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The ViOptix ODISsey Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. This is performed in medical environments including physician offices, hospitals, ambulatory care and Emergency Medical Services.

The ODISsey Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations of skeletal muscle or when there is a suspicion of compromised circulation.

The ODISsey Tissue Oximeter is an optically based device that noninvasively estimates the percent oxygen saturation (StO2) in a volume of tissue underneath the sensor.

This document describes an animal study used to demonstrate the performance of the ViOptix ODISsey Tissue Oximeter.

1. Table of Acceptance Criteria & Reported Device Performance

Note: The document does not specify quantitative acceptance criteria (e.g., a specific correlation coefficient or accuracy range). The reported performance is qualitative ("excellent correlation").

2. Sample Size & Data Provenance

• Test Set Sample Size: The study used three dog limbs.
• Data Provenance: Animal study, specifically using surgically removed and perfused dog limbs. The country of origin is not specified but is implicitly the location of the ViOptix, Inc. in Fremont, CA, or the testing facility they contracted. This is a prospective study.

3. Number of Experts and Qualifications for Ground Truth

• The ground truth was established by a Radiometer OSM3™ Hemoximeter (CO-Oximeter), which is described as a "gold standard." There is no mention of human experts establishing or adjudicating the ground truth in this specific animal study documentation. The CO-Oximeter itself serves as the reference measurement.

4. Adjudication Method for the Test Set

• None (as ground truth was established by an instrument, not human experts).

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

• No, an MRMC comparative effectiveness study was not conducted according to this document. The study focuses on comparing the device's readings against a "gold standard" instrument and a predicate device.

6. Standalone (Algorithm Only) Performance Study

• Yes, this constitutes a standalone performance study. The device, the ViOptix ODISsey Tissue Oximeter, directly measured StO2 in tissue, and its output was compared to reference measurements. There is no human intervention in the device's measurement process itself.

7. Type of Ground Truth Used

• Instrumental Gold Standard: The ground truth for tissue oxygen saturation (StO2) was established by a Radiometer OSM3™ Hemoximeter (CO-Oximeter), which is referred to as a "gold standard."

8. Sample Size for the Training Set

• The document does not provide information regarding a training set. This is a performance validation study, not a description of the algorithm development or internal training.

9. How Ground Truth for the Training Set Was Established

• As no information on a training set is provided, the method for establishing its ground truth is not applicable/not available in this document.

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