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The OxyVu™-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:

• . oxygen saturation (HT-Sat),
• oxyhemoglobin level (HT-Oxy), and .
• deoxyhemoglobin (HT-Deoxy) level .
  in superficial tissue. The Oxy Vu™-1 system displays two-dimensional colorcoded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.

The OxyVu™-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

The OxyVu™-1 system is based on hyperspectral imaging technology. The technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the Oxy Vu™-1 system, the spectral analysis determines in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HToxy), and deoxyhemoglobin levels (HT-deoxy). The OxyVu™-1 system displays the tissue oxygenation in a two-dimensional, color-coded image.

The system consists of:

• System console: cart, system electronics, CPU, monitor, keyboard, pointing . device and printer.
• Hyperspectral imaging instrument head with support arm: broadband . illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
• Single use Oxy VuTM Check Pads and Targets: The Oxy VuTM Check Pad is . used to perform an instrument check prior to patient measurements. The OxyVu™ Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.

This document is a 510(k) summary for the OxyVu™-1 Hyperspectral Tissue Oxygenation Measurement System. It describes a Special 510(k) submission, meaning the device is essentially the same as a previously cleared predicate device (K061848), with changes focused on improving robustness rather than fundamental accuracy. Therefore, the document explicitly states that the "changes increase robustness of operation, but not fundamental accuracy of results."

Given this context, the document does not report any new acceptance criteria or new studies proving the device meets those criteria. Instead, it relies on the substantial equivalence to the predicate device, which would have established such criteria and studies previously. The current submission's "Basis of Substantial Equivalence" states: "Based on virtually the same methods of validation, the OxyVu™-1 Hyperspectral Tissue Oxygenation Measurement System as modified is substantially equivalent to the OxyVu™-1 cleared in 510(k) K061848."

Therefore, I cannot directly provide the requested information from this document. However, I can infer the implied acceptance criteria for this Special 510(k) would be maintaining the performance and safety characteristics of the predicate device.

Here's an analysis based on the provided document, addressing what it does and does not state in relation to your request:

1. A table of acceptance criteria and the reported device performance

• Not provided in this document. This Special 510(k) explicitly states that the changes "increase robustness of operation, but not fundamental accuracy of results." It relies on the validation methods of the predicate device (K061848). Therefore, no new performance criteria or new reported performance data is presented here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided in this document. Since it's a Special 510(k) focused on robustness improvements rather than a new device or significant accuracy changes, no new test set details are presented.

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)

• Not provided in this document. As with the test set itself, details on ground truth establishment are not discussed in this Special 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided in this 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

• Not applicable / not provided. The device is a "Hyperspectral Tissue Oxygenation Measurement System" that provides objective measurements (oxygen saturation, oxyhemoglobin, deoxyhemoglobin). It is not an AI-assisted diagnostic tool for human readers, nor does it present data that would typically involve a multi-reader multi-case study for comparative effectiveness with human interpretation in the context of improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Implied, but details not provided. The device is described as "reporting approximate values" and displaying "color-coded images of tissue oxygenation." This suggests a standalone algorithm generating these outputs. However, no specific study details are provided in this document. The original 510(k) (K061848) would have contained such standalone performance data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not provided in this document. The nature of "tissue oxygenation" measurements often involves comparison to established physiological measurements or phantoms, but this document does not specify the ground truth methodology.

8. The sample size for the training set

• Not provided in this document.

9. How the ground truth for the training set was established

• Not provided in this document.

In summary: This 510(k) submission is for a modified version of an already cleared device, focusing on "robustness of operation" rather than fundamental accuracy. Therefore, it explicitly avoids re-presenting clinical performance data or acceptance criteria, instead relying on the substantial equivalence to the predicate device (K061848) and its prior validation. To find the details requested, one would need to refer to the original 510(k) submission for the predicate device, K061848.

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The OxyVu-1 Hyperspectral Tissue Oxygenation (HTO) Measurement System is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of:

• oxygen saturation (HT-Sat),
• oxyhemoglobin level (HT-Oxy), and
• deoxyhemoglobin (HT-Deoxy) level
  in superficial tissue. The OxyVu-1 system displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports hyperspectral tissue oxygenation measurements for selected tissue regions.

The OxyVu-1 system is indicated for use to determine oxygenation levels in superficial tissues for patients with potential circulatory compromise.

The OxyVu-1 system is based on hyperspectral imaging technology. The technology performs spectral analysis at each point in a two-dimensional scanned area producing an image displaying information derived from the analysis. For the OxyVu-1 system, the spectral analysis determines in superficial tissues approximate values of oxygen saturation (HT-Sat), oxyhemoglobin levels (HT-oxy), and deoxyhemoglobin levels (HT-deoxy). The OxyVu-1 system displays the tissue oxygenation in a two-dimensional, color-coded image.

The system consists of:

• System console: cart, system electronics, CPU, monitor, keyboard, pointing device and printer.
• Hyperspectral instrument head with support arm: broadband illuminator, camera and spectral filter for collecting hyperspectral imaging cube.
• Single use OxyVu Check Pads and Targets: The OxyVu Check Pad is used to perform an instrument check prior to patient measurements. The OxyVu Target is placed within the intended field of view and is used as a fiduciary mark for image registration and for focusing.

The provided text is a 510(k) summary for the OxyVu-1 Hyperspectral Tissue Oxygenation Measurement System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics. Therefore, many of the requested specific details, such as precise acceptance criteria values, sample sizes for training/test sets, expert qualifications, and adjudication methods, are not explicitly stated in this type of regulatory submission.

However, I can extract the information that is present and indicate where the requested details are missing.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

The 510(k) summary does not provide specific quantitative acceptance criteria or detailed performance metrics from a dedicated study. Instead, it relies on demonstrating substantial equivalence to a predicate device.

The "performance" is implied by the equivalence of "intended uses and technologies and on comparable results in clinical testing" with the Inspectra Model 325.

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not explicitly stated in the 510(k) summary. The document mentions "clinical testing" but does not detail the size or nature of the test set.

2. 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):

   • Not explicitly stated. A 510(k) summary for a tissue oximeter typically focuses on physiological measurement accuracy rather than expert image interpretation. Ground truth for such devices usually involves direct physiological measurements or established clinical standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not explicitly stated. This type of adjudication method is usually relevant for studies involving human interpretation of medical images. For a device measuring physiological parameters, the "ground truth" is typically established by other validated measurement techniques or clinical outcomes, not by expert consensus on interpretations.

4. 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. An MRMC study is not mentioned. This device is a measurement system, not an AI-assisted diagnostic tool that aids human readers in image interpretation. The comparison is between the device's output and a "ground truth" or predicate device, not human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The device is a standalone measurement system. Its performance is evaluated on its ability to measure and report approximate values of oxygen saturation, oxyhemoglobin, and deoxyhemoglobin levels. The "clinical testing" mentioned for substantial equivalence would have evaluated the device's performance in this standalone manner.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not explicitly stated but for a tissue oximeter, ground truth typically involves other validated physiological measurement techniques or established clinical diagnostic standards for oxygenation levels. It is highly unlikely to be expert consensus or pathology in the context of real-time oxygenation measurement.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. The 510(k) summary suggests the device uses hyperspectral imaging technology for spectral analysis. While such systems might involve calibration or model development, the term "training set" in the AI context is not used here, and no details about such a set are provided. The device's operation is based on physical principles of light absorption by hemoglobin.

8. How the ground truth for the training set was established:

   • Not applicable/Not explicitly stated. As there is no mention of a "training set" in the AI sense, there's no information on how its ground truth would have been established. Any calibration or model development would likely rely on physically characterized phantoms or in-vitro/in-vivo studies with known oxygenation states.

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