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Measure blood pressure (systolic and diastolic) and pulse rate.

The Electronic Sphygmomanometer uses an inflatable cuff which is wrapped around the patient's upper arm. After the user pushes the "START/STOP" button, the cuff is inflated automatically by an internal pump. The systolic and diastolic blood pressures are determined by oscillometric method. The deflation rate is controlled by the internal exhaust valve. There is a quick exhaust mechanism so that the cuff pressure can be completely released urgently. There is a maximum pressure safety setting at 300 mmHg. The device will not inflate the cuff higher than 300 mmHg. The device will turn on an irregular heartbeat indicator if an irregular heartbeat was detected during the measurement process. At the end of the measurement, the systolic and diastolic pressures with pulse rate are shown on the LCD and stored in the device memory. The cuff is also deflated automatically to 0 mmHg at the same time.

Below is the information regarding the acceptance criteria and the study that proves the device meets those criteria, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines an "Accuracy" acceptance criterion for the device, which is consistent with the predicate device. The clinical study results are stated to have met this criterion.

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

• Sample Size: 120 subjects
• Data Provenance: Not explicitly stated, but the study was conducted to meet ISO 81060-2 standards, which are international. It's implied to be prospective as it describes a clinical validation study.

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. For blood pressure monitors validated according to ISO 81060-2, the "ground truth" (reference blood pressure) is typically established by trained observers (usually clinicians) using a mercury sphygmomanometer or an equivalent reference device, but the specific number and qualifications of these observers are not detailed here.

4. Adjudication method for the test set:

The adjudication method is not explicitly described. However, the ISO 81060-2 standard, which the study adhered to, typically involves simultaneous auscultatory measurements by two trained observers, often with a third observer for adjudication in cases of discrepancies.

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:

Not applicable. This device is an Electronic Sphygmomanometer for automated blood pressure measurement, not an AI-assisted diagnostic tool requiring human reader interpretation. No MRMC study was conducted or is relevant.

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

Yes, a standalone clinical validation study was performed for the device. The study evaluated the accuracy of the automated non-invasive sphygmomanometer (Electronic Sphygmomanometer Model: LT-P30) against a reference method as per ISO 81060-2.

7. The type of ground truth used:

The ground truth for the clinical validation was established by a reference method, typically auscultation by trained observers, as specified by the ISO 81060-2 standard for clinical validation of automated non-invasive sphygmomanometers.

8. The sample size for the training set:

Not applicable. This document describes the validation of a medical device (Electronic Sphygmomanometer) which is likely based on an algorithmic approach but not an "AI" device in the sense of requiring a "training set" in machine learning. Its accuracy and performance are based on its physical design and established oscillometric principles.

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

Not applicable, as there is no mention of a "training set" in the context of machine learning for this device. The device's operational principles are established, and its accuracy is clinically validated.

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The Fingertip 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 Fingertip Pulse Oximeter is intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Fingertip 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 is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The Pulse Oximeter is powered by 2 AAA alkaline batteries. The device mainly composed of PCB board, On/Off button, OLED or LED or 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.

Here's an analysis of the provided text to fulfill your request, focusing on the acceptance criteria and the study proving the device meets them:

The document is a 510(k) Premarket Notification for a Fingertip Pulse Oximeter (Model LT-F20 and LT-F21). It seeks to demonstrate substantial equivalence to a legally marketed predicate device. The core of the performance data revolves around meeting established standards for pulse oximeters.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the ISO 80601-2-61:2017 standard for pulse oximeter equipment, which the subject device claims compliance with. The reported performance is directly stated.

Note on PR Accuracy: The document explicitly highlights a difference in PR accuracy between the subject and predicate devices. While the predicate states "±2", the subject device states "±1% or ±3bpm, whichever is greater." The manufacturer justifies this difference by stating, "The PR measurement has been verified according to declared range and accuracy. Thus, this difference does not raise different questions of safety and effectiveness."

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

• Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, it does not specify the exact number of subjects or the sample size used for the clinical test set.
• Data Provenance: The data is described as collected from "human adult volunteers." The document doesn't explicitly state the country of origin, but given the manufacturer's location (Zhuhai Linte Medical Instrument Co., Ltd. in China), it's highly probable the study was conducted there. The clinical study is described as having been performed under an "approved protocol with subject informed consent," implying a prospective data collection.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. It mentions "co-oximetry," which is an objective measurement, not expert consensus.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The primary ground truth for oxygen saturation (SpO2) is stated as "arterial oxygen saturation (SaO2) as determined by co-oximetry," which is an objective, quantitative measurement technique and does not typically require human adjudication in the same way as, for example, image interpretation.

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

No. This document describes the validation of a medical device (pulse oximeter) against physiological measurements and established standards, not a comparative effectiveness study involving human readers and AI assistance for interpretation. Therefore, there is no discussion of MRMC studies or effect sizes of human reader improvement with AI.

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

Yes, implicitly. The core of the product is an automated measurement device. The clinical study evaluated the device's accuracy (its "algorithm" or measurement capability) in determining SpO2 and PR against a "human reference standard" (arterial co-oximetry). The device itself functions without human interpretation of its raw sensor data to produce the SpO2 and PR readings.

7. The Type of Ground Truth Used

The ground truth for SpO2 accuracy was "arterial oxygen saturation (SaO2) as determined by co-oximetry." Co-oximetry is an objective, gold-standard laboratory measurement for hemoglobin derivatives.

8. The Sample Size for the Training Set

This document describes a premarket notification for a hardware device (pulse oximeter) with embedded software/firmware for calculating SpO2 and PR. While such devices have internal algorithms, the document does not discuss a "training set" in the context of machine learning/AI models that might have distinct training and test phases. The performance validation is described as a clinical study evaluating the device's output against a reference standard. If an internal algorithm was developed using a dataset, that information is not provided here.

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

As no specific "training set" for an AI/ML model is mentioned, there is no information on how its ground truth was established. The clinical study described is for performance validation, not algorithm training.

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