(729 days)
The CapnoProbe Sublingual Tonometer System is indicated for monitoring sublingual PCO2. It is indicated for use in hospital patients. This device is indicated for use by qualified medical personnel only.
The CapnoProbe A System provides a measurement of Sublingual pCO2 (SL CO2). The CapnoProbe A consists of a Disposable Sensor, Instrument, Fiber Optic Interconnect Cable and Calibration Fluid. The Disposable Sensor contains a fiber optic pCO- sensor and temperature sensor. The Disposable Sensor is placed under the tongue for a measurement of pCO2 and temperature. The Disposable Sensor connects to the fiber optic interconnect cable. The fiber optic interconnect cable connects to a software modified ABG Module. The instrument is a software modified Optical CAM and ABO Module. The softwaremodified instruments measures SL CO2 and temperature, displaying SL CO2. The instrument is dedicated to the function as programmed by the software. The instruments are referred to as a CapnoProbe A Monitor and a CapnoProbe A Module. Prior to use the CapnoProbe A System with disposable pCO2 sensor is calibrated with provided tonometered saline. The saline calibration fluid is the same as the predicate SensiCath System initialization fluid.
Acceptance Criteria and Study for CapnoProbe A System
The provided 510(k) summary for the CapnoProbe A System does not explicitly state acceptance criteria in a quantitative table format as commonly seen in modern submissions. Instead, it focuses on demonstrating equivalence to predicate devices through various comparative studies. The underlying acceptance criterion for substantial equivalence is that the CapnoProbe A System performs "equally well" or is "as repeatable" as the predicate devices in relevant contexts.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the provided document, the "acceptance criteria" are inferred from the comparisons made to predicate devices.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (CapnoProbe A System) |
|---|---|
| Bench Performance: Perform equally well under laboratory conditions compared to predicate pCO2 measurement systems (e.g., Tonocap TC-200) with controlled levels of tonometered saline. | Performed "equally well" under laboratory conditions compared to Tonocap TC-200. |
| in vivo Performance (Animal Study): Demonstrate equivalence of pCO2 measurement compared to predicate systems (e.g., Tonocap TC-200) under varying physiological conditions (e.g., sublingual vs. stomach mucosal tissue). | "Both systems tracked pCO2 changes." The Pearson r Correlation Coefficient for two CapnoProbe A Systems was "higher than" that of two predicate Tonocap Systems. |
| Clinical Performance (Repeatability): Demonstrate repeatability comparable to published clinical data for predicate systems (e.g., Tonocap) in volunteer and stable subjects. | "CapnoProbe A System is as repeatable as the predicate TonoCap System." |
2. Sample Size and Data Provenance for Test Set
- Bench Data: No specific sample size is mentioned for the bench data. The data provenance is laboratory conditions using "controlled levels of tonometered saline."
- Animal Study: No specific sample size (number of animals) is mentioned. The study involved "test animals" and compared "pCO2 measurement under the tongue, versus stomach mucosal tissue." No country of origin is specified, but it's implied to be a laboratory setting. This was a prospective study.
- Clinical Data (Volunteer Study): No specific sample size (number of volunteers) is mentioned. The study involved "volunteer and stable subjects" to demonstrate repeatability. No country of origin is specified. This was a prospective study.
3. Number of Experts and Qualifications for Ground Truth
The document does not mention the use of experts to establish a ground truth for the test sets in the typical sense for medical imaging or diagnostic device studies. The "ground truth" used for comparison appears to be the performance of the predicate device (Tonocap TC-200) or established physiological measurements, rather than a consensus of human experts interpreting data for the CapnoProbe A System itself.
4. Adjudication Method
The document does not describe any adjudication method for establishing ground truth, as the studies primarily focused on comparative performance against a predicate device or controlled laboratory conditions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported. The device is a direct physiological measurement device and not one that typically involves human interpretation of outputs requiring an MRMC study.
6. Standalone Performance
Standalone performance of the algorithm (or device in this context) was implicitly evaluated through the bench, animal, and clinical studies. The device itself, when used without human interpretation in the loop (beyond medical personnel observing the displayed CO2 value), is presented as providing the measurement. The comparison is made directly between the CapnoProbe A System and the predicate Tonocap System.
7. Type of Ground Truth Used
- Bench Data: Controlled levels of pCO2 in tonometered saline served as the ground truth.
- Animal Study: The comparison was made against the predicate Tonocap System's measurement of pCO2 in animal tissues (sublingual and stomach mucosal), implying the predicate's readings served as a comparative "ground truth" or reference for tracking changes.
- Clinical Data: The "repeatability" of the CapnoProbe A System was compared against "published Tonocap clinical data," suggesting that established performance metrics of the predicate device derived from clinical studies served as the reference for repeatability.
8. Sample Size for Training Set
The document does not mention a "training set" in the context of machine learning or AI models, as the CapnoProbe A System is a physical measurement device. Therefore, no sample size for a training set is provided.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth would have been established. The device is described as measuring SL CO2 by a fiber optic sensor, implying its operation is based on known physical principles rather than learning from a training dataset.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).