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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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Spectros T-Stat™ 303 Microvascular The 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™ 303 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 is a 510(k) summary for the Spectros T-Stat™ 303 Microvascular Tissue Oximeter. This submission is for modifications to an existing device (K040684, the predicate device), not a new device requiring a full clinical study to establish performance. Therefore, the document does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a de novo or PMA submission would.

Instead, the submission focuses on demonstrating that the modifications do not negatively impact safety or effectiveness and that the modified device remains substantially equivalent to the predicate. The "Test Summary" section describes re-verification and re-validation activities related to these specific modifications, rather than a comprehensive performance study against specific clinical acceptance criteria.

Below is an attempt to address your request based on the limited information available in the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this 510(k) submission.

Analysis of Acceptance Criteria and Device Performance for Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K081233)

Summary: This 510(k) submission (K081233) concerns modifications to an already approved device (K040684). As such, the document primarily focuses on demonstrating substantial equivalence and the safety/effectiveness of the modifications, rather than presenting a de novo performance study against explicit clinical acceptance criteria for the entire device. The information provided outlines re-verification and re-validation steps for specific changes (housing, probes, software), indicating that the existing performance of the predicate device is assumed to be maintained for the core functionality.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for modifications, the "acceptance criteria" discussed are largely for the changes themselves to ensure they do not degrade existing performance, rather than new clinical performance goals. The document does not provide specific quantifiable performance metrics (e.g., accuracy, precision relative to a gold standard) for StO2% measurement as acceptance criteria for this submission.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical performance data for the StO2% measurement. The "tests" mentioned relate to engineering and software validation of the modifications.

• Sample Size for Test Set: Not applicable / Not provided. The tests mentioned (IEC compliance, shipping, sterilization, software validation) are typically engineering or bench tests, not clinical studies with patient sample sizes.
• Data Provenance: Not applicable / Not provided. The testing described is internal re-verification and re-validation of modifications, not clinical data collection from patients.

3. Number of Experts and Qualifications for Ground Truth

The concept of "experts" establishing ground truth (e.g., radiologists for image interpretation) is not applicable to this type of submission. This 510(k) is for modifications to a physiological monitoring device and does not involve subjective interpretation or a diagnostic decision that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the clinical sense, and therefore no adjudication method for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., images). The T-Stat™ 303 Microvascular Tissue Oximeter is a physiological monitoring device that provides a quantitative StO2% measurement, not a device requiring human interpretation of complex clinical cases in the way an MRMC study evaluates.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device is a monitor that provides a direct measurement (StO2%). Its performance is inherently "standalone" in that the algorithm generates the reading without human interpretation as an input to the measurement itself. However, the document does not describe a specific standalone performance study in the way one might for an AI/ML algorithm being validated against a ground truth. Rather, it generally refers to re-validation of software updates as part of the modifications. The performance of the core StO2% measurement algorithm would have been established in the predicate 510(k) (K040684).

7. Type of Ground Truth Used

For the modifications covered in this submission:

• Monitor housing: Ground truth is defined by compliance standards (IEC60601-1-2 for safety, ISTA-1a for shipping).
• Probes: Ground truth is established by manufacturers' final test and inspection standards, and re-validation of the sterilization process according to established protocols.
• Software updates: Ground truth is established by an "in-house validation procedure," which would typically involve testing against functional requirements and possibly simulations or comparison to expected outputs.

For the core StO2% measurement functionality (established by the predicate device K040684): The document does not specify the ground truth used for the original device's performance validation. Typically for oximeters, this would involve in vivo studies comparing the device's readings to directly measured blood oxygen saturation (e.g., co-oximetry).

8. Sample Size for the Training Set

Not applicable / Not provided. The device is not an AI/ML device that requires a training set in the conventional sense. The "software updates" mentioned are likely bug fixes and user interface clarifications, not a re-training of a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not provided. As there is no described training set, there is no ground truth establishment for it.

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The Spectros T-Stat™ 303 Microvascular The 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™ 303 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 (StQ2%).

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 Spectros T-Stat™ 303 Microvascular Tissue Oximeter's acceptance criteria are not explicitly stated in the provided text as numerical thresholds for performance metrics. Instead, the document describes the device's performance in comparison to predicate devices and previously published studies to establish substantial equivalence.

Here's an analysis of the provided information, structured around your request:

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria (e.g., "accuracy must be > 90%") are not detailed, this table will reflect the comparative performance statements provided in the submission.

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