(160 days)
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.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.