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The ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory:

. Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2;
. Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provided in the Disposable Kit);
Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power; and
. Quality Control (QC) Target: a single-use accessory (provided in the Disposable Kit) that provides an optical check once the Sheath is placed around the Main Unit.

The device uses spatially resolved optical measurements at five wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Intra.Ox 2.0 Handheld Tissue Oximeter, asserting its substantial equivalence to a predicate device (Intra.Ox Handheld Tissue Oximeter, K163472). The document details performance data from a heterogeneous blood phantom study and a non-significant risk clinical study to support this claim.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria with numerical targets for accuracy or other performance metrics. Instead, it relies on demonstrating "substantial equivalence" to the predicate device through agreement in measurement and physiological response.

The performance is reported in terms of agreement with a "gold standard" (blood cooximeter for the phantom study) and agreement with the predicate device (for the clinical study).

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Heterogeneous Blood Phantom Study
Agreement with Gold Standard	"Substantially equivalent to the predicate device in limits of agreement to the gold standard, as well as 95% confidence intervals in slope and intercept." (Implies that the device's agreement with the gold standard should be comparable to or better than the predicate.)	"Results show that the Intra.Ox 2.0 Handheld Tissue Oximeter is substantially equivalent to the predicate device in limits of agreement to the gold standard, as well as 95% confidence intervals in slope and intercept." "Provides as good or better agreement to the gold standard over the clinically relevant range than the predicate Intra.Ox Handheld Tissue Oximeter."
Clinical Study (StO2 measurement during transient ischemia)
Agreement in Deoxygenation Curve Shape	Not explicitly stated as a numerical criterion, but the implicit criterion is that the Intra.Ox 2.0 should show similar physiological responses during ischemic events as the predicate device.	"Excellent agreement in shape of the deoxygenation curve observed during ischemic events between the Intra.Ox 2.0 Handheld Tissue Oximeter and the predicate device for each analyzed subject."
Agreement in StO2 Values	Not explicitly stated as a numerical criterion, but the implicit criterion is that the Intra.Ox 2.0 should measure similar ranges of StO2 for both healthy and compromised tissue compared to the predicate device, demonstrating substantial equivalence. Also, agreement with literature-reported values.	"Direct comparison with paired data showed good agreement considering the physiological variances inherent between measurement sites." "Similar ranges of StO2 values for both healthy and compromised tissue." "Similarities in values for healthy tissue (65% [Intra.Ox 2.0] and 61% [predicate]) and mean desaturation dynamic range of 27 percentage points (both devices) agrees well with literature-reported values."

2. Sample Size Used for the Test Set and Data Provenance

Heterogeneous Blood Phantom Study (Test set): The sample size is not explicitly stated. The study involved measurements in a "heterogeneous phantom prepared with swine whole blood."
Clinical Study (Test set):
- Sample Size: "A total of 18 data sets from 18 subjects."
- Data Provenance: Prospective, healthy human volunteers. The document does not specify the country of origin of the data, but it was an "IRB-approved study."
- The subjects were "near-evenly distributed over age, gender, and skin color as determined by the Fitzpatrick skin type."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There is no mention of experts being used to establish a ground truth for either the phantom study or the clinical study in the traditional sense of medical image interpretation.

Heterogeneous Blood Phantom Study: The "gold standard" for this study was a "blood cooximeter." This suggests a reference instrument rather than expert opinion. The qualifications of a cooximeter operator would typically involve laboratory proficiency but are not specified here.
Clinical Study: The "ground truth" for the clinical study was the measurement from the predicate device and the physiological response during induced ischemia. This is a comparative study against an existing cleared device, rather than against an expert-determined ground truth.

4. Adjudication Method for the Test Set

No adjudication method is described for either the phantom study or the clinical study. The clinical study involved direct comparison of measurements between the new device and the predicate device, not a human consensus or adjudication process.

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 MRMC comparative effectiveness study was done. This device is a measurement instrument (oximeter), not an AI-powered diagnostic tool requiring human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies described are standalone performance evaluations of the device itself.

Heterogeneous Blood Phantom Study: Evaluated the Intra.Ox 2.0 Handheld Tissue Oximeter's measurements against a blood cooximeter using a phantom.
Clinical Study: Evaluated the Intra.Ox 2.0 Handheld Tissue Oximeter's measurements against the predicate Intra.Ox Handheld Tissue Oximeter in healthy human volunteers.

These studies assess the device's ability to measure StO2 and respond to physiological changes directly, without human interpretation as part of the primary measurement.

7. The Type of Ground Truth Used

Heterogeneous Blood Phantom Study: The ground truth was established by a "blood cooximeter." This is a reference instrument.
Clinical Study: The ground truth for comparative purposes was the predicate Intra.Ox Handheld Tissue Oximeter and the physiological changes induced by transient ischemia (i.e., the expected deoxygenation curve and StO2 values observed during healthy and compromised tissue states), benchmarked against "literature-reported values." This is a form of comparative ground truth against an established device and physiological understanding.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this device. The Intra.Ox 2.0 Handheld Tissue Oximeter is a spectrophotometric oximeter that uses fixed algorithms based on physical principles, not a machine learning or AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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