(27 days)
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.
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance (if stated) |
|---|---|---|
| Voluntary Standards (Electrical Safety & Performance) | Compliance with ASTM E 1965-98, ASTM E 1104, IEC 601-1-1, and IEC 601-1-2 requirements. | The submission states "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." This implies that the device met these standards. |
| Functional Equivalence | Identical functionality to predicate device (Model CT-30/30DX). | "The CT-31/31DX/32/32DX is identical in functionality and performance with the essential change being the external shape of the devices." |
| Safety and Effectiveness | Maintained original safety and effectiveness after modifications. | "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness." |
| Impact of Modifications | Modifications do not affect intended use or alter fundamental scientific principle. | "Those engineering changes do not: (1) affect the intended use or (2) alter the fundamental scientific of the 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.
§ 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.