Search Results

The noninvasive FORE-SIGHT ELITE Module Tissue Oximeter is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced flow or no-flow ischemic states. The FORE-SIGHT ELITE Module Tissue Oximeter is intended to allow for the display of StO2 on a third party display/patient monitor. The FORE-SIGHT ELITE Module Tissue Oximeter when used with large sensors, is indicated for use on adults and transitional adolescents ≥40 kg. When used with Medium Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for use on pediatric subjects ≥3 kg. When used with Small Sensors, the FORE-SIGHT ELITE Module Tissue Oximeter is indicated for cerebral use on pediatric subjects

The FORE-SIGHT ELITE Module Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation in the tissue (StO2). The Oximeter consists of a module / monitoring unit, power and communication cables and sensor cables to connect with FDA cleared FORE-SIGHT ELITE small, medium and large sensors. The Sensors use multiple wavelengths in the range of 660 to 900 nm to precisely measure light absorption in tissue. Sensors are sized to provide targeted penetration depths appropriate for the tissue and patient populations of interest. The module unit controls the measurement sequence, generating the sensor LED currents and processing the detected light signals after amplification. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The module unit provides simultaneous measurements on up to two Sensors with both numeric and real-time graphical display formats appearing on a host monitor. The Module unit is a host-powered device. The host configures the Oximeter and provides applicable audible, on-screen, and dedicated visual alarm indicators. Measurement data is delivered to the host through various interfaces including USB and serial connections.

The provided document describes the FORE-SIGHT ELITE Module Tissue Oximeter, but it does not contain a typical acceptance criteria table with reported device performance metrics like sensitivity, specificity, or accuracy, which are common for AI/ML device descriptions. This device is a tissue oximeter, and its performance would typically be evaluated against established physiological measurement standards, not necessarily against ground truth established by experts in a diagnostic context.

However, I can extract information related to clinical testing and equivalence demonstration:

Clinical Testing Approach and Equivalence:

The document states:
"The FORE-SIGHT ELITE Module Tissue Oximeter technology has successfully undergone extensive clinical validation for the indicated use, as demonstrated in the clearance of K143675 and earlier CASMED Premarket Notifications. As documented in the FORE-SIGHT ELITE Clinical Equivalency Report (21-07-0542), there is no difference between the clinical functionality of this Module and the Monitor cited in K143675 making the St02 performance of FORE-SIGHT ELITE Module and FORE-SIGHT ELITE monitor statistically the same."

This indicates that the device's performance is established by demonstrating its equivalence to a previously cleared predicate device (FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor, K143675). The key claim is that the StO2 performance of the new module is statistically the same as the predicate monitor.

Given the information, a table of acceptance criteria and reported device performance as typically expected for diagnostic AI/ML algorithms cannot be fully constructed. However, based on the provided text, the core "acceptance criteria" and "performance" for this device revolve around demonstrating statistical equivalence to the predicate.

Here's how we can frame the response based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of a dataset reviewed for metrics like sensitivity or specificity. Instead, it refers to "extensive clinical validation" and an "equivalence report" (21-07-0542) comparing the new module to the predicate device (K143675). The sample size and data provenance for these underlying clinical validations are not detailed in this summary.

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

This information is not provided. For a tissue oximeter, the "ground truth" would typically be established by validated physiological measurements rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

This information is not provided for a "test set" in the context of expert review.

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

No such MRMC study is mentioned. This device is a physiological monitoring device, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output for diagnostic purposes.

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

The device is a standalone physiological monitor. Its performance is inherent in its measurement of StO2. The clinical testing mentioned ("clinical validation for the indicated use") implicitly refers to the standalone performance of the technology, evaluated against clinical outcomes or comparison to a reference standard, and then its equivalence to the predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the type of ground truth for the underlying clinical validations of the oximetry technology. For tissue oximeters, ground truth typically involves reference oximetry methods, in-vitro experiments, or correlation with clinical outcomes related to tissue oxygenation. The primary evidence presented for this specific submission is the equivalence to a predicate device that has already established its performance via prior clinical validation.

8. The sample size for the training set

This information is not provided. The FORE-SIGHT ELITE Module uses an algorithm ("FORE-SIGHT algorithm") to determine StO2 values, but the details of its development and any "training set" are not disclosed in this summary.

9. How the ground truth for the training set was established

This information is not provided.

Ask a specific question about this device