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510(k) Data Aggregation
(102 days)
It is an electronic thermometer used for clinical temperature measurement. It is intended for use at home and hospital environment for both children and adult.
The Rapid Digital Thermometer is an electronic thermometer by using a thermistor as the temperature sensor. The thermometer uses a 1.5V button battery for operation.
It's important to clarify that the provided document does not describe a study that proves the device meets acceptance criteria in the way a clinical trial or a performance study for an AI-powered diagnostic device would.
This document is a 510(k) Summary for a Rapid Digital Thermometer, which is a Class II medical device. For such devices, regulatory clearance often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical studies proving novel diagnostic performance.
Therefore, many of the typical questions regarding AI device studies (like expert consensus, MRMC studies, training set details) are not applicable to this type of device and submission.
Here's an analysis based on the provided text, addressing the applicable points:
Acceptance Criteria and Device Performance for Rapid Digital Thermometer (Model RDT-18-XY)
The "acceptance criteria" for this device are largely defined by compliance with established performance standards for clinical electronic thermometers and by demonstrating substantial equivalence to a predicate device. The "study" referenced is primarily a series of non-clinical tests performed according to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from standards/predicate) | Reported Device Performance (RDT-18 series) |
|---|---|---|
| Intended Use | Measure body temperature (oral, axillary, rectal) | Same as predicate; Intended for clinical temperature measurement at home & hospital for children & adults |
| Technological Characteristics | Electronic thermometer using thermistor | Same as predicate; Electronic thermometer using thermistor |
| Temperature Range Test | Compliance with ASTM E1112 standards | Compliant with ASTM E1112 standards |
| Accuracy Test | Compliance with ASTM E1112 standards | Compliant with ASTM E1112 standards |
| Resolution Test | Compliance with ASTM E1112 standards | Compliant with ASTM E1112 standards |
| Cleaning Test | Compliance with ASTM E1112 standards | Compliant with ASTM E1112 standards |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-2 | Compliant with IEC 60601-1 and IEC 60601-1-2 |
| Biocompatibility | Compliance with ISO 10993-1 (skin irritation, in vitro cytotoxicity, sensitivity) | Compliant with ISO 10993-1 |
| Overall Equivalence | Substantially equivalent to predicate device (Electronic Thermometer GT010706; K021052) in safety and effectiveness | Declared substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. For performance tests like temperature range, accuracy, and resolution conducted according to ASTM E1112, there would be specific sample sizes (e.g., number of readings, number of devices tested). However, this detail is not included in the summary.
- Data Provenance: The tests were "conducted according to ASTM E1112 standards," "IEC 60601-1, IEC 60601-1-2 requirements," and "ISO 10993-1:2003 biocompatibility testing." The location where these tests were performed is not explicitly stated but is likely within a lab setting. The data is non-clinical/bench testing, not data collected from patients. It's retrospective in the sense that these are lab tests designed to demonstrate performance characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. For a basic electronic thermometer, "ground truth" is typically established by reference standards or calibrated equipment (e.g., a highly accurate reference thermometer in a temperature-controlled bath) for the performance tests, not by human experts interpreting clinical data.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "adjudication" in the sense of resolving discrepancies between human readers or between an algorithm and human readers, as this is a non-AI, non-diagnostic device. The tests involve comparing device readings against a known reference or standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-powered diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is an electronic thermometer, not an algorithm. Its performance is inherent in its design and manufacturing. The "standalone" performance refers to the device's ability to measure temperature accurately on its own.
7. The Type of Ground Truth Used
- Reference Standards/Calibrated Equipment: For performance tests like accuracy, the ground truth would be established by highly accurate, calibrated reference instruments (e.g., a standard thermometer or a temperature bath maintained at precise temperatures) as prescribed by standards like ASTM E1112. For electrical safety and biocompatibility, the "ground truth" is compliance with documented international standards.
8. The Sample Size for the Training Set
- Not Applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is irrelevant.
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