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Arm Blood Pressure Monitor is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the arm of which the circumference includes 22 cm~36 cm.

The Arm Blood Pressure Monitor is a battery powered automatic non-invasive pressure monitor, powered by 4 x1.5V AAA battery. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure and pulse rate of the adult person at upper arm within its claimed range and accuracy via the oscillometric technique. User can select the unit of the measurement: mmHg or kPa. The device has the data storage function for data reviewing. The proposed Arm Blood Pressure Monitor share the same software, measurement principle and NIBP algorithm. The product is provided non-sterile, and not to be sterilized by the user prior to use.

The provided text describes the 510(k) summary for an Arm Blood Pressure Monitor (models OB30, OB31, OB32, OB33). This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The information primarily focuses on the device's technical specifications and how it meets the requirements for a non-invasive blood pressure measurement system.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Arm Blood Pressure Monitor are primarily defined by adherence to recognized international standards, particularly ISO 81060-2 for clinical performance, and other IEC standards for safety and electromagnetic compatibility.

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

• Sample Size: The clinical performance testing included 85 subjects.
• 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 submitter's location in China (Yibin Junxin Electronics Technology Co., Ltd., SiChuan, China) and the application correspondent's location also in China (Share Info (Guangzhou) Medical Consultant Ltd., Guangzhou, China), it is highly probable that the study was conducted in China. The study was a prospective clinical performance test conducted to meet the ISO 81060-2 standard.
• Subject Demographics: Aged from 22 to 81, with 52.9% male and 47.1% female participants. The limb size distribution complied with clause 5.1.4 of ISO 81060-2.

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

• The document does not specify the number of experts or their qualifications. For blood pressure measurement device validation, the ground truth is typically established by trained clinical personnel using a reference standard device (e.g., a mercury sphygmomanometer) and following a strict protocol as outlined in ISO 81060-2.

4. Adjudication Method for the Test Set

• The document does not explicitly mention an adjudication method. In the context of blood pressure device validation (ISO 81060-2), ground truth derivation involves simultaneous or near-simultaneous measurements by trained observers using a reference method, against which the device's readings are compared. It's a direct comparison method rather than an "adjudication" in the sense of resolving disagreements between multiple independent expert interpretations, as would be common in imaging studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for diagnostic imaging AI systems where human readers interpret medical images with and without AI assistance. For a blood pressure monitor, the study evaluates the device's accuracy against a clinical reference standard, not the improvement of human readers with AI assistance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, a standalone performance study was done. The clinical performance testing described is precisely a standalone performance evaluation of the device. The device itself performs the measurement using an oscillometric technique, and its readings are directly compared to a reference standard to assess its accuracy. There is no "human-in-the-loop" in the generation of the device's measured blood pressure values.

7. Type of Ground Truth Used

• The type of ground truth used was a clinical reference standard, as specified by ISO 81060-2. This typically involves simultaneous or sequential measurements by a trained observer using a validated reference method (e.g., a mercury sphygmomanometer with a Y-adapter or similar setup) against which the test device's readings are compared. It is a form of outcomes/measurement data validated against a gold standard in a clinical setting.

8. Sample Size for the Training Set

• The document does not specify the sample size for a training set. This device is a hardware product with embedded software and an algorithm for oscillometric blood pressure measurement. While the algorithm was developed, the document focuses on the validation test set (85 subjects) and compliance with standards. It does not provide details on the data used for the development or training of the oscillometric algorithm itself. This information is typically proprietary and not included in a 510(k) summary unless specific software modifications or AI components require it.

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

• As the document does not specify a training set or its size, it also does not provide information on how the ground truth for a training set (if applicable for algorithm development) was established. For blood pressure monitoring, algorithms are usually developed and refined using large datasets of oscillometric waveforms and corresponding reference blood pressure values, established through similar rigorous clinical measurement protocols used for validation.

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Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead at a distance of 2-5cm for people of all ages. The device is reusable for home use and clinical use.

Infrared thermometer (Models: YRK-002A, T8, T9, T10, T11) is a hand-held, battery powered, infrared Thermometer that coverts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead temperature when measure from 2-5 cm of the subject's forehead with no contact. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings. lt composed by a measuring sensor, PCB, 4 buttons, an LCD and an enclosure. The functions of the five models are same. Press the measurement key to turn on the device. The screen of the device lights up. The LCD screen has the power status, measurement mode, temperature unit and measurement temperature. Press the "Setting" key to open the F1: The function of "Temperature Unit" can be set. When measuring body temperature, users need to measure in body mode from 2-5 cm from their forehead. Press the trigger, after 1 second with the sound of "beep", the measurement is completed and the temperature is displayed on the LCD screen. Without any operation, it will close automatically in 17 sec. The difference between these models is only the model's name.

The provided text describes the regulatory clearance for an infrared thermometer and includes sections on non-clinical and clinical testing. However, it does not contain the specific level of detail requested for a comprehensive breakdown of acceptance criteria and study particulars, especially regarding AI/ML device performance.

Therefore, for aspects directly related to the performance of the infrared thermometer and its compliance with standards, I can extract information. For aspects like "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Sample size for the training set," the document does not provide this level of detail as it pertains to a medical device clearance, not an AI/ML algorithm study.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the standards the device claims to meet, particularly ISO 80601-2-56 and ASTM E1965-98. The reported performance is that the device "complied" with these standards. Specific numerical values for criteria and performance are given for "Measuring accuracy."

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

• Sample Size for Test Set: 240 subjects.
• Data Provenance: The document does not explicitly state the country of origin but implies a clinical setting ("clinical tests were conducted"). It is a prospective clinical performance test ("clinical performance test protocol and data analysis is conducted as a requirement of ASTM E1965-98 (2016)").

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 context is a clinical thermometer, where ground truth is typically established by direct measurement of body temperature using a reference standard thermometer (e.g., a rectal thermometer or other highly accurate clinical thermometer) at the same time and under controlled conditions, not by expert consensus on image interpretation.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided and is not typically relevant for a clinical thermometer performance study.

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/ML-driven diagnostic tools where human readers interpret medical images or data. The device in question is a standalone infrared thermometer.

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 performance test evaluated the device (models YRK-002A, T8, T9, T10, T11) directly by measuring human body temperature. The report states that "the clinical performance of the subject device complied with ASTM E1965-98 (2016)." This indicates the device's performance was assessed as a standalone unit.

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

• The ground truth in clinical thermometer studies is typically a simultaneous measurement from a highly accurate reference thermometer (e.g., a rectal or oral thermometer, traceable to national standards) in a controlled clinical setting. The document only states "The clinical performance test protocol and data analysis were conducted in accordance with the ASTM E1965-98 (2016)," which would implicitly define the ground truth methodology.

8. The Sample Size for the Training Set

• Not applicable / not provided. This device is a traditional infrared thermometer, not an AI/ML device that requires a training set.

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

• Not applicable / not provided. As mentioned above, this is not an AI/ML device.

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