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The C1 Series Patient Monitor series are multi-parameter patient monitors that are used to monitor ECG waveforms, heart rate, noninvasive blood pressure (systolic, dialstolic), functional atterial oxygen saturation and temperature for adult and pediatric patients in all hospital areas and health care facilities.

The C1 Series Patient Monitor is a compact, lightweight monitor for measuring, processing, storing, and displaying information derived from five physiological measurements: Electrocardiogram (ECG), Pulse Oximetry (SpO2), Temperature, Non-invasive Blood Pressure (NIBP), and an external optional thermal printer. It is powered by internal sealed lead-acid batteries.

This document refers to the Analogic Corporation C1 Series Patient Monitor, which measures and displays physiological data. The information provided heavily emphasizes non-clinical testing for substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the types of tests conducted rather than specific quantitative acceptance criteria or reported performance values. The primary acceptance criterion is that the device "meets all elements of its Requirements Specification" and is "substantially equivalent to the predicate device." The performance is reported through compliance with various recognized national and international standards.

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

The document does not provide details on sample sizes for specific test sets (e.g., number of patients, test cases). The testing described is primarily non-clinical compliance testing against engineering standards rather than clinical performance testing with patient data. Therefore, the concept of "data provenance" (country of origin, retrospective/prospective) related to patient data is not applicable in this context. The testing is based on engineering validation and laboratory compliance.

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

This information is not provided. Given the nature of the non-clinical, engineering, and standards compliance testing, the "ground truth" would be defined by the technical specifications of the standards themselves and the proper functioning of the measurement equipment, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the non-clinical, standards-based testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical and safety compliance to standards and comparison of technological characteristics with a predicate device, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a patient monitor, which inherently provides data for human interpretation. The "algorithms" mentioned (e.g., predictive temperature algorithm, NIBP oscillometric method, SpO2 calculation) are integrated functions of the device. The testing described focuses on the device's adherence to performance and safety standards, implying standalone function of these measurement capabilities. However, a specific "standalone algorithm performance" study, as might be done for an AI diagnostic tool, is not described in these terms. The performance of the integrated algorithms is validated as part of the overall device's compliance with relevant standards.

7. The Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" is established by:

• International and National Standards: The specifications and requirements outlined in standards like IEC 60601 series, CISPR 11, ANSI/AAMI EC-13, and ANSI/AAMI SP10 serve as the objective criteria for what constitutes correct and safe device performance.
• Predicate Device Characteristics: Substantial equivalence is largely based on the C1 Series Patient Monitor sharing similar technological characteristics and performance with the legally marketed predicate device, the NPB 3900 (A1) Patient Monitor.

8. The Sample Size for the Training Set

This information is not applicable. The Analogic C1 Series Patient Monitor is a hardware device with integrated firmware and algorithms for physiological measurements (ECG, SpO2, NIBP, temperature). It is not an AI/ML-driven diagnostic or predictive model that typically requires a "training set" of data in the modern sense. The algorithms for its functions (e.g., oscillometric NIBP, SpO2 calculation, predictive temperature) are established medical technologies.

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

This information is not applicable, as there is no mention of a "training set" for AI/ML model development. The ground truth for the device's measurements would be derived from physical principles, validated medical references, and engineering specifications.

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