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The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use. This product is a non-invasive and re-usable electronic device for multiple patients at home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

The Bluetooth Wearable Thermometer is a contact electronic thermometer using a sensor to measure armpit temperature. The Sensor detects heat and measures the temperature using a resistance that changes with heat. Displays the highest temperature among consecutive temperature readings. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device. This product is in conjunction with the App, and information can be checked through a mobile device. Application Name: H-Health. The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.

The document provided is a 510(k) summary for a medical device, the Fever Garde (Model: HMT-100), a Bluetooth Wearable Thermometer. While it details the device's non-clinical testing and comparison to a predicate device, it does not contain information about a clinical study involving human participants for demonstrating performance against acceptance criteria in the way typically seen for AI/ML-based medical devices or comparative effectiveness studies with human readers.

The document focuses on demonstrating substantial equivalence to a predicate device (Fever Scout™ Continuous Monitoring Thermometer, K181013) through non-clinical performance testing and compliance with various international standards. The "acceptance criteria" here are primarily tied to meeting specific performance parameters verified through laboratory testing and engineering benchmarks, rather than clinical endpoints from a human study.

Given the nature of the device (a thermometer) and the provided document, I will extract information related to the technical performance testing rather than a clinical study in the typical sense of a comparative effectiveness study with human readers assisting AI.

Here's the breakdown of the acceptance criteria and the technical performance testing as described in the document:

Acceptance Criteria and Reported Device Performance

The device's performance acceptance criteria are derived from the applicable standards and internal testing specifications for a clinical electronic thermometer. The document primarily focuses on demonstrating that the device meets these technical specifications and that the differences from the predicate device do not impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical performance and engineering validation tests. There is no mention of a "test set" in the context of a clinical study with human subjects providing data. The tests performed are laboratory-based and include:

• Laboratory Accuracy: Implies a test setup to verify the stated accuracy. No specific sample size (e.g., number of temperature readings or devices tested) is given.
• Time Response (heating/cooling): Likely performed on a few devices in controlled environments. No specific sample size is given.
• Movement Test: Involves observation of alarm behavior during movement. No specific sample size is given.
• Adhesion Test: "The product was attached to the armpit with an adhesive band for 24 hours". It doesn't specify if this was on a human or a simulated armpit, or how many "products" or "armpits" were tested.
• Monitoring Distance Test: "product and mobile device were not disconnected for all participants." This suggests human participants, but the number of participants is not specified.
• Data Transfer Test: "body temperature data was transmitted to all participants." Again, suggests human participants, but the number is not specified.

The provenance of this data is from the manufacturer's (HuBDIC Co., Ltd.) internal testing, which would be prospective for the purpose of this submission. The origin is implied to be where the testing labs are located (e.g., Korea, given the manufacturer's address).

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

Not applicable in the context of this 510(k) summary. The document describes engineering and laboratory performance tests, not a clinical study where expert consensus establishes ground truth for medical image interpretation or diagnosis. The "ground truth" for the technical tests would be established by calibrated reference standards (e.g., precise temperature sources, timers).

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as would be used in a clinical study with multiple human reviewers.

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

No. This document does not refer to an MRMC comparative effectiveness study. The device is a thermometer, and the submission is for substantial equivalence to a predicate, not for demonstrating improved diagnostic performance for human readers using AI assistance.

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

The device is a measurement device. Its core function is to measure temperature. The "performance" described is its standalone performance (e.g., accuracy, response time, signal transmission). There's no complex algorithm for interpretation or diagnosis that would typically be evaluated with a separate "standalone" study in the context of AI/ML.

7. The Type of Ground Truth Used

For the technical performance tests:

• Laboratory Accuracy: Likely against a calibrated reference thermometer or temperature bath.
• Biocompatibility: In vitro and in vivo laboratory assays following ISO standards.
• Electrical Safety & EMC: Compliance with international safety and electromagnetic compatibility standards, typically verified through measurements against defined limits.
• Software/Cybersecurity: Verification against established software development lifecycle (SDLC) processes, requirements, and industry best practices.
• Functional tests (Display, Charging, Communication, etc.): Verification against documented functional requirements.

There is no mention of "expert consensus," "pathology," or "outcomes data" as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional electronic thermometer. It does not employ machine learning or AI that would require a "training set" of data.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.

The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.

Here's a breakdown of the acceptance criteria and study information for the Non-Contact Infrared Thermometer, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the accuracy specifications, which are implicitly the performance requirements for the device. The reported device performance is presented as its specifications. Since this is a 510(k) submission where the device is effectively the same as its predicate, the performance criteria are met by demonstrating the device has these specifications.

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

The document does not specify a separate "test set" or a sample size beyond stating that the device "has been manufactured and tested to meet" the listed standards. This implies that the testing for these specifications was conducted, but the details of how many units were tested or what specific individuals were tested on are not provided.

The provenance of this data is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned for any clinical testing. The core argument for substantial equivalence relies on the fact that the device is "exactly same as its predicate device (K101912)", meaning its performance is considered equivalent to the predicate's established performance.

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

This information is not provided in the document. Given that this is a thermometer and the key performance metrics are accuracy against defined temperature ranges, it's highly probable that ground truth would be established using NIST-traceable reference thermometers or controlled temperature environments, rather than expert human interpretation in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, the nature of thermometer testing typically involves direct measurement comparisons, not expert adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for image-based diagnostic devices where human readers interpret results, comparing their performance with and without AI assistance. This is not applicable to a non-contact infrared thermometer.

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

The device itself is a standalone measurement device with no explicit "algorithm" in the sense of a complex AI or diagnostic algorithm that would require a separate standalone performance study. Its performance as an independent device is described by its accuracy specifications. The device includes a "calculation that factors in room temperature," but this is a standard engineering control, not an AI algorithm requiring a standalone study in the context of device approval.

7. The Type of Ground Truth Used

The ground truth used for verifying the accuracy of a non-contact infrared thermometer would typically be established by controlled laboratory conditions using calibrated reference thermometers (e.g., fluid baths, blackbody simulators) and/or potentially comparison with invasive core body temperature measurements in clinical studies. The document does not explicitly state the specific method of ground truth establishment, but it refers to meeting specific accuracy claims.

8. The Sample Size for the Training Set

No training set is referenced or relevant to this device. This device is a hardware measurement tool, not an AI/ML model that requires training data.

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

Not applicable, as there is no training set for this device.

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The Infrared Forehead Thermometer, FS-300&301 is intended for intermittent measurement of human body temperature in people of all ages.

The Infrared Forehead Thermometer, Modelfype FS-300&301 is an electronic thermometer using an infrared i sensor (thermopile) to measure forehead temperature, then get a reading and display it on the LCD. Its operation is based on measuring the natural thermal radiation emanating from the forehead and the adjacent surfaces. This product is an Infrared Forehead Thermometer with measuring room temperature and relative humidity.

The provided 510(k) summary for "The Infrared Forehead Thermometer, FS-300&301" does not contain detailed information regarding specific acceptance criteria, a dedicated clinical study with defined performance metrics, or the other requested points (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

The summary primarily focuses on:

• Substantial Equivalence: Stating that "The performance tests demonstrated that The Infrared Forehead Thermometer. FS-3008301 is as safe, as effective and performs in a substantially equivalent manner to the predicate device."
• Compliance with Standards: Mentioning compliance with IEC 60601-1 and IEC 60601-1-2 for safety and electromagnetic compatibility.
• Technological Characteristics: Describing how it measures temperature (5,000 times in one second, displays highest temperature, scans forehead to temple).

Without specific acceptance criteria and detailed study results in the provided document, the requested table and information cannot be fully populated.

However, based on the provided text, here's what can be extracted and inferred:

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

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

• This information is not provided in the summary. The summary refers to "performance tests" in a general sense without detailing the specifics of these tests, including sample size or data provenance.

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 provided. The summary does not mention any expert involvement for establishing ground truth. For a thermometer, "ground truth" would typically refer to a consensus reference temperature measurement (e.g., from a rectal or oral thermometer), not expert interpretation.

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

• This information is not provided. Adjudication methods are typically relevant for subjective assessments, which are not applicable to measuring temperature with a device like this.

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 applicable. The device is a standalone temperature measurement device, not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

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

• Yes, implicitly. As a clinical electronic thermometer, its "performance" is inherently standalone. The summary states "The Infrared Forehead Thermometer... has been manufactured and tested to meet the safety requirements of IEC" and "The performance tests demonstrated that The Infrared Forehead Thermometer... is as safe, as effective and performs in a substantially equivalent manner to the predicate device." This implies standalone testing of the device's accuracy and safety without human interpretation of its readings, beyond simply taking the measurement.

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

• This information is not explicitly stated, but for a clinical thermometer, the ground truth for performance testing would typically be established by comparison to a highly accurate reference thermometer (e.g., a calibrated mercury-in-glass thermometer or a highly precise electronic rectal/oral thermometer).

8. The sample size for the training set

• This information is not provided. This device is a traditional electronic thermometer, not an AI/ML device, so the concept of a "training set" in the context of machine learning does not apply.

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

• This information is not provided and is not applicable, as this is not an AI/ML device requiring a training set.

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The Duo-Max Blood pressure and Glucose Monitor, Model HMF-100 consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric metric method of measurement.

The Blood pressure and glucose monitor. Duo-Max™ consists of a meter with wrist cuff and glucose test strips. The glucose test system is intended for use in the quantitative measurement of glucose in capillary whole blood taken from the fingertip, dorsal hand, ventral palm, upper arm, forearm, calf and thigh. Glucose testing is done outside the body (In Vitro diabetes mellitus, or in clinical settings by healthcare professionals. Glucose testing system is not to be used for the diagnosis or screening of diabetes. It is not intended for use on neonates. Also the blood pressure test system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillomentric metric method of measurement.

HuBDIC's Duo- Max Blood Pressure and Glucose Monitor System, Model HMF-100 combines the function of a blood pressure meter and a blood glucose monitoring system in one unit. Supplies with the meter are test strips, lancets, Lancing device, storage case, batteries and log book.

HMF-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface pane has power switch, timer switch, memory switch for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 180 most recent measurement results.

The provided text describes a medical device called the "Duo-Max Blood Pressure and Glucose Monitor, Model HMF-100" and its 510(k) submission. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested.

The document primarily focuses on:

• Device Description: What the device is and its components.
• Intended Use: For whom and how the device is to be used (blood pressure and glucose monitoring).
• Comparison to Predicate Device: Highlighting similarities and minor physical differences (dimensions, weight, memory capacity) with an existing device (Sein BGP-100).
• Standards Conformance: Stating that the device "conforms to applicable standards including ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements" and "met all relevant requirements of the aforementioned tests." This implies that the device achieved performance in line with these standards, but the specific numerical acceptance criteria or test results are not provided in this summary.
• Conclusion of Substantial Equivalence: The manufacturer's assertion that the device is as safe and effective as predicate devices.
• FDA Clearance Letter: Confirming the FDA's decision that the device is substantially equivalent.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Explanation: The document states the device "conforms to applicable standards including ANSI/AAMI SP-10, IEC 60601-1 and IEC 60601-1-2 requirements" and "met all relevant requirements of the aforementioned tests." However, it does not explicitly list the numerical acceptance criteria from these standards or provide the specific numerical results of the device's performance against those criteria. It only makes a general statement of compliance.

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

• Not provided. The summary mentions "performance testing results" but does not detail the sample size (number of participants or measurements), the nature of the study (retrospective or prospective), or the data provenance.

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. For a blood pressure and glucose monitor, the ground truth is typically established by comparing the device readings to a reference method (e.g., a clinically validated sphygmomanometer for BP, or a laboratory analyzer for glucose). This does not involve human expert consensus in the same way as image interpretation. The document does not describe how ground truth was established, beyond implying comparison to reference methods as part of standardized testing.

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

• Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective assessment (e.g., medical image interpretation by multiple readers). For an objective measurement device like this, ground truth is established by a reference method, not by expert adjudication.

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 direct measurement tool (blood pressure and glucose monitor), not an AI-powered diagnostic imaging tool that assists human readers. Therefore, an MRMC study or AI assistance is not relevant to this product.

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

• Not applicable for "algorithm only" in the typical sense. The device itself is a standalone system for measurement. The performance described "met all relevant requirements of the aforementioned tests," implying that the device was tested as a complete system (hardware and internal algorithms) without human intervention in the measurement process itself. However, it's not an "algorithm only" study in the context of AI models.

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

• Implicitly Reference Methods. For blood pressure, the ground truth would typically be established using a carefully calibrated and validated reference sphygmomanometer (e.g., mercury or an oscillometric device that has passed a higher level of validation). For blood glucose, the ground truth would be established by laboratory-grade glucose analyzers. The document does not explicitly state this, but it is standard practice for validating such devices.

8. The sample size for the training set

• Not applicable / Not provided. As this is a traditional medical device for objective measurement (not an AI/machine learning model in the usual sense that requires a "training set"), the concept of a training set as understood in AI development does not apply here. The device's internal algorithms for measurement are likely developed through engineering and calibration, not statistical training on a dataset.

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

• Not applicable / Not provided. See explanation for question 8.

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This device is an electronic clinical thermometer using an infrared sensor to detect body temperature over the temporal artery on the forehead. It is intended for people of all ages.

hand held, battery operated device that measures the skin temperature of the skin over the temporal artery. Operation is based on measuring the natural thermal infrared radiation emitted from the surface of the skin over the temporal artery.

The provided text is a 510(k) summary for the Digital Forehead Thermometer FS-100, which is seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

Crucially, the document provided does not contain a study or data proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device, or for a device requiring more rigorous validation.

Instead, the provided text relies on demonstrating substantial equivalence to a predicate device (Exergen Corporation's Temporal Scanner Thermometer K 011291). The assessment of substantial equivalence involves comparing the new device's technological characteristics, intended use, and materials to a predicate, to argue that it raises no new questions of safety and effectiveness.

Therefore, the requested information elements related to detailed study results, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not present in this document because the regulatory pathway chosen (510(k) for substantial equivalence) typically focuses on comparative analysis rather than extensive de novo clinical trials with detailed performance metrics and acceptance criteria in the context implied by your questions.

However, based on the information provided, I can infer some aspects relevant to your request regarding the basis for acceptance as described in the 510(k) process:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim):

The acceptance criteria for the Digital Forehead Thermometer FS-100, as understood within the 510(k) framework, are that its technological characteristics, intended use, and general design are sufficiently similar to a legally marketed predicate device such that it raises no new questions of safety and effectiveness.

Since no specific performance data or a formal study with statistical acceptance criteria is detailed for the device itself in this submission, I cannot populate a table with "reported device performance." The "performance" being evaluated implicitly is its ability to meet the same intended use as the predicate device without introducing new risks.

Study Information (Based on the provided K093331/K043331 document):

Given the nature of a 510(k) summary for a thermometer seeking substantial equivalence, information typically associated with complex clinical studies for novel diagnostic or treatment devices is not present. The "study" here is primarily a comparative analysis against a predicate device, as described in the 510(k) submission.

• 1. Table of Acceptance Criteria and Reported Device Performance: Already addressed above. Specific quantitative performance data (e.g., accuracy, precision) for the FS-100 are not provided in this document. The "performance" is implicitly deemed equivalent to the predicate.

• 2. Sample size used for the test set and the data provenance: Not applicable/Not provided. This document does not describe a test set with a specific sample size in the context of performance metrics for the FS-100. The comparison is against the established characteristics of the predicate device.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment by experts for a test set is not detailed as part of this substantial equivalence claim.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. Adjudication methods are not described in this regulatory submission.

• 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 digital forehead 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: Not applicable. While the thermometer operates without human interpretive input for temperature readings, the detailed performance of the underlying "algorithm" (i.e., the infrared sensing and processing) is not independently evaluated and reported in this document beyond the claim of substantial equivalence.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided in the context of a specific study for the FS-100. For a thermometer, "ground truth" would typically involve highly accurate reference temperature measurements, but no such study is detailed here.

• 8. The sample size for the training set: Not applicable/Not provided. This device is not described as involving machine learning or AI that would require a "training set."

• 9. How the ground truth for the training set was established: Not applicable/Not provided. As there's no described training set, this question is not relevant to the provided text.

Summary of the "Study" (or Basis for Acceptance) from the Document:

The "study" in this context is the 510(k) premarket notification process, where the manufacturer (Hubdic Company Limited, via Media Trade Corporation) submitted an application to the FDA. The core of this submission, as summarized, is a comparative analysis demonstrating that the Digital Forehead Thermometer FS-100 is:

• Intended Use: Identical to the predicate device (intermittent measurement of human body temperature of people of all ages).
• Technological Characteristics: Based on the same principles (measuring natural thermal infrared radiation from the temporal artery).
• General Design: Similar general design and performance characteristics, with main differences being physical size, shape, and weight (which are not considered to impact safety or effectiveness negatively for this type of device).
• Materials and Components: Incorporates similar materials and components.

The conclusion is that these similarities mean the device "should therefore raise no new questions of safety and effectiveness." The FDA's review of this submission resulted in a substantial equivalence determination, allowing the device to be marketed. This regulatory approval itself serves as the "proof" that the device is deemed to meet the necessary criteria for market entry based on the chosen regulatory pathway.

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This 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 at home.

The Thermo Buddy Ear Thermometer is a hand held instrument that measures body temperature through the opening of the auditory canal. Operation is based on measuring the natural thermal radiation emitted from the tympanic membrane and adjacent surfaces.

The provided document is a 510(k) premarket notification for the "Thermo Buddy Ear Thermometer, Model TB-100." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials to establish acceptance criteria and device performance in the same way a PMA (Premarket Approval) would.

Therefore, the document does not contain the information requested regarding acceptance criteria and the detailed study that proves the device meets those criteria, as typically found in clinical efficacy studies. The information provided primarily asserts the device's technological characteristics and intended use are similar to predicate devices.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance derived from a study on the device itself.
• Sample sizes used for a test set, data provenance, number of experts for ground truth, or adjudication methods for a specific study conducted for this device.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with AI.
• Details on a standalone algorithm performance study.
• The type of ground truth used, sample size for training, or how ground truth was established for a training set.

The summary states: "The Thermo Buddy Ear Thermometer has the same general design and performance characteristics as the predicate devices from Braun and Omron. The main difference is the physical size, shape and weight. The Thermo Buddy Ear Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness. This submitter concludes that the Thermo Buddy Thermometer is therefore substantially equivalent to the predicate devices 'Braun Thermoscan IRT3020' and the 'Omron Gentletemp Instant Ear Thermometer MC-509'."

This indicates that the "proof" of meeting acceptance criteria is through demonstrating equivalence to already approved predicate devices, rather than through an independent clinical study that would generate the specific data points requested in your prompt.

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