(240 days)
The Thermometer is a non- invasive and re-usable electronic device for home use. The thermometer is intended for nonurgent ambulatory continuous left chest body temperature monitoring from ages 29 days and older.
Wireless Intelligent Thermometer
This document is a 510(k) clearance letter for the Jumper Wireless Intelligent Thermometer (K182437). It doesn't contain a detailed description of the acceptance criteria or the specific study that proves the device meets those criteria.
However, based on the nature of the device (a clinical electronic thermometer) and standard regulatory practices for such devices, we can infer the likely type of acceptance criteria and study that would have been performed.
Inferred Acceptance Criteria and Study Information (Based on common practices for clinical thermometers):
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Inferred; from a successful 510(k) submission, it implies meeting these) |
|---|---|---|
| Accuracy (Temperature measurement) | ISO 80601-2-56:2017 or similar standard for clinical thermometers. Typically, this involves limits on measurement error (e.g., ±0.1°C to ±0.3°C depending on the temperature range and measurement site). The predicate device's performance would also have served as a benchmark. | The device would have demonstrated accuracy within the specified limits of the relevant standard and/or comparable to the predicate device. |
| Precision/Reproducibility | Repeat measurements under identical conditions should yield consistent results, typically quantified by standard deviation or coefficient of variation. | Demonstrated high precision and reproducibility according to standard testing methods. |
| Response Time | The time taken for the thermometer to display a stable temperature reading. | Met the required response time for clinical thermometers. |
| Drift | The change in readings over prolonged use or storage. | Demonstrated minimal drift over time and under various storage conditions. |
| Environmental Performance | Performance within specified operating (e.g., temperature, humidity) and storage conditions. | Maintained accuracy and functionality across the specified environmental ranges. |
| Biocompatibility | ISO 10993 series. For patient-contacting parts (even indirect skin contact for a surface thermometer). | Met biocompatibility requirements to ensure no adverse biological reactions. |
| Electrical Safety | IEC 60601 series. | Complied with relevant electrical safety standards. |
| EMC (Electromagnetic Compatibility) | IEC 60601-1-2. | Demonstrated compliance with EMC standards, indicating it does not interfere with or is not affected by other electronic devices. |
Study Description (Inferred for a Clinical Electronic Thermometer):
The study alluded to in a 510(k) submission for a thermometer would typically be a performance validation study, often comparing the new device against a legally marketed predicate device or a highly accurate reference standard.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set: For a clinical thermometer, the "test set" would typically refer to the number of subjects (persons) on whom the thermometer was tested and/or the number of temperature measurements taken.
- Inferred: Likely involves a statistically significant number of subjects (e.g., several dozens to hundreds, possibly across different age groups if applicable, as the device is for "ages 29 days and older"). The sample size would be determined to ensure sufficient statistical power to detect equivalence or non-inferiority to the predicate device or a reference standard based on the accuracy criteria.
- Data Provenance:
- Inferred: Most likely prospective clinical testing conducted in a controlled environment (e.g., a clinic or lab) or in a relevant home-use setting simulating real-world conditions. The country of origin for such testing would typically be where the manufacturer is based or a region where clinical trials can be efficiently and ethically conducted (e.g., China, or possibly a country with regulatory alignment).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Inferred: For a thermometer, "ground truth" for temperature is typically established by highly accurate, calibrated reference thermometers or established clinical methods. It would not typically involve "experts" in the sense of clinicians interpreting images or diagnoses.
- "Experts" (Metrology Technicians/Clinicians): The "experts" would be the skilled technicians or clinical staff responsible for operating the reference thermometer, performing the measurements correctly, ensuring calibration, and recording data accurately. Their qualifications would involve training in metrology and clinical measurement techniques.
4. Adjudication Method for the Test Set
- Inferred: Adjudication methods like "2+1" or "3+1" are primarily for subjective assessments (e.g., image interpretation). For objective measurements like temperature, there is no "adjudication" of the ground truth itself in that sense.
- Method: Instead, the method would involve direct comparison of the device's readings against a highly accurate, calibrated reference thermometer or against the predicate device's readings. Statistical methods (e.g., Bland-Altman analysis, regression analysis) would be used to compare agreement and bias.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- Inferred: No, an MRMC study is highly unlikely for a clinical electronic thermometer. MRMC studies are specific to diagnostic devices where multiple human readers interpret medical images or data. Temperature measurement is an objective, automated process once the device is in place.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Inferred: Yes, the fundamental performance testing of a thermometer (its accuracy, precision, response time) is inherently a standalone assessment of the device's measurement capabilities. While human interaction is needed to place the thermometer, the temperature reading itself is generated by the device's sensors and algorithms. The device's performance would be evaluated purely on its ability to accurately and consistently measure temperature. "Human-in-the-loop" would primarily refer to usability aspects, not the core measurement function's accuracy.
7. The Type of Ground Truth Used
- Inferred: The ground truth for temperature measurement is typically established using:
- Reference Standard Instruments: Highly accurate, calibrated thermometers (e.g., mercury-in-glass thermometers traceable to national standards, or precise electronic reference thermometers).
- Established Clinical Methods: Simultaneous measurement using the device under test and a cleared/approved clinical thermometer on the same subject or body site.
8. The Sample Size for the Training Set
- Inferred: For a device like a thermometer, there isn't typically a "training set" in the sense of machine learning algorithms that learn from labeled data. The thermometer's underlying measurement principle is based on physics and calibrated sensors, not a trained AI model.
- If there are any digital signal processing or adaptive algorithms (e.g., for noise reduction or artifact rejection) that might be considered "AI," these would likely be developed and validated internally using lab data, simulations, and possibly limited human data, but not a formally defined "training set" as seen in diagnostic AI.
- Most Likely: No distinct "training set" for the core temperature measurement function.
9. How the Ground Truth for the Training Set Was Established
- Inferred: Since there's unlikely a formal "training set" in the AI/ML sense:
- Any internal development or calibration of sensor parameters or basic signal processing would rely on physical models, laboratory measurements with highly accurate reference instruments, and engineering specifications.
- If any adaptive algorithms exist, the "ground truth" for their development would similarly come from controlled experiments using reference measurements.
§ 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.