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The Digital Thermometer with Battery-Less Patch, Model KD-2100, is intended to measure and monitor human body temperature with a wireless digital LCD reader and a sensor coupled patch. The device is reusable and intended for ear and mouth measurement of adults and pediatric patients.

The Digital Thermometer with Battery Less Patch, Model KD -2100, consists of a DC battery powered wireless LCD reader and a battery less patch. The LCD reader part consists mainly of a plastic body, four keys (ON/OFF power, memory, read and LED on), two printed circuit boards (CPU and RFID), and and CD assembly with four backlight LEDs, a buzzer, a battery compartment and four AAA type batteries. The patch part includes a plastic body, a thermister sensor, and a TAG printed circuit board.

The provided text describes a 510(k) premarket notification for the K-Jump Digital Thermometer with Battery-Less Patch, Model KD-2100. Based on the information provided, here's a breakdown of the acceptance criteria and the study (or lack thereof) to prove the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical tests were performed to establish the device's performance in a real-world setting with human subjects. Therefore, there is no information regarding sample size for a test set or data provenance in the context of 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 clinical tests were performed and thus no test set with human data or ground truth established by experts.

4. Adjudication method for the test set

Not applicable, as no clinical tests were performed.

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 digital thermometer, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or a comparison of human reader performance with or without AI assistance is irrelevant and was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This refers to the performance of the device itself (the thermometer). The document states that the device complies with EN 60601-1-2 (2001), ASTM E112-00, and FCC Part 15. These are standards for electronic safety, and accuracy/performance of electronic thermometers, respectively. While not explicitly detailed as a "standalone study" with specific results, the compliance statements imply that the device met the technical requirements of these standards through bench testing. The submission confirms: "bench testing contained in this submission demonstrate that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the technical standards (EN 60601-1-2, ASTM E112-00, FCC Part 15), the "ground truth" would be the established benchmarks and measurement protocols defined within those standards. For example, for temperature accuracy, the ground truth would be a highly accurate reference thermometer or temperature bath used to calibrate and verify the device's readings according to the ASTM E112-00 standard. The document doesn't provide details on how these benchmarks were applied.

8. The sample size for the training set

Not applicable. This device is a digital thermometer, not a machine learning or AI model that requires 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 this type of device.

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