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Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.

Here's an analysis of the acceptance criteria and study details for the Infrared Thermometer Model YJ600, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Infrared Thermometer Model YJ600 are primarily defined by the standards ISO 80601-2-56 and ASTM E1965-98. The 510(k) summary directly states that the device "meets the requirement of the standard" for these and other tests. The most critical performance criterion for a thermometer is its accuracy.

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

• Sample Size (Clinical Test): 200 subjects.
  • Age Group A (0 up to 3 months): 50 subjects
  • Age Group B (3 months to one year): 50 subjects
  • Age Group C (older than one year to five years): 50 subjects
  • Age Group D (older than five years): 50 subjects
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, clinical accuracy testing is typically prospective, as it involves taking real-time measurements in a controlled study. Given the manufacturer's location (China), the study likely took place in China.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for temperature measurements in the clinical study. For infrared thermometers, the "ground truth" (reference temperature) is typically established using a highly accurate, calibrated clinical thermometer (e.g., a rectal thermometer for core body temperature) as per standards like ISO 80601-2-56 and ASTM E1965-98. The experts involved would typically be clinical staff (nurses, physicians) following a strict protocol for reference temperature measurement.

4. Adjudication Method (for the test set)

The document does not detail an adjudication method. For clinical thermometer accuracy studies, adjudication is generally not a separate process as the reference standard measurement (ground truth) is considered definitive. The "test" is how closely the device's reading matches this established reference, not a subjective interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an infrared thermometer, not an AI-powered diagnostic imaging tool. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

Yes, the primary clinical accuracy and performance testing of the Infrared Thermometer Model YJ600, as described, is a standalone (algorithm only) performance assessment. The device measures and displays temperature without human interpretation of the measurement itself. While a human operates the device, the core performance being evaluated is the device's ability to accurately measure temperature independently of human judgment.

7. The Type of Ground Truth Used

The ground truth used for the clinical accuracy test is the reference body temperature measurement obtained through methods specified in ISO 80601-2-56 and ASTM E1965-98. These standards typically require comparative measurements against a highly accurate reference thermometer (e.g., an electronic thermometer measuring core body temperature, often rectal, or a precise oral measurement) to assess the deviation and repeatability of the infrared thermometer. The document specifically states "clinical repeatability" and that it "meets the clinical repeatability requirement," implying comparison against a gold standard in a clinical setting.

8. The Sample Size for the Training Set

The document does not mention or specify a "training set" because this device is a physical medical device (thermometer) and not an AI/Machine Learning algorithm that requires a separate training dataset. Its performance is based on its hardware and firmware, which are designed and then validated through testing.

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

As there is no "training set" in the context of an AI/ML algorithm for this device, the question of how its ground truth was established is not applicable. The device's design implicitly relies on established physics principles of infrared radiation and measurement, and its accuracy is validated against clinical ground truth during performance testing.

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Wrist Blood Pressure Monitor is used to measure adult systolic blood pressure and pulse rate. The values are for diagnostic reference only. Suitable for medical institutions (such as hospitals, clinics, health centers, etc.) and home use.

Wrist Blood Pressure Monitor mainly consist of pressure sensor, air pump, valve, cuff, main board and plastic case. Wrist Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. The Wrist Blood Pressure Monitor include two models: YJ110, YJ111

The provided text describes the non-clinical testing and a clinical validation study for a Wrist Blood Pressure Monitor (models YJ110, YJ111) to demonstrate its substantial equivalence to a predicate device (K223291).

It is important to note that the document primarily focuses on non-clinical testing (e.g., appearance, safety indices, performance indices, electrical safety, EMC, software verification) and a clinical validation study that demonstrates the accuracy of the device against a reference method, rather than a comparative effectiveness study involving human readers with and without AI assistance. The device is a blood pressure monitor, not an AI-powered diagnostic tool requiring expert interpretation of images. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, expert adjudication, AI standalone performance) would not be applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a detailed table (Table VII-1) of "Inspecting item" with "Inspection content and acceptance standard" and the "Conclusion". Below is a summary, focusing on performance-related criteria:

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

The clinical validation study for the Wrist Blood Pressure Monitor (model YJ110, covering YJ111) used:

• Sample Size: 86 adult subjects (47 females, 39 males).
• Data Provenance: Not explicitly stated, but given the manufacturer is based in China, it is highly probable the study was conducted there.
• Retrospective/Prospective: The text describes the study as "performed," indicating a prospective clinical validation study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This section is not applicable as the device is a blood pressure monitor, not an AI diagnostic tool requiring expert interpretation of medical images. The ground truth for blood pressure is established through a reference measurement method (e.g., auscultatory mercury sphygmomanometer in a supervised setting, following a recognized standard).

4. Adjudication Method for the Test Set

This section is not applicable for the same reason as above. Blood pressure measurement accuracy is typically assessed by comparing device readings to a reference standard, not through expert adjudication in the context of diagnostic interpretation. The study was performed using the "Same Arm Sequential Method" according to ISO 81060-2:2018.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human reader performance is being evaluated with and without AI assistance. This device is a direct measurement device (blood pressure monitor), not an AI-powered image interpretation device.

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

Yes, the primary evaluation of the device's performance is essentially a standalone evaluation of the device's ability to accurately measure blood pressure. The clinical validation adhered to ISO 81060-2:2018, which is a standard for validating automated measurement type non-invasive sphygmomanometers. This standard assesses the device's measurement accuracy, which is its inherent algorithmic function for determining blood pressure and pulse rate from oscillometric signals.

7. The Type of Ground Truth Used

The ground truth for the clinical validation study was established by comparison to a reference measurement method per ISO 81060-2:2018. This standard specifies clinical procedures for validating the accuracy of automated non-invasive sphygmomanometers. Typically, this involves simultaneous or sequential measurements by the device under test and a calibrated reference sphygmomanometer (e.g., mercury sphygmomanometer) using an auscultatory method by trained observers. The "Same Arm Sequential Method" was chosen. The standard dictates the statistical analysis (mean error and standard deviation of differences) against the reference values.

8. The Sample Size for the Training Set

The document does not provide information on a specific "training set" sample size, as this device is not explicitly described as an AI/ML model that undergoes a distinct training phase. Its operation is based on the oscillometric principle with a non-invasive blood pressure (NIBP) algorithm, which implies a fixed, deterministic algorithm rather than a continuously learning or adaptable AI model. The "software function is justified by the software documents," as stated in "Different 2- Records Quantity" implies a validated software rather than a trained one.

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

As there is no explicit mention of a training set or a distinct AI/ML training phase, this question is not directly applicable based on the provided text. The device uses an established "oscillometric principle" and "NIBP algorithm," suggesting a conventional engineering approach to device development and calibration, rather than a machine learning approach where "ground truth" is established for a training dataset. Accuracy is demonstrated via clinical validation against a reference standard.

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Electronic Blood Pressure Monitor intended for use in measuring blood pressure and pulse rate in adult patient population. It is intended to measure the diastolic, systolic blood pressures and pulse rate through an inflatable cuff wrapped around the arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-42 cm.

Electronic Blood Pressure Monitor mainly consist of the main body (include screen display, air tube connector, memory button and start/stop button), cuff, USB cable, air tube, and AA batteries. Electronic Blood Pressure Monitor that uses the oscillometric principle to measure your blood pressure and pulse rate. The radial artery in the arm changes from blocked to open as the pressure in the cuff tied around the arm changes from high to low, causing the pressure in the cuff to be superimposed on a series of small pressure pulses. The sphygmomanometer senses these signals and, after certain calculations, finds the systolic and diastolic pressures of the radial artery in the body. Electronic Blood Pressure Monitor can be divided into three models (YJ320, YJ321E, YJ326E) according to their appearance and functions.

The provided text is for an FDA 510(k) clearance for an Electronic Blood Pressure Monitor. It details non-clinical and clinical testing performed to demonstrate substantial equivalence to a predicate device.

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

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

The document provides a comprehensive table of non-clinical performance and safety acceptance criteria, along with the reported "Conclusion" (Pass/Fail). For the clinical validation, it states the acceptance criteria are met based on deviations from a reference standard.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Clinical Validation Acceptance Criteria (Simplified, based on ISO 81060-2:2018):

For the clinical study, the acceptance criteria are implicit in the statement: "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018."

• Reported Device Performance: The device (YJ320) met these limits, indicating it performed within the required accuracy for blood pressure measurement against a reference standard.

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

• Test Set Sample Size:
  • Clinical Data: 86 adult subjects (49 females, 37 males).
  • Non-Clinical Data: Not explicitly stated as a "test set" in terms of subject count, but performance was evaluated based on the device itself and its components against established standards.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study participants or if it was retrospective or prospective. Given it's a 510(k) submission from a Chinese company, common practice would be for the clinical study to be prospective and likely conducted in China or a region where the standard is recognized.

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

• Clinical Ground Truth: The clinical validation was conducted according to ISO 81060-2:2018, which is "Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type." This standard outlines specific methods for clinical validation, typically involving simultaneous measurements by trained observers (auscultation) against the automated device being tested. The number of experts (observers) involved in establishing the reference measurement (ground truth) is usually prescribed by this standard, but not explicitly stated in this summary. The standard generally requires at least two trained observers. Their qualifications would typically involve being trained and validated to perform accurate auscultatory blood pressure measurements.
• Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 10993, IEC 80601-2-30). Test equipment and calibrated reference standards are used by technical personnel to verify compliance.

4. Adjudication method for the test set

• Clinical Data: The "Same Arm Sequential Method" was used as per ISO 81060-2:2018. This method involves taking sequential measurements from the same patient's arm using both the test device and a reference method (typically auscultation by trained observers). The standard itself dictates how discrepancies are handled and how the mean error and standard deviation of differences are calculated, which serves as the "adjudication" against the standard's limits. No explicit "expert adjudication" process like 2+1 or 3+1 is mentioned, as the standard relies on the statistical agreement of measurements.
• Non-Clinical Data: Not applicable in the context of expert adjudication for defining a "ground truth" in the same way as clinical or image-based studies. Tests are performed against objective criteria and measured by calibrated equipment.

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 type of study is relevant for AI-powered diagnostic or assistive devices where human interpretation is involved. This device is an automated blood pressure monitor, not an AI diagnostic tool.

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

• Yes, the clinical validation study (ISO 81060-2:2018) is essentially a standalone performance assessment of the automated blood pressure monitor against a reference standard. The device's algorithm performs the measurement autonomously, and its output (systolic and diastolic pressure) is compared directly to the ground truth.

7. The type of ground truth used

• Clinical Ground Truth: The ground truth for blood pressure measurements in the clinical study was established by comparison with a reference method as defined by ISO 81060-2:2018. This standard typically refers to invasive measurements or, more commonly for non-invasive validation, simultaneous auscultatory measurements performed by trained observers. The document also states, "All data's mean error and standard deviation of differences for systolic, diastolic pressure is not over the limits of ISO 81060-2: 2018," which confirms adherence to this specific standard for ground truth establishment.
• Non-Clinical Ground Truth: The "ground truth" for non-clinical tests (e.g., accuracy, range, safety features) is based on the objective technical specifications and performance requirements outlined in referenced international standards, tested using appropriate calibrated measuring equipment.

8. The sample size for the training set

• This device is an Electronic Blood Pressure Monitor, which likely uses traditional signal processing and algorithms (oscillometric principle) rather than deep learning or AI that requires a "training set" in the modern machine learning sense. Therefore, a distinct "training set" of data for algorithm development, as seen in AI/ML medical devices, is not referenced or applicable here. The algorithms are based on established physiological principles and engineering.

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

• As explained in point 8, the concept of a "training set" as it applies to establishing ground truth for machine learning models is not relevant to this traditional medical device. The underlying algorithms are based on established physical and biological principles, and their accuracy is demonstrated through the clinical and non-clinical validation studies described.

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