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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 sensor 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 O3 Module, O3 Sensors (e.g., O3 Adult, O3 Pediatric, O3 Infant/Neonatal sensors), and a Host/Backboard Device (e.g., Root).

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

• Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue local to the sensor site.
• Delta Baseline (Δbase): 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 (ΔSpO2): Calculation of the difference between SpO2 and rSO2. The source of SpO2 is from peripheral SpO2 measurement (using pulse oximeter).
• Delta HHb (ΔHHb): Index associated with the relative change in deoxygenated hemoglobin.
• Delta O2Hb (ΔO2Hb): Index associated with the relative change in the oxygenated hemoglobin.
• Delta cHb (ΔcHb): 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 provided FDA 510(k) clearance letter and summary for the Masimo O3 Regional Oximeter (K243324) states that the submission is for an expansion of indications for existing "delta features" (ΔO2Hb, ΔHHb, ΔcHb) of the device. This means the core rSO2 measurement accuracy was not re-evaluated, as it was previously cleared under the predicate (K214072) and no changes were made to the device's fundamental operation.

Therefore, the acceptance criteria and study detailed below focus specifically on the expansion of trending ability of the delta features to new patient populations (pediatric and neonates) and non-cerebral sites.

Acceptance Criteria and Device Performance for Masimo O3 Regional Oximeter (K243324)

Based on the provided document, the acceptance criteria and study focus on confirming the trending ability of the delta features (ΔO2Hb, ΔHHb, ΔcHb) for expanded indications. The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range) for these delta features, unlike the rSO2 accuracy (ARMS) specifications which are quantitative. Instead, it speaks of "strong correlation" and "equivalent performance."

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Non-cerebral trending study: Data from 25 subjects.
• Pediatric/Neonatal trending study: Data from 29 subjects.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Clinical studies for 510(k) submissions are typically prospective, but this is not confirmed here.

3. Number of Experts and Qualifications for Ground Truth

• The document describes studies for "trending ability" of physiological parameters (hemoglobin changes). For such physiological measurements, the ground truth is typically established by direct physiological measurement or well-established reference methods, not by expert panel review of images or clinical assessments. Therefore, the concept of "experts establishing ground truth" in the manner of diagnostic imaging studies (e.g., radiologists) is not applicable here. The ground truth would be the actual physiological changes occurring in the subjects, measured by a gold standard method (though not explicitly detailed in the summary).

4. Adjudication Method for the Test Set

• Given that the studies are evaluating the trending ability of physiological measurements against an assumed physiological ground truth (not expert interpretations), an "adjudication method" in the sense of reconciling multiple expert opinions (e.g., 2+1, 3+1) is not applicable.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human readers interpret medical images or data with and without AI assistance to measure improvement in reader performance. The Masimo O3 Regional Oximeter is a physiological monitoring device that provides direct measurements, and the current submission is about expanding the trending indications of those measurements, not assisting human interpretation of complex medical cases.

6. Standalone (Algorithm Only) Performance

• Yes, implicitly. The studies described evaluate the device's ability to trend delta features. This is a direct measurement of the device's algorithm performance in a clinical setting against physiological changes. The device itself produces these measurements, so the performance reported is inherently "algorithm only" in terms of its output, even though it's measured on human subjects.

7. Type of Ground Truth Used

• The ground truth for studies of physiological monitoring devices like oximeters is typically actual physiological values measured concurrently by a highly accurate or gold-standard reference method. For regional oximetry and hemoglobin changes, this might involve induced changes in oxygenation/perfusion and simultaneous measurement with a more invasive or laboratory-based technique, though the summary does not detail the specific reference method used for these "delta features" studies. It is implied to be a quantitative, objective physiological ground truth, not based on expert consensus, pathology, or outcomes data in the traditional sense of diagnostic imaging.

8. Sample Size for the Training Set

• The document does not provide information on the training set sample size. This submission is for an expanded indication based on clinical study data, not a new algorithm development submission where training data sets are typically detailed. It is assumed the algorithms for the delta features were trained/developed prior to the predicate device clearance (K214072) or during earlier development cycles, and the current submission is about validating their performance for new uses.

9. How Ground Truth for Training Set was Established

• The document does not provide information on how the ground truth for any potential training set was established. As this submission pertains to an expanded indication for existing features, the focus is on clinical validation of those features in new contexts rather than the de novo development process.

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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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Model 8004CB (Adhesive Version)

The 8004CB Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms).. The sensor may be repositioned or replaced with another 8004CB sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments.

Model 8004CB-NA (Non-Adhesive Version)

The 8004CB-NA Non-Adhesive, Single-Patient use, Non-Sterile, Disposable Regional Oximetry Sensor is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. The sensor is for spot-checking and continuous monitoring of neonate, infant, and pediatric patients weighing less than 88 pounds (40 kilograms). The sensor may be repositioned or replaced with another 8004CB-NA sensor without baseline reestablishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long term care and mobile environments. I

Model 7600 Regional Oximeter System

Nonin's non-invasive Model 7600 4- Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of hemoglobin oxygen saturation of blood underneath the sensor at cerebral and somatic sites. It is intended for spot-checking or continuous monitoring of adult, or neonate, infant and pediatric patients. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Nonin's® EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series for use with the Model 7600 4-Channel Regional Oximeter System continuously monitors and records the mixed arterial/venous blood oxygen levels (rSO2) through non-invasive near-infrared spectroscopy of tissue under the sensors.

The 7600 system is comprised of three subsystems; sensor, patient oximetry device (pod) and display unit. The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is sized appropriately for the patient population.

The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning via the sensor photodiodes. From these measurements, the 7600PA pod determines specific absorption values and calculates the rSO2 value. The pod then communicates the rSO2 readings and other data to the display unit. Up to 4 pods with attached sensors may be used with a single 7600 display unit.

The 7600 display unit displays real-time regional oximetry data. It is a battery-backed, mains-powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module or serial RS-232 connection.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series:

Acceptance Criteria and Device Performance

Note: The document explicitly states the accuracy specification as "absolute rSO2 accuracy (Arms*): 45% to 95% rSO2 ±5.9%." This serves as the acceptance criterion that the device aims to meet. The reported device performance matches this criterion, as the study was conducted to demonstrate this specific accuracy.

Study Details

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: 44 subjects
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Study Type: Prospective, controlled, multisite study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• The document does not mention the use of experts to establish ground truth in the traditional sense of image or clinical interpretation.
• Ground Truth Establishment: The ground truth for rSO2 (regional hemoglobin oxygen saturation) was established by comparing the sensor's measurements to actual SavO2 (arterial/venous hemoglobin oxygen) values. These SavO2 values were "determined from venous and arterial blood samples." This implies direct laboratory analysis of blood samples, which serves as the gold standard for oxygen saturation.
• Qualifications of Experts: Not applicable, as expert consensus on interpretation wasn't the method for ground truth. The ground truth was derived from direct physiological measurements (blood gas analysis).

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

• Not applicable/None. The "ground truth" was established through direct physiological measurement (blood gas analysis of SavO2), not through human interpretation or a scenario requiring adjudication of disparate expert opinions.

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. This was not an MRMC comparative effectiveness study. The study focused on the standalone accuracy of the device itself against a physiological ground truth, not on how a human reader's performance might be augmented by the device.

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

• Yes. The study assessed the "absolute rSO2 accuracy" of the EQUANOX Advance Neonatal/Pediatric Sensor 8004CB Series with the Model 7600 Regional Oximeter System against a physiological ground truth (blood gas analysis). This is a standalone performance assessment of the device.

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

• Type of Ground Truth: Physiological measurements from blood samples. Specifically, the "SavO2 (value determined from venous and arterial blood samples)" served as the ground truth. A model of 70% venous and 30% arterial blood was used for brain blood.

8. The sample size for the training set

• The document does not explicitly mention a separate "training set" or sample size for training. This typically indicates that the device's algorithms or parameters were either pre-developed, or the accuracy study itself demonstrated the device's performance without explicitly detailing an iterative training/validation process in this summary. For medical devices of this type, initial algorithm development often relies on internal data and testing, with the submission focusing on performance in a clinical validation set.

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

• Not applicable, as a distinct training set with established ground truth is not described in this document.

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Nonin's non-invasive Model 7600 4-Channel Regional Oximeter System is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

The 8004CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an absolute real-time adjunct monitor of regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8004CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

The 8000CA Single-Patient use, Non-Sterile, Disposable Sensor is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor of adult and pediatric patients weighing greater than 88 pounds (>40 kilograms). The sensor may be repositioned or replaced with another 8000CA sensor without baseline re-establishment. It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Nonin's® Model 7600 4-Channel Regional Oximeter System with Equanox™ Technology and Bluetooth® Wireless Technology and compatible sensors (8004CA, 8000CA) continuously monitor and record the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors. The system is comprised of three subsystems; sensor, patient oximetry device (pod) and 4-channel display unit.

The sensor allows light absorption measurements at various wavelengths in the near-infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches.

The sensors plug into the patient oximetry device (pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The pods then communicate the regional oxygen saturation readings and other data to the display unit.

The 4-channel display unit displays absolute real-time regional hemoglobin oxygen saturation (rSO2) numeric data and trend lines. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.

The Nonin Medical, Inc. K102715 submission for the Model 7600 4-Channel Regional Oximeter System does not contain specific acceptance criteria or a detailed study description with reported device performance metrics in the provided document sections.

The document states that the device "successfully undergone extensive performance, electromagnetic, safety, clinical, environmental, and software testing to ensure that it has appropriate functional features and is substantially equivalent to the predicate devices." (Section 2) However, it does not elaborate on what constituted "successful" in terms of specific performance metrics or acceptance criteria.

The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of novel performance studies with specific statistical acceptance criteria.

Therefore, I cannot populate the table or provide answers to most of the requested points as the specific information is not present in the provided text.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective). The document only mentions "clinical" testing was performed.

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.

4. Adjudication method (e.g., 2+1, 3+1, none) 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 information is not provided in the document. The device is a regional oximeter, not an AI-assisted diagnostic imaging device, so an MRMC study with human readers assisting AI would be out of scope for this type of device.

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

• The device is an oximeter, which inherently functions as a "standalone" measurement device that provides output for human interpretation. The clinical testing mentioned would implicitly evaluate the algorithm's performance in generating these measurements. However, no specific "standalone study" with detailed methodology or results (like those seen for AI algorithms) is described. The document states it "continuously monitor[s] and record the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors," implying the device produces measurements independently.

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

• Not explicitly stated. For oximeters, the "ground truth" for oxygen saturation is typically established through co-oximetry of arterial blood samples. However, this specific method is not detailed in the provided text.

8. The sample size for the training set

• This information is not provided in the document. Given that this is a 510(k) for a regional oximeter (a sensor and measurement device), rather than a machine learning algorithm that requires extensive training data, the concept of a "training set" in the context of AI/ML is likely not directly applicable here. The device's "training" would likely refer to the design and calibration process during manufacturing.

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

• This information is not provided in the document. As noted above, the concept of a "training set" in the AI/ML sense is likely not applicable.

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Nonin's stand-alone non-invasive Model 7600 Regional Oximeter System is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Nonin's® Model 7600 non-invasive Regional Oximeter System continuously monitors and records the mixed arterial/venous blood oxygen levels through non-invasive near-infrared spectroscopy sensors placed on the patient's forehead. The stand-alone system is comprised of three subsystems; sensor, patient oximetry device (Pod) and display unit. The sensor allows light absorption measurements at various wavelengths in the near infrared spectrum (approximately 700 to 900 nanometers). The sensor is approximately 1.5 by 3 inches. The sensors plug into the patient oximetry device (Pod) which controls the light emitted from the sensor LEDs and measures the light returning to the sensor photodiodes. From these measurements, the Pod determines specific absorption values and calculates the mixed arterial/venous oxygen saturation values. The Pods then communicate the cerebral oxygen saturation readings and other data to the display unit. The display unit displays real-time cerebral oximetry trend data. It is a battery-backed, mains powered device equipped with audio and visual alarm indicators. Real-time data and playback output is accomplished through a Bluetooth transceiver module.

The provided text is a 510(k) summary for the Nonin Model 7600 Regional Oximeter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results in the format requested.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, ground truth establishment, and MRMC studies is not available in the provided text.

Here's an attempt to answer the questions based only on the provided text, indicating what information is missing:

Acceptance Criteria and Device Performance for Nonin Model 7600 Regional Oximeter System

1. Table of acceptance criteria and the reported device performance

Note: The document primarily asserts substantial equivalence and successful testing, but does not provide quantitative performance metrics or specific, measurable acceptance criteria beyond this high-level claim.

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: Not specified in the provided text. The document only mentions "clinical testing" without detailing the number of participants or cases.
• Data Provenance: Not specified. The text does not mention the country of origin or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not specified. The document does not describe the establishment of ground truth or the involvement of experts for this purpose.

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

• Not specified. There is no mention of an adjudication method.

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. The device described is a regional oximeter system, which is a standalone non-invasive physical measurement device, not an AI-based diagnostic image analysis tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• Yes, implicitly. The device itself is a "stand-alone non-invasive Model 7600 Regional Oximeter System" that "continuously monitors and records the mixed arterial/venous blood oxygen levels." Its performance is inherent to its design and measurements. The 510(k) summary focuses on the device's functional integrity rather than an algorithm's performance in isolation from a human. The system calculates and displays oxygen saturation readings.

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

• Not explicitly stated. For physiological measurement devices like oximeters, ground truth typically involves comparison to a recognized gold-standard measurement (e.g., arterial blood gas analysis for oxygen saturation). However, this specific detail is not provided in the summary.

8. The sample size for the training set

• Not applicable/Not specified. The document describes a medical device, not a machine learning algorithm that requires a distinct "training set" in the conventional sense. The "training" for such a device would be part of its engineering and calibration, rather than a separate data set for an AI model.

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

• Not applicable/Not specified, as this is not an AI-based system with a training set.

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