(313 days)
The Cloud Smart Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human axillary temperature continuously via wireless signal transmission of the measuring result. Meanwhile, the device is reusable and is intended for axillary temperature monitoring for persons over two years old, and it is used for household and medical institutions.
The Cloud Smart Thermometer (WT001-1) which is a combination device of thermometer and Bluetooth communication unit is to be worn in the axillary temperature continuously for household and medical institutions.
To start the monitoring operation, switch the thermometer on and place it on the plaster (which is a waterproof medical dressing), and then paste the plaster in the user's axilla. The thermometer will make a Bluetooth connection between the thermometer and the receiver automatically (User should setup Bluetooth properly on receiver). Then the thermometer starts to measure the body temperature by means of testing the thermistor's resistance value and calculates the body temperature every four seconds continuously and sends the temperature data to the receiver through Bluetooth connection.
The thermometer uses a CR2025 battery for operation. When the battery capacity is below 90% rated voltage, internal circuit will detect the low battery condition automatically and send "low battery" signal through Bluetooth communication unit to receiver, then the receiver will send out a warning. Meanwhile, the thermometer is capable of monitoring the axillary temperature continuously for 24 hours and it can also save measured data in the Cloud for remote real-time monitoring.
The extracted text is a premarket notification 510(k) summary for a medical device, the "Cloud Smart Thermometer." This document is focused on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding an acceptance criteria table, sample sizes, expert involvement, ground truth establishment, MRMC studies, or standalone performance studies is not present in the provided text.
The document primarily addresses the device's technical specifications, non-clinical testing for safety and electromagnetic compatibility, and a comparison to a predicate device to argue for substantial equivalence.
Here's a breakdown of the information that can and cannot be extracted from the provided text based on your request:
Information NOT present in the document:
- 1. A table of acceptance criteria and the reported device performance: While there is a table comparing specifications between the targeted device and the predicate (Table 1 Comparison), it doesn't present "acceptance criteria" in the sense of predefined thresholds for a study to pass, nor does it present "reported device performance" from a clinical study. It shows comparative specifications.
- 2. Sample sizes used for the test set and the data provenance: No clinical test set or sample size for human subjects is mentioned. The document refers to non-clinical testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no human-based ground truth establishment is described for a clinical study.
- 4. Adjudication method for the test set: Not applicable as no clinical study with adjudication is described.
- 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 a thermometer, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the device's inherent function, but not a "standalone performance" study in the context of an algorithm's diagnostic performance. Its "performance" refers to its accuracy in temperature measurement, which is verified through non-clinical standards.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in the context of a clinical study for diagnostic accuracy, is not discussed. The device's accuracy is presumably verified against a reference standard in non-clinical tests (e.g., a calibrated temperature source), but this isn't detailed as "ground truth" for a clinical performance study.
- 8. The sample size for the training set: The document does not describe any machine learning/AI training, so no training set is mentioned.
- 9. How the ground truth for the training set was established: Not applicable.
Information that can be extracted, though not directly in the format requested for a clinical study:
While the document doesn't describe a clinical study to prove the device met acceptance criteria, it does state that the device underwent non-clinical tests to verify it met design specifications. The acceptance criteria for a thermometer typically relate to its accuracy, repeatability, and adherence to specific temperature range tolerances.
Based on Table 1: Comparison on pages 4-5, we can infer some "performance" characteristics and their comparison to the predicate device, which implicitly serve as a proxy for meeting expected performance.
Inferred "Acceptance Criteria" and "Reported Device Performance" (based on Table 1 for the targeted device):
| Parameter | Acceptance/Targeted Performance (Cloud Smart Thermometer) | Predicate Performance (Wireless Thermometer, K132761) | Notes |
|---|---|---|---|
| Measuring range | 25°C ~ 45°C | 25°C ~ 45°C | Both devices have the same measuring range. Implicit acceptance is to match or exceed predicate. |
| Accuracy | ±0.1°C (at 36.0~40.0°C) | ||
| ±0.2°C (at other temperature range) | ±0.05°C (35°C~38.5°C) | ||
| ±0.1°C (25°C | Difference: The targeted device has slightly lower accuracy specified than the predicate in the core temperature range (±0.1°C vs ±0.05°C). The document states: "Although some specifications are slightly different from the predicate device, the thermometer quality has been verified and validated as a part of performance testing..." | ||
| Repeatability error | ≤0.2°C | N/A | Specific to the targeted device; predicate does not report this. Implicit acceptance is meeting this specified value. |
| Response time | 10 minutes at least required for the device to obtain a steady state reading | 8 minutes at least required for the device to obtain a steady state reading | Difference: The targeted device has a longer response time. The document implies this is acceptable through the general statement about verified quality. |
| Measuring frequency/time | Every 4 seconds | Every 4 seconds | Same. Implicit acceptance is to match predicate. |
Details from the document explaining the "proof":
- Type of Study / Proof: The document states "Non-clinical tests were conducted to verify that the targeted device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device." These tests focus on meeting safety and performance standards.
- Standards Met (Non-Clinical):
- IEC 60601-1 (Basic safety and essential performance)
- IEC 60601-1-2 (Electromagnetic compatibility)
- IEC 60601-1-11 (Home healthcare environment)
- ISO 80601-2-56 (Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement)
- ASTM E1112-00 (Reapproved 2011) (Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature)
- CFR 47 FCC PART 15 Subpart C: 2014 section 15.247 (Wireless communication)
- Software verification and validation (for "moderate level of concern")
- Biocompatibility testing for skin-contacting components (ISO 10993-1, ISO 10993-5, ISO 10993-10).
Summary regarding "proof":
The "Cloud Smart Thermometer" demonstrated its performance and safety not through a clinical study with human subjects, but through adherence to a comprehensive set of recognized non-clinical standards for electronic thermometers, electrical safety, electromagnetic compatibility, and biocompatibility. The comparison table highlights its technical specifications against a predicate device, and the slight differences in accuracy and response time are deemed acceptable because the device's "quality has been verified and validated as a part of performance testing and safety /EMC testing." The FDA's 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate, meaning it is as safe and effective as the predicate 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.