(129 days)
The noninvasive FORE-SIGHT Elite Absolute 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 and is indicated for use as follows:
When used with large sensors, the FORE-SIGHT Oximeter is indicated for use on the brain of adults and transitional adolescents ≥ 40 kg.
The FORE-SIGHT Elite Absolute Tissue Oximeter measures hemoglobin under the Sensor, allowing the clinician to continuously and accurately determine absolute levels of blood oxygenation saturation in the tissue (StO2).
The Oximeter consists of a monitor unit, preamplifier assembly, and sensor uses multiple wavelengths of light 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 monitor unit controls the measurement sequence, regulating sensor light output and processing the detected light signals after amplification by the dual-channel preamplifier assembly. The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics. The monitor unit provides simultaneous measurements on up to four sensors with both numeric and real-time graphical display formats.
The monitor unit is a mains-powered device with a field-replaceable battery backup module. A touchscreen user interface allows configuration of the Oximeter including audible, on-screen, and dedicated visual alarm indicators. The monitor display can be replicated for simultaneous remote viewing through an auxiliary VGA video output. Measurement data can be exported through various interfaces such as USB and RS-232.
The provided text describes the CASMED FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER (K123700) and its substantial equivalence to predicate devices, but it does not include detailed acceptance criteria tables or specific reported device performance metrics against those criteria. It also does not provide information about a study proving the device meets specific acceptance criteria in the format requested, particularly regarding sample sizes for test sets, data provenance, expert qualifications, or details about comparative effectiveness studies.
The document primarily focuses on establishing substantial equivalence to previously cleared devices through non-clinical and clinical testing, stating that it "successfully underwent extensive performance, safety, electromagnetic, clinical, software and environmental testing" and "extensive clinical validation for the indicated use." However, it does not provide the specifics of these tests as requested in the prompt.
Therefore, for aspects relating to specific performance criteria, reported device performance against those criteria, sample sizes, expert details, and adjudication methods, the provided document does not contain the necessary information.
Here's an attempt to answer based on the information provided and to explicitly state when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria or specific reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined criteria. It generally states that the device "successfully underwent extensive performance... testing" to ensure substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "extensive clinical validation for the indicated use" and "a validation report for Cerebral Tissue Oxygen Saturation (StO2%) in Adult and Transitional Adolescent Subjects." However, it does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not provided in the document.
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
This document describes an oximeter, which is a measurement device for physiological parameters (blood oxygen saturation). It is not an AI-assisted diagnostic imaging device for which MRMC comparative effectiveness studies involving human readers and AI assistance would typically be conducted. Therefore, this question is not applicable in the context of the provided device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an oximeter with an algorithm to determine StO2 values. The "accuracy" or "performance" of such a device is inherently its standalone measurement capability. The document states: "The FORE-SIGHT algorithm determines the StO2 values for the tissue under the sensor from the light absorption values and measured patient characteristics." It also mentions "extensive performance... testing" and "clinical validation." This implies standalone performance was evaluated, but specific metrics are not provided.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For an oximeter, the ground truth would typically be established against a reference standard method for blood oxygen saturation measurement (e.g., arterial blood gas analysis, co-oximetry). The document does not explicitly state the "type of ground truth" used for its clinical validation studies, but for physiological measurements, it is usually a recognized clinical gold standard.
8. The Sample Size for the Training Set
The document does not mention a "training set" or its sample size. This type of information is typically relevant for machine learning or AI models that require distinct training and testing phases. While the device uses an "algorithm," the document doesn't explicitly refer to its development structure in terms of training sets.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" and its ground truth establishment are not discussed, this information is 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).