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Infrared Forehead Thermometers (model2: JA-11S; model3: JA-11C) are non-sterile, reusable, noncontact and handheld devices. They can be used by consumers in homecare environment and doctors in clinic as reference. They are intended for measuring human body temperature of people over one month old by detecting infrared heat from the forehead.

Infrared Forehead Thermometers (model1: JA-11A; model2: JA-11S; model3: JA-11C) are hand-held, battery powered, Infrared Forehead Thermometers that covert a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead to an equivalent temperature when measuring from 1-3 cm of the subject's forehead with no contact.

It is composed of a probe, a display, two buttons (start button and power button), an enclosure and a battery cover.

It is used to measure human body temperature based on the relationship between temperature and measurable infrared radiation. Simply aim the unit's probe toward the surface to be measured to obtain a quick and accurate temperature.

When measuring body temperature, users need to measure in body mode from 1-3 cm from their forehead. Press the measuring key and then release it. The instrument will start measuring the target temperature. After about 1 second, the buzzer emits the corresponding alert sound, the measurement result is displayed on the LCD, and the backlight of the corresponding color is turned on. After about 3 seconds, the backlight is turned off, the unit symbol flashes, and the buzzer beeps shortly. Wait until the key is pressed to measure the temperature again. Start the thermometer without any operation, or no operation after temperature measurement, the thermometer will shut off and LCD go out with one short beep in 60 s ± 20 s.

It can store 32 sets of measurements. Press the 【M】button to cycle through them.

User contact components are the enclosure and keys. The materials of the components are ABS plastic.

The thermometer is for intermittent use.

The provided text describes information about an Infrared Forehead Thermometer (models: JA-11A, JA-11S, JA-11C) and its substantial equivalence submission to the FDA. The information focuses on the device's technical specifications, comparison to a predicate device, and the standards it conforms to for safety and effectiveness.

However, the document does not provide details about a study that proves the device meets specific acceptance criteria in the context of AI/machine learning performance, which is implied by several of your questions (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)"). This is a medical device clearance, not an AI/ML software clearance.

The "Clinical Accuracy Validation" section mentions that the device was tested per ASTM 1965-98, which is a standard for infrared thermometers. This standard typically defines the accuracy requirements for temperature measurement.

Therefore, I will extract the relevant performance criteria and reported performance for this non-AI medical device from the provided text. Many of your specific questions related to AI/ML studies cannot be answered from this document.

Acceptance Criteria and Device Performance for Infrared Forehead Thermometer

Based on the provided FDA 510(k) summary, the device's performance is demonstrated through adherence to relevant medical device standards, particularly related to temperature measurement accuracy and safety. The "acceptance criteria" here are the specifications outlined in the standards, and the "reported device performance" is the claim that the device conforms to these standards and their specified accuracy limits.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "ASTM 1965-98: Sample size, Patient population age, compared to reference thermometer, reference thermometer, designed per ASTM 1965-98: Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature."

• Sample Size: The exact sample size for the clinical accuracy validation is not explicitly stated in this summary, other than referring to compliance with ASTM 1965-98 criteria for sample size.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies a clinical study was conducted as part of the ASTM 1965-98 validation.

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

This type of information (experts, qualifications) is not applicable to the performance testing described for this device. The ground truth for temperature measurement, as per ASTM 1965-98, typically involves comparison to a highly accurate reference thermometer (e.g., a blackbody radiator or a calibrated clinical standard thermometer) and direct patient measurements. It does not involve expert consensus in the way AI/ML diagnostic studies do.

4. Adjudication Method for the Test Set

This is not applicable as the test involves direct measurement against a reference standard, not subjective 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, an MRMC comparative effectiveness study was not conducted and is not applicable to this device. This is a non-AI device for direct temperature measurement, not an AI-assisted diagnostic tool.

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

This refers to AI algorithm performance. Not applicable as this is a non-AI device. The device's "standalone" performance is its direct measurement accuracy.

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

For temperature measurement validation according to ASTM 1965-98, the ground truth is typically established by:

• Highly accurate reference thermometers: Used in controlled laboratory settings (e.g., blackbody radiator) to test the device's accuracy at different temperature points.
• Simultaneous measurements with a clinically accepted reference thermometer: On human subjects to compare the device's reading to a trusted standard.

The specific details are not provided in this summary but are inherent in the referenced standard.

8. The Sample Size for the Training Set

This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.

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

This question relates to AI/machine learning model training. Not applicable, as this is a non-AI device.

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Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.

Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.

The provided document is an FDA 510(k) Premarket Notification for an Infrared Forehead Thermometer, model: HS-9802D. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials for new technologies.

Therefore, the information requested in your prompt related to AI/ML device performance, expert adjudication, MRMC studies, and detailed ground truth establishment for training sets (which would be typical for an AI/ML device) is not present in this document because this is a traditional medical device submission for a thermometer, not an AI/ML diagnostic tool.

The "acceptance criteria" for this device are its ability to accurately measure temperature within specified tolerances, which is demonstrated through non-clinical performance testing and clinical accuracy testing as per established standards for thermometers.

Here's a breakdown of the information that is available in the document, framed as close as possible to your prompt, along with explanations for the missing information:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to the acceptance criteria as compliance with recognized consensus standards. The performance of the device is assessed against these standards.

• For the operating range of the device, the clinical accuracy should be within specified limits (e.g., ±0.2 °C or ±0.3 °C for certain temperature ranges, or specific deviations from reference oral temperature). Specific values are in the standard, not explicitly detailed here for criteria, but the "Measuring accuracy" in the comparison table gives inferred criteria for this device's claimed accuracy. | Measuring Accuracy (as per 6. Summary of technological characteristics):
  ±0.3°C (0.5°F): 34.0 to 42.0 °C (93.2 to 107.6 °F).

Study Conclusion: "The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016)." |
| Material Biocompatibility | ISO 10993-5, ISO 10993-10 | ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) compliance. | "The proposed device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10." |
| Electrical Safety | ANSI AAMI ES60601-1 | Compliance with the general requirements for basic safety and essential performance of medical electrical equipment. | "Meets ANSI AAMI ES60601-1" |
| Electromagnetic Compatibility| IEC 60601-1-2 | Compliance with requirements for electromagnetic disturbances. | "Meets IEC 60601-1-2" |
| Software (if applicable) | IEC 62304, FDA Guidance for Software (2005) | Compliance with medical device software life cycle processes and FDA guidance for software in medical devices. | "IEC 62304 are complied."
"Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005." |
| General Requirements | IEC 60601-1-11 | Compliance with general requirements for basic safety and essential performance, specifically for home healthcare environment. | "The subject device complies the standard IEC 60601-1-11." |
| Packaging/Transport | ISTA 2A | Not explicitly stated, but compliance implies the device can withstand typical transport conditions. | "The operating condition of subject device has passed the tests... ISTA 2A." |

Study Proving Device Meets Acceptance Criteria

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

• Sample Size: "The clinical accuracy testing evaluated 105 of subjects."
• Data Provenance: Not explicitly stated regarding country of origin. The test is described as "clinical accuracy testing" and is presumably prospective as it involves "subjects" undergoing measurement. It's safe to assume this was a prospective study conducted for the purpose of this submission.
• Retrospective/Prospective: Implied prospective as it "evaluated 105 subjects."

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

• Not Applicable in the traditional sense for a thermometer. Ground truth for temperature measurement is established by a reference thermometer (or method) that is itself calibrated and adheres to metrological standards. The document states:
  • "Summary of reference equipment: Digital Thermometer, Model KFT-03, Manufacturer Kangfu Medical Equipment Factory, K Number K182652."
  • This Digital Thermometer serves as the ground truth. It is a legally marketed device likely calibrated to national/international temperature standards.
• There were no "experts" establishing qualitative ground truth through image review or similar tasks as would be seen for an AI/ML diagnostic device.

4. Adjudication method for the test set:

• None. Adjudication is not relevant for direct temperature measurement, where the ground truth is a quantitative reading from a reference device.

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 an AI/ML diagnostic device and does not involve human readers interpreting AI output. It is a standalone measurement device.

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

• Yes, implicitly. The device is an "Infrared Forehead Thermometer." Its performance is inherently "standalone" in that it takes a measurement directly. There's no separate "algorithm" being evaluated beyond the device's internal measurement and calculation process as a whole. The clinical accuracy study assesses the device's output against a reference standard without human interpretative input.

7. The type of ground truth used:

• Reference Device Measurement: The "ground truth" for body temperature was established by simultaneously measuring the subjects' temperatures using a "Digital Thermometer, Model KFT-03," which is a legally marketed and presumably well-calibrated device. This is analogous to using a gold-standard measurement tool.

8. The sample size for the training set:

• Not Applicable. This is a traditional medical device (thermometer), not an AI/ML model that requires a "training set." The device's internal algorithms are based on physics and calibration, not machine learning from a large dataset.

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

• Not Applicable. As there is no training set (as in AI/ML), there is no ground truth established for one. The device is designed, manufactured, and calibrated according to established engineering principles for infrared thermometry. Calibration occurs at the factory using known temperature references.

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The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the «Microlife Connected Health +» APP. The memory data can be transferred to the smart phone via Bluetooth.

The Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) is an electronic thermometer using an infrared sensor, which is composed of thermistor and thermopile, to measures infrared energy radiated from the forehead as well as objects. This energy is collected through the lens and converted to a temperature value. The thermistor measures the ambient temperature of the sensor by changing the resistance. The function of thermopile is to measure the voltage difference between the temperature corresponding to the infrared radiation induction and the temperature difference measured by thermistor. Based on the voltage difference, difference temperature can be calculated, and the target temperature can be obtained by adding thermistor's temperature. The Microlife Non-Contact Infrared forehead thermometer, Model FR1MF1-B (NC150 BT), consists of the following parts: a) Thermopile Sensor b) Microcontroller Unit c) LCD and Backlight d) 4 buttons ("START" button, "ON/OFF" button, "M" button, "MODE" button) e) Alkaline batteries; size AAA, 2 x 1.5 V f) Lens g) Bluetooth module

The provided text is a 510(k) summary for the Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT). It focuses on demonstrating substantial equivalence to a predicate device (Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DG1 (NC200)) rather than describing an independent study of the device's acceptance criteria and proven performance.

Therefore, much of the requested information regarding acceptance criteria, specific study design details (sample size, data provenance, expert numbers/qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment for this specific device's test set (FR1MF1-B) is not explicitly present in the provided document.

Instead, the document primarily leverages the equivalence to its predicate device (FR1DG1), whose clinical validation is referenced indirectly. The key argument is that because the core measurement technology and algorithm are the same as the predicate which has already undergone clinical testing, a new clinical test for the identical measurement algorithm in the subject device is not required.

However, I can extract the following information that is available or implied:

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

The document refers to the accuracy specifications shared between the subject device and the predicate device. These can be considered the performance criteria.

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

• Sample Size: Not explicitly stated for the FR1MF1-B (NC150 BT) in a direct clinical test. The document states that a new clinical test is "not necessary" for this device because its measurement algorithm is identical to the predicate (FR1DG1).
• Data Provenance: Not specified for a direct clinical test on FR1MF1-B (NC150 BT). The predicate device's clinical test report (Clinical Test Report of FR1DG1 NC200) is referenced but not detailed. It is implied that any relevant clinical data comes from the predicate's validation.

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

• Not applicable/Not specified for this submission, as a new clinical test for FR1MF1-B (NC150 BT) was deemed unnecessary. This information would be found in the clinical test report for the predicate device (FR1DG1), which is not included here.

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

• Not applicable/Not specified, as a new clinical test for FR1MF1-B (NC150 BT) was deemed unnecessary.

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 would involve "human readers" or "AI assistance" in the context of MRMC studies.

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

• The device itself is a standalone clinical electronic thermometer. Its performance is based on its measurement algorithm and hardware. The document implies that the "measurement algorithm" (which is the core of its standalone performance) for the subject device is "identical" to that of the predicate, which has been validated to standards like ASTM E1965-98 and ISO 80601-2-56. These standards typically involve rigorous standalone testing.

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

• For clinical thermometers, the "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or direct invasive methods (e.g., rectal or oral core temperature) in a controlled clinical setting, as specified by standards like ASTM E1965-98 and ISO 80601-2-56. The document mentions "Body mode/laboratory" accuracy, indicating the use of controlled laboratory conditions.

8. The sample size for the training set:

• Not applicable. This is a non-AI/ML device. There is no concept of a "training set" in the context of this 510(k) submission for a clinical electronic thermometer.

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

• Not applicable (see point 8).

Summary of Device Performance Study (as implied for the predicate device, and by extension the subject device):

The document references that the predicate device (Model FR1DG1 (NC200)) has been validated in accordance with ISO 80601-2-56 and ASTM E1965-98. These are international and US standards for clinical thermometers, which prescribe specific methodologies for clinical accuracy testing.

• ASTM E1965-98 (Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature): This standard outlines clinical accuracy requirements and test methods for infrared thermometers, including specifics on how to conduct a clinical study to assess performance against a reference temperature. It defines statistical requirements for accuracy (e.g., mean difference, standard deviation) when compared to a reference temperature.
• ISO 80601-2-56 (Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement): This international standard also details requirements for clinical accuracy validation of thermometers, including clinical study design, patient population, and statistical analysis.

The "Clinical Test Report of FR1DG1 NC200" is cited as evidence for the predicate's validation, and thus, indirectly for the subject device's. While the details of that report are not present, it would contain the specific sample sizes, methods for ground truth establishment (likely using high-precision reference thermometers in a clinical setting), and other study parameters. The core argument for K211776's substantial equivalence is that the critical components (IC, sensor, measuring algorithm) affecting temperature measurement performance are identical to the already-cleared predicate.

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The infrared forehead thermometer is a nonsterile, reusable clinical thermometer intended for measuring the human body temperature in non-contact mode on the center of the forehead as the measurement site on people of all ages except the age under the 1 year.

The HONSUN infrared forehead thermometer is designed for measuring the body's temperature, is a handheld non-contact infrared thermometer, battery powered, detecting the infrared energy emitted in the forehead area within 0-3 cm (exclude 0 cm) that converts to a body temperature. The measurement site is center of the forehead, while reference body site is the oral. It is intended to measure the temperature of human body in home and hospital. lt consists of thermopile sensor, printed circuit board, enclosure, button and liquid crystal display. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then displayed on the LCD screen in digital form. It will be automatically power off if left idle for 20 seconds.

The document describes the acceptance criteria and study proving the device meets them for the HONSUN infrared forehead thermometer LD-FT-100B.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infrared Forehead Thermometer LD-FT-100B are primarily based on the international standard ISO 80601-2-56 for clinical thermometers and ASTM E 1965. The device's performance is demonstrated through testing against these standards.

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

• Sample Size:
  • Clinical Accuracy Test Set: 105 subjects in total.
    • 40 people were older than 1 year and younger than 5 years (17 with fever).
    • 65 people were older than 5 years (28 with fever).
• Data Provenance: The details of the country of origin are not explicitly stated for the clinical accuracy test. However, given that HONSUN (Nantong) Co., Ltd is located in China, it is reasonable to infer the study was conducted there. The clinical accuracy test was conducted in September 2020, implying a prospective study design for this specific test.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the clinical accuracy test. It states that the YUWELL infrared thermometer YT-1 (the predicate device) was used as the reference device to establish the "ground truth" for temperature measurements in the clinical accuracy study. It implies comparison with a calibrated, legally marketed device rather than human experts interpreting results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense (e.g., 2+1, 3+1). For the clinical accuracy test, the comparison was made against a reference thermometer (YUWELL infrared thermometer YT-1) by taking three measurements at the same site (forehead) alternately with the reference thermometer and the subject device. The ground truth was essentially the measurement reported by the reference device, as per the standard.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a thermometer, not an AI diagnostic tool that requires human interpretation. Therefore, a study comparing human readers with and without AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the primary performance evaluation for the thermometer is its standalone accuracy and compliance with relevant standards (ISO 80601-2-56, ASTM E 1965) without human interpretation being part of the measurement process itself. The clinical accuracy test directly measured the device's performance against a reference.

7. The Type of Ground Truth Used

The ground truth used for the clinical accuracy study was established by comparison against a reference thermometer (YUWELL infrared thermometer YT-1), in accordance with the requirements of ISO 80601-2-56. This is a form of device-based ground truth, where a well-characterized and established medical device serves as the standard for comparison.

8. The Sample Size for the Training Set

The document does not provide information about a "training set" as this device is a physical medical device, not a machine learning model that undergoes a training phase with data. The tests described are for validation and verification of the device's hardware and software performance.

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

As there is no mention of a training set for a machine learning model, this question is not applicable to the information provided. The device's design and operating principle are based on known physics of infrared detection and conversion, rather than learned patterns from a training dataset.

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The Infrared forehead thermometer is a non-contact infrared thermometer (model BSX976) intended for the intermittent measurement of temperature from forehead at a distance of 1~3cm for people older than 2 years. The device is reusable for home use and clinical use and the safety of the device has not been established for use in neonates/infants.

BSX976 measures the body temperature through receiving the infrared energy radiation from the surface of objects. It is with forehead temperature mode, directly show on the LCD screen.

• The device is widely used for home healthcare, medical institutes, and many other occasions.
• The product is mainly composed with infrared temperature sensors, signal receiving processor, buttons, buzzer, LCD display, battery, etc.
• It focuses the infrared from the human's forehead by the Fresnel lens.

The provided document is a 510(k) summary for a non-contact infrared forehead thermometer (Model BSX976). It outlines the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence.

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

Acceptance Criteria and Device Performance

The device's performance is primarily assessed against recognized international standards for medical electrical equipment and clinical thermometers. The acceptance criteria are implicitly defined by compliance with these standards, particularly regarding accuracy and safety.

Table of Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

The document describes both non-clinical (bench) data and clinical data collected to demonstrate product performance.

1. Sample sizes used for the test set and data provenance:

   • Clinical Data (Test Set): 150 subjects were involved in the clinical testing. 32 of these subjects were febrile.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the submitter's location (Shenzhen, China) and the nature of a 510(k) submission, it is highly probable the clinical study was conducted prospectively, but this is not explicitly confirmed.

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

   • The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. The clinical testing was conducted "per ISO 80601-2-56 Clause 201.102," which is a standard for clinical thermometers. This standard itself outlines methods for clinical evaluation, including comparison to reference thermometers, but the specific details of the human expertise involved in the ground truth establishment for this specific study are not described in the provided summary.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method. For a clinical thermometer study, ground truth is typically established by simultaneous measurement with a highly accurate reference thermometer (e.g., a rectal thermometer) under controlled conditions, rather than by human adjudication of readings.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is a review of a basic medical device (a thermometer), not an AI-assisted diagnostic imaging device. Therefore, an MRMC study with human readers and AI assistance is not relevant and was not performed.

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

   • Yes, indirectly. The "Clinical data" and "Bench Testing" sections describe the device's performance in isolation. The compliance with ISO 80601-2-56 and ASTM E 1965-98 specifically evaluates the thermometer's direct measurement accuracy, which is its standalone performance. This device is not an algorithm in the sense of AI; it is a physical device that performs a measurement.

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

   • The ground truth for the clinical data (temperature measurement) is established by comparison to a reference temperature measurement method as defined by the standard ISO 80601-2-56. This standard typically involves using a highly accurate alternative method (e.g., a calibrated contact thermometer, such as a rectal or oral thermometer, serving as the "true" body temperature) against which the infrared thermometer's readings are compared. The summary does not explicitly state the exact reference method used, but compliance with the standard implies such a comparison.

7. The sample size for the training set:

   • This device is a physical thermometer, not a traditional machine learning model that undergoes a "training set" process in the AI sense. Therefore, there is no specific training set sample size as would be described for an AI/ML algorithm. Its "training" is in its design, calibration, and manufacturing processes, guided by engineering principles and adherence to standards.

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

   • As there is no "training set" in the AI/ML context, this question is not applicable. The device's calibration and design are based on established physics principles of infrared thermometry and validated against recognized metrology standards for temperature measurement.

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Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of forehead temperature. The device is indicated for use by people of all ages in the home.

The Infrared Forehead Thermometer, model FR200 is a hand-held forehead thermometer and it is intended for the non-contact intermittent measurement and monitoring of forehead temperature which is based on the infrared energy emitted from the forehead. It is indicated for use by people of all ages in the home. After measurement, the temperature is directly shown on the LCD display so that the users can quickly get measurement results after properly scanning the forehead.

The provided document is a 510(k) summary for an Infrared Forehead Thermometer (Model FR200). It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets general acceptance criteria for a novel AI/software medical device.

Therefore, much of the requested information regarding acceptance criteria and study details for an AI/software device is not available in this document because it pertains to a different type of medical device (a thermometer) and regulatory pathway (substantial equivalence of a hardware device incorporating standard technology).

However, I can extract the information that is present and point out where the requested information is absent or not applicable given the context.

Here's a breakdown of what can be inferred or directly stated from the document:

Device Type: Infrared Forehead Thermometer (hardware device, not an AI/software image analysis device).
Regulatory Pathway: 510(k) - demonstrating substantial equivalence to a predicate device.

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

The document does not provide a general table of "acceptance criteria" for an AI/software device, as it is a thermometer. However, it does list performance specifications and testing standards that serve as benchmarks for this type of device.

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

• Test Set Sample Size: For the Clinical Accuracy study, the document states: "a clinical study was carried out on 160 subjects for all ages of population" (Page 7) and "consisting of 180 subjects, of which 60 subjects are infants, 60 subjects are children and the rest 60 subjects are adults" (Page 8). There is a discrepancy in the total number of subjects (160 vs 180). Assuming 60 per age group (infants, children, adults), 180 seems more consistent.
• Data Provenance: Not explicitly stated (e.g., country of origin, specific hospitals). The study is described as a "randomization, simple blind homologous control, pairing design of clinical investigation" (Page 8), indicating it was a prospective study specifically conducted for this submission.

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

Not applicable/available. This device is a thermometer. Its "ground truth" for temperature measurement is typically established by comparing readings against a reference thermometer (e.g., a rectal thermometer or other highly accurate standard) in a clinical setting, not through expert consensus on images. The document refers to meeting "acceptance criteria of the clinical study protocol" for repeatability, which would involve quantitative comparisons to a reference.

4. Adjudication method for the test set

Not applicable/available. Adjudication methods (e.g., 2+1, 3+1) are typically used for subjective assessments, like image reading, where multiple experts interpret data. For a thermometer, objective measurement comparisons are used.

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 is not an AI-assisted diagnostic device. It's a standalone thermometer.

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

Yes, in essence. The device functions as a "standalone" measurement tool. Its performance is evaluated intrinsically (how accurately it measures temperature), not in conjunction with human interpretation of complex data. The clinical accuracy study assesses the device's direct measurement capability.

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

For "Clinical Accuracy," the ground truth would be established by simultaneous measurements using a recognized reference standard thermometer (e.g., a rectal thermometer, an oral thermometer, or a highly accurate laboratory-grade thermometer) according to the ASTM E1965-98 and ISO 80601-2-56 standards. The document doesn't explicitly name the reference method used within the clinical study, but these standards prescribe such methods. It's an objective, quantitative comparison rather than subjective consensus.

8. The sample size for the training set

Not applicable. This is a traditional infrared 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 above, no training set for an AI model.

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The Infrared Forehead Thermometer (Model: T80、T81、T82、T83、T84、T85) is a non-contact thermometer used to measurement forehead temperature at home or hospital. The device is indicated for use on people of all ages except for neonates/newborns.

The Infrared Forehead Thermometer (Model: T80、T81、T84、T84、T85) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value.

The Infrared Forehead Thermometer (Model: T80、T81、T84、T85),consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuitry
c) Erasable Programmable Read-Only Memory Integrated Circuit
d) Capacitance-touch Integrated Circuit
e) LCD and Backlight
f) 4 buttons (Setting button, Memory button, ON/OFF button, Measurement Trigger)
g) 2×1.5V AA dry batteries

The operation principle is based on Infrared Sensor technology. The sensor can turn body's temperature to analog signals, and a MCU with an AD can get the result by intelligent analyze and treat the analog signals.

The Infrared Forehead Thermometer (Models: T80, T81, T82, T83, T84, T85) has acceptance criteria primarily based on the ASTM E 1965-98 standard for infrared thermometers and ISO 80601-2-56 for clinical thermometers.

Here's a breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the referenced standards (ASTM E 1965-98, ISO 80601-2-56) and are demonstrated through performance tests.

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

• Sample Size: 150 subjects.
  • Divided into three age groups: Infants (less than 1 year), Children (1 to 5 years old), and Adults (greater than 5 years old).
  • No less than 50 subjects in each group.
  • 30% of the subjects had a temperature equaling or exceeding 37.5°C.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, "Clinical tests were conducted" and "The study excluded subjects..." indicate a prospective clinical trial involving human subjects.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth. It can be inferred that standard clinical temperature measurement methods (e.g., rectal or oral thermometry, depending on age group) were used as the reference standard against which the infrared forehead thermometer was compared, consistent with the requirements of ISO 80601-2-56 and ASTM E 1965.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method. Clinical accuracy studies for thermometers typically compare the device's readings directly against a trusted reference method, rather than requiring expert adjudication of the disease state itself.

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 is not applicable. The device is an Infrared Forehead Thermometer, which is a standalone medical device for temperature measurement, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, a standalone performance evaluation of the device was conducted. The clinical accuracy study evaluated the device's ability to measure temperature accurately directly against a reference standard, without human interpretation for diagnosis. The device itself is the "algorithm only" in the context of its function as a measurement instrument.

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

The ground truth for temperature measurement would be established by simultaneous measurements using a highly accurate and validated reference thermometer (e.g., a clinical reference thermometer, such as a rectal thermometer for infants, or an oral/tympanic thermometer for older children/adults, adhering to the requirements of the standards). The document refers to "clinical bias with stated uncertainty and clinical repeatability" evaluated against ISO 80601-2-56, which implies comparison to a reference standard for body temperature.

8. The sample size for the training set

The document only describes a clinical test set. No information about a separate "training set" is provided because this device is a physical measurement instrument, not a machine learning algorithm that requires a training set. The device's internal calibration and algorithms are developed during its engineering and manufacturing process, optimized through testing against known temperature sources, not through a "training set" in the AI sense.

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

Not applicable, as there is no training set in the context of an infrared thermometer as described in the document. The ground truth for the device's internal calibration would be established through highly accurate laboratory-grade temperature references.

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The Infrared forehead thermometer (Models JZK-602, JZK-603) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 1-5cm for people of all ages. The device is reusable for home use and clinical use.

Infrared forehead thermometers (includes model JZK-602, JZK-602, JZK-603) are intended to measure the body temperature through receiving infrared energy radiation via the forehead for people of all ages. These thermometers have the capability to measure temperature via body mode or object mode, and the temperature is directly shown on the LCD display. These thermometers have the following features:

1. The device is intended to be reusable for home use and clinical use.
2. The device is mainly composed of infrared sensor, signal receiving processor, kevs, buzzer, LCD display.
3. Switching of temperature unit between °C and °F.
4. The latest 32 sets of memory for measuring human body and object; the user can view or delete the previous measurement results.
5. Buzzer on or off to set the prompt tone on or off.
6. Prompt tone function and backlights function.
7. The prompt limit setting function.
8. Low battery indication, and auto power-off.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text for the Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603):

Device: Infrared Forehead Thermometer (Models JZK-601, JZK-602, JZK-603)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 200 subjects were evaluated in the clinical study.
  • 50 newborns (0 to 3 months)
  • 50 infants (older than 3 months up to 1 year)
  • 50 children (older than 1 year and younger than 5 years)
  • 50 adults (older than 5 years old)
• Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It merely describes the study design and its findings. It was a clinical investigation, implying a prospective data collection, rather than retrospective.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study. It refers to a "randomization, simple blind homologous control, pairing design of clinical investigation" that evaluated the device against the requirements of ASTM E1965-98 (Reapproved 2016). This standard itself defines the acceptable reference methods for temperature measurement (e.g., oral, rectal, axillary, tympanic) and their accuracy, which would serve as the defacto "ground truth" rather than direct expert consensus reading of the device's output.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method in the traditional sense of multiple reviewers resolving discrepancies, as might be found in imaging studies. Given it's a thermometer study comparing to a reference method, the "ground truth" is likely established by the reference thermometer measurements as per ASTM E1965-98, negating the need for complex expert adjudication of device readings. The study design is described as "randomization, simple blind homologous control, pairing design."

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typical for diagnostic AI tools where human readers interpret medical images with and without AI assistance to measure improvement in diagnostic performance. For a temperature measurement device, the objective is to accurately measure temperature against a reference standard, not to assist human interpretation of complex data. Therefore, an MRMC study is not applicable here.

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

Yes, the primary performance evaluation appears to be a standalone (algorithm only) assessment. The device's accuracy and performance criteria (measurement range, accuracy, response time) are tested directly against performance standards (ISO 80601-2-56, ASTM E1965-98) and in a clinical study where its readings are compared to a reference method, without explicit human interpretation being part of the primary performance metric beyond using the device as intended. The "human-in-the-loop" here is the user taking the temperature, but the device's measurement itself is the standalone output being validated.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was based on reference temperature measurements as required by the ASTM E1965-98 (Reapproved 2016) standard. This typically involves using highly accurate reference thermometers (e.g., direct contact electronic thermometers, mercury-in-glass thermometers at a core body site) as the "true" temperature against which the infrared forehead thermometer's readings are compared.

8. The Sample Size for the Training Set

The document does not provide information on the sample size for the training set. This is a medical device, not an AI/ML diagnostic algorithm in the sense of requiring separate training datasets. While internal calibration or factory data might be used in manufacturing, it's not a "training set" in the context of deep learning models.

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

As this is a physical measurement device (infrared thermometer) and not a machine learning model requiring a distinct training phase with annotated data, the concept of a "training set" and its ground truth establishment in the AI/ML sense does not apply. The device's internal algorithms are likely based on physical principles of infrared detection and calibrated during manufacturing, rather than "trained" on a dataset of patient temperatures.

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The Medical infrared forehead thermometer (Model: HGO1, HGO1 V1, HGO6 ) is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one year old and above. The device is reusable for home use and clinical use.

The proposed device. Medical infrared forehead thermometer, which includes model HGO1 VI, HGO6 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead of people aged over 1 year.

The proposed devices measure temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The distance of the measurement is 3cm~5cm. The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.

The devices have the following features: About one-second measuring Body or Ambient temperature, 32-memory recalls, 9 and 9F unit switchable, over range message (Hi/Lo), low battery indication, auto shut-off when the device is idle for 15 seconds. When completes, the results will be displayed on the LCD display screen, and the buzzer will tell the measurement has been completed. The device will display 3 different background colors according to the result.

The power supply of Medical infrared forehead thermometer is 3.0V DC, it is powered by two AAA batteries. The package includes the following parts:

2xAAA batteries, 1xManual and 1 pcs thermometer

This document is a 510(k) summary for a Medical infrared forehead thermometer, demonstrating its substantial equivalence to a predicate device. The information provided focuses on the safety and effectiveness testing for regulatory clearance.

Here's a breakdown of the requested information based on the provided text:

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

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

• Sample Size for Test Set: 100 subjects for clinical tests.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. Given the manufacturer's location in China, it is plausible the study was conducted in China.

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 or qualifications of experts used to establish ground truth for the clinical test set. It mentions "clinical tests were conducted," and the "clinical accuracy of the proposed device was evaluated by ISO 80601-2-56 - clinical bias with stated uncertainty and clinical repeatability." This implies a comparison against a reference thermometer, but not necessarily against expert human readers.

4. Adjudication method for the test set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set. The clinical study focused on comparing the device's temperature readings against a reference method as per ISO 80601-2-56, not on human interpretation or adjudication of results.

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 was not done. This device is an infrared thermometer, not an AI-assisted diagnostic device that would involve human readers interpreting images or data. The clinical study was to assess the accuracy of temperature measurement.

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

Yes, a standalone performance assessment was done for the device. The clinical trials evaluated the device's ability to measure temperature accurately on its own. The "device" in this context refers to the thermometer and its embedded algorithms/sensors, not a separate AI algorithm being applied to external data.

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

The ground truth for the clinical performance test was established by comparison with a reference thermometer, implied by the adherence to ISO 80601-2-56, which specifies accuracy testing against a traceable temperature standard. The document mentions "clinical bias with stated uncertainty and clinical repeatability."

8. The sample size for the training set

The document does not explicitly state a "training set" sample size. For simple medical devices like thermometers, there isn't typically a distinct "training set" in the machine learning sense. The device's internal algorithms are developed and calibrated during manufacturing and design, and then validated through laboratory and clinical testing.

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

Not applicable in the machine learning sense of a training set. The "ground truth" for the device's development and calibration would have been established through controlled laboratory measurements using highly accurate reference temperature sources and then verified in a clinical setting as described in point 7.

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The infrared forehead Thermometer DPT-IFT100 is a non-contact thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

The infrared forehead thermometer, Model DPT-IFT100, is an electronic thermometer using an infrared temperature sensor to measure infrared energy radiated from the forehead. This energy is collected through the infrared temperature sensor convert to a voltage signal. The signal is measured by the main microcontroller, calculated by the internal algorithm, finally converted into a digital temperature value to display on the LCD.

The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a 3~5 cm distance without contact with the object to be measured.

The Infrared forehead thermometer, Model DPT-IFT100, consists of the following parts:
a) Thermopile Sensor
b) Application-Specific Integrated Circuit
c) Housing
d) LCD and Backlight
e) 1 button (Power on/Power off/Measurement)
f) Alkaline batteries; size AAA, 2 x 1.5 V
g) LCD cover

This document (K202420) is a 510(k) summary for the Conmo Electronic Company Limited's Infrared Forehead Thermometer, Model DPT-IFT100. It details the device's characteristics, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infrared Forehead Thermometer DPT-IFT100 are primarily defined by adherence to recognized performance standards and demonstrated substantial equivalence to a predicate device. The performance data presented focuses on accuracy and the clinical study results.

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

• Sample Size: 150 subjects.
  • Breakdown: 50 infants (newborn to one year), 50 children (greater than one to five years), and 50 adults (greater than five years old).
• Data Provenance: Not explicitly stated regarding country of origin. The study was conducted for a device manufactured by Conmo Electronic Company Limited, based in Guangxi Province, China, and submitted through a US Agent in Arizona. Clinical studies are typically conducted where the product is intended for market or where clinical trial infrastructure exists. The document does not specify if it was retrospective or prospective, but clinical studies for regulatory submissions are generally prospective.

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

This document describes a clinical study for a medical device (thermometer) where the "ground truth" is the actual body temperature measurements. This is a direct measurement, not a subjective interpretation requiring multiple experts. The document does not mention the use of experts to establish a "ground truth" in the way one would for an AI-powered diagnostic image analysis system. The ground truth for temperature measurement would be established by the reference temperature measurement method used in the clinical setting, typically a calibrated device.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is a temperature measurement device, not an interpretative diagnostic device requiring adjudication of expert opinions.

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 is a standalone medical device (thermometer) and not an AI-assisted diagnostic tool that involves human readers.

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

Yes, implicitly. The performance of the Infrared Forehead Thermometer DPT-IFT100 is its standalone measurement accuracy, clinical bias, and clinical repeatability. The device operates independently to measure temperature. The "algorithm" mentioned (CM3.1 Algorithm) is internal to the device for processing the infrared signal into a temperature reading. The clinical study directly assesses this standalone performance against accepted standards.

7. The Type of Ground Truth Used

The ground truth used for the clinical study was the actual body temperature, presumably measured by a reference thermometer, against which the DPT-IFT100's readings were compared to determine clinical bias and repeatability. This is akin to outcomes data or a highly accurate reference standard measurement. The study report stated: "The test report demonstrated that the clinical data, represented by clinical bias and clinical repeatability met the acceptance criteria of the clinical study protocol."

8. The Sample Size for the Training Set

Not applicable. This device is a traditional electronic thermometer, not an AI/machine learning device that requires a separate training set. The "algorithm" (CM3.1) refers to its internal firmware/logic for temperature calculation, not a learned model from a dataset.

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

Not applicable, as there is no training set mentioned for this type of device. The device's internal algorithm (CM3.1) is a fixed computational process, not an AI model that learns from a training set.

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