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The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used to noninvasively monitor inspired and end tidal CO2 and respiration rate by trained medical professionals by or on the order of a physician. The Fukuda Denshi model HC-500 End Tidal CO2 Module will function with all Novametrix reusable and disposable main stream sensors.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used in an adult, infant and/or neonate patient population who are under the care of a physician, within the confines of a health care facility. The intended environment is critical care monitoring situations, including ventilator support and anesthesia where the Fukuda Denshi model DS-5300 Patient Monitor is being utilized.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is not intended for home use.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is intended to be used as part of the Fukuda Denshi DynaScope™ DS-5000 series of bedside patient monitoring systems. The HC-500 will not function as a stand alone device.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is indicated in those situation where it is desirable to perform real-time end tidal or inspired carbon dioxide concentration and/or respiration rate monitoring of intubated adult, infant and/or neonate patients who are under the care of a physician, within the confines of a health care facility.

The Fukuda Denshi model HC-500 End Tidal CO2 Module is a computer controlled medical device. It is designed to non-invasively provide respiration, inspired and expired CO2 values when used as part of the DS-5300 Patient Monitoring System (K964187). The HC-500 is a module, not a stand alone device. As a module, it will only operate when installed into a DS-5300 bedside patient monitor. The Fukuda Denshi model HC-500 ETCO2 module will function with all NOVAMETRIX main stream sensors.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fukuda Denshi model HC-500 End Tidal CO2 Module:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics in a tabular format as might be found in a more recent submission. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized standards.

Here's a summary of the implied "acceptance criteria" and the reported performance based on the text:

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

The document does not specify a sample size for a test set in terms of patient data or clinical cases. The testing described is primarily laboratory-based to verify design specifications and compliance with standards.

• Sample Size: Not specified.
• Data Provenance: Not applicable in the context of clinical patient data, as the testing described is laboratory-based and involves general compliance and verification.

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

This information is not provided in the document. The submission focuses on technical specifications, verification, and substantial equivalence to a predicate device, rather than a study involving expert-established ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not provided in the document as it did not involve a study with a test set requiring adjudication of findings (clinical patient data).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done.
• Effect Size: Not applicable.

This type of study is relevant for AI-powered diagnostic devices. The HC-500 is an End Tidal CO2 Module, which is a physiological monitoring device, not an AI-assisted diagnostic tool in the sense of image interpretation or complex clinical decision support.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The document implies that the "ETCO2 sensing and calculation algorithms" were tested as part of the overall device validation. However, it does not specifically describe a standalone algorithm-only performance study separate from the integrated device. The device itself is not a standalone algorithm; it's a hardware module that relies on these algorithms.
• The text states: "All ETCO2 sensing and calculation algorithms are similar to those used in the HC-300 (K950044) and are the same as those employed by Novametrix Medical Systems Inc." This suggests reliance on previously validated algorithms within the predicate device and the sensor manufacturer's technology.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims appears to be:

• Predicate Device Performance: The Fukuda Denshi model HC-300 (K950044) served as the primary reference for performance and safety.
• Novametrix Medical Systems Inc. Testing Protocols: End Tidal CO2 validation and verification testing was "conducted according to Novametrix Medical Systems Inc. testing protocol," implying that Novametrix's established and validated methods for CO2 measurement were used as a reference.
• Industry Standards: Compliance with electrical safety standards (UL 2601, CSA 22.2, AAMI) and environmental testing guidance (FDA DCRND) also forms a basis for "ground truth" regarding safety and basic functionality.

8. The Sample Size for the Training Set

• Not applicable. The device described is not an AI/ML device that requires a "training set" in the modern sense. Its algorithms are based on established physiological principles and have been carried over from a predicate device.

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

• Not applicable. See point 8.

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