Search Results

This device is an electronic clinical thermometer using an infrared sensor to detect body temperature via the auditory canal in the neonatal, pediatric and adult population used at home.

The easytem Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.

The provided text is a 510(k) summary for the Easytem Ear Thermometer, Model BT-020. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any details about test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth for training was established.

The document focuses on:

• Administrative details: Submitter information, contact, date of summary, trade name, classification, and predicate devices.
• Device description: How it measures temperature (infrared sensor in the auditory canal).
• Intended use: Intermittent measurement and monitoring of human body temperature in the home for people of all ages.
• Technological characteristics: States that it has the same general design and performance characteristics as predicate devices, with the main difference being physical size, shape, and weight. It claims "no new questions of safety and effectiveness."
• Purpose of submission: New device for the USA, similar to approved predicate devices.
• FDA correspondence: The letter from the FDA confirming the substantial equivalence and allowing the device to be marketed.

Without specific performance data, I cannot complete the requested table or answer most of the questions.

Here's what can be inferred or explicitly stated based only on the provided text, with the understanding that key information is missing:

1. A table of acceptance criteria and the reported device performance

No acceptance criteria or reported device performance data are provided in the document. The 510(k) summary asserts "the same general design and performance characteristics as the predicate devices" but does not quantify these characteristics or provide test results.

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

No information provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

No information provided.

4. Adjudication method for the test set

No information provided.

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 an ear thermometer, not an AI-assisted diagnostic tool for human readers.

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

Not applicable. This device is a direct measurement tool, not an algorithm. Its performance is inherent in its design and operation.

7. The type of ground truth used

No information provided, as no study details are given. For a thermometer, "ground truth" performance typically involves comparison against a highly accurate reference thermometer in a controlled setting, but no such details are mentioned.

8. The sample size for the training set

Not applicable. This device is a hardware measurement device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this device does not involve a training set.

Conclusion: The provided 510(k) summary for the Easytem Ear Thermometer focuses on establishing substantial equivalence to predicate devices based on design and intended use, rather than detailing a specific performance study with acceptance criteria and results. Therefore, most of the requested information regarding study details, sample sizes, and ground truth establishment is not available in the given document.

Ask a specific question about this device