(49 days)
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.
The T.Ox™ Tissue Oximeter is a lightweight and portable, AC poweroperated, unit with a lithium-ion battery backup that non-invasively estimates the percent oxygen saturation (StO2%) in a volume of tissue underneath the sensor. The console has a color LCD display monitor, a standard one sampling channel (with a two-channel option), and up to two fiber optic sensors. It has adjustable audible and visual alarms for:
· StO2 low and high alarm limits
· Low battery
The T.Ox™ Tissue Oximeter has visual alarms.
The T.Ox™ Tissue Oximeter consists of three parts:
· Small computer console display module
· AC power cord
· Fiber optic sensor(s)
If the console is using two channels, both channels can be used at the same time. Each channel samples and displays data independently of the other channel. Each channel can accommodate one sensor.
The provided text is a 510(k) summary for the ViOptix ODISsey Tissue Oximeter, specifically a special 510(k) submission for changes in patient contact materials and design. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in estimating oxygen saturation (StO2).
The document states:
"After performing non-clinical performance studies, Biocompatibility to ISO 10993, Packaging Validation, Sterilization Validations and Aging Studies, the data shows that the ODISsey Tissue Oximeter is substantially equivalent to the predicate as an estimate the percent oxygen saturation (StO2) in a volume of tissue."
This indicates that the focus of this specific 510(k) was on demonstrating substantial equivalence for the changes made (sensor use, sterility, packaging, cable cover materials), rather than re-proving the core performance of oxygen saturation estimation. The original predicate device (K042657) would have had performance data for its StO2 estimation, but that information is not present in this document.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study demonstrating performance in estimating StO2 from the provided text.
Based on the provided document, the following information can be extracted, but it primarily relates to non-clinical performance studies for material and design changes, not clinical performance for StO2 estimation:
Acceptance Criteria and Device Performance Study (as described for the changes in this Special 510(k))
Since this is a Special 510(k) for changes in materials and design, the "acceptance criteria" and "device performance" discussed are related to the safety and functionality of these changes to maintain substantial equivalence, rather than a clinical performance study measuring StO2 accuracy.
The document states that "non-clinical performance studies" were conducted. The "reported device performance" in this context is the conclusion drawn from these studies: that the device remains substantially equivalent to its predicate for estimating StO2 despite the changes.
| Acceptance Criteria Category (for changes) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility (to ISO 10993) | Data shows substantial equivalence. (Implies new materials meet biocompatibility standards) |
| Packaging Validation | Data shows substantial equivalence. (Implies new sterile packaging maintains sterility and integrity) |
| Sterilization Validations | Data shows substantial equivalence. (Implies new sterilization process for the entire sensor is effective) |
| Aging Studies | Data shows substantial equivalence. (Implies the device, with new materials/design, maintains performance over time as expected) |
| Overall Substantial Equivalence | The data shows that the ODISsey Tissue Oximeter is substantially equivalent to the predicate as an estimate of the percent oxygen saturation (StO2) in a volume of tissue. |
Details of the Study (related to the changes in this Special 510(k))
Due to the nature of this submission being a Special 510(k) for material and design changes, the document does not contain most of the requested information pertaining to a clinical performance study for StO2 estimation. The information below reflects what can be inferred or directly stated about the studies conducted for the changes rather than a full clinical performance study for StO2 accuracy.
-
Sample size used for the test set and the data provenance: Not specified for the non-clinical studies mentioned. These are likely bench tests and material analyses. The origin (e.g., country of origin) is not mentioned. These studies would be retrospective in the sense that they are conducted on the new design before market release.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for the non-clinical biocompatibility, packaging, sterilization, and aging studies. These studies rely on standard protocols and laboratory analysis, not expert consensus on ground truth in a clinical sense.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the non-clinical studies mentioned.
-
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: Not applicable. This device is an oximeter, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "performance" being discussed for this 510(k) is related to material safety and manufacturing processes, not the standalone accuracy of the StO2 algorithm itself, which was established by the predicate device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical studies, "ground truth" would be established by validated test methods (e.g., chemical analysis for biocompatibility, sterility indicator results for sterilization validation, physical integrity tests for packaging). This is not expert consensus, pathology, or outcomes data in a clinical sense.
-
The sample size for the training set: Not applicable. This document does not describe the development or training of an algorithm for StO2 estimation. It concerns physical device changes.
-
How the ground truth for the training set was established: Not applicable.
Summary of why most fields are "Not Applicable" for this document:
This document is a Special 510(k) for demonstrating substantial equivalence after material and design changes to an already cleared device. It primarily focuses on non-clinical performance, such as biocompatibility, sterilization, and packaging validation. It does not present a clinical performance study or data related to the accuracy of the device's core function (StO2 estimation), as that performance was established for the predicate device (K042657). Therefore, questions related to clinical study design, expert ground truth, reader studies, and algorithm training/ground truth are not addressed in this specific submission.
§ 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).