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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 StO>:
Sheath: a single-use, sterile Sheath placed around the Main Unit during device use . (provide in the Disposable Kit); and
Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the . Main Unit to provide power.

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. The Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.

The device shares the same indication for use and the same technological characteristics as the predicate device (K191676), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ViOptix Intra.Ox 2.0 Handheld Tissue Oximeter. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K191676). Consequently, the "acceptance criteria" and "device performance" are framed in terms of equivalence to the predicate device and meeting specifications, rather than absolute performance metrics against a fixed clinical threshold.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list distinct "acceptance criteria" for the modified device in terms of specific performance thresholds for StO2 accuracy, beyond stating it should perform "as intended" and be "substantially equivalent" to the predicate. The performance data primarily focuses on demonstrating that the modifications did not negatively impact the device's performance compared to the predicate and a "gold standard."

Acceptance Criteria (Implied from Substantial Equivalence and Performance Testing)	Reported Device Performance (Summary)
Functional Equivalence to Predicate Device: Maintain the same intended use, indications for use, principle of operation, measured parameters, energy delivered, power source, StO2 measurement range, and physical design as the predicate.	All technological characteristics, including intended use, indications, principle of operation, measured parameters, energy delivered, power source, StO2 range, and physical design, are the same as the predicate device (K191676). The only component difference (removal of Quality Control Target) does not raise different questions of safety and effectiveness as demonstrated by performance testing.
Safety and Effectiveness Equivalence to Predicate Device: Modifications do not raise new questions of safety or effectiveness.	Performance testing (mechanical, sterility, latch, shelf-life, transport, software V&V, heterogeneous blood phantom study) demonstrates that the modified device performs as intended and does not raise different questions of safety or effectiveness compared to the predicate.
Agreement with "Gold Standard" (Heterogeneous Blood Phantom Study): Demonstrate agreement with a "gold standard" blood co-oximeter similar to or better than the predicate device.	The Intra.Ox 2.0 Handheld Tissue Oximeter showed substantial equivalence to the predicate device in limits of agreement to the gold standard, as well as 95% confidence intervals in slope and intercept. This supports that it provides "as good or better agreement" to the gold standard over the clinically relevant range.
Met specifications and requirements for intended use.	The collective performance testing demonstrates that the Intra.Ox 2.0 Handheld Tissue Oximeter performs as intended and meets its specifications and requirements for its intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The only specific performance study mentioned with a "test set" is the Heterogeneous Blood Phantom Study. The sample size for this study is not explicitly stated in the provided document. The data provenance is also not explicitly stated, however, it is a non-clinical phantom study rather than a human clinical study, using swine whole blood and an Intralipid solution. This implies an in-vitro or bench-top study, not tied to a specific country of origin in the way clinical data would be. It is a prospective study in the sense that the measurements were actively made for this evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

For the Heterogeneous Blood Phantom Study, the "ground truth" was established by a "gold standard" blood co-oximeter. This implies a technical or laboratory instrument, not human experts. Therefore, no human experts were used to establish ground truth for this particular test.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Since the ground truth was established by a "gold standard" instrument, there was no adjudication method involving human reviewers for the test set.

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. The device itself is an oximeter, not an AI diagnostic tool requiring human interpretation or assistance augmentation. Clinical testing was explicitly stated as "not required."

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

Yes, the Heterogeneous Blood Phantom Study is a form of standalone performance study. The device, the Intra.Ox 2.0 Handheld Tissue Oximeter, was tested independently, and its measurements were compared to a "gold standard" blood co-oximeter. This test evaluated the algorithm's performance (how it estimates StO2 from optical measurements) in a controlled phantom environment without human intervention in the measurement process itself.

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

For the Heterogeneous Blood Phantom Study, the ground truth was based on a "gold standard" blood co-oximeter.

8. The sample size for the training set

The document does not provide information on a training set sample size. The submission is for a modification to an already cleared device, and the focus is on demonstrating substantial equivalence through non-clinical performance testing. It is likely that the underlying algorithm was trained during the development of the original predicate device (K191676), but no details are given here for either device.

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

As no information is provided on a training set in this document, there is no information on how its ground truth was established.

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K Number

K191676

Device Name

Intra.Ox 2.0 Handheld Tissue Oximeter

Manufacturer

ViOptix, Inc.

Date Cleared

2019-09-16

(84 days)

Product Code

MUD

Regulation Number

870.2700

Type

Traditional

Panel

General & Plastic Surgery

Reference & Predicate Devices

K163472

Predicate For

K221010

Intended Use

The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (SKO2) in a volume of tissue.

The Intra. OxTM 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.

The Intra. Oxim 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.

The Intra. OxTM 2.0 Handheld Tissue Oximeter should only be used on adult patients.

Device Description

. 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.

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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