(88 days)
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.
| Acceptance Criteria (for Modifications) | Reported Device Performance (for Modifications) |
|---|---|
| Compliance with IEC60601-1-2 (Monitor housing) | Re-verification of compliance with IEC60601-1-2 completed. |
| Shipping test per ISTA-1a (Monitor housing) | Shipping test per ISTA-1a completed. |
| Normal manufacturing final test and inspection (Probes) | The normal manufacturing final test and inspection was determined to be the only validation required for the endoscopic and oral probes. |
| Sterilization process re-validation (Smaller oral probe) | Sterilization process was revalidated with the new smaller oral probe. |
| Software updates re-validation (Software) | Software updates were revalidated using an in-house validation procedure. |
| Overall System Improvement/Equivalence | "The modified T-Stat 303™ Oximeter System represents an improvement over the predicate with better software performance, equivalent safety performance, and improved probe assortment that allows for better patient fit." |
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.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).