(139 days)
Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.
The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures. The proposed device is available in two models, which are WT1 and WT2. Similarities between models: a. Both of them incorporate a temperature sensitive sensor b. Both of them can measure and monitor human body temperature under arm; C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature; Differences between models: a. WT1 has an automatic power on/off feature; b. WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for measuring and monitoring; c. WT2 can be used with a designated probe cover; d. WT2 can be used for measurement of oral temperature.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Electronic Thermometer (Models WT1 and WT2), formatted as requested.
Electronic Thermometer (Models WT1 and WT2)
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the acceptance criteria are generally established by compliance with recognized standards and the reported performance is directly stated in the comparison table.
| Acceptance Criteria Category | Specific Acceptance Criteria (from standards or implied) | Reported Device Performance (from comparison table) | Meets Criteria? |
|---|---|---|---|
| Accuracy | Not explicitly stated as a separate acceptance criterion, but implied by comparison to predicate. The standard ISO 80601-2-56 sets specific requirements for accuracy. The predicate device claims ±0.1°C within its operational range. | ±0.1°C (25.00°C | |
| ±0.05°C (35.00°C~38.50°C) | YES, claims higher accuracy in certain ranges than the predicate. Implied compliance with ISO 80601-2-56 suggests meeting its accuracy requirements. | ||
| Precision | Not explicitly stated, but common for medical thermometers. | 4 numeric digits displayed in 0.01 degree increments | YES (Matches predicate) |
| Response Time | Not explicitly stated as an acceptance criterion other than being "acceptable" and communicated in the user manual. The predicate device has a much faster response time. | 5 minutes | YES (Stated as acceptable, though slower than predicate) |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10. | No Cytotoxicity, No Sensitization, Irritation-negligible | YES |
| Electrical Safety | Compliance with IEC 60601-1. | Complied with IEC 60601-1 | YES |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Complied with IEC 60601-1-2 | YES |
| Range | Consistent with clinical thermometer use. | 25.00°C~45.00°C | YES (Wider than predicate) |
Notes on Acceptance Criteria: The document primarily relies on non-clinical testing against recognized national and international standards (ISO, IEC) to demonstrate substantial equivalence. The detailed accuracy claims are a performance specification that needs to be verified by testing.
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no information about:
- Sample size used for the test set.
- Data provenance (e.g., country of origin, retrospective or prospective).
The "test set" in this context refers to non-clinical tests (e.g., biocompatibility testing, electrical safety testing, EMC testing), which are performed on device samples, not human participants or clinical data. The precise number of device units or samples used for each non-clinical test (e.g., for biocompatibility or electrical safety) is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable as no clinical studies were performed, and thus no clinical ground truth was established by experts for a test set. Non-clinical tests establish "ground truth" based on standard protocols, calibrated equipment, and laboratory measurements.
4. Adjudication Method for the Test Set
Not applicable as no clinical studies were performed. Adjudication methods are typically employed in clinical trials or studies where human readers/experts independently assess cases, and a process is needed to resolve discrepancies.
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
Not applicable. This device is an electronic thermometer, not an AI-assisted diagnostic tool involving human readers or interpretation of medical images/data. Therefore, an MRMC study is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a standalone electronic thermometer. The performance described (accuracy, precision, response time) is for the device operating independently to measure temperature. There isn't an "algorithm" in the sense of AI or image processing, but the device's measurement functionality itself operates in a standalone manner to generate a temperature reading. The companion mobile application "Temp Sitter" serves for display and potentially trend monitoring, but the temperature measurement occurs directly by the physical device. The compliance with standards like ISO 80601-2-56 reflects this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests that were performed:
- Accuracy and Response Time: Ground truth would be established using calibrated reference thermometers and temperature sources as per the methodologies outlined in ISO 80601-2-56 or similar standards.
- Biocompatibility: Ground truth is established by laboratory testing results (e.g., cell viability assays for cytotoxicity, skin patch tests for sensitization, observation of tissue reactions for irritation) against specified limits.
- Electrical Safety and EMC: Ground truth is established by laboratory measurements taken by specialized equipment as per the IEC standards.
8. The Sample Size for the Training Set
Not applicable as no AI or machine learning algorithm requiring a "training set" is mentioned or implied for this device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set was used.
§ 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.