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The non-invasive Masimo O3® Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors in patients in healthcare environments. The O3® Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40kg.

When used with the O3 Pediatric Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation (rSO2) in the tissue under the sensor. The Masimo O3 Regional Oximeter consists of the following components: 03 Module, 03 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root).

The O3 Regional Oximeter System provides the following key measurements and calculated features:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Abase): Calculation of the relative difference in rSO2 with respect to baseline rSO2.
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user defined rSO2 low alarm limit (LAL).
• Delta SpO2 (4SpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (1HHb): Index associated with the change in deoxygenated hemoglobin.
• Delta O2Hb (ΔO2Hb): Index associated with the change in the oxygenated.
• Delta cHb (AcHb): Calculation of the sum of the Delta HHb and Delta O2Hb, and is an index, associated with the change in the total (oxygenated and deoxygenated) hemoglobin.

The document describes the Masimo O3 Regional Oximeter System and its update to include adjunct monitoring of absolute rSO2 in non-cerebral sites, specifically for adults. The performance data presented focuses on the accuracy (ARMS) of the Oximeter.

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

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

The document provides the acceptance criteria in terms of accuracy (ARMS) specifications for different measurements and patient populations. It implicitly states that the clinical study data supports these specifications.

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

• Sample Size for the Test Set: 25 subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted clinically with "a controlled desaturation protocol," which implies a prospective study design.

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

The document states that the rSO2 readings were compared against "tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples." This indicates that the ground truth was established through direct physiological measurement rather than expert interpretation of images or other data. Therefore, the concept of "experts" to establish ground truth in the traditional sense of, e.g., radiologists interpreting images, does not directly apply here.

4. Adjudication method for the test set

Not applicable. The ground truth was established through physiological measurements (arterial and venous blood samples), not through human adjudication of interpretations.

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 oximeter, a physiological monitoring device, not an AI-powered diagnostic imaging tool that would typically involve human readers. The study focuses on the device's accuracy in measuring rSO2.

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

Yes, the clinical testing described in the document is a standalone performance study. The Masimo O3 Regional Oximeter's rSO2 readings were recorded and directly compared to the physiological ground truth (SvO2 computed from blood samples). There is no mention of a human-in-the-loop component in evaluating the device's accuracy.

7. The type of ground truth used

The ground truth used was outcomes data directly related to physiological measurement: tissue oxygen saturation (SvO2) computed using a combination of arterial and venous blood samples.

8. The sample size for the training set

The document does not specify a separate "training set" or its size. This type of device relies on established biophysics and calibration rather than a machine learning model that requires a distinct training phase with annotated data. The clinical study described served as a validation (test) set for the device's performance against a gold standard.

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

As no distinct training set for a machine learning model is described, this question is not applicable. The device's underlying principle relies on multi-distance diffusion spectroscopy, which is a physical measurement technique. Calibration and validation would have been performed during the device's development using known physiological states. The clinical study served as the final validation of its performance in a clinical setting against a direct physiological measure.

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The non-invasive Masimo O3® Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the tissue under the sensors in patients in healthcare environments. The O3® Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3® Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (tSO2) on cerebral sites and trending rSO2 on non-cerebral sites in adults > 40kg.

When used with the O3 Pediatric Sensor, the O3® Regional Oximeter for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in pediatrics ≥ 5 kg and

The Masimo O3 Regional Oximeter is a noninvasive regional oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation under the sensor. The Masimo O3 Regional Oximeter consists of the following components: 03 Module, O3 Sensors (e.g. O3 Adult, O3 Pediatric, and O3 Infant/Neonatal Sensors), and a display monitor (e.g. Root) same as those cleared under K182429.

The O3 System provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2.
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time) the patient stays below rSO2 low alarm limit and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
• Delta SpO2 (ASpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (ΔHHb): a measure of the relative change in deoxygenated hemoglobin.
• Delta 02Hb (ΔΟ2Hb): a measure of the relative change in the oxygenated hemoglobin.
• Delta cHb (ΔcHb): the sum of the Delta HHbi and Delta O2Hbi, as a measure of the relative change in the total hemoglobin.

The provided text is a 510(k) premarket notification from Masimo Corporation for their O3 Regional Oximeter System. The purpose of this submission is to expand the indications for use of an existing device. It does not describe a study that validates the device meets acceptance criteria in the format typically seen for novel AI/ML devices or diagnostic accuracy studies. Instead, it aims to demonstrate substantial equivalence to a predicate device, particularly for expanded indications.

Therefore, many of the requested details about acceptance criteria, ground truth, expert adjudication, MRMC studies, and training set information are not explicitly present in this document because the nature of the submission (510(k) for expanded indications) focuses on demonstrating equivalence rather than a full de novo validation of a new device's performance against specific clinical endpoints with granular data.

However, I can extract the relevant performance specifications and describe the studies conducted to support the expanded indications based on the information available.

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

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

The document doesn't present "acceptance criteria" in the typical sense of a diagnostic claim (e.g., sensitivity, specificity, AUC). Instead, it provides performance specifications for the regional oximeter and describes studies designed to demonstrate that the device performs comparably to reference methods or predicate devices for the expanded indications.

The key performance specifications listed are:

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The non-invasive Masimo O3 Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. The use of any other sensor is not supported or recommended by Masimo and could give erroneous results.

When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40 kg.

When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in pediatrics ≥ 5 kg and

The Masimo Regional Oximetry System monitors regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System includes the O3 Sensors that acquire physiological signals and the O3 Module that processes those signals. The FDA has previously cleared the O3 System in K160526 (with an O3 Adult Sensor) and K162603 (with an O3 Pediatric Sensor). In this submission, Masimo seeks clearance of its O3 System with an 03 Neonatal Sensor.

Similar to the cleared O3 Adult and Pediatric Sensors, the O3 Neonatal Sensor is a singlepatient use, adhesive sensor and is supplied non-sterile. The O3 Neonatal Sensor attaches to the patient's forehead. The sensor includes four emitters and two detectors. The emitters radiate multiple wavelengths of near infrared light, while the detectors sense the reflected light. The detector outputs are physiological signals and these signals pass through the other end of the sensor that connects to a patient cable, passing these signals to the O3 Module for processing.

The O3 Module is unchanged from K160526. It includes Masimo technology for processing those signals and outputting regional oximetry (tSO2) measurements. Specifically, the O3 Module includes Near Infra Red Spectroscopy (NIRS) technology. When O3 module is connected to an O3 Neonatal Sensor, the O3 Monitor continuously and accurately determines the trending measurement of regional blood oxygen saturation in the tissue (rSO2) in neonates. In turn, the Host/Backboard device displays this measurement. The O3 Module can connect to up to two O3 Sensors, both connected to a patient.

The O3 System does not have an internal battery or an AC power input. The O3 Module, instead, receives power via its connection to a Host/Backboard Device, such as the Root Monitoring System (Root). Root in turn receives power from either AC power or internal rechargeable batteries.

Similar to K160526, the O3 System using an O3 Neonatal Sensor provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site, including cerebral tissue
• Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the userdefined rSO2 low alarm limit (LAL)
• . Delta SpO2 (4SpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

Here's an analysis of the acceptance criteria and study information for the Masimo O3 Regional Oximeter System, specifically focusing on the O3 Neonatal Sensor, based on the provided text:

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter System (O3 Neonatal Sensor)

1. Table of Acceptance Criteria and Reported Device Performance:

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The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and

The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.

The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn is connected to the 03 Module. Up to two 03 Sensors can be connected to each 03 Module and both sensors can be connected to a patient.

The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root in turn is powered by either AC power or internal rechargeable batteries.

The O3 System provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site, including cerebral tissue
• Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
• Delta SpO2 (ΔSpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

The provided document describes the Masimo O3 Regional Oximeter System, specifically focusing on the O3 Pediatric Sensor, and its equivalence to predicate devices (K160526 and K082327). The document outlines non-clinical and clinical testing performed to demonstrate substantial equivalence.

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

The acceptance criteria for accuracy are presented as ARMS (Accuracy Root Mean Square) values.

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The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (tSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg in healthcare environments.

The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.

The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn connected to the 03 Module. Up to two 03 Sensors can be connected to each O3 Module and both sensors can be connected to a patient.

The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root). Root in turn is powered by either AC power or internal rechargeable batteries.

The O3 System provides the following key measurements:

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep o tissue local to the sensor site, including cerebral tissue
• o Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2
• Area Under the Limit (AUL index): Index that quantifies the duration (amount of ● time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
• o Delta SpO2 (dSpO2): The difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).

Here's a summary of the acceptance criteria and study information for the Masimo O3 Regional Oximeter System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "SavO2": The document mentions "SavO2" in the context of the clinical study, stating accuracy against "30% arterial and 70% jugular venous blood oxygen saturations". This implies that SavO2 is a composite measure or target for regional oxygen saturation, often calculated based on arterial and venous contributions. The acceptance criteria for rSO2 accuracy are directly related to this measured range.

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

• Sample Size: "healthy adult male and female subjects with light to dark skin pigmentation." The specific number of subjects is not provided in the document.
• Data Provenance: The study was a prospective clinical study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be from a region where clinical trials meet FDA standards, likely the USA.

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

• Number of Experts: This information is not applicable as the ground truth was established by direct physiological measurements, not expert review of images or data.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by direct physiological measurements using a laboratory CO-Oximeter.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a measurement device, not an imaging interpretation aid for human readers.

6. Standalone Performance Study

• Standalone Performance: Yes, the clinical study explicitly evaluates the device's accuracy ("trending and absolute rSO2 accuracies were determined") against a laboratory standard, indicating a standalone performance study without human intervention in the primary measurement.

7. Type of Ground Truth Used

• Ground Truth Type: Physiological measurements: "30% arterial and 70% jugular venous blood oxygen saturations, measured by a laboratory CO-Oximeter." This is a direct, objective physiological measurement.

8. Sample Size for the Training Set

• Sample Size: The document does not specify a separate training set or its sample size. For simple measurement devices like an oximeter, "training" often refers to the device's inherent calibration and algorithm development, which might not involve a distinct, large-scale "training set" in the same way machine learning models for image analysis do. The clinical study described appears to be the primary validation set.

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

• Ground Truth for Training: As no distinct training set is described, this information is not provided in the document. It's likely that the device's algorithms were developed and refined through engineering and calibration processes against established physiological principles and potentially internal studies, rather than a publicly reported "training set" with ground truth established through a formal process analogous to a clinical trial.

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