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This looks like a 510(k) clearance letter for an ear thermometer, not a study report. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not typically found in this type of document.

However, I can extract the information that is present and explain why other requested details are absent.

Here's the breakdown based only on the provided text:

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

This document does not contain a table of acceptance criteria or reported device performance in the manner typically seen for algorithmic or diagnostic device studies (e.g., sensitivity, specificity, AUC).

For thermometers, acceptance criteria often relate to accuracy (e.g., ±0.2°C) when compared to a reference standard (like a rectal thermometer or oral thermometer) across a range of temperatures. The presented document is a regulatory clearance letter, not the study report itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document. The 510(k) clearance letter does not describe the specific performance testing conducted or its details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not available for a simple ear thermometer. Temperature measurement does not typically involve expert interpretation for ground truth establishment; it's usually a direct comparison to a validated reference device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not available for an ear thermometer. Adjudication methods are relevant when expert interpretation can vary and a consensus is needed (e.g., image interpretation).

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 information is not applicable and not available. An ear thermometer is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.

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

The device itself, the "NpaC Ear Thermometer Model #TD402", is a standalone device. Its performance is measured directly by whether it accurately reports temperature, not in conjunction with human interpretation or an algorithm in the AI sense. The 510(k) clearance process inherently relies on the device performing its intended function accurately and safely in a standalone manner. The details of how that performance was assessed are not in this letter.

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

The exact type of ground truth is not specified in this document. However, for a thermometer, the ground truth for temperature measurement would typically be established by a primary reference thermometer (e.g., a calibrated mercury thermometer, a high-accuracy rectal thermometer, or an oral thermometer) that is considered a gold standard for body temperature.

8. The sample size for the training set

This information is not available and not applicable in the context of an ear thermometer. Training sets are relevant for machine learning algorithms. An ear thermometer relies on physical principles of infrared detection and conversion, not a learned model from a training set.

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

This information is not available and not applicable for the same reasons as point 8.

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