(85 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ASTM E1112 | Stated compliance with ASTM E1112 |
| Compliance with IEC 60601-1 | Stated compliance with IEC 60601-1 |
| Compliance with IEC 60601-1-2 | Stated compliance with IEC 60601-1-2 |
| Similar design and intended use to predicate devices | "Similar in design and intended use to the predicates" |
| No new questions of safety or effectiveness compared to predicates | "differences in their technological characteristics do not raise any new questions of safety or effectiveness." |
| Functional operation (e.g., power supply, display) | Described features like 1.5V DC battery, LCD display, buzzer, water-resistant function (for some models). |
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.
§ 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.