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

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Its operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

The Microlife Digital Infrared Ear Thermometer, consists mainly of five parts:

• IR Thermopile Sensor a)
• b) ASIC
• E2 PROM IC C)
• LCD and Blacklight d)
• Key "2, Buzzer" 1 e)

Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1, based on the provided text:

Important Note: The provided text is a 510(k) summary for a device seeking substantial equivalence to a predicate device. It primarily discusses non-clinical tests for compliance with standards and a clinical study to validate a specific change (probe cover-free use). It does not provide detailed acceptance criteria and performance data in the way a clinical study report for a novel device would. Many of the requested details are therefore not available from this document.

Acceptance Criteria and Reported Device Performance

The document refers to compliance with ASTM E-1965-98 as an applicable voluntary standard. This standard likely outlines the performance requirements for infrared thermometers, including accuracy specifications. However, the exact numerical acceptance criteria and the device's reported performance against these criteria are not explicitly stated in this 510(k) summary. The summary only generally states that "verification and validation tests contained in this submission demonstrate that the modified portions maintained its original safety and effectiveness."

Study Details where Information is Available:

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

• Sample Size: Not specified. The document states "Controlled human clinical studies were conducted," but does not give the number of subjects.
• Data Provenance: Not specified (e.g., country of origin). The studies were "controlled human clinical studies," implying prospective data collection in a clinical setting.

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)

• Not Applicable / Not Provided. This type of information is typically relevant for studies involving image interpretation or complex diagnostic assessments. For a thermometer, "ground truth" would typically come from a highly accurate reference thermometer, not expert consensus on interpretations.

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

• Not Applicable / Not Provided. Adjudication methods are used when multiple experts are interpreting data and their opinions need to be reconciled. This is not relevant to a thermometer's performance testing where accuracy is measured 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

• No. This is not relevant. The device is a 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

• Yes, implied. The "clinical studies" mentioned are to "validate the effectiveness of use without a probe cover." This implies testing the device's performance (i.e., its algorithm and sensor) in a standalone manner, measuring its output directly.

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

• Implied Reference Standard. For a thermometer, the "ground truth" would be established using a highly accurate reference thermometer (e.g., a laboratory-grade precision thermometer or a rectal thermometer) with known calibration. This is not explicitly stated in the document but is the standard practice for thermometer validation.

8. The sample size for the training set

• Not applicable. This device is a traditional electronic thermometer, not an AI/ML-based device that requires a distinct "training set." The phrase "temperature measurements algorithm and its software codes of the modified devices remains unchanged" suggests the core algorithm was already established.

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

• Not applicable. As above, no training set for an AI/ML model for this device.

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

The Microlife Digital Infrared Ear Thermometer, Model IR1DE1 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal. Their operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces.

The Microlife Digital Infrared Ear Thermometer, consists mainly of the five parts:

• IR Thermopile Sensor a)
• ASIC b)
• E2 PROM IC C)
• LCD and Blacklight d)
• Kev "2. Buzzer" 1 e)

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1:

Key Finding: This 510(k) submission does not contain any clinical study data for the IR1DE1 model. It relies on the substantial equivalence to a previously cleared device (IR1DA1) and states that clinical studies were already conducted for the original, unmodified device. Therefore, a complete table of acceptance criteria and reported device performance directly from this document, as well as several other requested details, cannot be provided.

Acceptance Criteria and Study Details for Microlife Digital Infrared Ear Thermometer, Model IR1DE1

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific numerical acceptance criteria and reported device performance from a new study for the specific model IR1DE1 are not available. The submission states that compliance to various standards was performed, but it does not detail specific performance thresholds or results.

However, the document indicates compliance with the following:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. No new clinical human testing was conducted for this specific modified device (IR1DE1).
• Data Provenance: Not applicable for new clinical data. The submission refers to "clinical studies/low power testing were conducted for the original unmodified device," but details of those prior studies are not provided in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. No new clinical studies requiring expert ground truth establishment for a test set were conducted for this device according to the document.

4. Adjudication Method for the Test Set:

• Not applicable. No new clinical studies were conducted for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, a MRMC comparative effectiveness study was not done for the modified device (IR1DE1). Clinical studies were explicitly not conducted for this modified device.

6. Standalone Performance Study:

• No, a standalone (algorithm only without human-in-the-loop) performance study was not done specifically for the modified device (IR1DE1) as a new clinical study. The submission states that "Accuracy performance, reliability and EMC testing is only applicable," suggesting engineering and bench testing, but no specific in-depth performance study results are detailed in this document.

7. Type of Ground Truth Used:

• Not applicable for new clinical data. The ground truth for the original device's clinical studies (referenced but not detailed here) would likely have been reference thermometer readings or medical consensus, but this is speculative given the lack of detail.

8. Sample Size for the Training Set:

• Not applicable. The device's temperature measurement algorithm and software codes "remain unchanged" from the predicate device. Therefore, no new training set was used for the IR1DE1 model. The document does not provide details on the training set (if any, as an infrared thermometer might not 'train' in the AI sense) used for the original algorithm development.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as no new training set was described for the IR1DE1 model. Details on the ground truth establishment for the original algorithm are not provided in this document.

Summary of the Submission's Approach:

The submission for the Microlife Digital Infrared Ear Thermometer, Model IR1DE1, is a 510(k) for a modified device. The core argument for substantial equivalence relies on:

1. The device having the same intended use as the predicate device (Model IR1DA1).
2. The temperature measurement algorithm and software codes remaining unchanged.
3. The fundamental scientific technology remaining the same.
4. Modifications being limited to "ergonomics of the user interface, dimensional specifications and environmental specifications," and PCB layout, which are considered to not affect the intended use or alter the fundamental scientific technology.
5. Compliance with applicable voluntary standards and guidance documents.

Therefore, the submission explicitly states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices, as well as no low power test as clinical studies/low power testing were conducted for the original unmodified device and remain unchanged." This means no new primary clinical data for the IR1DE1 model is presented in this document.

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