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The Spectrum monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use for the Spectrum device include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3, 5 or 12 lead measurements
• Heart Rate derived from selected sources (ECG, SpO3, IBP, NIBP)
• Pulse Oximetry (SpO2, )
• ST Segment Analysis derived from 3, 5 or 12 ECG lead measurements
• Arrhythmia Detection derived from 3, 5 of 12 ECG lead measurements
• Interpretation of Resting 12 lead ECG
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) - up to four (4) channels
• Cardiac Output
• Respiration Rate/ waveform derived from ECG or CO2
• CO2, inspired and end tidal microstream/ waveform
• Temperature - up to two (2) channels
• Hemodynamic Calculations
• IV Drug Calculations

The Spectrum Monitor is an enhanced version of the Datascope Corp. Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module, previously cleared by FDA under K020550. There have been no significant changes to the Passport 2® Vital Signs Monitor with View 12 ™ ECG Analysis Module since its clearance. Datascope Corp. has modified the Passport 2® Vital Signs Monitor with View 12™ ECG Analysis Module by including the following parameters: Cardiac Output, Drug Calculations, Hemodynamic Calculations, a second Temperature, and two additional Invasive Blood Pressure Channels. The Spectrum monitor is a device that is used to monitor, display, trend and print a patient's physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, Non- Invasive Blood Pressure (NIBP), Respiration, Continuous Temperature and IV Drug Calculations. Optional software includes ST and Arrhythmia Analysis. Optional hardware features include View12 ECG Analysis Module (which includes ST Arrhythmia and 12 Lead interpretation), up to 4 Invasive Blood Pressure Channels, Microstream CO2, Anesthetic Gases, Nellcor Oxismart SpO2, second temperature source, dual trace recorder, and Cardiac Output. A comprehensive calculation package including Hemodynamic Calculations is available if the Spectrum is equipped with an External Parameter Module. Digital displays are provided for Heart Rate, NIBP, SpO2, Respiration Rate, and Temperature. Optional digital displays are provided for up to four Invasive Blood Pressure, Anesthetic Agents, O2, and N20, ST and CO2, The optional internal recorder provides hard copies of all digital data and waveforms, as well as trend information.

The provided text describes a 510(k) summary for the "Spectrum Monitor" and a clearance letter from the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study proving the device meets those criteria.

Therefore, much of the requested information regarding detailed acceptance criteria, specific study design, sample sizes for test and training sets, expert qualifications, adjudication methods, and MRMC studies is not available in the provided document.

However, I can extract the general claims about testing and the overall conclusion.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, accuracy thresholds) and corresponding reported performance metrics are not detailed. The document states that the device was subjected to various tests and complies with voluntary standards, implicitly suggesting performance met certain established benchmarks.

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

This information is not provided in the given 510(k) summary. The document does not describe a clinical study with a defined test set.

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

This information is not provided in the given 510(k) summary. There is no mention of expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided as no specific test set requiring adjudication is described.

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

This information is not provided. The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's performance compared to predicate devices, not on improving human reader performance.

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

While the device itself is a standalone monitor, the document does not detail specific "algorithm only" performance studies in a way that aligns with typical AI/algorithm standalone studies. It broadly mentions "Hardware and Software validation" and "Performance testing" but does not break down the results for specific algorithms independently. Given the device's nature as a multi-parameter patient monitor, its performance inherently involves algorithms, but a distinct "standalone" performance study akin to AI diagnostic tools is not described.

7. The Type of Ground Truth Used

The type of ground truth used for performance testing (e.g., expert consensus, pathology, outcomes data) is not specified in the provided summary. The document states "Performance testing" and "Hardware and Software validation" were conducted, implying ground truth was established to verify these, but the method is not elaborated upon.

8. The Sample Size for the Training Set

This information is not provided. There is no mention of a "training set" in the context of this 510(k) summary, as the device is presented as an enhanced version of an existing monitor rather than a new AI model requiring a distinct training phase description.

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

This information is not provided as no training set is described.

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