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The Fingertip Pulse Oximeter are intended for measuring function of arterial hemoglobin (SpO2) and pulse rate for both adults and adolescent as not checking in home and professional caring environment. It is designed for fingers between 7mm and 25.4mm in diameter (0.28 inches to 1.0inches). And it is not intended to be used under motion or low perfusion scenarios.

The Fingertip Pulse Oximeter X1609P is a fingertip device, which can measure the arterial SpO2 and pulse rate value and can display the results to the user. Moreover, the X1609P also has the function of low battery voltage indicate and automatically power off. The power source is 2xAAA batteries. Fingertip Pulse Oximeter X1609P is small in volume, light in weight and convenient in carrying. It is composed of light signal driving circuit, preamplification circuit, low pass filtering circuit, DC bias circuit, gain control circuit, display control circuit, and main control circuit. The device is for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterile.

Here's an analysis of the provided FDA 510(k) summary for the Finger Pulse Oximeter, Model: X1906P, organized to address your specific points about acceptance criteria and study proof.

It's important to note that this document is a summary for a 510(k) submission, and therefore provides high-level information. Full details of the protocols, raw data, and statistical analyses would be found in the complete submission documents, which are not provided here.

Acceptance Criteria and Device Performance

The core of the performance evaluation for a pulse oximeter revolves around its accuracy in measuring oxygen saturation (SpO2) and pulse rate (PR). The key standard referenced is ISO 80601-2-61: 2017 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of Fingertip Pulse Oximeter Equipment. The acceptance criteria are typically derived from this standard.

1. Table of Acceptance Criteria and Reported Device Performance:

Note on Acceptance Criteria Interpretation: The document states that "Bench testing was conducted, and the results show that the subject device complies with the ISO 80601-2-61: 2017... standard. And Pulse Rate Accuracy meets the requirements defined in ISO 80601-2-61, Clause 201.12.1.104." This implies the acceptance criteria were the specific performance requirements outlined in that ISO standard for accuracy, which is typically Average Root Mean Square (ARMS) difference for SpO2. The specific numerical ARMS values are not explicitly stated for the device's performance, but rather that it "conformed with the requirements."

Study Details

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

• Sample Size: 13 adult volunteers.
  • Breakdown: 5 males, 8 females.
  • Fitzpatrick skin types included: 3 subjects with Fitzpatrick VI, 3 subjects with Fitzpatrick II, and 7 subjects with Fitzpatrick IV. This inclusion of diverse skin tones is crucial for pulse oximetry accuracy.
• Data Provenance: The document does not explicitly state the country of origin for the clinical study. Given the manufacturer (Shenzhen Changkun Technology Co., Ltd. from China) and consultant (Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. from China), it is highly probable the study was conducted in China.
• Retrospective or Prospective: The study description "Clinical studies were conducted to verify the accuracy of proposed device" and "There were 13 adult volunteers to validated the accuracy of finger pulse oximeter" indicates a prospective clinical study.

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

The document does not mention the use of experts to establish ground truth in the traditional sense of image adjudication or clinical interpretation, as this is a pulse oximeter accuracy study. The "ground truth" for SpO2 and pulse rate is established through direct, highly accurate physiological measurements:

• SpO2 Ground Truth: Measured by a blood gas analyzer (SaO2).
• Pulse Rate Ground Truth: Measured by a patient monitor (HR).

These are considered gold standards for these physiological parameters. Therefore, the concept of "experts establishing ground truth" as it applies to subjective interpretation (like radiology reads) is not directly applicable here. The expertise lies in the certified laboratory/clinical personnel performing the blood gas analysis and operating the patient monitor, ensuring proper calibration and technique. Specific qualifications of these operators are not detailed but are assumed to be standard for clinical laboratory and patient monitoring practices.

4. Adjudication Method for the Test Set:

Not applicable in the context of this study. This study directly compares the device's numerical output against gold-standard physiological measurements (blood gas analyzer for SaO2, patient monitor for HR). There is no "adjudication" of the device's readings by human experts in the sense of consensus reading or interpretation.

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 more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. For a pulse oximeter, the study design is centered on direct numerical accuracy against a gold standard, not human reader performance.

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

Yes, the clinical accuracy study described for the pulse oximeter is effectively a standalone study. The device's measurement (SpO2 and PR) is directly compared to the reference measurement (blood gas analyzer and patient monitor) without an explicit "human-in-the-loop" component influencing the device's output or the ground truth measurement. The user of the oximeter reads the displayed value, but the study validates the intrinsic accuracy of the measurement.

7. The Type of Ground Truth Used:

• SpO2 Ground Truth: Physiological measurement via arterial blood gas analysis (SaO2). This is considered a gold standard for true arterial oxygen saturation.
• Pulse Rate Ground Truth: Physiological measurement via a patient monitor (HR). This is also considered a gold standard for heart rate.

8. The Sample Size for the Training Set:

The document does not provide information on a training set size. For a traditional medical device like a pulse oximeter, "training set" is usually not a relevant concept in the same way it is for AI/ML algorithms. The device's underlying principles (Lambert Beer Law, photo-plethysmography) are based on established physics and physiology, not on learning from a dataset. Any internal calibration or algorithm refinement would be part of the engineering design process, not typically referred to as a "training set" in the context of FDA submissions for such devices.

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

As there is no mention of a "training set" in the context of AI/ML, this question is not applicable. The device's design and calibration are based on established scientific principles and engineering practices, not on a machine learning training dataset. The clinical study validates the final, produced device's performance against established physiological ground truth.

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The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion. The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.

The provided text is a 510(k) summary for the YUWELL® Finger Pulse Oximeter. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter, K101577). The key performance acceptance criteria can be inferred from the comparison table and the clinical study results.

Table of Acceptance Criteria and Reported Device Performance (Inferred from comparison and study results):

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The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital.

The fingertip pulse oximeter features a small size, low power consumption, a convenient operation, and portability.It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement.

Principle of the fingertip pulse oximeter as follows:

A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones.

Operation principle of the instrument:

Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The core acceptance criteria for the Fingertip Pulse Oximeter relate to its accuracy in measuring SpO2 and Pulse Rate.

Note: For SpO2, no definition is provided for the 0%~69% range, implying the device is not specified to be accurate in this range.

The device's performance is stated to meet the criteria specified in ISO 80601-2-61.

Study Details

The assessment of the device's accuracy was conducted through a clinical study described as a "Clinical hypoxia accuracy testing (controlled desaturation study)."

1. Sample Size used for the test set and Data Provenance:

   • Sample Size: 12 subjects were enrolled.
   • Total Data Sets Collected: 294
   • Valid Data Sets: 288 (6 data sets less than 70% SpO2 were excluded).
   • Data Provenance: The study was conducted during "induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory." This indicates a prospective study design. The country of origin is not explicitly stated, but the manufacturer and consultant are based in China.

2. Number of experts used to establish the ground truth for the test set and their qualifications:
   The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the ground truth was established by a "CO-oximeter (control device)" from arterial blood samples. This implies that medical professionals (e.g., lab technicians, clinicians) would have been involved in collecting and analyzing these samples, but their specific roles or qualifications are not detailed.

3. Adjudication method for the test set:
   The text does not mention an adjudication method (like 2+1, 3+1). The "ground truth" was directly compared from the CO-oximeter.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
   No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a ground truth, not on how human readers' performance improved with or without AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, a standalone performance study was done. The "measured arterial hemoglobin saturation value (SpO2) of the subject device" was directly compared to the arterial blood samples, indicating an assessment of the device's accuracy on its own.

6. The type of ground truth used:
   The ground truth was established using arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). This is considered a highly accurate and direct measurement suitable for establishing ground truth for oxygen saturation.

7. The sample size for the training set:
   The document does not provide information about a specific training set or its size. This submission is for the device's performance evaluation, implying the device (or its underlying algorithms) would have been developed and "trained" prior to this evaluation.

8. How the ground truth for the training set was established:
   As no information about a training set is provided, how its ground truth was established is also not available in this document.

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PM601 Finger pulse oximeter is intended for spot-checking oxygen saturation in blood (SpO2) and pulse rate. The pulse oximeter is used on adults at hospital, clinics, and/or home. Not for continuously monitoring.

The proposed device, Finger Pulse Oximeters PM601 is a fingertip device, which can display % SpO2. pulse rate value and pulse strength. It is based on digital blood oxygen. Power consumption of the proposed device is low and the two originally-equipped AAA alkaline batteries can be operated continuously for 24 hours. It will automatically turned off when no signal is detected for more than 8 seconds. And low voltage warning will be displayed and battery symbol flash when battery voltage is low.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring.

The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse. Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. The device incorporates a battery state indicator and provides a visual indication of low battery.

Here's a breakdown of the acceptance criteria and the study information for the SB100II Finger Pulse Oximeter, based on the provided documents:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Discussion of Performance vs. Criteria:

• SpO2 Accuracy: The SB100II reports an accuracy of +/-3% in the 70-99% range. The document states this is "Similar, actual Arms 2.5 Meets FDA guidance for non-motion ≤ 3.0 % Meets ISO 9919 for non-motion

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The Nonin® Onyx II® Model 9560 Finger Pulse Oximeter is a small, lightweight, portable, device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 -- 2.5 cm) thick. The index finger is the recommended site.

The Model 9560 is a small, lightweight, portable finger pulse oximeter with Bluetooth® communication which can be integrated into a telemedicine system or other health data collection system through the wireless connection. The device displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light emitting diodes (LEDs) are contained within the sensor along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and heart rate are displayed on the LED digital displays contained within the finger clip sensor. A tricolor LED display provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates as inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by inserting a patient's finger. This allows the power to be applied to all the internal circuitry upon activation. The Model 9560 uses 2 "AAA" disposable alkaline batteries for power, which shall provide 600 spot-checks. The 9560 requires no routine calibration or maintenance other than replacement of the alkaline batteries.

The provided text from K081285 describes a 510(k) submission for the Nonin Onyx II Model 9560 Finger Pulse Oximeter. While it states that the device "has successfully undergone both bench and human testing to support the determination of substantial equivalence," it does not provide explicit acceptance criteria or detailed study results and methodologies to definitively prove the device meets specific acceptance criteria. The document focuses on establishing substantial equivalence to predicate devices based on accuracy, functional design, and operating principles.

However, based on the context of pulse oximeter submissions, we can infer typical acceptance criteria and study types. I will construct an answer assuming standard practices for pulse oximeter submissions, explaining where information is explicitly stated and where it is inferred.

Inferred Acceptance Criteria for Pulse Oximeters based on FDA Guidance:

For pulse oximeters, key performance metrics typically involve accuracy for oxygen saturation (SpO2) and pulse rate (PR).

• SpO2 Accuracy: Often, the accuracy requirement for SpO2 is expressed as the Root Mean Square (RMS) difference between the oximeter reading and a reference standard (e.g., arterial blood gas co-oximetry). A common range for this is ≤ 3% ARMS (Accuracy Root Mean Square) across the specified SpO2 range (e.g., 70-100%).
• Pulse Rate Accuracy: Similarly, pulse rate accuracy is typically assessed against an ECG reference. A common requirement is ± 3 bpm (beats per minute).

Study and Performance Details from the Provided Text (and inferred standards):

Given the limitations of the provided document, the table below will combine explicitly stated information with common expectations for pulse oximeter 510(k) submissions.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Nonin's Model 9560 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence." This implies that the device met internal acceptance criteria for these tests, which would align with the inferred clinical accuracy requirements for pulse oximeters. However, the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.

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

• Sample Size for Test Set: Not explicitly stated. For clinical accuracy studies of pulse oximeters, the FDA typically recommends a minimum of 10 healthy adult subjects in a desaturation study to obtain sufficient data points across the hypoxic range (70-100% SpO2).
• Data Provenance: The document does not specify the country of origin of the data. It states "human testing," which usually implies prospective clinical studies where subjects are enrolled and data collected for the specific purpose of the device evaluation. There is no indication of retrospective data use.

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

• Number of Experts: Not applicable/Not explicitly stated. For pulse oximeter accuracy studies, ground truth for SpO2 is typically established using a laboratory co-oximeter to analyze arterial blood samples, not through expert review of data. For pulse rate, an ECG machine provides the ground truth.
• Qualifications of Experts: N/A for establishing SpO2/PR ground truth in this context. Medical professionals (e.g., anesthesiologists, nurses) would oversee the subject desaturation protocol and blood draws, but they are not "experts" establishing a consensus ground truth like in image interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used when subjective interpretations are involved, such as in clinical trials requiring event confirmation or in diagnostic imaging studies where multiple readers interpret images to establish a consensus ground truth. For pulse oximeter accuracy, the ground truth is objective (co-oximetry and ECG), so no adjudication of device readings or reference measurements is needed in the same way.

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

• MRMC Study: No, not applicable. MRMC studies are designed for diagnostic devices where human readers (e.g., radiologists, pathologists) interpret cases (e.g., medical images) to diagnose conditions, and the study evaluates the impact of an AI algorithm on their performance. The Nonin Onyx II Model 9560 is a direct measurement device; it does not involve human interpretation of complex "cases" that an AI would assist with. Therefore, an MRMC study is not relevant for this type of device.
• Effect Size of Human Readers with/without AI assistance: N/A, as no MRMC study was conducted.

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

• Standalone Performance: Yes, implicitly. The core "human testing" mentioned for a pulse oximeter involves directly comparing the device's readings (SpO2 and pulse rate) against the objective reference standards (arterial blood gas co-oximetry for SpO2 and ECG for pulse rate). This is a standalone evaluation of the device's algorithm and sensor performance in producing accurate readings. The device is designed to display these measurements directly, not to provide an AI-driven interpretation that then guides a human.

7. The Type of Ground Truth Used

• Type of Ground Truth:
  • For SpO2: Arterial blood gas co-oximetry. This is the gold standard for determining arterial oxygen saturation (SaO2), against which pulse oximeters' SpO2 readings are compared.
  • For Pulse Rate: Electrocardiogram (ECG). An ECG provides an accurate measure of heart rate, which serves as the reference for the pulse oximeter's pulse rate measurement.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not explicitly stated. The document describes a traditional medical device (pulse oximeter) that uses fixed algorithms and signal processing, not a machine learning or AI-based algorithm that typically requires a distinct "training set" in the common sense. Therefore, the concept of a separate training set, as understood in AI/ML, doesn't directly apply here. The device's algorithms are likely developed and refined using engineering principles and historical physiological data rather than a specific "training set" for a submission study.

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

• How Ground Truth for Training Set was Established: Not applicable. As explained above, for this type of device, a "training set" as commonly defined in AI/ML is not relevant. The device's underlying physiological models and calibration would have been established through extensive research and development, likely using various physiological data and established scientific principles, rather than a single "training set" with an explicitly established ground truth for regulatory purposes.

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The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of patients who are well or poorly perfused. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 – 1.0 inch (0.8 – 2.5 cm) thick. The index finger is the recommended site.

The Onyx® II Model 9550 is a small, lightweight, portable, finger pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light omitting diodes (LEDs) are contained within the sensor along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and heart rate are displayed on the LED digital displays contained within the finger clip sensor. A tricolor LED display provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates as inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by inserting a patient's finger. This allows the power to be applied to all the internal circuitry upon activation. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

The provided text is a 510(k) summary for the Onyx® II Model 9550 Finger Pulse Oximeter. It unfortunately lacks detailed information regarding specific acceptance criteria for performance metrics and the associated study data that would directly "prove" the device meets them in the way requested. This document primarily focuses on establishing substantial equivalence to a predicate device.

However, based on what is available, I can extract and infer some information, particularly around the "Functional and Safety Testing" section:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Nonin's Model 9550 Finger Pulse Oximeter has successfully undergone bench testing in order to demonstrate that it has appropriate functional features and is substantially equivalent to the predicate device." While specific numerical acceptance criteria are not provided, the implied acceptance criterion is "has appropriate functional features and is substantially equivalent to the predicate device." The reported performance is that the device "successfully undergone bench testing" and meets this criterion.

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

• Sample Size for Test Set: Not explicitly stated. The summary refers to "bench testing" but does not give numerical sample sizes for any performance testing.
• Data Provenance: Not explicitly stated. However, "bench testing" typically implies laboratory or controlled environment testing, not necessarily clinical data with geographic provenance. It's likely prospective for the specific tests conducted for this submission.

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. Oximeters typically rely on direct comparison to arterial blood gas analysis (co-oximetry) for accuracy, which wouldn't involve "experts" establishing ground truth in the same way an imaging study would.

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

This information is not provided. Given the nature of oximetry testing, an adjudication method for ground truth establishment as typically seen in image interpretation studies is not usually applicable.

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 study was NOT done. This device is a pulse oximeter, not an AI-assisted diagnostic imaging tool. Therefore, the concept of "human readers improve with AI" is not applicable.

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

• Yes, in essence. A pulse oximeter operates as a standalone device, providing SpO2 and pulse rate readings directly. The "bench testing" mentioned would assess the algorithm's accuracy in calculating these values against a reference standard. There is no explicit "human-in-the-loop" component for interpretation of the raw data by the end-user.

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

While not explicitly stated for this specific submission, the industry standard for establishing ground truth for pulse oximeters is typically co-oximetry (arterial blood gas analysis). This involves simultaneous measurement of SpO2 by the device and a laboratory co-oximeter from an arterial blood sample.

8. The sample size for the training set:

• Not applicable. This device is not described as involving machine learning or AI models that require a "training set."

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

• Not applicable. (See point 8.)

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The Nonin® Onyx® II Model 9550 Finger Pulse Oximeter is a small, lightweight, portable device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for spot-checking of adult and pediatric patients on fingers (other than the thumb) between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick. The index finger is the recommended site.

The Model 9550 Onyx® II is a small, lightweight, portable, finger pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate. Light omitting diodes (LEDs) are contained within the sensor along with the photo detector, which is on the opposite side of the probe from the LEDs. The SpO2 and heart rate are displayed on the LED digital displays contained within the finger clip sensor. A tricolor LED display provides a visual indication of the pulse quality signal, while blinking at the corresponding pulse rate. This display changes colors to alert you to changes in pulse quality that may affect the readings: green indicates a good pulse quality signal, yellow indicates a marginal pulse quality, and red indicates as inadequate pulse signal. All associated electronics and the microprocessor are within the sensor, which is activated by inserting a patient's finger. This allows the power to be applied to all the internal circuitry upon activation. The device is intended for spot-checking adult and pediatric patients who are well or poorly perfused.

This document describes the acceptance criteria and study used to demonstrate the performance of the Nonin Medical, Inc. Onyx® II Model 9550 Finger Pulse Oximeter.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria with specific thresholds for accuracy or precision of SpO2 and pulse rate measurements. However, it indicates that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications." The conclusion states that the device "is substantially equivalent to the predicate devices in terms of accuracy, functional design and principles of operation," implying that its performance meets comparable levels to the predicate device, the Model 9500 Onyx® Finger Pulse Oximeter (K001085).

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of human subjects or data points used in the "human oxygenation evaluations."
• Data Provenance: The document does not explicitly state the country of origin. It indicates "human testing to support the determination of substantial equivalence." Given the submitter (Nonin Medical, Inc.) is based in Plymouth, MN, USA, it is highly probable the data was collected in the USA. The study was prospective, as it involved human oxygenation evaluations specifically conducted to confirm conformance to specifications for this new device.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. This device is a pulse oximeter which directly measures physiological parameters (SpO2 and pulse rate). Ground truth for such devices is typically established through a reference method, not expert consensus on interpretations. The ground truth for oxygen saturation would likely be based on an arterial blood gas analyzer.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study is based on direct physiological measurements against a reference standard, not interpretations requiring adjudication.

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

Not applicable. This device is a standalone diagnostic tool, not an AI-assisted interpretation system for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "human oxygenation evaluations" were conducted to assess the performance of the device itself (algorithm only) in measuring SpO2 and pulse rate against reference standards. The document explicitly states, "Functional and Safety Testing: Nonin's Onyx® II Model 9550 Finger Pulse Oximeter has successfully undergone both bench and human testing to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications."

7. Type of Ground Truth Used

The ground truth for the "human oxygenation evaluations" was almost certainly a reference method for blood oxygen saturation and pulse rate measurement, such as direct arterial blood gas analysis for oxygen saturation and an ECG or manual pulse check for pulse rate. The term "human oxygenation evaluations" strongly implies a comparison against a more invasive and accurate reference standard.

8. Sample Size for the Training Set

Not applicable. Pulse oximeters are typically developed based on established physiological principles and algorithms, not through machine learning models requiring a "training set" in the common AI sense. The algorithms are built upon physics of light absorption and blood pulsation.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there isn't a "training set" in the machine learning context for this type of device. The underlying principles and algorithms are based on established physiological and engineering principles.

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