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The Spectros T-Stat™ 2.0 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states.

The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.

The Spectros T-Stat™ 2.0 Microvascular Tissue Oximeter is a broadband, multiwavelength, Visible Light Spectroscopy (VLS) monitoring system for measuring the saturation of hemoglobin with oxygen in the microvascular tissue spaces (StO2%).

The complete system consists of a disposable sensor probe connected to a software-driven electronic monitor. Data collection, analysis, and display functions are provided by the monitor. Illumination of the tissue is provided by a visible light source in the sensor probe placed near, on, or into the target tissue to be studied. Reflected light is captured and returned to the monitor via a detachable connection at the monitor end of the patient probe. StO2% is estimated using differential optical diffuse reflectance spectroscopy and fitting for background scattering over a range of reflected visible wavelengths.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report for the T-Stat 2.0 Microvascular Tissue Oximeter. Instead, it focuses on the device's substantial equivalence to a predicate device (T-Stat 303™ Microvascular Tissue Oximeter) based on design modifications and re-verification of existing standards.

Therefore, I cannot provide a detailed answer to all parts of your request. However, I can extract what is available regarding testing and validation:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the T-Stat 2.0. The test summary mentions compliance verification with international standards and re-verification of functional requirements.

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

The document does not specify a "test set" in the context of patient data or clinical samples. The testing described is primarily engineering and software validation. Therefore, information about sample size for a clinical test set and data provenance is not available.

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)

This information is not provided as the document does not describe a clinical study where ground truth would be established by experts.

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

This information is not provided as the document does not describe a clinical study.

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 information is not provided. The T-Stat 2.0 is a tissue oximeter, not an AI-assisted diagnostic imaging device for human readers.

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

The T-Stat 2.0 provides StO2% measurements. The "functional continuity" re-verification suggests standalone performance relative to the predicate device's established functionality. However, detailed performance metrics for just the algorithm are not provided.

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

The document focuses on engineering and software validation against established standards and the functional requirements of the predicate device. It does not mention a "ground truth" in the clinical sense (e.g., pathology, outcomes data) for the T-Stat 2.0's performance validation. The predicate device's existing clearance would have relied on such ground truth for its initial establishment of effectiveness.

8. The sample size for the training set

The document does not mention a "training set" as it describes re-verification of a modified device, not the development of a new algorithm requiring a training set.

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

This information is not provided as there is no mention of a training set.

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