Search Results

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 reducedflow or no-flow ischemic states.

When used with FORE-SIGHT large sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter Monitor is indicated for use with adults and children over 40Kg. When used with the FORE-SIGHT medium sensors, the FORE-SIGHT MC-2000 Cerebral Oximeter is indicated for use with small adults and children between 4 kg and 80 kg. When used with FORE-SIGHT small sensors the FORE-SIGHT MC-2000 Series Cerebral Oximeter Monitor is indicated for infants and neonates ≤ 8Kg.

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 a summary of the acceptance criteria and the study details for the CASMED FORE-SIGHT® Cerebral Oximeter Monitor, Model MC-2000, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device's performance is not explicitly stated as a target value in the document. Instead, the "Precision (1 Standard deviation)" is reported for different patient populations. This precision value reflects the agreement between the device's SctO2 measurement and the reference SctO2 derived from co-oximetry of blood samples.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Adult Subject Validation: Healthy adult volunteers. The exact number of subjects is not provided. Data collected at Duke University Medical Center in Durham, North Carolina. Prospective study design.
   • Infant & Neonate Subject Validation: 2044 hours of clinical data collected from subjects undergoing venous Extracorporeal Membrane Oxygenation (VV-ECMO) with cephalad catheterization. The exact number of subjects is not provided, but the duration of data collection suggests a significant number of data points. Data collected at Children's National Medical Center in Washington, DC, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA. Prospective study design.
   • Pediatric Subject Validation: Subjects undergoing cardiac catheterization. The exact number of subjects is not provided. Data collected at Boston Children's Hospital in Boston, MA. Prospective study design.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not mention the use of experts to establish ground truth. The ground truth was established through direct physiological measurements from blood samples analyzed by co-oximetry.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was based on objective physiological measurements (co-oximetry of blood samples) rather than expert interpretation.

4. 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:

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a diagnostic/monitoring device, not an AI-assisted interpretation tool for human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance reported (Precision of SctO2) is the standalone performance of the algorithm/device. The device directly measures and calculates SctO2, and its output is compared against a reference standard.

6. The type of ground truth used:

   • Physiological Measurement/Co-Oximetry of Blood Samples:
     • For adults and pediatric subjects: Reference SctO2 derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples.
     • For infant & neonate subjects: Reference SctO2 derived from pulse oximetry measured arterial oxygen saturation (SaO2) and co-oximetry measured internal jugular vein venous oxygen saturation (SjvO2) from blood samples.

7. The sample size for the training set:

   • The document does not explicitly mention a separate "training set" or its size. In the context of medical devices like oximeters, the algorithm is often developed and refined using a dataset that precedes the formal validation studies presented here. The provided clinical studies are validation studies demonstrating the device's performance against a reference standard. If algorithm development involved clinical data, it's not detailed as a distinct training set.

8. How the ground truth for the training set was established:

   • As no separate "training set" is explicitly described, the method for establishing ground truth for any potential internal development/training data is not detailed in this document. However, it can be inferred that any data used for algorithm development would likely rely on similar physiological measurement techniques as those used for validation.

Ask a specific question about this device