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The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and is available for use by medical personnel on patients within a medical facility including adults, children and infants.

The optional AG-920RA module will measure carbon dioxide (CO2), nitrous oxide (N₂O), oxygen (O₂), and any of five anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) of a patient undergoing anesthesia and display the results on a bedside monitor.

The device currently marketed per K001693 is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring including arrhythmia detection and alarms within a medical facility. With the new AG-920PA option, the device will measure and display Carbon dioxide (CO2), nitrous oxide (N2O), oxygen (O2), and any of five anesthetic agents (Halothane, Isofilurane, Enflurane, Sevoflurane, and Desflurane).

The provided documentation for the NIHON KOHDEN AMERICA, INC. BSM-4100A Series with AG-920RA Option does not contain the detailed information necessary to complete all sections of the request.

Specifically, the document focuses on regulatory equivalence and general performance testing, not on a specific study designed to prove the device meets acceptance criteria related to accuracy, specificity, or sensitivity of gas measurement.

Here's an attempt to answer based on the available information, with many sections marked as "Not provided in the document."

Acceptance Criteria and Device Performance Study for BSM-4100A Series with AG-920RA Option

Based on the provided 510(k) notification summary (K020046), the acceptance criteria and study details are largely about general performance and safety rather than specific measurement accuracy criteria for the gas analyzer function.

The document states that "The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the device software. The results confirmed that the device performed within specifications." However, it does not specify what those "specifications" or "acceptance criteria" are for the gas measurement accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not provided for the gas analysis function. The document refers to "testing procedures" without specifying sample sizes for specific performance metrics of the AG-920RA module.
• Data Provenance: Not provided. The company is based in Foothill Ranch, California, USA, but actual test location/origin is not specified.
• Retrospective or Prospective: Not provided. The testing described appears to be pre-market validation testing.

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

• Not applicable/Not provided. The testing described focuses on engineering validation and compliance with standards, not on clinical interpretation or expert-derived ground truth for gas analysis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. This type of adjudication pertains to human interpretation/review, which is not relevant to the described engineering and performance testing.

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. This device is a measurement instrument, not an AI-assisted diagnostic tool requiring human reader studies.

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

• The AG-920RA module, as a measurement device, inherently operates in a "standalone" fashion to measure gas concentrations. The "performance testing procedures" and "software validation" would constitute its standalone evaluation for its specified functions. However, specific results for accuracy, precision, etc., for each gas are not detailed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For a gas analyzer, the "ground truth" would typically be established by reference instruments or known gas concentrations, calibrated against traceable standards. The document does not specify the exact methods or reference standards used to establish ground truth for the gas measurements. It implies that "performance testing" was conducted which would involve such methods.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not applicable. (See #8)

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