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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 < 40 kg.

When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg.

The ΔcHb, ΔO2Hb, ΔHHb provided as part of the Masimo O3 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (ΔO2Hb), deoxygenated hemoglobin (ΔHHb), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensors in adults, pediatrics, and neonates.

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 < 40 kg.

When used with the O3 Neonatal Sensor, the O3® Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg.

The ΔcHb, ΔΟ2Hb, ΔΗΗb provided as part of the Masimo Ο3 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (ΔΟ2Ηb), deoxygenated hemoglobin (ΔΗΗΒ), and total hemoglobin (ΔcHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.

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.

Ask a specific question about this device

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 < 40 kg.

When used with the O3 Neonatal Sensor, the O3® Regional Oximeter is indicated for measuring regional hemoglobin oxygen saturation of blood (tSO2) on cerebral sites and trending rSO2 on non-cerebral sites in neonates < 10kg.

The AcHb, AO2Hb, AHHb provided as part of the Masimo O3 are indicated for the monitoring of the relative hemoglobin changes of oxygenated hemoglobin (△O2Hb), deoxygenated hemoglobin (△HHb), and total hemoglobin (△cHb) as measured from the Masimo O3 sensor when applied to the cerebral tissue in adults.

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:

Reported Device Performance: The document states that the studies "supported the substantial equivalence" and "supported there are no significant technological characteristic differences." It does not provide specific numerical outcomes (e.g., mean difference, bias, precision) from these studies comparable to the specifications listed above for the expanded indications. The focus of the 510(k) is often on the conclusion of equivalence rather than granular performance metrics from the validation studies themselves. The provided "Specification" table appears to be the design specification rather than the measured performance from the described clinical studies for the expanded indications.

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

The document describes three clinical studies:

• Study 1 (rSO2 Trending, Non-Cerebral):
  • Sample Size: 42 adult subjects.
  • Data Provenance: Not explicitly stated (e.g., country of origin, hospital site), but it's a prospective controlled desaturation study.
• Study 2 (rSO2 Trending Comparison to Other Cleared Devices, Non-Cerebral):
  • Sample Size: 59 adult subjects.
  • Data Provenance: Not explicitly stated, but it's a prospective controlled desaturation study.
• Study 3 (ΔO2Hb, ΔHHb, ΔcHb Trending Comparison, Cerebral):
  • Sample Size: 22 adult subjects.
  • Data Provenance: Not explicitly stated, but it's a prospective hemodilution protocol study.

All studies appear to be prospective as they involved controlled physiological interventions (step-wise desaturation, hemodilution) on live subjects.

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

The concept of "experts" establish ground truth is not applicable to these studies. The studies are evaluating a physiological monitoring device against a direct physiological reference or similar devices.

• For rSO2 trending studies, the "ground truth" for oxygen saturation decrease was confirmed by arterial oxygen saturation (SpO2), which is a direct physiological measurement, not an expert interpretation.
• For the hemoglobin change study, the "ground truth" for hemoglobin concentration changes was established via a hemodilution protocol, a controlled physiological intervention designed to induce changes in blood volume and thus, relative hemoglobin concentrations.

4. Adjudication method for the test set

Not applicable. As the ground truth is established by physiological measurements or controlled interventions, there is no need for expert adjudication in the classic sense found in image-based diagnostic studies.

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 a physiological monitor, not an AI/ML diagnostic interpretation tool that assists human readers. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this technology.

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

The device itself is the "standalone algorithm" in terms of its measurement capabilities. The studies described are evaluations of the device's performance in measuring the specified physiological parameters. These are not "human-in-the-loop" studies but rather direct performance evaluations of the hardware and integrated algorithms.

7. The type of ground truth used

The ground truth used in these studies was physiological data from direct measurements or controlled interventions:

• For rSO2 trending on non-cerebral sites, the reference was arterial oxygen saturation (SpO2).
• For trending of ΔO2Hb, ΔHHb, and ΔcHb, the changes were induced through a hemodilution protocol, serving as the "ground truth" for induced relative changes in hemoglobin levels.

8. The sample size for the training set

Not applicable. This document describes clinical validation studies for an expanded indication of an existing physiological monitoring device. It does not mention any "training set" in the context of machine learning model development. This is a traditional medical device, not an AI/ML device that requires a distinct training/test set methodology for algorithm development or performance evaluation.

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

Not applicable. As explained above, there is no mention of a "training set" for an AI/ML model in this submission.

Ask a specific question about this device

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 < 40 kg.

When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) in neonates < 10 kg.

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:

Notes on the "Reported Device Performance":

• For the display ranges and resolutions, the "Reported Device Performance" can be inferred to match the "Acceptance Criteria (Specification)" as these are direct specifications of the device.
• For Trending ARMS, the document states the specification is "3% for SavO2 of 45%-85%" and explains the methodology to determine this for the Neonatal sensor, but doesn't explicitly state "the study demonstrated the device met the 3% Trending ARMS." However, it's listed as a specification, so the implication is that the outcome of the calculation supports this specification.
• Absolute accuracy was not a claim but reported as a "convenience sample," indicating it's not a formal acceptance criterion for this submission's claims.

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

• Sample Size (Clinical Study for Trending ARMS): The text indicates a combined approach:
  • One clinical study for the O3 Adult Sensor to establish its trending accuracy with respect to blood testing (sample size not specified).
  • A separate study where relative rSO2 data was collected for both the O3 Adult Sensor and O3 Neonatal Sensor on the same subject to calculate the O3 Neonatal Sensor's Trending ARMS relative to the O3 Adult Sensor (sample size for this specific part is not provided).
• Sample Size (Clinical Study for Absolute Accuracy - convenience sample): 11 hospitalized patients.
• Data Provenance: The document does not specify the country of origin. The studies appear to be prospective clinical studies conducted by Masimo to support the device's performance claims.

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

• Not applicable / Not specified. The ground truth for this device's performance is established through direct physiological measurements (blood testing/SavO2), not through expert interpretation of images or other data that would require multiple human experts for ground truth establishment.

4. Adjudication Method for the Test Set:

• None. As the ground truth is established via quantitative physiological measurements (SavO2 from blood draws), there is no need for expert adjudication methods in this context.

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

• No. An MRMC comparative effectiveness study was not performed. This device is a diagnostic/monitoring tool that directly measures a physiological parameter, not an AI-assisted diagnostic imaging tool where human reader performance would be a relevant metric for comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Yes. The performance of the O3 Regional Oximeter System (including the O3 Neonatal Sensor) is evaluated as a standalone device. Its "Trending ARMS" and "Absolute Accuracy" are measured against physiological ground truth (SavO2 from blood). There is no "human-in-the-loop" component in its core functional performance evaluation described here, as it directly outputs rSO2 measurements.

7. The Type of Ground Truth Used:

• Physiological Ground Truth:
  • For Trending ARMS: Blood testing (specifically SavO2, which is defined as "0.3 SaO2 + 0.7 SjvO2"). This is considered the gold standard for blood oxygen saturation. The Neonatal Sensor's performance was also compared relative to the O3 Adult Sensor, which was previously validated against blood testing.
  • For the absolute accuracy convenience sample: Invasive SavO2 blood draws.

8. The Sample Size for the Training Set:

• Not specified. The document describes clinical studies performed for performance validation (test set), but does not provide information about any training sets used for the development or calibration of the device's algorithms. As an oximetry device, its core algorithms are likely based on established biophotonics principles and may not involve a separate "training set" in the same way machine learning algorithms do, but rather extensive calibration and verification data.

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

• Not specified. Since details about a specific "training set" are not provided, the method for establishing its ground truth is also not mentioned. It is generally understood that the algorithms for such devices are developed and calibrated using a controlled experimental setup with known ground truth parameters for oxygen saturation.

Ask a specific question about this device

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 < 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 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.

(Emphasis added to highlight the performance of the device under review, the O3 Pediatric Sensor)

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

• Sample Size for Absolute ARMS (Pediatric): 33 male and female pediatric patients.
• Sample Size for Trending ARMS (Pediatric): Not explicitly stated as a distinct number of patients. The trending study used the O3 Large Sensor as a reference and collected rSO2 data from both the O3 Large Sensor and O3 Pediatric Sensor. It's implied this was performed on a subset or all of the 33 pediatric patients, but the exact number for the trending analysis isn't isolated.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study involved "pediatric patients," suggesting human clinical data. It is a prospective study, as blood draws were taken "before and after his/her medical procedure" for the absolute ARMS, and trending data was collected.

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

The ground truth for the rSO2 measurements was established by "blood draws (arterial and jugular blood)" which were then analyzed to determine blood oxygen saturation. This is a direct physiological measurement, considered objective, and does not involve human expert interpretation in the same way imaging studies might. Therefore, the concept of "number of experts" with specific qualifications for ground truth establishment (like radiologists) is not applicable here. The accuracy is against a direct physiological laboratory standard, not an expert consensus.

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

Since the ground truth for both absolute and trending accuracy was based on direct blood measurements (physiological reference), there was no adjudication method involving human experts for the test set.

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 MRMC comparative effectiveness study was done. This device is an oximeter, which provides a direct measurement (rSO2) rather than an interpretation that would be assisted by AI. The document describes a comparison of the device (O3 Pediatric Sensor) against a physiological reference and against another sensor (O3 Large Sensor for trending), not human reader performance with or without AI assistance.

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

Yes, the primary performance evaluation for accuracy (Absolute ARMS and Trending ARMS) is a standalone (algorithm only) performance evaluation. The device provides the rSO2 measurements directly, based on its NIRS technology and signal processing. The accuracy is reported for the device's measurements compared to a reference standard (blood draws or another sensor). While a human user reads the display, the accuracy itself is of the device's output.

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

The ground truth used was physiological measurements (blood draws) for absolute accuracy. Specifically, "Blood draws (arterial and jugular blood) were taken for each subject." For trending accuracy, the O3 Large Sensor's measurements (which were previously established via blood reference) served as the comparative ground truth.

8. The sample size for the training set

The document does not specify a separate training set sample size. This is typical for a device submission that primarily focuses on hardware and embedded algorithms, where the "training" (calibration and algorithm development) often occurs internally during the device development phase, and the submission focuses on the validation or test data. The "Clinical Testing" section describes the validation study for the new O3 Pediatric Sensor.

9. How the ground truth for the training set was established
As the document does not explicitly mention a separate "training set," it does not describe how ground truth for such a set was established. It describes the ground truth for the clinical validation (test) set, which was established through blood draws (arterial and jugular blood), considered the reference standard for blood oxygen saturation. It's reasonable to infer that the underlying scientific principles and initial calibrations would have relied on similar, well-established physiological measurement techniques.

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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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