(28 days)
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.
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.
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.
§ 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).