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510(k) Data Aggregation
(17 days)
The Device measures the human body temperature from oral, axillary, and rectal. -The device is reusable and intended for clinical or home use on people of all ages.
The Digital Thermometer is an electronic clinical thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans. Classic type and Flexible type have the same indication for use; however, Flexible type has a flexible tip.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study conducted for the Digital Thermometer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM E1112 ("Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | Conforms to ASTM E1112 |
| IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) | Conforms to IEC 60601-1 |
| IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | Conforms to IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain information about a test set sample size or data provenance for human clinical studies. It explicitly states: "Controlled human clinical studies ware not conducted using the Digital Thermometer Classic type and Flexible type and predicate devices."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no human clinical studies were conducted, there were no experts used to establish ground truth for a test set. The substantial equivalence was based on conformance to recognized standards.
4. Adjudication Method for the Test Set
As no human clinical studies were conducted, no adjudication method was used for a test set.
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
This device is a digital thermometer, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was done regarding human readers and AI assistance, and there is no effect size to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a digital thermometer, not an algorithm. Therefore, no standalone algorithm performance testing was done. The performance was assessed against recognized physical and operating standards.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established by conformance to internationally recognized standards for electronic thermometers (ASTM E1112, IEC 60601-1, IEC 60601-1-2). These standards define acceptable levels of accuracy, safety, and electromagnetic compatibility.
8. The Sample Size for the Training Set
This device is a digital thermometer, not a machine learning model. Therefore, there is no concept of a "training set" or "sample size for a training set" in this context.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this device. The "ground truth" for the device's design and manufacturing was established by the requirements and specifications outlined in the referenced international standards. Developers ensure their device can meet these established, industry-accepted criteria through design, testing, and manufacturing processes, rather than through a machine learning training paradigm.
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