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The non-invasive FORE-SIGHT Cerebral Oximeter Monitor, model 2040 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 40 Kg. When used with FORE-SIGHT Small sensors, the Cerebral Oximeter Monitor is indicated for infants. The Cerebral Oximeter Monitor should not be used as the sole basis for decisions as to the diagnosis or therapy. The value of data from the Cerebral Oximeter Monitor 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 and, in conjunction with pulse oximetry, provides absolute readings of brain venous oxygen saturation.

Here's a breakdown of the acceptance criteria and the study details for the FORE-SIGHT™ Cerebral Oximeter Monitor, Model 2040, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the reported Root Mean Squared Error (RSME) values, which the document uses to determine the accuracy of the monitor. The device is considered acceptable if its RSME for each parameter meets the specified values.

Note: The document states that "RSME accounts for errors relating to both the bias and precision (1 standard deviation) in calculating accuracy." It also notes that "RSME values are approximately equal to the prevision or one standard deviation when the bias is small." This suggests that the RSME values effectively serve as the acceptance criteria for the device's accuracy.

2. Sample Sizes and Data Provenance

• Adult Study (Test Set):

  • Sample Size: Not explicitly stated as a number, but refers to "healthy adult volunteers."
  • Data Provenance: Retrospective, collected at Duke University Medical Center in Durham, North Carolina, USA.

• Infant Study (Test Set):

  • Sample Size: Not explicitly stated as a number, but refers to "VV-ECMO neonates."
  • Data Provenance: Retrospective, collected at the Children's National Medical Center in Washington, DC, USA, and the Children's Hospital of Atlanta (CHOA), Emory University, Atlanta, GA, USA.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the use of human experts to establish ground truth in the traditional sense (e.g., radiologists reviewing images).
• Instead, the ground truth was established through direct physiological measurements from blood samples analyzed by a co-oximeter. This method inherently serves as a "gold standard" reference, negating the need for expert panels for interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The ground truth was established by direct physiological measurements (blood samples analyzed by co-oximeter), not by expert opinion requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed or mentioned. This device is a standalone physiological monitor, not an AI-assisted diagnostic tool that would typically involve human reader performance enhancement.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical testing section describes the direct measurement capabilities of the algorithm (Cerebral Oximeter Monitor) against established physiological reference methods (co-oximetry of blood samples) to determine its accuracy (RSME). The reported RSME values directly reflect the algorithm's performance without human intervention in the measurement or interpretation beyond initial setup.

7. Type of Ground Truth Used

• Physiological Reference Measurements:
  • For SctO2 (Cerebral Oxygen Saturation): Derived from co-oximetry of arterial (SaO2) and jugular bulb (SjvO2) blood samples using Equation 1.
  • For SvO2 (Cerebral Venous Oxygen Saturation): Derived from co-oximetry of jugular bulb blood samples (SjvO2) using Equation 2, which also incorporates SaO2 from a pulse oximeter and the device's SctO2.
  • Essentially, the ground truth was established by direct, invasive blood gas analysis, considered the gold standard for oxygen saturation.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. The descriptions of the adult and infant studies focus on "validation" (testing) of the device against reference standards. It's common for such devices to be developed and refined using internal data, but the specific details of a formal "training set" and its size are not provided in this summary.

9. How Ground Truth for the Training Set Was Established

• This information is not provided in the document. As mentioned above, the text focuses on the validation studies. If a training set was used, it would likely have been established using similar physiological reference measurement methods as the test set.

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