(130 days)
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.
| Measurement / Patient Population | Acceptance Criteria (ARMS) | Reported Device Performance (Implied) |
|---|---|---|
| Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | ||
| rSO2 (trending) (from 45% to 85% SavO2) - Adult, Pediatric, Neonate | 3% | Met (study supported performance) |
| rSO2 (absolute) (from 45% to 85% SavO2) - Adult | 4% | Met (study supported performance) |
| rSO2 (absolute) (from 45% to 85% SavO2) - Pediatric | 5% | Met (study supported performance) |
| Non-Cerebral Hemoglobin Oxygen Saturation of Blood (rSO2) | ||
| rSO2 (trending) (from 45% to 85% SavO2) - Adult, Pediatric, Neonate | 3% | Met (study supported performance) |
| rSO2 (absolute) (from 60% to 90% SavO2) - Adult | 5% | Met (clinical study supported this) |
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.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).