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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 < 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.

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