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510(k) Data Aggregation
(389 days)
Guangzhou Berrcom Medical Device Co., Ltd.
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
The basic principle of Digital Thermometer is that a change in thermistor resistance is caused by a change in temperature. The device measure body temperature by using a direct mode. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance. And the temperature value is displayed on the LCD screen. The device can be used for axillary, oral in the home, and used for axillary, oral and rectal temperature measurement in the hospital. The device is reusable and provided non-sterile. The device is intended for use on people of all ages. The probe cover is required when measuring the oral or rectal temperature, but not when measuring the axillary temperature.
The Digital Thermometer includes two models: DT007 and DT008. The differences of these two models are in appearance, PCB layout, external dimension and weight. All of them have the same function and they have the following basic functions:
- Data displayed on LCD
- Automatic stop (energy saver)
- Small, convenient, easy to use
The provided text describes the acceptance criteria and a study for a Digital Thermometer (Models DT007, DT008). Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are generally implied by conformity to specific standards and the stated "Measuring Accuracy". The reported device performance is presented in the comparison table with the predicate device and the non-clinical test summary.
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Subject Device) |
|---|---|
| Measuring Accuracy: To meet requirements of ASTM E1112 and ISO 80601-2-56. | * $32.0^\circ C \sim 35.9^\circ C \pm 0.2^\circ C$ |
| * $36.0^\circ C \sim 39.0^\circ C \pm 0.1^\circ C$ | |
| * $39.1^\circ C \sim 42.9^\circ C \pm 0.2^\circ C$ | |
| Electromagnetic Compatibility & Electrical Safety: Compliance with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11. | Tested in compliance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. |
| Biocompatibility: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 for human body contacting material. | Same human body contacting material as cleared device K163603; safety demonstrated in K163603 submission, complying with ISO 10993-1, ISO 10993-5 and ISO 10993-10. |
| General Performance: Compliance with ISO 80601-2-56 and ASTM E1112 for body temperature measurement. | Tested in compliance with ISO 80601-2-56:2017+A1:2018 and ASTM E1112-00 (Reapproved 2011). |
| Software Verification: Compliance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" (May 11, 2005). | Software documentation provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued May 11, 2005. |
| Operating Environment Condition: Ambient temperature, relative humidity, pressure altitude. | Ambient temperature: $5^\circ C \sim 40^\circ C$ ($41^\circ F \sim 104^\circ F$); Relative humidity: $\le 85%$; Pressure altitude: 700hPa to 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Storage Condition: Storage temperature, storage humidity, pressure altitude. | Storage temperature: $-20^\circ C \sim 55^\circ C$ ($-4^\circ F \sim 131^\circ F$); Storage humidity: $\le 95%$; Pressure altitude: 700hPa $\sim$ 1060hPa. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Response Time: Sufficient response time for temperature measurement. | 30s. (Passed performance tests; no adverse impact on safety/effectiveness) |
| Auto-off Time: Sufficient for intended use. | 10 mins. (Sufficient for intended user to obtain temperature data; no adverse impact on safety/effectiveness) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance test" against standards like ASTM E1112 and ISO 80601-2-56. These typically involve rigorous testing of multiple units under controlled conditions. However, the specific sample size of devices tested and the number of measurements taken for these performance tests are not explicitly stated in the provided text. The document also does not provide details on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the device is a digital thermometer, and the "ground truth" for temperature measurements is established against traceable reference standards and methods as defined by the performance standards (e.g., ASTM E1112, ISO 80601-2-56), not by human expert consensus or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for a digital thermometer as its performance is objectively measured against physical standards, not through expert adjudication of subjective interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable as the device is a digital thermometer and does not involve AI assistance or human reader interpretation for its primary function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a digital thermometer in the context of diagnostic AI algorithms. The device itself is solely responsible for measuring temperature, and its performance is evaluated in a "standalone" manner (i.e., the device itself without human intervention affecting the measurement accuracy).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluation of the digital thermometer is based on established metrological standards and reference temperatures as outlined in the technical standards ASTM E1112 and ISO 80601-2-56. These standards define the acceptable deviation from a true reference temperature.
8. The sample size for the training set
This information is not applicable as the digital thermometer is a hardware device with embedded firmware for measurement, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as #8.
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(127 days)
Guangzhou Berrcom Medical Device Co., Ltd.
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(155 days)
Guangzhou Berrcom Medical Device Co., Ltd.
The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.
The Ear Thermometers are a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.
The Berrcom Ear Thermometer (models ET005, ET008, ET009) underwent a clinical accuracy validation to demonstrate its performance. The study followed ISO 80601-2-56:2017+AMD2018.
1. Acceptance Criteria and Reported Device Performance:
The document explicitly states that the clinical validation results demonstrated that "the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol." However, the specific numerical acceptance criteria (e.g., maximum allowable bias or repeatability) are not provided in the submitted text. Therefore, the table below reflects what is stated in the document regarding meeting the criteria, but the exact values for the criteria cannot be extracted.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance |
|---|---|---|
| Clinical Bias | (Not explicitly stated, but met) | Met acceptance criteria |
| Clinical Repeatability | (Not explicitly stated, but met) | Met acceptance criteria |
The document also provides measurement accuracy specifications which act as performance criteria:
| Temperature Range | Performance Criteria |
|---|---|
| Ear & Forehead: 32.0°C ~ 34.9°C (89.6°F ~ 94.8°F) | ± 0.3°C (± 0.5°F) |
| Ear & Forehead: 35.0°C ~ 42.0°C (95°F ~ 107.6°F) | ± 0.2°C (± 0.4°F) |
| Ear & Forehead: 42.1°C ~ 43.0°C (107.8°F ~ 109.4°F) | ± 0.3°C (± 0.5°F) |
| The document does not explicitly state that these criteria were tested during the clinical accuracy validation for individual subjects. Instead, it states the overall clinical bias and clinical repeatability met the acceptance criteria. |
2. Sample Size and Data Provenance:
- Sample Size: 150 subjects. This included:
- 50 infants (newborn to one year)
- 50 children (greater than one to five years)
- 50 adults (greater than five years old)
- Data Provenance: The document does not specify the country of origin of the data. It mentions "clinical investigation," which implies a prospective study.
3. Number of Experts and Qualifications:
The document does not provide information regarding the involvement of experts to establish ground truth, nor their qualifications.
4. Adjudication Method:
The document does not provide information regarding any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study focuses on the accuracy of a single device against a ground truth, not on the improvement of human readers with AI assistance.
6. Standalone Performance:
Yes, a standalone performance study was done. The "Clinical accuracy validation" described is a test of the device's accuracy in measuring body temperature.
7. Type of Ground Truth Used:
The document refers to "clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol." While it implies a comparison to a referent temperature measurement standard (which would constitute the ground truth), the specific method for establishing this ground truth (e.g., rectal thermometer, oral thermometer, etc.) is not explicitly stated. However, given the context of clinical thermometry standards, it is highly likely a validated reference thermometer was used.
8. Sample Size for Training Set:
The document does not provide information about a training set since this is a medical device validation (Ear Thermometer), not an AI/machine learning model that typically has a training set.
9. How Ground Truth for Training Set was Established:
Not applicable, as no training set is mentioned for this device.
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(148 days)
Guangzhou Berrcom Medical Device Co., Ltd.
The Ear Thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It is a non-contact method for forehead measurement, the recommended measurement distance is 0cm. The Ear Thermometer can be used by consumers in the household environment and by healthcare providers.
The Ear Thermometer, model of ET001 is a hand-held, battery powered infrared thermometer. It is intended to measure the temperature of human body from ear or forehead. The infrared sensor contained in the device can monitor the energy radiated from the human ear tympanum and forehead. The device can analyze and processes the signal transmitted by the infrared sensor, and finally displays it on the screen in digital form to achieve the measurement of human body temperature. People of all ages in household environment and doctors in clinic as reference are suitable for using the device.
It has the following features:
- Forehead and ear temperature measurement.
- Fahrenheit and Celsius temperature unit setting.
- Display resolution is 0.1°C (0.1°F);
- Memorize the latest 10 measurement data;
- Three color backlight display (red, orange, green)
- Low battery indication.
- Prompt for Measurement completion.
- Buzzer feature setting (mute or unmute)
- Turn off automatically after 75 seconds of inactivity.
The provided text describes the clinical accuracy validation for the Berrcom Ear Thermometer, Model ET001. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the clinical accuracy validation was conducted according to ISO 80601-2-56:2017+AMD2018. This standard defines the performance requirements for clinical thermometers, including accuracy. While the specific numerical acceptance criteria (e.g., maximum allowable bias, standard deviation of clinical repeatability) are not explicitly listed in the table provided in the input, the text clearly states:
"The clinical validation results demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol."
Therefore, the reported device performance is that it meets the acceptance criteria for clinical bias and clinical repeatability as defined by ISO 80601-2-56:2017+AMD2018.
| Metric | Acceptance Criteria (from ISO 80601-2-56:2017+AMD2018) | Reported Device Performance |
|---|---|---|
| Clinical Bias | (Not explicitly listed in the document) | Met the acceptance criteria |
| Clinical Repeatability | (Not explicitly listed in the document) | Met the acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 subjects
- 50 infants (newborn to one year)
- 50 children (greater than one to five years)
- 50 adults (greater than five years old)
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical study" and "clinical investigation," implying prospective data collection specifically for this validation.
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. The text only mentions "clinical accuracy validation was conducted in according to ISO 80601-2-56:2017+AMD2018" and doesn't detail the role or number of experts for ground truth establishment. Clinical thermometers typically use a reference thermometry method (e.g., rectal or oral core temperature measurement) as ground truth, rather than expert consensus on images.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically relevant for studies involving human interpretation (e.g., imaging studies) where disagreements among readers need to be resolved. For clinical thermometer accuracy, the ground truth is established by a reference thermometer, not by interpretation requiring 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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers (e.g., radiologists) use AI to improve their performance. The device here is a standalone thermometer, not an AI diagnostic assistant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The "Clinical Accuracy Validation" described for the Ear Thermometer, Model ET001, demonstrates the device's accuracy in measuring body temperature directly, without human interpretation for the measurement itself. The device is a direct measurement tool, not an algorithm assisting human interpretation.
7. The Type of Ground Truth Used
The ground truth used for clinical accuracy validation of a clinical thermometer is typically a reference temperature measurement obtained through a highly accurate and validated method (e.g., rectal, oral, or arterial core temperature) according to the standards like ISO 80601-2-56. The document mentions "represented by clinical bias and clinical repeatability," which are calculated by comparing the device's readings to such a reference.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Ear Thermometer is a hardware device based on infrared radiation detection and signal processing, not a machine learning or AI model that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable. As stated above, the device does not use a "training set" in the context of machine learning. Its performance relies on the design, calibration, and physical principles of thermometry.
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(127 days)
Guangzhou Berrcom Medical Device Co., Ltd.
The Non-Contact Infrared Thermometer, Models JXB-315, JXB-320, JXB-311, is a non-sterile, reusable, handheld device. It can be used by consumers in household environment and doctor in clinic as reference. It is intended for non-contact measuring of human body temperature of people of all ages (neonate, infant, pediatric, adult) by detecting infrared heat from the center of the forehead.
The Non-contact Infrared Thermometer (include models JXB-315, JXB-320, JXB-311) is a hand-held forehead thermometer, and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature of human body which measures the body temperature based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages. The thermometer is also intended to measure the object temperature. After measurement, the temperature is directly displayed on the LED screen. These thermometers have the following features: 1) Body temperature mode 2) Fahrenheit and Celsius temperature unit setting LED display screen with automatic range selection, resolution is 0.1 degree Celsius (0.1 degree Fahrenheit) 3) 4) Memorize the latest 32 measurement data LED display screen 5) 6) Low battery indication 7) Measurement distance indication 8) Over range prompt (HI/LO) 9) Auto shutdown when the device is idle for 30 seconds 10) High temperature indication
The provided document describes the acceptance criteria and a clinical study conducted for the Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with specific standards for measurement accuracy rather than explicitly stating numerical acceptance criteria. However, it does compare the subject device's declared accuracy with the predicate device and relevant standards.
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Subject Device) |
|---|---|
| Measurement Accuracy (Body Temperature Mode): ASTM E1965-98 and ISO 80601-2-56 standards (range-specific accuracies) | Within the range of $34.0°C$ to $43.0°C$, the accuracy is the same as the predicate device ($±0.2°C$ for $35.0°C-42.0°C$, $±0.3°C$ for edges). For $32.0°C-34.9°C$, it is $±0.3°C$. Verified to comply with ASTM E1965-98 and ISO 80601-2-56. |
| Clinical Accuracy (Clinical Bias and Repeatability): Acceptance criteria of the clinical validation protocol based on ISO 80601-2-56:2017+AMD2018. | Clinical bias and clinical repeatability met the acceptance criteria of the clinical validation protocol. |
| Electromagnetic Compatibility (EMC): IEC 60601-1-2:2014 | Passed |
| Electrical Safety: ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, IEC 60601-1-11:2015 | Passed |
| Biocompatibility: ISO 10993-5:2009 (in vitro cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization) | Passed (demonstrated no potential toxicity, skin sensitization, and skin irritation) |
| Software Verification and Validation: Consistent with moderate level of concern. All software requirement specifications met, and hazards mitigated. | Passed |
2. Sample size used for the test set and the data provenance
- Sample Size: 150 subjects for the clinical accuracy validation.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is described as a "clinical investigation," which implies prospective data collection for the purpose of the validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study.
4. Adjudication method for the test set
The document does not specify an adjudication method for the test set.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a standalone thermometer, and the study focused on its accuracy in measuring body temperature, not on assisting human readers with interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the device itself to measure its accuracy against established standards. The section "Clinical Accuracy Validation" specifically details how the device's readings were validated against clinical ground truth.
7. The type of ground truth used
The ground truth for the clinical accuracy validation was based on clinical measurements performed on subjects, implicitly alongside a reference method (though the reference method is not explicitly named, it's standard practice in such studies to compare against a highly accurate clinical thermometer). The study assessed "clinical bias and clinical repeatability" against this ground truth.
8. The sample size for the training set
The document does not mention a training set because this is a hardware medical device (a thermometer), not an AI/machine learning algorithm that typically requires a distinct training phase.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for this hardware device.
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(153 days)
Guangzhou Berrcom Medical Device Co., Ltd.
The infrared thermometer is intended for the intermittent measurement of body temperature from the auditory canal or central forehead skin surface on people of all ages. It can be used by consumers in the household environment and by healthcare providers.
The Infrared Thermometer, Model MD-H30 is an electronic thermometer using an infrared sensor (thermopile) to detect body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead. To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's central forehead. Pressing the activation button (for ear or forehead) to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.
The provided text is related to the FDA 510(k) premarket notification for an Infrared Thermometer (Model MD-H30). This document focuses on demonstrating that the device is "substantially equivalent" to a legally marketed predicate device, rather than providing a detailed clinical study report with the typical elements of acceptance criteria and performance data for an AI/ML medical device.
Key takeaway: This document describes a medical thermometer, not an AI/ML device. Therefore, many of the questions regarding AI/ML specific criteria (e.g., training set, expert adjudication, MRMC study, standalone performance) are not applicable to the information contained here.
However, I can extract the relevant information concerning the device's accuracy and the validation study performed:
Acceptance Criteria and Reported Device Performance
Given that this is a non-AI/ML device (an infrared thermometer), the "acceptance criteria" primarily revolve around its stated accuracy specifications and compliance with relevant performance standards for thermometers.
Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (Standard Specification) | Reported Device Performance (as demonstrated by compliance) |
|---|---|---|
| Measurement Accuracy | ± 0.4°F (0.2°C) within 95 | Demonstrated to meet this accuracy specification. (Stated as "Same" as predicate, which has this spec) |
| ± 0.5°F (0.3°C) for other range | Demonstrated to meet this accuracy specification. (Stated as "Same" as predicate, which has this spec) | |
| Measurement Range | Meets requirements of ISO80601-2-56 and ASTM E1965-98 (Predicate range: 34 | Proposed Device Range: 32.0-43°C (89.6-109.4°F). This wider range is noted as "Similar" and stated to meet the requirements of ISO80601-2-56 and ASTM E1965-98, not raising different safety and effectiveness issues. |
| Compliance with Standards | ASTM E 1965-98, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-56 | Confirmed compliance with all listed standards through non-clinical tests. |
| Biocompatibility | Compliance with ISO 10993-5 and ISO 10993-10 for skin-contacting components (ABS material) | Biocompatibility tested and found compliant with ISO 10993-5 and ISO 10993-10. |
| Electrical Safety | Compliance with requirements for electrical safety (implied by IEC standards and battery difference note) | Demonstrated to comply with electrical safety requirements. |
| Cleaning and Disinfection | Validation of reprocessing according to Instructions for Use for a non-sterile device | Cleaning validation performed according to IFU. |
| Clinical Accuracy Validation | Clinical investigation report and data analysis to meet the requirements of ASTM E 1965-98 for acceptable temperature readings compared to a digital thermometer. | The test report shows the three group's temperature readings difference between digital thermometer and the subject device, MD-H30 are within acceptable range. "It can conclude that the Infrared Thermometer, Model MD-H30 is acceptable to measure human body's temperature." |
Study Details (Focusing on a non-AI/ML device)
-
Sample size used for the test set and the data provenance:
- The document states, "The clinical investigation report and data analysis met the requirements of the ASTM E 1965-98."
- It mentions "the three group's temperature readings." However, the exact sample size (number of subjects or measurements) for this clinical accuracy validation is not provided in the submitted text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information would typically be in the full clinical study report, which is not provided here. The manufacturer is based in China, so it's plausible the study was conducted there.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of an infrared thermometer. Ground truth for temperature measurement would be established by a reference thermometer or standard. The document mentions comparison to a "digital thermometer."
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is a device for direct physical measurement, not an interpretative AI/ML system.
-
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 is not an AI-assisted device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone physical device. Its performance is its direct measurement output.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the clinical accuracy validation was established by comparison to a "digital thermometer." For thermometer validation, this typically refers to a highly accurate reference thermometer, often using a controlled environment or comparing against an established method (e.g., rectal temperature for core body temperature, depending on the standard).
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a 510(k) summary for an infrared thermometer, focusing on its substantial equivalence to a predicate device based on its design, intended use, and performance against established non-clinical and clinical (accuracy) standards for medical thermometers. It does not contain the detailed information typically found in a clinical study report for an AI/ML-driven medical device.
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