(86 days)
The CoSense ETCO Monitor is indicated for the monitoring of carbon monoxide from endogenous sources (including hemolysis) and exogenous sources (including CO poisoning and smoke inhalation) in exhaled breath. The end tidal carbon monoxide level can be used for the monitoring of carbon monoxide in medical conditions in which the rate of hemolysis may be relevant. It is also for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation.
The CoSense ETCO Monitor is a battery-operated carbon monoxide (CO) monitor. It uses an infrared capnometer to detect the end-tidal portion of the breath and an electrochemical carbon monoxide sensor to measure the end-tidal breath CO concentration. The device consists of a portable unit with software controlled menu (date, time, patient identification, measurement time of monitoring), single-use nasal cannula, replaceable CO Sensor, and a battery charger / power supply.
This document is a 510(k) premarket notification for the Capnia CoSense ETCO Monitor. It seeks to demonstrate substantial equivalence to a predicate device (K130036), which is also a Capnia CoSense ETCO Monitor.
The submission focuses on the argument that the "design and performance specifications are identical and unchanged from our predicate device." Modifications primarily involved a heating element, cannula configuration, flow rate sensor, and software updates, which the manufacturer states do not alter performance specifications or intended use.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that the subject device shares "identical performance specifications (accuracy, range, and resolution)" with the predicate device. Therefore, the acceptance criteria are implicitly that the subject device maintains these identical specifications.
| Acceptance Criterion (from Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|
| Accuracy: +/- 10% or +/- 0.5ppm (whichever is greater) | +/- 10% or +/- 0.5ppm (whichever is greater) |
| CO Measurement Range: 1.0 – 25.0ppm | 1.0 – 25.0ppm |
| Resolution: 0.1 ppm | 0.1 ppm |
| Breaths per Minute: 10 – 50 bpm | 10 – 50 bpm |
| Sample Collection Rate: 48 mL/min +/- 2.0 mL/min | 48 mL/min +/- 2.0 mL/min |
| Measurement Time: Less than 5 minutes | Less than 5 minutes |
2. Sample size used for the test set and the data provenance:
The document does not provide specific sample sizes for a separate test set used to evaluate the subject device's performance against the predicate. Instead, it states that "representative samples of the device underwent biocompatibility (Cytotoxicity, Sensitization, and Irritation), software, electrical, and mechanical testing, specifically CO Measurement accuracy." The provenance of this data is not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The study appears to rely on established performance specifications rather than a new ground truth established by experts for this specific 510(k) submission.
4. Adjudication method for the test set:
This information is not provided.
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 is not applicable to the CoSense ETCO Monitor. It is a carbon monoxide monitor, not an AI-assisted diagnostic imaging or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not directly applicable in the context of an "algorithm only" study as it is a medical device for direct measurement. The "software" was tested, but not as a standalone AI algorithm in the typical sense. The device itself is designed for standalone operation (measuring CO in exhaled breath).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the performance specifications of the device (both subject and predicate), the implied ground truth would be precise measurements from calibrated gas analyzers for CO concentration. However, this document does not detail how these original performance specifications for the predicate were established, only that the subject device maintains them.
8. The sample size for the training set:
This is not an AI/machine learning device in the context of a "training set" as typically used for AI model development. Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established:
Not applicable, as it's not an AI/machine learning device with a training set.
§ 868.1430 Carbon monoxide gas analyzer.
(a)
Identification. A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.(b)
Classification. Class II (performance standards).