(124 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, including bowel 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 (device) 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 (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. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that and other liquids such as disinfectants and marking materials. The device shares the same technological characteristics as the predicate device (K221010), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.
The provided text does not contain detailed information regarding the acceptance criteria of a device for regulatory approval or a specific study proving it meets these criteria with the level of detail requested in the prompt.
The document is an FDA 510(k) clearance letter for the ViOptix Intra.OxTM 2.0 Handheld Tissue Oximeter. It states that the device is substantially equivalent to a previously marketed predicate device (K221010). The information provided is primarily about the regulatory basis for clearance, the device's intended use, and a high-level summary of studies performed.
Here's an analysis of what information is available and what is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision targets) for the device's performance, nor does it present a table of reported device performance against such criteria. It generally states that the device "responds appropriately" and "provides clinically relevant information."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions an "animal study" and "human clinical data from published scientific literature (Gonzalez-Jacobo et al.)".
- Sample Size: The exact sample sizes for both the animal study and the human clinical data are not provided.
- Data Provenance:
- Animal study: No details on country of origin or whether it was retrospective/prospective.
- Human clinical data (Gonzalez-Jacobo et al.): No details on country of origin or whether it was retrospective/prospective from the provided text. It merely states it included "multiple surgical" settings.
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)
- Missing. The document does not specify how ground truth was established, nor does it mention the number or qualifications of experts involved in any ground truth determination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No information on adjudication methods is present.
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
- Not applicable / Missing. This device is an oximeter, not an AI-assisted diagnostic imaging device that requires human readers to interpret results. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant to this type of device. The document mentions the device provides "comparable information to the existing standard of care" but doesn't quantify improvement in human performance with the device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The Intra.Ox™ 2.0 Handheld Tissue Oximeter is a standalone device that measures StO2. Its performance as a measurement device is inherent. The studies mentioned (animal and human clinical data) would assess the device's ability to accurately measure oxygen saturation. So, in essence, the "standalone performance" of the device is what these studies would have evaluated.
- Stated from text: "The animal study demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter responds appropriately to the presence of transient ischemia induced by arterial occlusion" and the human study "demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter provides clinically relevant information regarding bowel ischemia". This describes its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the animal study: The ground truth was likely induced "transient ischemia induced by arterial occlusion" which is a physiological challenge.
- For the human study: The "existing standard of care" is mentioned, implying that the device's measurements were compared against established clinical methods for assessing bowel ischemia. The specific nature of this "standard of care" (e.g., pathology, clinical observation, other monitoring devices) is not detailed.
8. The sample size for the training set
- Not applicable / Missing. This is not an AI/ML device that typically has a separate "training set" in the common understanding of machine learning. It's a measurement device. It was likely "calibrated" or developed using internal data, but the document doesn't provide details on sample sizes for such development or calibration processes.
9. How the ground truth for the training set was established
- Not applicable / Missing. See point 8.
In summary: The provided document is a regulatory clearance letter, not a detailed clinical study report. It confirms the device's substantial equivalence based on summaries of testing, but it does not contain the granular detail on acceptance criteria, sample sizes, expert involvement, or ground truth establishment that you are requesting. Such details would typically be found in the full 510(k) submission, specifically the non-clinical and clinical test reports, which are not part of this public clearance letter.
§ 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).