Search Results

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:

Ask a specific question about this device

The non-invasive CerOx 3215FOP monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue. The CerOx3215FOP monitor is intended for monitoring of newborn - adult. The prospective clinical value of data from the CerOx 3215FOP monitor has not been demonstrated in disease states. The CerOx 3215FOP monitor should not be used as the sole basis for diagnosis or therapy.

The CerOx Model 3215FOP uses the well-established principles of near infrared spectroscopy (NIRS) and flowmetry to monitor blood flow in tissue. CerOx Model 3215FOP is identical to the CerOx Model 3210FO technically and operationally.

The provided text describes a 510(k) submission for the CerOx Model 3215FOP, which is a blood flowmeter. The submission asserts substantial equivalence to a predicate device, the CerOx 3210FO.

Crucially, the document explicitly states that no performance testing, animal testing, or clinical studies were included in this 510(k) submission. Instead, the argument for substantial equivalence relies on the fact that the CerOx Model 3215FOP is "identical to the CerOx Model 3210FO technically and operationally."

Therefore, based on the provided text, the device itself (CerOx 3215FOP) does not have its own acceptance criteria or a study provided to demonstrate it meets them. Its acceptance is predicated on the substantial equivalence to a previously cleared device.

Since there are no performance studies described for the CerOx Model 3215FOP in this document, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide details about sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies.

Ask a specific question about this device