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The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, Bluetooth® module and plastic shell. The device has wireless connection via Bluetooth®. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

The provided document is a 510(k) premarket notification for a Pulse Oximeter, establishing its substantial equivalence to a previously cleared predicate device. It includes sections on the device description, intended use, comparison to the predicate, and performance data. The following details are extracted to answer your request:

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

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

Based on the "Comparison to the Predicate Device" table and "Clinical data" section:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Clinical Test Set: 12 healthy adult volunteers (4 men and 8 women).
• Data Provenance: The document does not explicitly state the country of origin for the clinical data. It generally refers to "laboratory CO-Oximeter," implying a controlled clinical setting. The study was prospective in nature, involving desaturation of subjects to collect data across the specified SpO2 range.

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

The ground truth for SpO2 accuracy was established by a laboratory CO-Oximeter analysis of arterial blood samples. This does not involve human experts establishing ground truth in the traditional sense of image interpretation. The CO-Oximeter itself serves as the gold standard instrument. The document does not specify the number or qualifications of personnel operating the CO-Oximeter or analyzing blood samples, but it implies a standard laboratory setting.

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

Not applicable for this type of device and study. The ground truth (SpO2 values from CO-Oximeter, PR from reference method implied by the standard) is objective and instrument-based, not based on expert consensus or adjudication. The agreement was analyzed using Bland and Altman statistics.

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

There was no MRMC comparative effectiveness study done. This device is a standalone measurement device (pulse oximeter) and does not involve AI assistance for human readers/interpreters. The focus is on the accuracy of the device's measurements compared to a recognized standard.

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

Yes, the primary performance evaluation for SpO2 and PR accuracy was a standalone performance study of the device's measurements against a reference method (CO-Oximeter for SpO2).

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

For SpO2, the ground truth was instrumental measurement (CO-Oximeter) of arterial hemoglobin oxygen (SaO2) from blood samples. This is considered a highly accurate and objective gold standard for oxygen saturation.
For Pulse Rate (PR), while not explicitly detailed for ground truth method, given the context of ISO 80601-2-61, it would typically involve a reference ECG or other validated heart rate measurement.

8. The sample size for the training set

This document describes a clinical validation study for a medical device, not a machine learning model specific training and test set. Therefore, there is no "training set" in the context of AI/ML. The clinical data of 12 healthy adult volunteers and 1440 data points were used for performance validation.

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

As there is no "training set" for an AI/ML model, this question is not applicable. The device's underlying principle relies on light absorption, not trained algorithms in the sense of deep learning or similar AI methodologies that require large labeled training datasets.

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The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.

The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 mm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. This equipment mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.

The provided text details the 510(k) summary for a Pulse Oximeter (K190869). While it doesn't use the exact term "acceptance criteria" for all performance aspects, it does specify accuracy requirements and the study conducted to demonstrate compliance.

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

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states the SpO2 accuracy and lists successful compliance with relevant standards. For other parameters like SpO2/PR range and resolution, the reported performance matches or exceeds that of the predicate device, implicitly meaning they meet the "acceptance criteria" of being comparable or better.

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

• Sample Size for Physiological (Clinical) Test Set (SpO2 Accuracy): 12 healthy adult volunteers (4 men and 8 women).
• Data Points Collected: Total 1440 data points were sampled for analysis.
• Data Provenance: The study was clinical testing of human subjects. The document does not specify the country of origin for the clinical study, but the submitting company and correspondent are based in Shenzhen, China. It was a prospective study involving human subjects for direct measurement.

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

The ground truth for SpO2 accuracy was established against a laboratory CO-Oximeter, which is an objective, gold-standard laboratory instrument for measuring arterial blood gas saturation (SaO2). Therefore, "experts" in the sense of human readers interpreting data were not used for the primary SpO2 accuracy ground truth. The expertise would lie in the accurate operation and calibration of the CO-Oximeter and the proper execution of the clinical trial protocol.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 accuracy was established using a laboratory CO-Oximeter, which provides a direct, objective measurement (SaO2) from blood samples. This does not involve human interpretation or subjective assessment that would require an adjudication method.

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

No. The document describes a clinical study to assess the device's accuracy against a laboratory reference standard (CO-Oximeter), not a comparative effectiveness study involving multiple human readers with and without AI assistance (as this is a standalone measurement device, not an AI interpretation tool).

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

Yes, for its primary function (SpO2 and PR measurement), the device operates in a standalone manner. The clinical study described evaluates the device's direct measurement performance (algorithm only) against a gold standard, without human interpretation in the loop influencing the measurement itself.

7. The Type of Ground Truth Used

The primary ground truth for the clinical accuracy study was objective laboratory measurement data: arterial hemoglobin oxygen (SaO2) values determined from blood samples using a CO-oximeter.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. This is a medical device (pulse oximeter) that performs real-time physiological measurements based on established physical principles of light absorption, rather than an AI/machine learning algorithm that requires a distinct training phase on a large dataset. The device's underlying principles (e.g., Beer-Lambert Law principles applied to pulsatile blood flow) are physics-based, not learned from a training dataset in the AI sense.

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

Not applicable. As explained in point 8, this is not an AI/machine learning device requiring a training set and associated ground truth establishment in that context. The device's operation is based on fundamental optical and physiological principles. The "training" for such devices typically involves extensive engineering, calibration, and verification against physical models and known physiological responses, rather than data-driven learning from a labeled training set.

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The Infrared thermometer model A200 is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature by Forehead mode for people of all ages.

The Infrared thermometer model A201 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode or Forehead mode for people of all ages.

The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or central forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or central forehead.

The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of contact or no-contact use and compensation of the temperature reading.

The device consists of the MCU, enclosure and LED and the device is powered by 2 AAA alkaline batteries.

The device has a memory function that automatically stores 25 sets data of the latest measurements. It can also display the latest measurement result.

The Infrared thermometer included A200 & A201. A200 unit is a no- contact Infrared forehead thermometer, A201 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode.

The provided text describes the 510(k) Summary for the Infrared thermometer models A200 and A201. It includes a comparison to predicate devices and discusses performance data but does not provide a comprehensive study proving the device meets specific acceptance criteria in the format requested.

The document discusses conformance to standards as evidence of performance, but does not present a detailed study with acceptance criteria and results for each.

However, based on the provided text, here's an attempt to extract and infer the closest information to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily refers to compliance with established standards rather than specific acceptance criteria thresholds in a direct table format. The "Accuracy" section under the predicate comparisons acts as the closest representation of performance.

Model A200 (Forehead Mode)

Model A201 (Ear/Forehead Mode)

Note: The document states that "the measurement range of subject devices meet the requirements of ISO80601-2-56" and that the "performance test result of A200 & A201 shows the accuracy meets the requirements within the distance range." This implies that the device met the requirements outlined in these standards for accuracy and measurement distance, which serve as the acceptance criteria.

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

The document mentions:

• Clinical data: "According to the ASTM E 1965-98, the clinical trial was performed for people of all ages."
• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is inferred to be prospective as it's a "clinical trial."

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

This information is not provided in the document. The reference to a "clinical trial" implies expert involvement in temperature measurement (e.g., using a reference thermometer), but details about these experts (number, qualifications) are absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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 as the device is an infrared thermometer for direct measurement, not an AI-assisted diagnostic tool that would involve human "readers."

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

Yes, the device operates in a standalone manner as an infrared thermometer. Its performance is evaluated intrinsically through various tests and a clinical trial. The "Performance Data" section details compliance to standards and verification of:

• Measurement Range & Accuracy
• Measurement distance
• Response time

The "Clinical data" section further confirms its standalone performance: "The test report shows clinical accuracy meets the range claimed by manufacturer. It can conclude that the subject devices, model A200 & A201, are acceptable to measure human body's temperature."

7. The Type of Ground Truth Used

The ground truth for the clinical trial would likely be established using a (reference) clinical thermometer considered the gold standard for body temperature measurement, against which the infrared thermometer's readings are compared. This is implied by "clinical accuracy" evaluation. It is not pathology or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable as the device is not described as involving machine learning or AI algorithms requiring a training set. It is a traditional medical device based on established physical principles (infrared radiation detection).

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

This information is not applicable for the reasons stated in point 8.

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