(80 days)
The FORE-SIGHT® Cerebral Oximeter, Model MC-2000 Series is indicated for the continuous noninvasive monitoring of regional hemoglobin oxygen saturation of blood in the brain (SctO2). It is intended for use in any individual at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the FORE-SIGHT has not been demonstrated in disease states.
The Cerebral Oximeter Monitor measures cerebral tissue oxygen saturation allowing the clinician to accurately determine absolute levels of brain tissue blood oxygen saturation and brain venous oxygen saturation in the brain. This measurement can be of significant value in numerous acute care (OR ICU. ER) situations, providing health care professionals with information to guard against neurological injuries due to compromised brain oxygenation, which can occur during many surgical and clinical procedures.
The Cerebral Oximeter Monitor consists of an optical transducer containing a laser light source and photodiode detectors, and a graphic display monitor with user interface. The non-invasive, reflection mode, optical transducer is placed on the forehead of the subject via a disposable sensor attachment to determine cerebral oxygenation. The Cerebral Oximeter Monitor is safe to use, because it is designed to operate as a Class I laser product, the safest FDA laser classification. Additional safety features include a laser interlock system designed to prevent laser operation in case the optical transducer is not securely attached to the subject. A patent-protected algorithm optimizes accuracy of the device for measurements of absolute cerebral tissue oxygen saturation ..
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000 Series
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as target values or thresholds in the provided document. Instead, the document presents the measured "Precision" (1 Standard deviation) of the device's SctO2 readings compared to a reference method, and implies that these precision values are considered acceptable for demonstrating substantial equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Precision (1 standard deviation) for SctO2 compared to reference method for Adult subjects over a spectrum of 45-95% SctO2 | ± 3.7 % (Adult SctO2: "The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to reference SctO2 derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples was ± 3.7 %, based on Equation 1 below.") |
| Precision (1 standard deviation) for SctO2 compared to reference method for Pediatric subjects over a spectrum of 50-99% SctO2 | ± 4.86 % (Pediatric SctO2: "The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to reference SctO, derived from co-oximetry of arterial (SaO) and jugular bulb (SivO2) blood samples was ± 4.86 %, based on Equation 1 below.") |
| Precision (1 standard deviation) for SctO2 compared to reference method for Infant & Neonate subjects over a spectrum of 50-99% SctO2 | ± 5.0 % (Infant & Neonate SctO2: "The Precision (1 Standard deviation) for the Cerebral Oximeter Monitor SctO2 compared to the reference SctO2 derived from pulse oximetry measured arterial oxygen saturation SaO2 and cooximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples was ± 5.0 %, based on Equation 1.") |
2. Sample Size Used for the Test Set and Data Provenance
The document provides information about the patient cohorts used for clinical validation, which serve as the test sets for demonstrating performance.
- Adult Subjects:
- Sample Size: Not explicitly stated as a number of subjects. The text mentions "healthy adult volunteers."
- Data Provenance: Prospective. Data was collected at Duke University Medical Center in Durham, North Carolina, on currently enrolled subjects.
- Infant & Neonate Subjects:
- Sample Size: "2044 hours of clinical data" were collected. The number of individual subjects is not specified.
- Data Provenance: Prospective. Data was collected at the Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA. Subjects were undergoing veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO).
- Pediatric Subjects:
- Sample Size: Not explicitly stated as a number of subjects.
- Data Provenance: Prospective. Data was collected at Boston Children's Hospital in Boston, MA. Subjects were undergoing cardiac catheterization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established through direct physiological measurements, not by expert interpretation. Experts (medical staff) were involved in the collection of these physiological samples and managing the patient protocols, but not in establishing an "expert consensus" ground truth.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct physiological measurements (blood samples analyzed by co-oximetry) which are considered objective. There was no need for expert adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement
No, an MRMC comparative effectiveness study was not done. This device is a direct measurement device (oximeter), not an AI-assisted diagnostic tool that requires human interpretation. The clinical studies focused on validating the device's accuracy against direct physiological measurements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance reported is inherently standalone. The FORE-SIGHT® Cerebral Oximeter Monitor provides a direct SctO2 reading. The clinical studies evaluated the accuracy of this reading by comparing it to reference physiological measurements, without human interpretation of the device's output influencing the reported performance metrics (precision).
7. The Type of Ground Truth Used
The ground truth used was physiological measurements (blood samples) analyzed by co-oximetry.
- Adult and Pediatric: Reference SctO2 was derived from simultaneously drawn arterial (SaO2) and jugular bulb (SjvO2) blood samples, analyzed by a co-oximeter, and calculated using the formula: Reference SctO2% = SaO2 x 0.3 + SjvO2 x 0.7.
- Infant & Neonate: Reference SctO2 was derived from pulse oximetry measured arterial oxygen saturation (SaO2) and co-oximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples, using the same formula mentioned above.
8. The Sample Size for the Training Set
The provided document describes clinical validation studies, which are typically for testing and not for training. It does not explicitly mention a "training set" or its sample size in the context of device development. The "patent-protected algorithm" for optimizing accuracy implies an internal development and calibration process, but details of the data used for that are not provided in this regulatory submission.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is described for algorithm development in this document, the method for establishing ground truth for it is also not detailed. Based on the validation methods, it's highly probable that similar physiological measurement techniques would have been used during the device's development and calibration phases.
§ 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).