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The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable cuff is wrapped around the upper arm. It can be used at medical facilities or at home. The intended upper arm circumference is 22-32cm.Suitable for adults who over the age of 12.

The arm blood pressure monitor model AES-U171, AES-U181, AES-U131 are sphygmomanometers with electronic manometer intended to be used for the indirect (noninvasive) measurement of diastolic, systolic blood pressure and pulse rate using a standard oscillometric method for adults who over the age of 12 (not for neonatal) . The inflatable cuff is wrapped around the upper arm of an individual. The systolic and diastolic blood pressures are transmitted via air pressure and determined by the transducer integrated on the monitor with the oscillometric method. The systolic and diastolic blood pressure values and pulse rate per minute are displayed on the LCD panel.

The monitors AES-U171, AES-U181 and AES-U131 have the same measurement principle, specification, structure, intended use and similar software, the main differences are appearance, and AES-U171 have print function.

The provided text describes the 510(k) summary for the Alicn Medical (Shenzhen), Inc. Arm Blood Pressure Monitor. This document is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a detailed study report of a new, complex AI/ML device. Therefore, it does not fully align with all the requested subsections, especially those related to AI/ML specific criteria like MRMC studies, training set details, or complex ground truth establishment requiring multiple experts.

However, I can extract the relevant information regarding acceptance criteria and performance as presented for this type of medical device (a non-invasive blood pressure monitor) based on the principles of substantial equivalence and relevant standards.

Here's a breakdown of the information and how it relates to your request:

Acceptance Criteria and Study Details for the Arm Blood Pressure Monitor:

The primary acceptance criteria for this device, being a non-invasive blood pressure monitor, are defined by adherence to recognized international standards for accuracy and safety. The study proves the device meets these criteria by showing compliance with these standards.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Eighty-six patients (43 males and 43 females) for the clinical test.
• Data Provenance: The document does not explicitly state the country of origin for the clinical test data, but the company is based in Shenzhen, China. The study is prospective, as it describes inviting patients for the study and conducting measurements.

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

• For non-invasive blood pressure monitors, the "ground truth" for accuracy is typically established by comparative measurements against a reference standard method, not by multiple human experts forming a consensus.
• In this case, the standard is the auscultation method, which is performed by healthcare professionals trained in its use. The document states: "Standard auscultation method was used as the reference blood pressure monitor measuring in the left arm." The number and qualifications of the individuals performing the auscultation are not specified but are presumed to be appropriately trained medical personnel as per the ISO 81060-2 standard.

4. Adjudication Method for the Test Set:

• No "adjudication method" in the sense of multiple experts independently reviewing and then resolving discrepancies (common in imaging studies for AI/ML) is mentioned or relevant here. The ground truth is directly measured using a standard, established method (auscultation). The ISO 81060-2 standard itself outlines the comparison methodology.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for AI often used in diagnostic imaging, where multiple human readers review cases to assess diagnostic performance with and without AI assistance. This device is a direct measurement medical device (blood pressure monitor), not an AI diagnostic tool.

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

• Yes, in essence, the primary performance evaluation of the device's accuracy is a standalone assessment. The device's measurements (systolic and diastolic BP, pulse rate) are compared directly against the reference standard (auscultation). While a human applies the cuff and initiates the measurement, the core measurement and algorithm for determining BP are intrinsic to the device, and its accuracy is evaluated independently of human interpretation of its output beyond simple reading.

7. The Type of Ground Truth Used:

• Reference Standard Measurement: The ground truth for blood pressure and pulse rate accuracy was established using the standard auscultation method, as mandated by ISO 81060-2. This is a direct comparative measurement rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

• This document describes a 510(k) submission for a non-AI/ML device. Therefore, there is no specific "training set" in the machine learning sense. The device's underlying algorithm for oscillometric blood pressure measurement is based on established principles and calibrated to meet the accuracy requirements of the relevant standards (ISO 81060-2, IEC 80601-2-30).

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

• As there is no distinct "training set" for an AI/ML algorithm, this question is not directly applicable. The device's design and calibration process would involve engineering and physiological principles to ensure accurate oscillometric measurements, rather than learning from a labeled dataset. The clinical testing described serves as validation that the developed device performs accurately against a gold standard.

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Non-contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of two months and above of people by detecting infrared heat from the center of the forehead.

The thermometer measures the temperatures of people by detecting the energy. The external probe plays an important role in the measuring process. As soon as the thermometer is placed at the center of the forehead or the object with a distance of 15mm-50mm and the radiation sensor is activated, the measurement will be taken instantly by detection of the infrared heat.

The thermometer AET-R161 can be connected with FOND APP through Bluetooth. The FOND APP applies to mobile phones which systems are Android 4.3 and above, or IOS 8.0 and above, and can be downloaded from Google store (for Android 4.3 and above) or iPhone APP Store (for IOS 8.0 and above). The data measured with AET-R161 can be transmitted to the FOND APP, where data can be recorded, saved and shared.

The device principle of operation is described as below:

All object, solid, liquid or gas, emit energy by radiation. The intensity of this energy depends on the temperature of the object. The Infrared Thermometer is therefore able to measure the temperature of a person by the energy the person emits. This measurement can be taken by an external temperature probe on the device for analysis and register the ambient temperature. Therefore, as soon as the operator holds the thermometer near forehead and activates the radiation sensor, the measurement is taken instantly by detection of the infrared heat generated by the arterial blood flow. Body heat can therefore be measured without any interference from the heat of the surrounding environment.

The thermometer includes four models: AET-R161, AET-R171, AET-R1D2, AET-R1B1. They all have the following basic functions:

• Sound alarm if the temperature exceeds 37.8℃.
• LCD back-lighted digital screen.
• Data displayed in Celsius or Fahrenheit.
• Automatic stop (energy saver).

This document describes the regulatory submission for a Non-contact Infrared Thermometer (Models: AET-R161, AET-R171, AET-R1D2, AET-R1B1) seeking substantial equivalence to a predicate device. The information provided is primarily focused on non-clinical and clinical performance testing to demonstrate that the device meets established standards for accuracy and safety.

Here's an analysis of the provided information, framed as acceptance criteria and proof, as well as limitations based on the document's content:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a "table of acceptance criteria" in the format of pass/fail thresholds for each metric alongside the reported performance. However, it implicitly defines acceptance by stating compliance with various international standards, particularly for performance and safety. The key performance criterion for a thermometer is its accuracy.

Implicit Acceptance Criteria (based on standards) and Reported Performance:

Study Details Proving Device Meets Acceptance Criteria

The primary study cited for clinical performance is the clinical accuracy validation conducted according to ASTM E1965-98 (2009).

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Infants (two months to 1 year old): 38 subjects
  • Children (1 up to 5 years old): 36 subjects
  • Adults (older than 5 years): 42 subjects
  • Total Sample Size: 38 + 36 + 42 = 116 subjects
• Data Provenance: The document does not explicitly state the country of origin. It is presented as a general clinical study. It is a prospective clinical accuracy test as it involves testing a device on live subjects to determine its performance characteristics.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts or their specific qualifications for establishing ground truth. However, the ground truth for human body temperature in a clinical accuracy study (like ASTM E1965-98) would typically be established by highly accurate, often invasive, reference thermometers (e.g., rectal thermometers) operated by trained medical professionals (e.g., nurses, doctors). The "RCT (model: WDJ-001)" mentioned for the clinical study likely refers to a Reference Clinical Thermometer.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. For a direct clinical accuracy study comparing a device's reading to a reference standard, "adjudication" in the sense of expert consensus on ambiguous cases is generally not applicable, as the "ground truth" is a direct measurement from a validated reference instrument.

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

No. An MRMC study was not performed. This device is a non-contact infrared thermometer, which directly measures temperature. Its performance is evaluated against a reference thermometer, not by human readers interpreting images or data. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes. The primary clinical accuracy study described assesses the standalone performance of the thermometer (the algorithm/device itself) in measuring temperature against a reference standard. While a human operates the device, the performance being evaluated is the device's accuracy in autonomously generating a temperature reading.

7. Type of Ground Truth Used

The ground truth used is based on direct measurements from a reference clinical thermometer (model: WDJ-001) in live human subjects across different age groups. This is a direct measurement ground truth, considered highly reliable for temperature measurement studies.

8. Sample Size for the Training Set

The document does not provide any information about a specific training set. Medical devices undergoing 510(k) clearance, especially non-AI based devices like a thermometer, typically rely on fixed algorithms and calibration rather than machine learning models that require training data. If any internal calibration or development was done, the data used for that is not disclosed here.

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

As no training set is described in the context of machine learning, this question is not applicable based on the provided document. The device's calibration and performance are validated against physical standards and clinical studies, rather than "training" an AI model.

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