(513 days)
The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use. This product is a non-invasive and re-usable electronic device for multiple patients at home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
The Bluetooth Wearable Thermometer is a contact electronic thermometer using a sensor to measure armpit temperature. The Sensor detects heat and measures the temperature using a resistance that changes with heat. Displays the highest temperature among consecutive temperature readings. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. This product is in conjunction with the App, and information can be checked through a mobile device. Application Name: H-Health. The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.
The document provided is a 510(k) summary for a medical device, the Fever Garde (Model: HMT-100), a Bluetooth Wearable Thermometer. While it details the device's non-clinical testing and comparison to a predicate device, it does not contain information about a clinical study involving human participants for demonstrating performance against acceptance criteria in the way typically seen for AI/ML-based medical devices or comparative effectiveness studies with human readers.
The document focuses on demonstrating substantial equivalence to a predicate device (Fever Scout™ Continuous Monitoring Thermometer, K181013) through non-clinical performance testing and compliance with various international standards. The "acceptance criteria" here are primarily tied to meeting specific performance parameters verified through laboratory testing and engineering benchmarks, rather than clinical endpoints from a human study.
Given the nature of the device (a thermometer) and the provided document, I will extract information related to the technical performance testing rather than a clinical study in the typical sense of a comparative effectiveness study with human readers assisting AI.
Here's the breakdown of the acceptance criteria and the technical performance testing as described in the document:
Acceptance Criteria and Reported Device Performance
The device's performance acceptance criteria are derived from the applicable standards and internal testing specifications for a clinical electronic thermometer. The document primarily focuses on demonstrating that the device meets these technical specifications and that the differences from the predicate device do not impact safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (Standard/Benchmark) | Reported Device Performance |
|---|---|---|
| Accuracy | ±0.1°C (from 37 | ±0.1°C (Reported for Fever Garde, Model: HMT-100) and Verified by Laboratory Accuracy Test which states "Equation(0.1°C)" and a rated output range of 34~42°C. |
| Measurement Range | 34 | |
| Time Response-heating transient time | Not explicitly stated as a general acceptance criterion, but predicate had 8 minutes. | 171.3 Seconds (Fever Garde). This is considerably faster than the predicate's 8 minutes and was tested according to IEC60601-1. |
| Time Response-cooling transient time | Not explicitly stated. | 113.8 Seconds (Fever Garde). |
| Monitoring Distance | Predicate: 1.5m (4.9ft). Subject claims "longer" distance. | 3~5m. Tested and confirmed connection for 24 hours at 3m. Deemed "Different 5" but passed relevant standards (EN 300 328 and EN 62479). |
| Biocompatibility | Conformance to ISO 10993-1, -5, -10 | Conformed to ISO 10993-1, -5, and -10. Specifically, Cytotoxicity (Noncytotoxic), Sensitization (No evidence), Acute Intracutaneous Reactivity (No evidence). |
| Electrical Safety | Conformance to IEC 60601-1 | Conformed to IEC 60601-1. |
| Electromagnetic Compatibility | Conformance to IEC 60601-1-2 | Conformed to IEC 60601-1-2. |
| Usability | Conformance to IEC 60601-1-6 | Conformed to IEC 60601-1-6. |
| Home Healthcare Environment Requirements | Conformance to IEC 60601-1-11 | Conformed to IEC 60601-1-11. |
| Software Verification & Validation | "Moderate" level of concern, in accordance with FDA Guidance. | Conducted and confirmed. |
| Cybersecurity | Appropriate information security controls to preserve integrity, confidentiality, and availability based on FDA Guidance. | Testing performed; confirmed appropriate controls implemented. |
| Movement Test | H-Health application alarm sounds within 30s without movement; not sounded during movement. | Before test: alarm sounded within 30s without moving sample. During test: alarm not sounded while sample moving. After test: alarm sounded within 30s without moving sample. |
| Adhesion Test | Product attached for 24 hours without falling. | The product was attached to the armpit with an adhesive band for 24 hours and checked to ensure that it did not fall. |
| Data Transfer Test | Body temperature data transmitted to all participants. | After attaching the product, it was checked the body temperature data was transmitted to all participants. |
| Charging Operation | Device not operating during charging. | Confirmed. |
| Communication Failure | Notification indicated. | Confirmed. |
| Temperature Notification | High and Low indication displayed. | Confirmed. |
| Internal Battery status | Internal battery status displayed. | Confirmed. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance and engineering validation tests. There is no mention of a "test set" in the context of a clinical study with human subjects providing data. The tests performed are laboratory-based and include:
- Laboratory Accuracy: Implies a test setup to verify the stated accuracy. No specific sample size (e.g., number of temperature readings or devices tested) is given.
- Time Response (heating/cooling): Likely performed on a few devices in controlled environments. No specific sample size is given.
- Movement Test: Involves observation of alarm behavior during movement. No specific sample size is given.
- Adhesion Test: "The product was attached to the armpit with an adhesive band for 24 hours". It doesn't specify if this was on a human or a simulated armpit, or how many "products" or "armpits" were tested.
- Monitoring Distance Test: "product and mobile device were not disconnected for all participants." This suggests human participants, but the number of participants is not specified.
- Data Transfer Test: "body temperature data was transmitted to all participants." Again, suggests human participants, but the number is not specified.
The provenance of this data is from the manufacturer's (HuBDIC Co., Ltd.) internal testing, which would be prospective for the purpose of this submission. The origin is implied to be where the testing labs are located (e.g., Korea, given the manufacturer's address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable in the context of this 510(k) summary. The document describes engineering and laboratory performance tests, not a clinical study where expert consensus establishes ground truth for medical image interpretation or diagnosis. The "ground truth" for the technical tests would be established by calibrated reference standards (e.g., precise temperature sources, timers).
4. Adjudication Method for the Test Set
Not applicable. There's no mention of an adjudication method as would be used in a clinical study with multiple human reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This document does not refer to an MRMC comparative effectiveness study. The device is a thermometer, and the submission is for substantial equivalence to a predicate, not for demonstrating improved diagnostic performance for human readers using AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a measurement device. Its core function is to measure temperature. The "performance" described is its standalone performance (e.g., accuracy, response time, signal transmission). There's no complex algorithm for interpretation or diagnosis that would typically be evaluated with a separate "standalone" study in the context of AI/ML.
7. The Type of Ground Truth Used
For the technical performance tests:
- Laboratory Accuracy: Likely against a calibrated reference thermometer or temperature bath.
- Biocompatibility: In vitro and in vivo laboratory assays following ISO standards.
- Electrical Safety & EMC: Compliance with international safety and electromagnetic compatibility standards, typically verified through measurements against defined limits.
- Software/Cybersecurity: Verification against established software development lifecycle (SDLC) processes, requirements, and industry best practices.
- Functional tests (Display, Charging, Communication, etc.): Verification against documented functional requirements.
There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth.
8. The Sample Size for the Training Set
Not applicable. This device is a traditional electronic thermometer. It does not employ machine learning or AI that would require a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.