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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.

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.

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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.

The CoSense ETCO Monitor is a carbon monoxide (CO) monitor that 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.

Here's an analysis of its acceptance criteria and the study that proves it:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not explicitly reported as a human test set. The submission relies on the identical performance specifications of its predicate device, K121768, and a clinical data analysis of published studies on other FDA-cleared CO monitoring devices.
• Data Provenance: The study performed an "analysis of published clinical data" on "uses of other FDA-cleared CO monitoring devices." This suggests the data is retrospective and collected from existing literature and studies, likely covering various clinical sites and geographical locations if the published data is diverse. No specific country of origin is mentioned for this retrospective analysis.

3. Number of Experts and Qualifications:

• Not applicable for establishing ground truth for a test set, as the study relied on an analysis of published clinical data on other devices and the identical performance specifications to a predicate device. The performance specifications themselves would have been established through engineering and laboratory testing, rather than expert interpretation of a specific test set.

4. Adjudication Method:

• Not applicable as the study did not involve a human-in-the-loop test set requiring expert adjudication.

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

• No. The submission does not describe an MRMC comparative effectiveness study for the subject device. It focuses on demonstrating equivalence to predicate devices and analyzing existing published clinical data.

6. Standalone Performance:

• Yes. The device's performance specifications (accuracy, range, resolution) are presented as "identical" to its predicate (Capnia CoSense CO Monitor K121768) and "similar" to a reference predicate (Natus CO-STAT End Tidal Breath Analyzer K974805), indicating a standalone assessment of the device's technical specifications. The submission states, "The CoSense ETCO Monitor uses the identical performance specifications (accuracy, range, and resolution), software algorithms, sensors, and accessories as our predicate device, the CoSense CO Monitor."

7. Type of Ground Truth Used:

• The ground truth for the performance specifications (accuracy, range, resolution) are established through objective measurements against known standards, typical for medical device engineering and testing.
• For the "analysis of published clinical data," the "ground truth" would be the clinical outcomes and CO measurements reported in those studies, which are assumed to be established by the methodologies used in the respective published research. The submission states this analysis provides "objective evidence that the functional and performance specifications of CoSense device are similar to the devices in the published studies."

8. Sample Size for the Training Set:

• Not applicable. This device is primarily hardware with established performance specifications. The "software algorithms" are stated to be "identical" to the predicate, implying they were developed and "trained" (if machine learning was involved, which is unlikely for this type of device based on the description) during the development of the predicate device. No details are provided on a specific training set for the subject device.

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

• Not applicable, as no training set for the subject device is described. The ground truth for the underlying performance of the electrochemical sensor and capnometer would have been established through precise laboratory calibration and gas measurement standards.

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The CoSense CO Monitor is indicated for the monitoring of Carbon Monoxide from endogenous and exogenous sources in exhaled breath. It is for use in smoking cessation programs and can be used for the screening of CO poisoning and smoke inhalation. It is for use by health professionals.

The CoSense CO Monitor is a battery-operated carbon monoxide 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 power supply.

The provided text describes the CoSense™ CO Monitor, its indications for use, and a 510(k) summary for its clearance. However, it does not contain details about specific acceptance criteria related to device performance (e.g., accuracy, precision) or a study that directly proves the device meets such criteria.

The document primarily focuses on:

• Regulatory Clearance: Listing the device's classification, product code, and predicate device.
• Device Description: Explaining how the monitor works.
• Intended Use: Defining its applications.
• Functional and Safety Testing: Mentioning adherence to industry standards for biocompatibility, software, electrical, and mechanical aspects. This testing verifies that the design meets its functional and performance requirements generally, but specific performance metrics (e.g., measurement accuracy against a gold standard) are not detailed here.
• Substantial Equivalence: Concluding that the device is equivalent to a predicate based on similarities in indications, operation, technology, and materials. This is a regulatory conclusion, not a performance study result.

Therefore, I cannot fulfill all parts of your request with the provided information. I will address the points that can be answered and clearly state where information is missing.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria (e.g., accuracy thresholds, precision values) for the device's CO measurement performance, nor does it provide a table of reported device performance metrics in terms of CO measurement accuracy or precision that would typically be found in a performance study.

The "Acceptance Criteria" mentioned are for functional and safety testing (biocompatibility, software, electrical, and mechanical testing against specific industry standards). The reported device performance in this context is simply the conclusion that the device meets these standards.

2. Sample size used for the test set and the data provenance

Not provided in the text. The document mentions "representative samples of the device underwent testing," but does not specify the number of devices, patients, or measurements used for any testing directly related to CO measurement performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided in the text. This type of information is typically relevant for medical imaging or diagnostic algorithms where expert consensus is used to establish ground truth for a disease state. For a carbon monoxide monitor measuring a physiological parameter, the "ground truth" would typically involve a reference standard CO measurement device or gas concentration, not human expert interpretation of the device's output.

4. Adjudication method for the test set

Not applicable/Not provided in the text. See point 3.

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

Not applicable/Not provided in the text. An MRMC study is not relevant for a CO monitor. The device's function is to objectively measure CO, not to assist human readers in interpreting complex medical images or data.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a standalone monitor (algorithm only without human-in-the-loop performance in terms of interpreting its raw output). The document implies that the device's measurement capability was evaluated, but details of a specific "standalone" performance study (e.g., accuracy against a known CO source) are not detailed in the provided text. The functional and safety testing ensures the device operates correctly, but specific performance metrics are absent.

7. The type of ground truth used

For objective measurements like CO concentration, the ground truth would typically be an independent, highly accurate reference standard method for measuring CO or certified gas mixtures. The provided text does not specify what ground truth method was used for performance validation of the CO measurement capabilities, but it would not be "expert consensus" or "pathology" for this type of device.

8. The sample size for the training set

Not applicable/Not provided in the text. The CoSense CO Monitor is described as using an infrared capnometer and an electrochemical CO sensor. This suggests it's a sensor-based measurement device rather than a machine learning model that would require a "training set" in the conventional sense (e.g., for image recognition or predictive analytics). While the device has "software controlled menu," it's not explicitly stated to be an AI/ML device requiring a training set for its core measurement function.

9. How the ground truth for the training set was established

Not applicable/Not provided in the text. See point 8.

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