(119 days)
The non-invasive FORE-SIGHT Cerebral Oximeter Model MC-2000 should be used as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain. When used with FORE-SIGHT large sensors, the Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with FORE-SIGHT small sensors, the Cerebral Oximeter Monitor is indicated for infants and neonates 2.5Kg and above. The Cerebral Oximeter Monitor System should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the oximeter 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 details for the CAS Medical Systems FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000 Series, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria for the FORE-SIGHT® Cerebral Oximeter Monitor are framed around the Root Mean Squared Error (RMSE) for its measurement of cerebral tissue oxygen saturation (SctO2) and venous oxygen saturation (SvO2) in different patient populations.
| Parameter | Patient Population | Acceptance Criteria (RMSE) | Reported Device Performance (RMSE) |
|---|---|---|---|
| SctO2 | Adults | Not explicitly stated | ± 3.70 % |
| SctO2 | Infants & Neonates | Not explicitly stated | ± 4.77 % |
| SvO2 | Adults | Not explicitly stated | ± 5.26 % |
Note: The document provides the reported RMSE values but does not explicitly state the pre-defined target acceptance criteria for these values. It implies that these results demonstrate "strong correlation" or "strong agreement" with reference values, suggesting the reported RMSE values were considered acceptable for demonstrating substantial equivalence.
Study Design and Ground Truth Details
1. Sample Sizes and Data Provenance
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Adult Subject Validation: The number of adult subjects is not explicitly stated, but the study was conducted at Duke University Medical Center in Durham, North Carolina, USA. The data collection involved "healthy adult volunteers" and appears to be prospective, as gas mixtures were actively delivered, and blood samples were drawn simultaneously during specified intervals.
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Infant & Neonate Subject Validation: The study involved "2030 hours of clinical data" collected from subjects at Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA, USA. The subjects were "undergoing veno-venous Extracorporeal Membrane Oxygenation (VV-ECMO) with cephalad catheterization." This appears to be prospective data collection, as blood samples and pulse oximetry data were recorded while patients were monitored by the device. The number of individual subjects is not explicitly stated, only the total hours of data collected.
2. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their specific qualifications (e.g., radiologist with 10 years of experience) used to establish the ground truth.
3. Adjudication Method
The document does not describe any adjudication method. The ground truth was established by direct physiological measurements rather than expert consensus on images or other subjective assessments.
4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The studies focused on the performance of the device in measuring physiological parameters against reference methods, not on how human readers might improve with or without AI assistance.
5. Standalone Performance
The provided studies describe the standalone performance of the FORE-SIGHT® Cerebral Oximeter Monitor. The device's SctO2 and SvO2 measurements were directly compared against blood gas analysis (co-oximetry and pulse oximetry) without human interpretation as an intermediary step.
6. Type of Ground Truth Used
The ground truth for both adult and infant/neonate studies was established using direct physiological measurements from blood samples:
- Adult SctO2: Reference SctO2 was derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples.
- Adult SvO2: Reference SjvO2 was derived from co-oximetry of jugular bulb blood samples.
- Infant & Neonate SctO2: 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.
7. Sample Size for the Training Set
The document does not mention a separate "training set" or its sample size. The described studies are "validation" studies for the device's performance, implying they concern the final, trained algorithm, rather than data used for initial development and training. It's common for medical device submissions to focus on validation studies and not detail internal development data.
8. How Ground Truth for the Training Set was Established
As no training set is discussed, the method for establishing its ground truth is also not provided.
§ 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).