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The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.

The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid. It features digital signal processing (16 channel-wide dynamic input compression, 3 channel fast-acting output compression, 16 channel noise reduction, feedback cancellation,) bi-directional microphone with windscreen, volume and program control (environment selection - Quiet, Noisy, Concert, TV), 3 channel equalizer, self-adjustable wire and ear tips, and customization through the Braun® Clear™ Mobile Application. The Braun® ClearCheck™ Hearing Test aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Braun® Clear™ Hearing Aid. These thresholds are used to program the device using a proprietary fitting algorithm.

This document describes a medical device, the BHA100 Series Braun® Clear™ Hearing Aid, and its supporting clinical study. The device is a self-fitting, air conduction hearing aid intended for individuals 18 years or older with perceived mild to moderate hearing impairment, for direct-to-consumer use without professional assistance.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly present a single table labeled "acceptance criteria" with a clear pass/fail status for each, but the study results are presented against implicit or stated criteria. I've synthesized these from the descriptions of the primary and secondary endpoints.

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

• Test Set Sample Size:
  • Phase 1 (Quantitative Measures - Audiometric Thresholds & REM): All 80 subjects participated in both self-fitting and audiologist-determined threshold measurements and Real Ear Measurements (REM). This implies 160 ears were tested for the PTA MAD (Figure 2a) and 159 ears for the REM MAD (Figure 3a).
  • Phase 2 (Qualitative Measures - COSI): 80 subjects were randomized (1:1) into two groups: "Audiologist-Fit" (N=40) and "Self-Fit" (N=40). For the COSI analysis, 39-40 subjects per cohort were used (Figure 4a, Figure 4b).
  • Usability Testing: 36 untrained participants.
• Data Provenance: The study was a "prospective, randomized, two-arm, multicenter (4 clinical sites) clinical validation study." The document does not specify the country of origin, but given the FDA submission, it's typically either conducted in the U.S. or under strict international standards acknowledged by the FDA. The nature of the study (prospective) means data was collected specifically for this study under predefined protocols.

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

• Phase 1 Ground Truth: The ground truth for audiometric thresholds and Real Ear Measurements (REM) was established by "a licensed audiologist using a calibrated, clinical audiometer." The study was conducted at "4 clinical sites," implying multiple audiologists, though the exact number isn't specified. The qualification is "licensed audiologist."
• Phase 2 Ground Truth: The "Audiologist-Fit" group in Phase 2 served as a comparative arm, where the device was fit by "a licensed audiologist." The ground truth for user satisfaction (COSI) was based on "participant-reported, adjective-scale" responses, comparing the outcomes of self-fitting with audiologist-fitting.
• Usability Testing Ground Truth: The assessment of critical tasks was moderated, but the "ground truth" for usability seems to be based on participants' successful completion of tasks and their subjective assessments, rather than expert judgment of performance against a predefined "correct" interaction.

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

The document does not describe an explicit adjudication method (like 2+1 or 3+1 with multiple readers/experts) for establishing ground truth in the clinical performance sections. For audiometric and REM measurements, the comparison was directly between the self-fitting method and a single audiologist's measurement. For the COSI scores, it was a comparison of subject-reported outcomes between two fitting strategies.

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

The study was a "two-arm" clinical validation study comparing self-fitting with audiologist-fitting. It was not an MRMC study in the typical sense of evaluating human reader performance with or without AI assistance. Instead, it directly compared a device's self-fitting capability to a professional fitting, both of which result in a device configuration. The "AI" aspect here is the "proprietary fitting algorithm" in the "Braun® ClearCheck™ Hearing Test" within the mobile application that performs the self-fitting. The study does not quantify how much human audiologists improve with AI assistance, but rather shows that the device's self-fitting capability is non-inferior to traditional audiologist fitting.

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

Yes, in a sense. Phase 1 of the study specifically evaluated the "self-fitting hearing test of the BHA100 Series Braun® Clear™ Hearing Aid." This "self-fitting" process is driven by the device's algorithm, with the user interacting with the mobile application rather than a human professional for the fitting process. The comparison was then made against audiologist-determined thresholds, effectively evaluating the algorithm's performance in generating fitting parameters.

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

• Phase 1 Ground Truth:
  • For audiometric thresholds (PTA): "audiologist executed hearing test [...] using a calibrated, clinical audiometer." This is a form of expert measurement/diagnostics, considered the clinical standard.
  • For Real Ear Measurements (REM): Gold standard clinical measurement (NAL-NL2 targets) performed by a licensed audiologist using calibrated equipment.
• Phase 2 Ground Truth:
  • For COSI scores (user satisfaction): "participant-reported, adjective-scale" responses. This is patient-reported outcomes data.
• Safety: Adverse event reporting and adjudication (clinical site PI determined SAE not device-related).
• Non-clinical: Compliance with established international and national standards (e.g., IEC, ISO, ANSI).

8. The sample size for the training set

The document does not specify a separate "training set" sample size for the device's proprietary fitting algorithm. The information provided heavily focuses on the clinical validation study (test set) for the premarket notification. Device algorithms are typically "trained" on large, diverse datasets before clinical validation. This document only describes the performance evaluation of the already trained and implemented algorithm.

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

Since the document does not discuss the training phase of the algorithm, it does not specify how the ground truth for any potential training set was established. However, for a self-fitting hearing aid using a proprietary fitting algorithm (Braun® ClearCheck™ Hearing Test), it's highly probable that the algorithm's development and training (if applicable) would have involved extensive audiometric data established by audiologists, similar to the "ground truth" established by the audiologist-executed tests in Phase 1 of this validation study.

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The Vicks® VNT200 No Touch Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a "no touch" mode, using the center of the forehead as the measurement site, on people of all ages, in a home use environment.

The Vicks® VNT200 No Touch Forehead Thermometer is a hand-held, battery-powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature. It is calibrated for non-contact use at a distance of up to 5 centimeters (2 inches) from the center of the forehead. It uses an infrared thermopile sensor with integrated thermistor mounted in the head of the thermometer for the target reading and ambient temperature reading.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) Summary for the Vicks® VNT200 No Touch Forehead Thermometer:

1. Table of Acceptance Criteria and Reported Device Performance

The non-clinical testing section (Section VIII) of the 510(k) summary provides a comprehensive table of acceptance criteria and results. Below is a summarized version focusing on key performance aspects:

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

• Clinical Study Test Set Sample Size: 208 subjects.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. It refers to "a pivotal study." It is a prospective study as it involves enrolling subjects and conducting measurements.

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

The document does not specify the number of experts or their qualifications (e.g., radiologists with 10 years of experience) used to establish ground truth for the clinical study. For a thermometer, "ground truth" for body temperature is typically established using a highly accurate reference thermometer measurement (e.g., rectal temperature for core body temperature, or a calibrated blackbody for laboratory accuracy testing) rather than expert subjective assessment of an image. The standards cited (ASTM E1965-98:2016 and ISO 80601-2-56:2017) lay out the methods for determining temperature accuracy against a reference.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where subjective interpretation is involved and multiple readers' opinions need to be reconciled for ground truth. For thermometer accuracy, the ground truth is often an objective measurement from a reference device.

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

Not applicable. This device is a thermometer, not an AI-assisted diagnostic imaging tool that would typically undergo an MRMC study comparing human reader performance with and without AI assistance. The study focuses on the device's accuracy in measuring temperature.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the majority of the "Non-Clinical Testing & Performance Data" (Section VIII) represents standalone performance of the device without human interpretation. This includes accuracy in test mode (against a blackbody), accuracy in various environments, response time, electrical safety, EMC, etc. The clinical testing evaluates its performance in actual human use, but the core measurement is automated "algorithm only."

7. The Type of Ground Truth Used

• Non-Clinical Testing: The ground truth for the non-clinical / laboratory testing (e.g., accuracy in test mode, accuracy as a function of supply voltage, accuracy in range of environments) was established using calibrated blackbody temperatures. A blackbody is a standardized thermal radiation source used to accurately calibrate and test infrared thermometers.
• Clinical Testing: For the clinical study, the ground truth for body temperature was established by comparing the device's measurements to a reference standard method for intermittent determination of patient temperature, as required by ASTM E1965-98:2016 and ISO 80601-2-56:2017. While the specific reference method isn't detailed, for clinical thermometers, this often involves simultaneous or nearly simultaneous measurements with a highly accurate rectal thermometer or other core body temperature measurement, or highly controlled environmental conditions with a known "true" temperature.

8. The Sample Size for the Training Set

This information is not provided. The document describes the "pivotal study" (clinical test set) and non-clinical testing. For a traditional medical device like a thermometer, there isn't typically a "training set" in the machine learning sense. The device is designed, calibrated, and validated based on physics and engineering principles, and then tested against established standards. If there were internal iterative design tests during development, those details are not part of this 510(k) summary. The software (MCU) was validated, but details on data used for its development are not disclosed.

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

As there's no explicitly defined "training set" for an AI model in this context, this question is not fully applicable. However, for the development and calibration of the device (which broadly analogous to "training" in AI development):

• For the Device Hardware/Software: Ground truth would have been established through robust engineering principles, use of highly accurate reference temperature sources (e.g., blackbody simulators), and adherence to international standards for thermometer design and performance.
• For the Software: The software verification and validation (V&V) involved ensuring the software met its specifications and handled errors correctly, potentially using defined test cases with expected "ground truth" outputs. The document notes that the software was validated according to the FDA's software guidance and IEC 62304:2015.

In summary, the Vicks® VNT200 No Touch Forehead Thermometer demonstrates adherence to established performance standards for thermometers through a combination of rigorous non-clinical laboratory testing using objective calibrated sources and a clinical study with a sufficient sample size of human subjects. The acceptance criteria are based on recognized international and national standards for medical thermometers.

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The Vicks® VDT972 RapidRead™ Digital Thermometer is a handheld, battery-powered, predictive, digital stick thermometer intended for the intermittent determination of human body temperature orally, rectally, or under the arm, in a home-use environment for people of all ages (infants, children, and adults). It is intended to be used with a single-use, disposable probe cover for all measurements.

The Vicks® VDT972 RapidRead™ Digital Thermometer is a predictive, thermistor-based, stick thermometer capable of measuring oral, axillary, or rectal temperature in 2 to 8 seconds. It is equipped with a site selection button that requires the operator to select the desired measurement site before taking a temperature. For each measurement, it must be used with a commercially-available, single-use, disposable probe cover.

The Vicks® VDT972 RapidRead™ Digital Thermometer is a contact thermometer, using a negative temperature coefficient (NTC) thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes. This change in resistance is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user.

The Vicks® VDT972 RapidRead™ Digital Thermometer does not use a clinical offset algorithm. clinical offset algorithms are typically used to perform a measurement on one physiological site (i.e. the forehead. temple, or ear) and represent what the equivalent measurement would be at a different physiological site (i.e. oral), had the measurement been performed at that site instead. Typically, these formulas account for ambient temperature, at a minimum, in calculating the appropriate offset. Because the Vicks® VDT972 RapidRead™ Digital Thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via the use of a clinical offset.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Vicks® VDT972 RapidRead™ Digital Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Vicks® VDT972 RapidRead™ Digital Thermometer are primarily based on demonstrating substantial equivalence to its predicate devices, especially regarding performance standards like accuracy, and compliance with relevant international standards. The study aimed to show non-inferiority in clinical performance compared to the predicate device and the "Gold Standard" reference device.

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

• Sample Size for Test Set: 165 subjects.
  • Breakdown by age group and measurement site:
    • 0 to 3 months: 13 (Axillary), 16 (Rectal), 0 (Oral) = 29 total

    • 3 to 12 months: 14 (Axillary), 14 (Rectal), 0 (Oral) = 28 total

    • 12 months to 5 years: 30 (Axillary), 28 (Rectal), 0 (Oral) = 58 total

    • 5 to 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total

    • 18 years: 0 (Axillary), 0 (Rectal), 25 (Oral) = 25 total

• Data Provenance: The document does not explicitly state the country of origin. It describes a "multicenter" clinical investigation, implying data collected from multiple locations, likely within the same country given the FDA submission.
• Retrospective or Prospective: The study was a prospective clinical investigation.

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

The ground truth was established by a "Gold Standard" reference device, the Welch Allyn SureTemp® Plus 690 Thermometer. The study methodology describes readings taken with this device. It does not mention human experts directly establishing ground truth for individual temperature readings. The accuracy of the reference device itself is presumed to be established through its own regulatory clearances and accepted metrological standards.

4. Adjudication Method for the Test Set

The document does not detail an adjudication method for disagreements between human readers, as the primary comparison was between devices. Instead, it describes:

• For afebrile subjects and febrile subjects ≥ 5 years of age: 1 reading with the reference thermometer, followed by 3 consecutive readings with the test thermometer, and 3 consecutive readings with the predicate thermometer, at one-minute intervals.
• For febrile subjects < 5 years of age: 1 reading with each of the reference, test, and predicate thermometers, at one-minute intervals.
• The use order of test and predicate thermometers was randomized.
• Test and predicate devices were randomized to eliminate bias.

This approach focuses on direct comparison and statistical analysis of device output rather than clinical adjudication of individual readings by multiple human experts.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This study is for a digital thermometer, which is a standalone measurement device, not an AI-powered diagnostic tool requiring human interpretation.

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

Yes, the core of the evaluation is a standalone performance assessment of the Vicks® VDT972 RapidRead™ Digital Thermometer. The predictive algorithm within the thermometer itself generates the temperature reading. The clinical study directly evaluated the accuracy and repeatability of this device's readings compared to a reference standard and a predicate device, without human intervention in the temperature measurement and display process.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established using an accepted "Gold Standard" reference device: the Welch Allyn SureTemp® Plus 690 Thermometer (510(k) # K030580). This reference device itself has established accuracy specifications, making its measurements the de facto ground truth for this particular study.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the clinical study. For a digital thermometer using a predictive algorithm, the "training" for the algorithm itself would likely occur during its development and calibration by the manufacturer, using a variety of temperature profiles and physiological data. This information is typically proprietary and not included in a 510(k) summary focused on clinical validation. The clinical study described here is primarily a validation study for the finished device.

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

As noted in point 8, the document does not provide details on a specific training set or how its ground truth was established. The "predictive algorithm" in the thermometer is mentioned, implying internal development and calibration, but the methodology for establishing ground truth for that specific algorithm's training is not detailed in this regulatory submission.

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The Braun BNT400 No Touch + Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages.

The Braun BNT400 No Touch + Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead or within one inch of the subject's forehead. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.

Here's an analysis of the provided text regarding the acceptance criteria and the study performed for the Braun BNT400 No Touch + Forehead Thermometer:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Braun No Touch + Forehead NTF3000 Thermometer, K163516). The acceptance criteria are largely based on meeting recognized consensus standards, particularly related to clinical accuracy and safety.

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

• Sample Size: The document states that a "controlled human clinical study was conducted" and tested to "ASTM E1965-98:2016 and ISO 80601-2-56:2017." However, the specific number of subjects/measurements (sample size) for this clinical study is not explicitly provided in the given text.
• Data Provenance: The document only mentions "multi-center, randomized clinical study." It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a clinical study, it would be prospective, but this is not explicitly stated.

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

• Not Applicable. For a clinical thermometer, the ground truth is typically established by comparing the device's readings against established reference temperature measurement methods (like rectal or oral temperatures in a clinical setting) using a standardized protocol outlined in standards like ASTM E1965 or ISO 80601-2-56. There isn't an "expert" consensus in the same way there would be for image interpretation.

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, the assessment of a clinical thermometer's accuracy involves direct comparison to a reference standard, not expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• No. An MRMC study is relevant for diagnostic devices where human readers interpret data (e.g., medical images). This is a clinical thermometer, which is a direct measurement device. Therefore, an MRMC study was not conducted.

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

• Yes, indirectly. The performance evaluation of the thermometer, particularly its clinical accuracy (bias, standard deviation, repeatability), represents the standalone performance of the device. The device is intended for direct temperature measurement, not as an assistive tool for a human.

7. The Type of Ground Truth Used:

• Reference Standard Temperature Measurement. The ground truth for the clinical accuracy study was established by comparing the thermometer's readings against a "reference" measurement, as stipulated by the ASTM E1965-98:2016 and ISO 80601-2-56:2017 standards for clinical thermometers. These standards typically involve comparison to an invasive, highly accurate reference thermometer (e.g., rectal probe) in a controlled clinical setting. The document states "compared to the reference."

8. The Sample Size for the Training Set:

• The document does not mention a training set sample size. Clinical thermometers, especially prior to the widespread use of sophisticated machine learning, are typically designed and calibrated based on engineering principles and validated through clinical testing, rather than "trained" in the machine learning sense. If there are internal algorithms for temperature compensation or conversion, their parameters would be derived from physical models or internal testing, not usually a distinct "training set" as understood in AI/ML contexts.

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

• Not Applicable. (See point 8). If any internal calibration or algorithm tuning occurred, it would have been based on established physical laws and engineering principles, likely utilizing highly controlled laboratory conditions with reference temperature sources. The document does not describe such a process as "training."

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The Braun BFH175 Infrared Forehead Thermometer is a non-sterile, clinical thermometer intended for the intermittent determination of human body temperature in a touch mode using the center of the forehead as the measurement site on people of all ages.

The Braun BFH175 Infrared Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.

The Braun BFH175 Infrared Forehead Thermometer was evaluated through non-clinical and clinical testing.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text for the clinical study. It is referred to as a "controlled human clinical study."
• Data Provenance: The nature of the clinical study (multi-center, randomized) suggests it was a prospective study. The country of origin of the data is not specified.

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

This information is not provided in the document.

4. Adjudication method for the test set

This information is not provided in the document.

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

An MRMC study was not conducted. This device is an infrared thermometer, not an AI-assisted diagnostic tool that would involve human readers.

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

A standalone performance evaluation was done as part of the clinical study, specifically for the device's accuracy (bias, standard deviation, repeatability) against a reference. The device being a thermometer, its primary function is standalone measurement.

7. The type of ground truth used

For the clinical performance, the ground truth was a reference measurement against which the device's bias, standard deviation, and repeatability were compared. The specific nature of this reference is implicitly tied to the ASTM E1965-98:2016 and ISO 80601-2-56:2017 standards, which typically involve highly accurate reference thermometers.

8. The sample size for the training set

The document does not describe a "training set" as would be relevant for machine learning models. The clinical study described is for validation, not training.

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

Not applicable, as there is no mention of a training set for a machine learning model.

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The Braun No Touch + Forehead NTF3000 Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the center of the forehead as the measurement site on people of all ages.

The Braun No Touch + Forehead NTF3000 Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead or within two inches of the subject's forehead.

The Braun No Touch + Forehead NTF3000 Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared proximity sensor for detection of contact or non-contact use and compensation of the temperature reading.

The provided document, a 510(k) summary for the Braun No Touch + Forehead NTF3000 Thermometer, details the device's acceptance criteria and the studies conducted to prove it meets these criteria. Since this is a submission for a medical device (thermometer), the "AI" related questions are not applicable.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

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

The document primarily refers to regulatory and performance standards rather than specific acceptance criteria values in a table. However, in the "Performance Standards" section (pages 6-7), there is a table summarizing non-clinical performance data with "Acceptance Criteria" and "Result."

Table: Non-Clinical Performance Data, Acceptance Criteria, and Results

The document also states the device's accuracy specifications, which can be considered acceptance criteria for temperature measurement:

• Accuracy for body temperature measurement:
  • ± 0.2°C / 0.36°F for 35.0°C to 42.0°C (95.0°F to 107.6°F)
  • ± 0.3°C / 0.54°F for 31.0°C to 35.0°C (87.8°F to 95.0°F)
  • ± 0.3°C / 0.54°F for Above 42.0°C (Above 107.6°F)

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

• Test Set Sample Size: The document mentions a "pivotal clinical study" (page 7) but does not specify the sample size for this clinical study.
• Data Provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state whether the clinical study was retrospective or prospective, but "pivotal clinical study" generally implies a prospective design.

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

• This information is not provided in the document. For a thermometer, "ground truth" would typically refer to highly accurate reference temperature measurements (e.g., from a rectal thermometer or other core body temperature measurement device in a controlled setting) compared against the device's readings, rather than expert consensus on images.

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

• This concept is not applicable to a clinical study for a thermometer, where readings are quantitative and compared against a reference standard. Adjudication methods are typically relevant for subjective assessments, like 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:

• Not applicable. This device is a thermometer, not an AI-assisted diagnostic imaging tool that involves human readers.

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

• Partially applicable/Implied. The non-clinical performance data (pages 6-7) represents standalone device performance under various conditions (electrical safety, EMC, environmental). The clinical accuracy testing also evaluates the device's performance directly against a reference thermometer, which is a standalone assessment of its accuracy.

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

• For the clinical accuracy testing, the ground truth would be reference thermometer measurements (e.g., highly accurate core body temperature readings) from human subjects, as stated by its compliance with "ASTM E1965-98:2009: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." This standard outlines methods for clinical accuracy studies, typically involving comparison to an accepted reference thermometer.

8. The sample size for the training set:

• Not applicable. This device is a traditional electronic thermometer, not an AI/machine learning model that requires a "training set."

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

• Not applicable. As stated above, this device does not use a training set as it's not an AI/ML model.

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The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intented for the intermittent measurement and monitoring of human body temperature by consumers in the home.

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces. The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is meant for intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use environment.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Braun ThermoScan® 3 High Speed Compact Ear Thermometer

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for the clinical accuracy validation test (ASTM E1965 Clause 5.5) or other non-clinical tests. It only states that the tests were completed and passed the requirements of the respective standards.

Given that this is a 510(k) submission for substantial equivalence, clinical data often relies on existing predicate device performance or standards-based testing rather than extensive new clinical trials with large patient cohorts. The "clinical accuracy validation test" passed requirements per ASTM E1965 Clause 5.5, which likely specifies the minimum number of subjects and measurements for clinical accuracy determination of ear thermometers.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, tests like those conforming to ASTM E1965 and ISO 80601-2-56 usually involve prospective testing to generate the required performance data.

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 thermometer, the "ground truth" for temperature measurements is typically established using highly accurate reference thermometers and controlled laboratory conditions, not through expert human assessment in the same way as, for example, image interpretation. The ASTM and ISO standards would dictate the methodology for establishing this reference.

4. Adjudication Method for the Test Set

This is not applicable in the context of this device and testing. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reading) where an expert consensus is needed. For thermometer accuracy, the "truth" is objectively measured against a reference standard.

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 assesses how human performance improves with or without AI assistance, which is irrelevant for a standalone electronic thermometer.

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

The device itself is a standalone algorithm (or rather, an electronic device) that provides temperature readings. The "non-clinical testing" and "clinical accuracy validation test" outlined directly evaluate the performance of this device in its intended standalone function, without human-in-the-loop comparison. It performs the measurement and displays the result directly.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's accuracy is based on objective measurements from reference standards/equipment in laboratory and clinical settings as defined by:

• Laboratory accuracy test: Passed requirements per ISO 80601-2-56 Clause 201.101.2 and ASTM E1965 Clause 5.3.1. This involves comparing the device's readings against highly precise reference temperature sensors under controlled conditions.
• Clinical accuracy validation test: Passed requirements per ASTM E1965 Clause 5.5. This involves comparing the device's readings against established core body temperature reference methods in actual human subjects.

8. The Sample Size for the Training Set

This document describes a medical device (thermometer), not an AI/ML algorithm that requires a "training set" in the conventional sense. The device operates based on fixed physical principles and pre-programmed algorithms. Therefore, the concept of a "training set" for an AI model is not applicable.

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

As established in point 8, there is no "training set" for this device. The physical and software parameters of the thermometer are designed and verified against established engineering and medical standards, not "trained" on data.

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The VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.

The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.

Here's a breakdown of the acceptance criteria and study information for the VDT985US Vicks® SmartTemp™ Thermometer, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample Size and Data Provenance

The document states that a comparison study and clinical repeatability testing were performed on four age groups: 0-12 months, 12 months- <5 years, 5 years- <18 years, and 18 years and older. However, the exact sample size for the test set is not explicitly provided in the furnished text.

The data provenance is implied to be prospective clinical data since it refers to a "clinical comparison study" and "clinical repeatability testing" performed in accordance with ASTM E1112-00(2006) and ASTM E1965. The country of origin of the data is not specified.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method.

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

There is no mention of an MRMC comparative effectiveness study in the provided text. The study described is a comparison study between the test device, a predicate device, and a gold standard reference thermometer.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the VDT985US Vicks® SmartTemp™ Thermometer (test thermometer) was compared directly to a "gold standard" device (Welch Allyn SureTemp® Plus in monitoring mode) and a predicate device (Vicks V966 Thermometer) to assess its clinical accuracy and repeatability. The results reported are for the device's performance itself.

7. Type of Ground Truth Used

The ground truth used was established by a reference device: the Welch Allyn SureTemp® Plus in the monitoring mode (K030580), which is referred to as the "gold standard."

8. Sample Size for the Training Set

The document does not provide information about a training set or its sample size. The study described appears to be a validation/testing study rather than a development study involving specific training data.

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

Since no training set is mentioned, this information is not available in the provided text.

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