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For intermittent measurement of body temperature in patients of all ages in home environment

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The provided document is a 510(k) clearance letter from the FDA for a clinical electronic thermometer. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document states that the device is a "NPAC Multi-Use Ear Thermometer, Models TP 700, TP 702" and its indications for use are "For intermittent measurement of body temperature in patients of all ages in home environment."

To answer the questions about acceptance criteria and a study, one would typically need access to the 510(k) submission document itself, which would detail the performance data and the comparison to a predicate device. This letter only confirms that the device has been found substantially equivalent to a legally marketed predicate device.

Therefore, none of the requested information (acceptance criteria table, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, or ground truth establishment for training set) can be extracted from the provided text.

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For intermittent measurement of body temperature in patient of all ages in home environment. The device is reusable and intended for oral, axillary or rectal temperature measurements.

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This document is a 510(k) clearance letter for a digital thermometer. It does not contain the specific technical details or study results required to construct the table and answer all the questions about acceptance criteria and performance studies. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

However, I can extract the following information that is present:

• Device Name: NPaC Digital Thermometer Models ET300, ET303, ET350, ET351 ET400, ET403, ET450, ET451 ET500, ET503, ET550, ET551
• Indications for Use: For intermittent measurement of body temperature in patients of all ages in a home environment. The device is reusable and intended for oral, axillary, or rectal temperature measurements.
• Regulatory Class: II
• Product Code: FLL
• Regulation Number: 21 CFR 880.2910 (Clinical Electronic Thermometer)
• 510(k) Number: K031907

Based on the provided text, I cannot answer most of your detailed questions regarding acceptance criteria and performance studies. This type of information is typically found in the 510(k) submission document itself, not in the FDA's clearance letter.

To fully answer your questions, I would need access to the actual 510(k) submission (K031907) which would include the performance data and testing details.

Here's what I can state based only on the provided document, addressing the questions where possible, and noting when information is absent:

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

• Information Absent: This document is a clearance letter, not the performance study itself. It does not contain a table of acceptance criteria or reported device performance metrics (e.g., accuracy, precision). For a digital thermometer, acceptance criteria would typically relate to accuracy (e.g., +/- 0.1°C or 0.2°F within a certain range), stability, and repeatability, as well as safety standards.

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

• Information Absent: The clearance letter does not specify the sample size, data provenance, or the nature of the study (retrospective or prospective) used to support the substantial equivalence.

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)

• Information Absent: This is not relevant for a digital thermometer's performance study, which typically relies on comparison to a traceable reference standard (e.g., a standardized temperature bath or a clinical reference thermometer) rather than expert consensus on images.

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

• Information Absent: Not applicable for a digital thermometer's objective performance testing against a reference standard.

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

• Information Absent: Not applicable. This device is a standalone digital thermometer, not an AI-assisted diagnostic tool that involves human readers or interpretation.

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

• Information Present & Indirectly Applicable: While not explicitly detailed, the performance study for a digital thermometer is inherently a "standalone" performance test. The device simply measures and displays temperature. There is no "human-in-the-loop" interpretation of results that would alter its measurement function. The study (which is not detailed here) would have evaluated the accuracy and precision of the device's measurements directly.

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

• Information Absent (but inferable for a thermometer): For a digital thermometer, the ground truth would typically be established using a traceable reference standard (e.g., highly accurate laboratory thermometer, calibrated temperature bath, or a clinical reference thermometer) that is significantly more accurate than the device under test. It would not typically involve expert consensus, pathology, or outcomes data in the way these terms are used for diagnostic imaging or clinical decision support systems.

8. The sample size for the training set

• Information Absent: This device is not described as an AI/ML device that requires a training set. Its function is based on physical principles, not learned patterns from data.

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

• Information Absent: Not applicable, as this device does not use a training set.

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For intermittent measurement of body temperature in patients of all ages in home environment.

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I apologize, but the provided text from the FDA 510(k) summary for the NPaC Multi-Use Ear Thermometers (K030126) does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

This document is a letter from the FDA confirming the substantial equivalence of the device to a legally marketed predicate and allowing it to be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not include the technical study details, performance data, or an explicit table of acceptance criteria that you've asked for.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study details
6. Standalone (algorithm only) performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

To obtain this information for an FDA-cleared device like this, you would typically need to consult the original 510(k) submission document itself, which contains the detailed technical and clinical performance data, or potentially the user manual/labeling for the device. The provided text is solely the FDA's regulatory clearance letter.

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For intermittent measurement of body temperature in patients of all ages in home environment.

NPaC Ear Thermometer TD402

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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