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The Mercury Medical StatCO2meter™ End Tidal CO2 Detector with Integrated Airway Pressure Manometer is intended to provide a semi-quantitative visualization of the CO2 in the patient airway while measuring Airway and PEEP pressure. It is an adjunct in patient assessment, to be used in conjunction with other methods to determine clinical signs and symptoms by or on the order of a physician.

The Mercury Medical StatCO2meter™ is a fast, durable colorimetric breath indicator for visualization of exhaled CO2 and also measures Airway and PEEP pressure. The StatCO2meter™ is designed to connect between an endotracheal tube and a breathing device to help verify proper intubation. Exhaled gas passes through the indicator to detect approximate ranges of end-tidal CO2 by color comparison. The detector may be used during patient transport or in locations where intubations are performed.

Here's an analysis of the provided text regarding the Mercury Medical StatCO2meter™:

Important Note: The provided text is a summary of safety and effectiveness for a 510(k) premarket notification and the FDA's clearance letter. It focuses on demonstrating substantial equivalence to predicate devices rather than a detailed clinical study demonstrating new performance criteria against defined metrics. As such, information typically found in detailed study reports (like precise sample sizes for test sets, expert qualifications for ground truth, specific statistical methods, standalone performance studies, training set details for AI, etc.) is largely not present in this type of document. The device is a physical, colorimetric and manometer device, not an AI/algorithm-driven device, so many of the requested AI-specific points are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the way an AI algorithm might define sensitivity, specificity, etc. Instead, it refers to consistency with established standards for physical devices and substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. This document relies on the technical characteristics and consistency with standards for its validation, not a patient-based test set with a specific sample size.
• Data Provenance: Not applicable in the context of a "test set" for this type of device. The evaluation is against engineering standards and comparison to existing, cleared devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not applicable. The "ground truth" for this device's performance is adherence to industry standards (ISO, ASTM) for its physical design and functional principles, and a comparison of its technical specifications to those of its predicate devices. It's not an AI system requiring expert-labeled data.
• Qualifications of Experts: Not applicable for establishing ground truth in this context. Regulatory bodies (like the FDA) and standards organizations set the requirements.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This device is a physical medical instrument, not a diagnostic AI algorithm that requires adjudicating expert disagreements on ground truth labels. Its performance is evaluated through engineering testing and comparison of technical specifications.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done, and it's not applicable for this type of device. This isn't an AI-assisted diagnostic tool for human readers; it's a direct-reading physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Not applicable. This device does not contain an AI algorithm. It's a physical detector and manometer. Its "standalone" performance would be its ability to display color changes and pressure readings consistently, which is covered by adherence to the cited ISO and ASTM standards.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" implicitly used for this device is compliance with established engineering and performance standards (ISO 5356-1:1987, ASTM F1054) and the established safety and effectiveness of its predicate devices. For a physical device, this typically involves manufacturing specifications, design verification, and bench testing against known reference values, not expert consensus on clinical cases or pathology.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not utilize an AI algorithm, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set was Established

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm.

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