(25 days)
The Wireless Body temperature monitor, model BTM-D1x series (model BTM-D1C, D, E, F, G and H) is the battery-operated electronic devices with intended use of measuring human ear temperature precisely and continuously monitors 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 old. In which, model BTM-D1C is with two functions of ear temperature measurement and armpit temperature monitor; the rest of models, BTM-D1D, E, F, G and H are only with the function of armpit temperature monitor.
The Wireless body temperature monitor, BTM-D1X series include the BTM-D1C, D, E, F, G and H, which are the battery-operated electronic devices with intended to be worn at left arm to monitor the armpit temperature continuously. In addition, BTM-D1C has additional function of ear thermometer.
The device 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. 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 if needed. The LCD will be returned to armpit temperature monitor after 30 sec.
Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard) | Reported Device Performance (BTM-D1x Series) |
|---|---|---|
| Armpit Temperature Accuracy | $\pm 0.1℃$ (implied by predicate device and substantial equivalence claim) | $\pm 0.1℃$ |
| Ear Temperature Accuracy | $\pm 0.2℃$ for $36℃ ~ 39℃$; $\pm 0.3℃$ for others (ASTM E1965:2002) | $\pm 0.2℃$ for $36℃ ~ 39℃$; $\pm 0.3℃$ for others (BTM-D1C only) |
| Electrical Safety | EN 60601-1 | Compliance to EN 60601-1 |
| EMC Conformity | EN 60601-1-2 & FCC | Compliance to EN 60601-1-2 & FCC |
| Bio-compatibility (Skin Contact) | ISO 10993 (Cytotoxicity, Sensitization, Primary skin irritation – all negative) | Compliance to ISO 10993 (Cytotoxicity, Sensitization, Primary skin irritation – all negative) |
| Device Performance (General) | ASTM E1112-00 and ASTM E1965-02 | Designed and verified according to ASTM E1112-00 and ASTM E1965-02 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the BTM-D1x series. It refers to a clinical report for ear temperature measurement accuracy (required by ASTM E1965:2002) that was included in the Taidoc 510(k) submission (K050463) for the chosen clear model Taidoc/TD-1107. However, no details about the sample size or data provenance (country of origin, retrospective/prospective) of that clinical report are provided in this document.
For the armpit temperature accuracy, the document implies that the BTM-D1x series meets the same accuracy as the predicate device (BTM-D1A) due to substantial equivalence, but no specific test set data is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document refers to compliance with standards like ASTM E1965:2002 for ear temperature accuracy, which typically involves clinical studies with reference thermometers. However, details about the experts involved in establishing ground truth (e.g., medical professionals, lab technicians) are missing.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device as it is a medical device for temperature measurement, not a diagnostic imaging or interpretation system where human readers are directly involved in interpretation with or without AI assistance. The context of an "effect size of how much human readers improve with AI vs without AI assistance" does not apply here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The studies mentioned are for the performance of the device itself (accuracy, safety, EMC, biocompatibility), which can be considered "standalone" in the sense that they assess the device's inherent performance without direct human interpretation in a diagnostic sense. The device measures and displays temperature, and its accuracy is tested against reference standards.
7. Type of Ground Truth Used
- For Ear Temperature Accuracy: The ground truth would have been established through a clinical study as required by ASTM E1965:2002. This typically involves comparison against a highly accurate reference thermometer (e.g., rectal thermometer or specialized aural thermometer) measurements taken by trained personnel. The document references the clinical report from a predicate device (Taidoc/TD-1107, K050463) for this, implying the ground truth methodology followed the standard.
- For Armpit Temperature Accuracy: The ground truth would similarly be established by comparing the device's readings against a highly accurate reference thermometer, though specific details of such a study for the BTM-D1x series are not provided beyond the claim of substantial equivalence to the predicate.
- Other tests (Electrical Safety, EMC, Biocompatibility): Ground truth for these is established by adherence to the specified international standards (EN 60601-1, EN 60601-1-2, FCC, ISO 10993) through laboratory testing, where established protocols and reference measurements define the "ground truth" for compliance.
8. Sample Size for the Training Set
The document does not provide information on a "training set" for this device. This device measures temperature based on physical principles (infrared for ear, thermistor for armpit) and signal processing, not a machine learning or AI algorithm that typically requires a distinct training set. The "software" mentioned in the comparison table refers to the operational program, not a learned model.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, this information is not applicable.
§ 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.