(178 days)
The Monitoring Ear Thermometer, model BTM-D1A is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitor armpit temperature via wireless signal transmission of measuring result. This device is reusable and intended for ear temperature measurement as well as the armpit temperature monitor for the person above two years olds.
The Monitoring Ear Thermometer/model BTM-D1A is the combination device of ear thermometer and wireless temperature monitor intended to be worn at left arm to monitor the armpit temperature continuously. BTM-D1A is composed of two operational parts, the receiver and armband. The receiver is the main operation unit on which the ear thermometer, the measuring circuit, LCD display control circuit and the main operation keys are included. And the armband was designed and constructed with the thermo sensor and the signal communication unit and is to be worn at left arm for the continuous armpit temperature monitor. For the monitoring operation, both receiver and armband shall be switched on. Sooner after these two parts are switched on, the wireless signal communication will be set up between receiver and armband. The temperature monitoring signal measured at armpit will be continuously indicated on the LCD of receiver every 12 sec. In addition to the continuous armpit temperature monitoring, the user can also operate the functional key on receiver to take temperature measurement on ear any time he needs. The LCD will be returned to armpit temperature monitor as soon as the ear temperature measurement operation is completed. This system uses a 3.0V DC battery for operation of complete system. Whenever the battery is low, the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of BTM-D1A, it was designed and verified according to the US standard ASTM E1112-00 and ASTM E1965-02.
The Rio Flexon Technology Co., Ltd. Monitoring Ear Thermometer, model BTM-D1A, is a combination device functioning as an ear thermometer and a wireless armpit temperature monitor. The device was designed according to US standards ASTM E1112-00 and ASTM E1965-02.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for accuracy (e.g., within +/- 0.1°C). Instead, it states that the device was designed and verified according to ASTM E1112-00 and ASTM E1965-02. Meeting these standards implies adherence to their specified accuracy requirements. The reported device performance is that it met the requirements of these standards.
| Feature/Metric | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Ear Temperature Measurement Accuracy | Meets ASTM E1965-02 standards | "Designed and verified according to the US standard ASTM E1965-02." |
| Armpit Temperature Measurement Accuracy | Meets ASTM E1112-00 standards | "Designed and verified according to the US standard ASTM E1112-00." |
| Wireless Signal Transmission | Functioning communication between receiver and armband | Wireless communication is established, and armpit temperature is indicated on LCD. |
| Low Battery Indication | Automatically displays 'Low battery' when condition met | ASIC circuit detects low battery and displays 'Low battery' on LCD. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No additional clinical report is included on this 510(k) submission."
This indicates that no dedicated new clinical study for the BTM-D1A was performed for this submission. Instead, the submission relies on the clinical report associated with its predicate device for the ear thermometer function.
Therefore:
- Sample Size for the Test Set: Not applicable for a new study. The sample size would be from the clinical report of the predicate device (Taidoc TD-1107), which is not detailed in this document.
- Data Provenance: Not applicable for a new study. Data provenance would be from the clinical report of the predicate device, which is not detailed here but likely retrospective for the predicate device's original submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no new clinical study was conducted for this device, information regarding experts for establishing ground truth for a new test set is not provided. The reliance is on the predicate device's clinical data.
4. Adjudication Method for the Test Set
As no new clinical study was conducted for this device, information regarding an adjudication method for a new test set is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. The submission relies on adherence to performance standards and comparison to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical thermometer system, not an AI algorithm. Therefore, an "algorithm only" or "standalone" study type in the context of AI performance is not applicable. The performance tests refer to the device's accuracy in temperature measurement against established standards.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation (not a clinical ground truth in the typical sense for diagnostic devices) would be:
- Reference temperature standards as defined by ASTM E1112-00 (for armpit) and ASTM E1965-02 (for ear). These standards specify methods for evaluating accuracy against known, highly accurate reference thermometers.
8. The Sample Size for the Training Set
This information is not applicable. The device is a traditional electronic thermometer, not an AI/machine learning model that requires a "training set." The engineering design and verification are based on established physical principles and standards.
9. How the Ground Truth for the Training Set Was Established
This information is 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.