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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.

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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:

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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):

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