(195 days)
The Digital temperature monitor, model KY-01 is the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for abdominal temperature measurement of a body less then eight ages old, and the measurement of oral, armpit and rectal temperature for all ages.
The Digital temperature monitor, model KY-01, are the electronic thermometers by using a thermistor as the temperature sensor. The signal of sensor is calculated and displayed by an ASIC (Application Specific IC) - controlled circuit, which is considered the hard-wire control instead of programmable control. From the construction point of view, the digital thermometer comprises of a thermistor for measuring sensor, a reference resistor for comparison of temperature, a buzzer for sounding effect, an ASIC for calculating, and LCD for displaying the measuring temperature digitally for which the thermistor contacts. This system uses a 1.5V DC battery for operation of complete system whenever the battery is low. the ASIC circuit will detect the low battery condition automatically, and displays 'Low battery' in LCD display. Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98.
Here's an analysis of the provided 510(k) summary, specifically focusing on acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to compliance with ASTM E1112-98 as the primary standard for performance verification. This standard is for electronic thermometers. Therefore, the acceptance criteria are derived from this standard. The document doesn't explicitly state all performance metrics or their specific values from the standard, but it asserts compliance.
| Acceptance Criteria (Based on ASTM E1112-98) | Reported Device Performance (Model KY-01) |
|---|---|
| Accuracy (e.g., maximum error allowed at specific temperatures) | "designed and verified according to the US standard ASTM E1112-98." |
| Response Time (e.g., time to stable reading) | Implied to meet ASTM E1112-98 requirements. The document states it's for "measuring human body temperature precisely." |
| Repeatability/Reproducibility | Implied to meet ASTM E1112-98 requirements. |
| Stability (e.g., drift over time) | Implied to meet ASTM E1112-98 requirements. |
| Operational Lifetime (e.g., battery life) | The ASIC circuit detects low battery automatically. |
| Environmental Performance (e.g., temperature, humidity limits) | Implied to meet ASTM E1112-98 requirements and EN standards (EN 60601-1, EN 60601-1-1, EN 60601-1-2). |
| Display Characteristics (e.g., readability) | "LCD for displaying the measuring temperature digitally." |
| Material Biocompatibility (if applicable to patient contact) | Not explicitly stated but implied by substantial equivalence and general safety requirements. |
| Electrical Safety | Compliance with EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirements. |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2 requirements. |
Study Proving Device Meets Acceptance Criteria:
The document states: "Regarding the performance of KY-01, it was designed and verified according to the US standard ASTM E1112-98." And also, "Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112: 1998, as well as EN 60601-1, EN 60601-1-1, and EN 60601-1-2 requirement."
This indicates that the device underwent non-clinical testing to demonstrate compliance with these standards. The specific details of these tests (e.g., number of measurements, specific temperature points tested) are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or any details about human subjects. The testing described is "non-clinical tests" and compliance with standards, which would typically involve laboratory measurements on the device itself, potentially using simulated body temperatures or calibrated constant temperature baths. Given the nature of a digital thermometer, a "test set" in the context of patient data (prospective or retrospective) is not the primary means of demonstrating compliance with performance standards like ASTM E1112.
The data provenance is not applicable in the human subject data sense, as the performance evaluation referenced appears to be engineering and laboratory-based. The device's manufacturer is Kang Ying Medical Appliances Inc. in Taiwan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This question is not applicable in the traditional sense of clinical imaging or diagnostic device ground truth. The "ground truth" for a thermometer's accuracy would be established by reference to highly accurate, calibrated temperature standards in a laboratory setting, not by human experts. The involved "experts" would be metrology engineers or technicians. The document does not specify their number or qualifications.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation described is laboratory-based compliance testing against a standard, not expert adjudication of a diagnostic finding.
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
This is not applicable. The device is a digital thermometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone electronic thermometer. Its performance, as measured by compliance with ASTM E1112-98, would be its "standalone" performance. The document doesn't describe separate "algorithm only" performance, as the device's functionality is directly tied to its physical components (thermistor, ASIC).
7. The Type of Ground Truth Used
The ground truth used for assessing the thermometer's performance would be:
- Calibrated Reference Temperatures: Highly accurate and traceable temperature standards (e.g., from a national metrology institute) used in a laboratory setting to verify the accuracy of the thermometer's readings.
- Compliance with ASTM E1112-98: This standard itself defines the acceptable deviations from true temperature for different temperature ranges, acting as the ground truth for performance.
8. The Sample Size for the Training Set
This is not applicable. The device is a digital thermometer that uses a thermistor and an ASIC for calculation. It is not an AI/machine learning device that requires a "training set" of data in the computational sense. Its "training" is in its design and calibration processes.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as point 8.
§ 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.