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The Microlife Digital Infrared Ear Thermometer, Model IRIDNI (IR210) device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediation used in the home setting.

The Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210) 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 provided text describes the Microlife Digital Infrared Ear Thermometer, Model IR1DN1 (IR210), and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 114 subjects.
• Data Provenance: The study was a clinical investigation, implying prospective data collection specifically for this study. The location of the clinical study is not explicitly stated, but it's a "clinical investigation" and a "clinical study" was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth. It states that "clinical data, represented by clinical bias, with uncertainty of bias, and clinical repeatability, met the acceptance criteria of the clinical study protocol," which implies a comparison against a reference standard or method for temperature measurement, likely managed by clinical professionals, but their specific roles, number, or qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes the clinical study as a "randomization, simple blind homologous control, pairing design," but this refers to the study design rather than a reader adjudication process. For temperature measurement, ground truth is typically established by high-precision reference thermometers rather than expert consensus on interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a digital infrared ear thermometer, and its performance is evaluated directly against known temperature standards and clinical correlations, not through human reader interpretation.

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

Yes, the performance testing described in the various standards (e.g., ASTM E1965-98, ISO 80601-2-56) and the accuracy in blackbody mode inherently represent standalone performance. The device provides a direct temperature reading. The clinical study then validated this standalone reading in a real-world setting.

7. The Type of Ground Truth Used

The ground truth for the device's accuracy is established through objective measurement against:

• Blackbody mode accuracy: For measuring the device's inherent precision against a controlled and known temperature source.
• Clinical Study Protocol: Which would involve comparing the device's readings to established clinical reference temperature measurement methods. The document mentions "clinical bias, with uncertainty of bias, and clinical repeatability," which are standard metrics for comparing a device to a reference measurement in a clinical setting.

8. The Sample Size for the Training Set

The document does not mention a training set or machine learning models. This device is a traditional electronic thermometer that uses an infrared sensor and an algorithm to convert infrared energy into a temperature value. It doesn't appear to use learning-based AI or require a training set in the conventional sense.

9. How the Ground Truth for the Training Set was Established

As no training set is indicated, this question is not applicable.

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The Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1 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 IR1DR1-1 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.

Mode of operation:

The unit measures the infrared energy emitting from the middle ear and the surrounding tissue. This energy is absorbed by lenses and converted into temperature values.

The Microlife Digital Infrared Ear thermometer, Model IR1DR1-1, consists of the following parts: a) Thermopile Sensor b) Application-Specific Integrated Circuit d) Lens e) LCD and Backlight f) 2 Keys (Start key, O/I key) g) 1 battery 3.0V

Here's an analysis of the provided text regarding the Microlife Digital Infrared Ear Thermometer, Model IR1DR1-1, based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device's accuracy are based on the ASTM E1965-98 (2009) standard for infrared thermometers. The reported performance for accuracy matches these criteria.

Other acceptance criteria implicitly met by the "Passed all testing requirements" statements for the listed standards (e.g., electrical safety, EMC, biocompatibility) are:

• Electrical Safety: Complies with IEC 60601-1: 2005 and A1:2012, ANSI/AAMI ES60601-1:2005/(R2012) and A1:2012, C1:2009/(R)2012 and A2:2010/(R2012), IEC 60601-1-11:2010.
• Electromagnetic Compatibility (EMC): Complies with IEC 60601-1-2: 2014.
• Biocompatibility: Complies with ISO 14971: 2007 (risk management), AAMI/ANSI/ISO 10993-1: 2010, AAMI/ANSI/ISO 10993-5: 2010, AAMI/ANSI/ISO 10993-10: 2010, AAMI/ANSI/ISO 10993-12: 2012 (biocompatibility standards).
• Software Verification and Validation: Complies with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005.

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

The document mentions "Controlled human clinical studies were conducted in accordance with ASTM E1965-98, IEC80601-2-56 Test Report." However, specific sample sizes (number of subjects/measurements) for the clinical test set are not provided in the document. The data provenance (e.g., country of origin, retrospective or prospective) is also not explicitly stated, though the nature of "Controlled human clinical studies" implies a prospective design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For a clinical thermometer, the "ground truth" (reference temperature) is typically established by another calibrated reference thermometer, not by human experts adjudicating readings.

4. Adjudication Method for the Test Set

This information is not applicable in the context of a clinical thermometer's performance evaluation, as "adjudication" typically refers to the resolution of disagreements among expert reviewers for image-based diagnostics. The ground truth for temperature measurement is an objective reading from a reference device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., images), which is not the case for a digital ear thermometer. The comparison is against a reference temperature.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the device performance was evaluated in a standalone manner. The "Accuracy Tested (blackbody)" refers to testing the device in a controlled environment against known temperature sources without human interpretation influencing the measurement itself. The clinical studies also evaluate the device's ability to measure temperature in humans without human intervention in the device's measurement process, though a human operates the device.

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth was established using blackbody radiators (controlled temperature sources) for in-vitro testing. For clinical studies, the ground truth would typically be established by simultaneously taking readings with a calibrated reference thermometer – most likely a traditional clinical thermometer known for high accuracy or another accepted medical standard. The document states "Clinical data was presented evaluating clinical uncertainty and clinical repeatability," which implies comparison against a reference.

8. The Sample Size for the Training Set

The document describes the device as a physical thermometer using an infrared sensor and an Application-Specific Integrated Circuit (ASIC). It does not mention any machine learning or AI algorithms that would require a "training set" in the conventional sense. The device's operation is based on physical principles of infrared measurement and conversion to temperature values. Therefore, a "training set" as understood in AI/ML is not applicable.

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

As explained in point 8, a "training set" is not applicable for this device.

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The Microlife Digital Infrared Ear Thermometer IR1DV1-1 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 1R1DV1-1 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: a) IR Thermopile Sensor b) ASIC c) E2PROM IC d) LCD and Backlight e) 2 Keys, 1 Buzzer This device is used probe cover free.

The provided text is a 510(k) summary for the Microlife Digital Infrared Ear Thermometer, Model IR1DV1-1. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

Here's a breakdown of what is and is not in the provided text in relation to your request:

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

• Not provided. The document states compliance with ASTM E1965 and IEC60601-1/-2, but does not list specific numeric acceptance criteria for temperature accuracy or other performance metrics, nor does it present the device's measured performance against such criteria.

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

• Partially provided. The submission mentions "Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover."
• Sample size: Not specified.
• Data provenance: "human clinical studies" is mentioned, implying prospective, but no country of origin is stated.
• Retrospective/Prospective: Implied prospective due to "conducted."

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 provided. This information is generally more relevant for diagnostic AI devices where expert interpretation is the gold standard. For a thermometer, "ground truth" would typically refer to a highly accurate reference thermometer measurement.

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

• Not provided. This is not typically relevant for a thermometer's performance validation.

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 provided. This is a question specifically for AI-assisted diagnostic devices and does not apply to a standalone medical device like a thermometer.

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

• Implied, but not explicitly detailed as "standalone performance study." The device is a thermometer, which inherently operates in a "standalone" manner to measure temperature. The clinical studies mentioned aimed to validate its "effectiveness of use without a probe cover," which implies testing its accuracy in that usage mode. No human "in-the-loop" interaction with an algorithm is described beyond reading the temperature.

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

• Not explicitly stated in the document. For a thermometer, the "ground truth" for temperature would typically be established by a highly accurate, calibrated reference thermometer measuring core body temperature (e.g., rectal or arterial measurement).

8. The sample size for the training set:

• Not applicable/Not provided. This device is a traditional electronic thermometer, not an AI/machine learning device that requires a "training set" in the sense of supervised learning. Its "algorithm" refers to the signal processing for temperature measurement, not a learned model.

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

• Not applicable/Not provided. (See point 8).

Summary of what is present:

The document states that the device complies with ASTM E1965, IEC60601-1, and IEC60601-1-2 requirements. ASTM E1965, "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," would contain the specific acceptance criteria for accuracy.

It also mentions that:

• "Controlled human clinical studies were conducted for the Microlife Digital Infrared Ear Thermometer Model IR1DV1-1 to validate the effectiveness of use without a probe cover."

To fully answer your request, one would need to refer to the actual ASTM E1965 standard to find the acceptance criteria and then examine the full submission or a detailed clinical report that would show the results of the "controlled human clinical studies" against these criteria. The 510(k) summary only provides a high-level overview.

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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 digital infrared Ear 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, Models IR1DA1-2 and IR1DE1-2 are Digital Infrared Ear Thermometers 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 five parts: a) IR Thermopile Sensor, b) ASIC, c) E2 PROM IC, d) LCD and Blacklight, e) Key "2, Buzzer" 1.

The provided text is a 510(k) summary for a Digital Infrared Ear Thermometer. It describes the device, its intended use, and compares it to a predicate device. However, it explicitly states that "Controlled human clinical studies were not conducted" and refers only to "Accuracy performance, reliability and EMC testing" as applicable.

Therefore, I cannot provide information on acceptance criteria for device performance based on clinical studies, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these types of studies were not conducted for this device submission.

Here's what can be extracted from the document regarding acceptance criteria and testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• None specified for clinical studies. The document 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 miral studies/low power testing were conducted for the original unmodified device and remain unchanged."
• Data provenance for the engineering tests (accuracy, reliability, EMC) is not detailed.

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 studies requiring expert ground truth were conducted.

4. Adjudication method for the test set:

• Not applicable, as no clinical studies requiring adjudication were conducted.

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 thermometer, not an AI-assisted diagnostic tool involving human readers. No MRMC study was mentioned.

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

• The document implies that engineering tests (accuracy, reliability, EMC) were conducted on the device itself ("algorithm only" in the context of device performance) to demonstrate compliance with standards. It does not provide specific metrics or results from these tests beyond claiming compliance.

7. The type of ground truth used:

• For the engineering tests, the ground truth would typically be established by calibrated reference standards used in laboratories conforming to the respective ASTM and IEC standards for thermometer performance. The document does not explicitly state the ground truth methodology, but adherence to these standards implies such a methodology.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning algorithm requiring a training set in the conventional sense.

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

• Not applicable. See point 8.

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The device is an digital infrared Ear 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, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290 are electronic thermometers 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 five parts: a) IR Thermopile Sensor, b) ASIC, c) E2 PROM IC, d) LCD and Blacklight, e) Kev "2. Buzzer" 1.

Here's a breakdown of the acceptance criteria and study information for the Microlife Digital Infrared Ear Thermometer, Models IR1DC1/V971, IR1DG1/SKU4289 and IR1DH1/SKU4290, based on the provided text:

Summary of Device Acceptance and Study Information

The provided 510(k) summary focuses on demonstrating substantial equivalence of the new models to a previously cleared predicate device (Microlife Digital Infrared Ear Thermometer, Model IR1DE1, K#020725). The key claim is that the new models are identical in functionality and performance to the predicate, with only differences in external shape, PCB layout, and some user interface ergonomics/features.

The document explicitly states that controlled human clinical studies were not conducted for the modified devices. This implies that the acceptance criteria and performance data for these new models are not directly derived from new clinical trials. Instead, the substantial equivalence relies on the unchanged core technology and performance specifications, and compliance with voluntary standards.

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not explicitly list quantitative acceptance criteria for accuracy, reliability, or specific performance metrics for the new devices. It relies on the predicate device's established performance and the claim that the core technology and algorithm remain unchanged. The compliance to the ASTM and IEC standards serves as the primary acceptance criteria for the modified devices, indicating they meet established design and safety requirements for electronic clinical thermometers.

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

• Test Set Sample Size: Not applicable/not specified. The document explicitly states that "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices." The evaluation of these new models relies on non-clinical tests (compliance to standards, engineering verification) and the assertion that their performance is identical to the predicate.
• Data Provenance: Not applicable, as no new clinical test data was generated for these modified devices. The regulatory submission leverages the performance data of the predicate device, which is not detailed in this excerpt regarding its own clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable, as no new clinical studies were conducted for the modified devices requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Not applicable, as no new clinical studies were conducted for the modified devices requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No MRMC comparative effectiveness study was done. The document states: "Controlled human clinical studies were not conducted for the Microlife Digital Infrared Ear Thermometer modified devices".

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

• The document implies that "Accuracy performance, reliability and EMC testing" was done for the modified devices. While not detailing 'standalone algorithm testing' in the modern sense of AI, it refers to the unchanged temperature measurement algorithm and software codes from the predicate device. This suggests that the core measurement logic itself was considered "standalone" and its performance was established with the predicate devices and considered directly transferable due to no changes.

7. The Type of Ground Truth Used

• For the modified devices, the "ground truth" for demonstrating substantial equivalence is primarily based on:
  • Compliance with established voluntary standards (ASTM, IEC).
  • The assertion of identical functionality and performance to the predicate device whose performance was previously established.
  • Engineering verification and validation tests (not detailed) to confirm that the modifications did not alter original safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. This device is an infrared thermometer, not an AI/machine learning model in the context that requires a "training set." The temperature measurement algorithm is described as "unchanged" from the predicate device, implying it was developed based on general physics and engineering principles for infrared thermometry, not through machine learning.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" in the context of an AI/machine learning model for this electronic thermometer. The core measurement algorithm's "ground truth" would have been established through a combination of physical principles, calibration against known temperature sources, and validation against clinical reference methods during the development of the predicate device (which is not detailed in this submission).

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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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