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510(k) Data Aggregation
(339 days)
The Intra. Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue.
The Intra. Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra. Ox™ Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra.Ox™ Handheld Tissue Oximeter should only be used on adult patients.
The ViOptix Intra.Ox" 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 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 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.
ViOptix has made modifications to the cleared Intra.Ox Handheld Tissue Oximeter (K133983) to optimize the design and improve manufacturability. The modified device shares the same indication for use and the same technological characteristics as the cleared device, including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.
The provided text does not contain detailed information on acceptance criteria or a study designed to explicitly prove the device meets those criteria in a quantitative sense with specific performance metrics against a predefined acceptance threshold.
Instead, the document is a 510(k) summary for a modified medical device (Intra.Ox™ Handheld Tissue Oximeter) seeking to demonstrate substantial equivalence to a predicate device (the original Intra.Ox™ Handheld Tissue Oximeter, K133983).
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. I will extract what is available and indicate where information is missing.
Here's a summary based on the provided text, focusing on the available information regarding the device's performance and the supporting studies for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria with specific thresholds (e.g., "accuracy > X% with a Y% confidence interval") and then report the device's performance against these thresholds. Instead, the performance claims are made in the context of demonstrating substantial equivalence to a predicate device.
The closest to "performance" stated is for Tissue Oxygen Saturation (StO2) Measurement Range:
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Modified Intra.Ox) |
|---|---|
| Measurement Range: 1-99% StO2 | Measurement Range: 1-99% StO2 |
| Agreement with gold standard (Co-oximeter) for StO2 | "Substantially equivalent to the predicate device in limits of agreement to the gold standard as well as 95% confidence intervals in slope and intercept." |
| Comparable dynamic range for StO2 between healthy and compromised tissue for the predicate device | "Similar ranges of StO2 values for both healthy and compromised tissue", "comparable dynamic range values" |
| Excellent agreement in shape of deoxygenation curve with predicate device during ischemic events | "Excellent agreement in shape of the deoxygenation curve observed during ischemic events between the Intra.Ox and predicate device for each analyzed subject." |
| Good agreement with physiological variances between measurement sites with predicate device | "Good agreement considering the physiological variances inherent between measurement sites." |
| Healthy tissue StO2 values comparable to literature | Healthy tissue: 65% (modified Intra.Ox) |
| Mean desaturation dynamic range comparable to literature | Mean desaturation dynamic range: 27 percentage points (both devices) |
2. Sample size used for the test set and the data provenance
- Heterogeneous Blood Phantom Study: The sample size is not explicitly stated, nor is the data provenance beyond "heterogeneous phantom prepared with swine whole blood."
- Clinical Study:
- Sample Size: 19 data sets from 19 subjects.
- Data Provenance: Healthy human volunteers. The country of origin is not specified but it is likely prospective, as it describes a specific study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable. The device is a tissue oximeter, not an AI-assisted diagnostic tool that human readers would interact with. The clinical study compares the modified device's performance to the predicate device's performance, and both are standalone measurement devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, standalone performance data was collected in both the Heterogeneous Blood Phantom Study and the Clinical Study, as the device provides direct measurements. The purpose was to compare the modified device's standalone performance to the predicate device's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Heterogeneous Blood Phantom Study: A "gold standard" blood co-oximeter was used as the ground truth reference.
- Clinical Study: The "ground truth" for the clinical study was the physiological state induced (transient ischemic events temporarily mimicking compromised tissue) and implied "true" StO2 values based on this physiological state and comparison to the predicate device and literature. There is no mention of an independent, higher-level ground truth such as pathology or expert consensus on the physiological state itself, beyond the direct measurement of StO2.
8. The sample size for the training set
This information is not applicable/not provided. The Intra.Ox™ Handheld Tissue Oximeter is a spectrophotometric device, not an AI/machine learning model that typically requires a distinct "training set" in the same way. Its internal algorithms are based on physics and calibration, not statistical learning from a large dataset.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reason as point 8.
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