance claim of "temperature stabilize reading within 10 sec in a 37℃ water bath at ambient temperature 23+/-2°C" is a standalone performance metric.

7. Type of Ground Truth Used:

• The ground truth for the clinical studies was implicitly based on "conventional /currently accepted reading by oral or rectal temperature." This typically refers to medical standards for temperature measurement, likely involving a reference thermometer or established clinical methods, but exact details are not provided.

8. Sample Size for the Training Set:

• The document describes a modified device that has undergone changes to its "Metal cap / Thermistor mechanical structure," "Firmware," "Material," and "Shape layout and dimension." While "Firmware" suggests software, the document does not mention any machine learning or AI components that would require a 'training set.' Therefore, this question is not applicable in the context of this device and documentation.

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

• As there is no mention of a training set for machine learning/AI, this question is not applicable.

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