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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.

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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."

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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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.

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 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.

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 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).

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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