Search Results

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.

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

The document does not explicitly state the sample sizes for human or animal studies that generated the performance data.

• Test Set Sample Size: Not explicitly stated. The document refers to "peer-reviewed animal and human studies."
• Data Provenance: The studies are described as "peer-reviewed animal and human studies." No specific country of origin is mentioned. The studies appear to be prospective, as the device is being tested for its functional performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The studies are referred to as "peer-reviewed," which implies scientific scrutiny, but details on ground truth establishment are absent.

4. Adjudication Method for the Test Set

The adjudication method is not described in the provided text.

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

An MRMC study was not conducted as described. The focus is on the device's standalone performance and its comparison to other measurement methods (NIRS, pulse oximetry) and general "predicate devices," rather than on how human readers improve with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done. The document focuses exclusively on the performance of the T-Stat™ device (alcohol only) in making measurements.

• "T-Stat™ accurately measured hemoglobin spectra and desaturation binding curves in peer-reviewed in vitro studies."
• "T-Stat™ StO2% determined using VLS was unbiased in comparison to StO2% determined using NIRS predicates..."
• "T-Stat™ VLS tissue oximetry was demonstrated sensitive to reduced-flow and no-flow ischemic states..."

These statements describe the direct output and accuracy of the device's measurements.

7. Type of Ground Truth Used

The type of ground truth appears to be based on:

• Comparison to established methods/predicates: For StO2% bias, it was compared to "StO2% determined using NIRS predicates."
• Physiological gold standards: For sensitivity to ischemic states, it was
  demonstrated against "reduced-flow and no-flow ischemic states," which represent clear physiological conditions. For in vitro studies, it measured "hemoglobin spectra and desaturation binding curves," presumably against known chemical or spectroscopic standards.

8. Sample Size for the Training Set

The document does not provide information on a training set. The descriptions relate to evaluation studies rather than the development of a machine learning model with distinct training and test sets.

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

As no training set is described, this information is not applicable.

Ask a specific question about this device