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510(k) Data Aggregation
(1191 days)
MicroTrend System
The MicroTrend is indicated for monitoring oral mucosal PCO2 in adult patients at risk of hemodynamic instability as an adjunct to other standard hemodynamic monitored parameters. This single-use device is indicated for use by qualified medical personnel to assess a patient's peripheral circulation status.
The MicroTrend Monitor provides trending information on tissue POMCO2 readings measured by the disposable sensor every two minutes over a maximum of a continuous 4-hour monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
The MicroTrend System provides a method of assessing the partial pressure of carbon dioxide (PCO2) in the oral mucosa (POMCO2). The MicroTrend System is a device composed of a Monitor, disposable POMCO2 Sensor, and associated connectors. It is designed to be easy to use with minimum training. A single-use disposable POMCO2 sensor is calibrated and then secured against the inside of the patient's cheek. Once the sensor initiates monitoring, the value of POMCO2 is reported on the MicroTrend Monitor instrument display. The MicroTrend Monitor provides trending information on tissue PCO2 readings measured by the disposable sensor every two minutes over a maximum of a 4-hour continuous monitoring period. Additional sensors may be utilized by the clinician for up to 4-hours each until monitoring is deemed unnecessary.
The MicroTrend System is intended for use as an adjunct to other standard hemodynamic monitored parameters to help interpret the patient condition, treatment, and action by qualified medical professionals.
This document describes the MicroTrend System, a device for monitoring oral mucosal PCO2 (POMCO2), and its substantial equivalence to the predicate device, CapnoProbe-A, based on performance tests.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format for a specific performance metric of the device in relation to the predicate. Instead, it states that the performance of the MicroTrend System was "demonstrated to be equivalent to the predicate CapnoProbe-A device" and that "measurements taken from healthy volunteer subjects using the MicroTrend System ... were found to be statistically similar to the historical, combined values obtained from healthy volunteers using the predicate CapnoProbe-A." Additionally, it mentions "no statistical difference between the MicroTrend System and the CapnoProbe-A related to repeatability and reproducibility."
Therefore, the implicit acceptance criterion for the primary clinical performance metric (PoMCO2 measurement accuracy/similarity to predicate) is statistical similarity or equivalence to the predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| PoMCO2 Measurement Performance (Animal Study) | Equivalent to predicate CapnoProbe-A under hemorrhagic shock conditions. | Demonstrated recognition of onset of hemorrhagic shock, correlation with severity, and response to reversal, consistent with CapnoProbe-A in an animal study. Reinfusion of shed blood promptly reversed hemodynamic abnormalities and reestablished PoMCO2 near baseline. |
| PoMCO2 Measurement Performance (Clinical Study) | Statistically similar to predicate CapnoProbe-A in healthy volunteers. | Measurements taken from healthy volunteer subjects using the MicroTrend System were found to be statistically similar to historical, combined values obtained from healthy volunteers using the predicate CapnoProbe-A. |
| Repeatability and Reproducibility | No statistical difference to predicate CapnoProbe-A. | Volunteer clinical study results demonstrated no statistical difference between the MicroTrend System and the CapnoProbe-A related to repeatability and reproducibility. These results indicate comparable levels of measurement variation. |
| Other Bench Verification | Pass (specific internal requirements) | Passed all listed bench tests including battery operation, useful life, operating environment, temperature measurement accuracy, and usability. |
| System Error Check | Sensor damage/chewing detected and accounted for. | Evaluation of MicroTrend Sensor design and error checking function when subjected to human chewing "Pass". |
| Simulated Bite/Chewing | Sensor damage and choking hazard assessed. | Assessment of damage to sensor assembly and risk of choking hazard "Pass". |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Study: The document mentions "A swine animal study was conducted," but does not specify the sample size (number of animals). The data provenance is prospective (study was conducted to demonstrate performance). No country of origin is specified.
- Clinical Study: The document states "A prospective, non-randomized, single-site historically controlled clinical study was performed to evaluate the Microtrend System performance and compared it to published predicate device data." It involved "healthy volunteer subjects," but the sample size (number of subjects) is not specified. The data provenance is prospective for the subject device data, and retrospective/historical for the predicate device data ("published predicate device data" and "historical, combined values"). No country of origin is specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for either the animal or clinical test sets. The ground truth in the animal study appears to be physiological responses to induced hemorrhagic shock and reversal. In the clinical study, the ground truth for "historical, combined values" from the predicate device would presumably have been established previously, but details are not provided.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test sets. The clinical study was a "historically controlled clinical study" comparing the subject device's performance to historical predicate data.
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
No, a MRMC comparative effectiveness study was not done. This device is a measurement system and not an AI-assisted diagnostic or interpretive tool that human readers would interact with in a MRMC study context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a measurement system. The "clinical study" compares the standalone performance of the MicroTrend System to the standalone performance of the predicate device. Therefore, the clinical study could be considered a form of standalone performance evaluation where the algorithm/device output is directly compared to a reference (the predicate's historical performance). The study "evaluated the Microtrend System performance" directly.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Animal Study: The ground truth appears to be physiological responses/physiological state (e.g., induction of hemorrhagic shock, systemic lactic acidosis, and reversal of these conditions by reinfusion of blood). The PoMCO2 measurements from the MicroTrend System were expected to reflect these physiological changes similarly to the predicate.
- Clinical Study: The ground truth for comparison appears to be historically established PoMCO2 values obtained from healthy volunteers using the predicate CapnoProbe-A. This implicitly relies on the predicate device's established accuracy. It's a comparison to a known, previously accepted measurement rather than an independent "gold standard" pathology or outcomes data.
8. The Sample Size for the Training Set
The document does not mention a "training set" for an algorithm. The MicroTrend System is described as a measurement device rather than a machine learning/AI algorithm that would typically have a specific training set. The clinical and animal studies described are for validation of the device's performance, not for training.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, this information is not applicable/provided.
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