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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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The device is an electronic clinical thermometer using an infrared sensor to detect the human body temperature from the auditory canal in the neonatal, pediatric and adult Populations used in the home setting.

The OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, is an electronic thermometer using an infrared sensor to detect human body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane (eardrum) and the adjacent tissue. OSTI TempTeller® Infrared Ear Thermometers, model CT-31/31DX/32/32DX, consists mainly of five parts: an IR sensor packed together with an ambient temperature sensor, a waveguide, a heat sink made of zinc alloy, a LCD display and the associated circuit. The tympanic membrane (eardrum) is thin and flooded with blood at the core temperature. The wavequide, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer without contacting the eardrum. When inserting the probe into the ear canal, the radiation fluxes transfer among the tympanum membrane (eardrum), the IR sensor, and the inner surface of the wavequide. The ambient sensor is packed with the IR sensor to monitor the ambient temperature of the IR sensor. To measure core temperature, an ear thermometer is inserted into a patient's outer ear canal. An activation button is pressed to start the measurement through the radiation exchanges. The electrical signal readouts form the IR sensor and the ambient temperature sensor are fed to the circuit for amplification, digitization and calculation. The measured temperature then appears on the LCD. The total operation takes one second. The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices. The modifications to our original 510(k) cleared device, model CT-30/30DX, include dimensional and firmware. The fundamental scientific technology of the modified device remains the same as that of the 510(k) cleared device.

Here's a summary of the acceptance criteria and study information for the Oriental System Technology Inc. TempTeller® Infrared Ear Thermometer, Model CT-31/31DX/32/32DX, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not detail specific numerical acceptance criteria or explicit reported device performance metrics beyond stating compliance with voluntary standards. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

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

The document does not explicitly state a sample size for a specific clinical test set. The submission references "verification and validation tests" but does not provide details on the number of subjects or the data provenance (e.g., country of origin, retrospective/prospective nature).

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

This information is not provided in the 510(k) summary. The nature of the device (infrared ear thermometer) suggests that ground truth would likely be established through comparative measurements with a reference thermometer, rather than expert interpretation of medical images or data.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of a thermometer, an adjudication method (like 2+1, 3+1) used for interpreting complex medical data is not typically applicable. Performance is usually assessed against a reference standard.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical cases, often with and without AI assistance. Infrared ear thermometers do not involve human interpretation in the same way.

6. If a Standalone Performance Study Was Done

Yes, implicitly. The statement, "Compliance to applicable voluntary standards include ASTM E 1965-98 and ASTM E 1104, as well as IEC 601-1-1 and IEC 601-1-2 requirements," indicates that the device's technical specifications and performance were evaluated against established standards without direct human interaction. These standards include tests for accuracy, stability, and other performance characteristics. The "verification and validation tests" also refer to standalone performance evaluation.

7. The Type of Ground Truth Used

The ground truth for evaluating a thermometer's performance would typically be established by:

• Reference Standard Thermometer: Comparing the device's readings against a highly accurate and calibrated reference thermometer.
• Known Temperature Environments: Testing the device's accuracy in controlled environments with precisely known temperatures.

The document does not explicitly state the specific type of ground truth employed, but compliance with ASTM E 1965-98 (Standard Specification for Clinical Thermometers, Infrared Ear Type) strongly implies the use of such reference standards and controlled testing.

8. The Sample Size for the Training Set

No training set information is applicable or provided. This device is a measurement tool, not a machine learning or AI algorithm that requires a "training set."

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

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

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

The OSTI Temp - Teller Digital Thermometer, (Models DT-101, DT-102, DT-103, DT-201, DT-202, and DT-203). is an electronic thermometer using a thermistor as the temperature sensor. The sensor's electric signal is then calculated and displayed by an ASIC (Application Specific IC) Models DT-101 and DT-201 display the temperature within a 100" of a degree. Models DT-101, DT-102 and DT-103 employ a 1.5 times larger LCD display than competitive products for easier reading. Models DT-101, DT-102, DT-201 and DT-202 have a water-resistant function. The 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 which the thermistor is immersed. The system uses a 1.5V DC battery for the power supply and the battery power is displayed in LCD if the battery is exhausted.

This document describes a 510(k) submission for the Temp Teller-Digital Thermometer. The information provided heavily emphasizes comparison to predicate devices and adherence to standards rather than a detailed study for performance. Therefore, many of the requested fields cannot be extracted or are explicitly stated as not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" in terms of specific performance thresholds for a study. Instead, it refers to compliance with voluntary standards. The "device performance" is primarily stated as being "similar" to predicate devices.

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

• Sample Size: Not applicable. The document explicitly states: "Controlled human clinical studies were not conducted using the OSTI Temp Teller Digital Thermometer and predicate devices." The substantiation relies on "bench testing" and "similarity to predicate devices."
• Data Provenance: Not applicable, as detailed clinical testing was not performed.

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

Not applicable, as controlled human clinical studies were not conducted.

4. Adjudication Method for the Test Set:

Not applicable, as controlled human clinical studies were not conducted.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Controlled human clinical studies were not conducted."

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

Based on the context of a digital thermometer, which is a physical device, the concept of an "algorithm only" performance study is not directly applicable in the same way it would be for AI software. The performance testing described is likely intrinsic to the device's hardware and embedded logic. The document indicates "bench testing" was performed, which would be a standalone evaluation of the device's physical and electronic properties.

7. The Type of Ground Truth Used:

For the "bench testing," the ground truth would have been established by calibrated reference thermometers and controlled environmental conditions, according to the standards (e.g., ASTM E1112 for electronic thermometers). The document does not specify the exact methods or reference standards used for setting this ground truth beyond referencing the ASTM standard itself.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical electronic thermometer, not a machine learning algorithm that requires a "training set" in the conventional sense. Its design and calibration are based on established engineering principles and compliance with standards.

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

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

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The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.

The OSTI Temp - Teller Infrared Tympanic Thermometer, Models TT-200, TT-201, is an electronic thermometer using an infrared sensor (pyroelectric heat sensor, employing the principle of the electrically calibrated pyroelectric radiometer (ECPR)) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

OSTI Temp -Teller Infrared Tympanic Thermometer, Model TT-201, consists mainly of five parts: an IR sensor, a barrel, a shutter, an ambient temperature sensor, and the associated circuit.

The ear canal guides sound to the eardrum, which is thin and flooded with blood at the core temperature. The barrel, usually a cylindrical pipe with a highly reflective inner surface for confining the radiation, is adaptive to the outer canal without contracting the eardrum. The shutter controls when the flux is transferred to the IR sensor. When the shutter is open, radiative fluxes transfer among the tympanum, the IR sensor, and the inner surface of the barrel. The ambient sensor is mounted near the IR sensor to monitor the ambient temperature.

To measure core temperature, a tympanic thermometer is inserted into a patient's outer ear canal. A start button is pressed to open the shutter momentarily and to start the measurement through the radiation exchanges. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The measured temperature then appears on a display. The total operation takes a few seconds.

The provided text describes the OTI Temp Teller-Infrared Tympanic Thermometer, Models TT-200 and TT-201, and its substantial equivalence to predicate devices, but it does not explicitly state specific acceptance criteria (numerical thresholds for accuracy, precision, etc.) or detailed results from the clinical study that would directly allow for filling out a table of acceptance criteria and reported performance.

However, I can extract information related to the study and provide what is available, noting the limitations.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of numerical accuracy or precision requirements. The text mentions compliance with "applicable voluntary standards includes ASTM E1112 and ASTM E1104," which would contain such criteria. Without access to those standards, the specific numerical thresholds are unstated in this document.
• Reported Device Performance: The document generally states that "clinical testing supplied demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness." This is a qualitative statement of equivalence, not a quantitative report of performance against specific metrics.

Therefore, a table cannot be fully populated with specific numerical values based only on the provided text.

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

• Sample Size: "The number of patients have been statistically justified." The specific number is not provided.
• Data Provenance: "Controlled human clinical studies were conducted," and the patient population "is well represented (neonatal, pediatrics and adults)." This indicates a prospective clinical study with participants from potentially diverse age groups, though specific country of origin is not mentioned.

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

• Not specified. The ground truth was established by "standard oral/rectal thermometers with readings representing a conventional/currently accepted reading." There's no mention of experts establishing a consensus ground truth in this context.

4. Adjudication method for the test set:

• Not applicable/Not specified. The comparison was against "standard oral/rectal thermometers," which are considered the reference. No human adjudication process for the test set itself is described beyond comparing the device readings to these reference measurements.

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:

• No. This device is a thermometer, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.

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

• Yes, this was a standalone device performance study. The device itself measures temperature and provides a reading. There isn't a "human-in-the-loop" aspect to its fundamental operation beyond taking the measurement. The clinical studies evaluated the device's inherent accuracy compared to reference methods.

7. The type of ground truth used:

• Reference method/Comparative measurement: "Standard oral/rectal thermometers with readings representing a conventional/currently accepted reading, i.e., rectal or oral."

8. The sample size for the training set:

• Not applicable/Not specified. This device is a traditional electronic thermometer (using an IR sensor and associated circuitry) and the document does not describe it as an AI/machine learning device that would require a "training set" in the conventional sense. The "training" in such devices typically refers to engineering calibration and algorithmic design, not a data-driven machine learning approach described with a 'training set'.

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

• Not applicable. As noted above, there's no mention of a training set for an AI/ML algorithm.

In summary, the provided document focuses on establishing substantial equivalence by aligning with predicate devices and voluntary standards, and by conducting clinical studies comparing its readings to conventional thermometers. However, it lacks the detailed quantitative performance metrics and specific study participant numbers that would typically be required to fully answer all the posed questions.

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