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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 Monitor 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, SpO2, IBP, NIBP)
• Pulse Oximetry (SpO2)
• ST Segment Analysis derived from 3, 5 or12 ECG lead measurements
• Arrhythmia Detection derived from 3, 5 or 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
• Bispectral Index (BIS)

The target populations are adult, pediatric and neonate with the exception of:

• Arrhythmia detection, ST Segment Analysis, Cardiac Output, Hemodynamic Calculations, Pulmonary Artery Wedge Pressure measurements, and
• Interpretation of Resting 12 Lead ECG and IV Drug Calculations, for which the target population is adult only.
• Bispectral Index. The BISx is intended for use under direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. Note: The clinical utility, risk/benefit, and application of the device have not undergone full evaluation in the pediatric population.

The Bispectral Index from available information is a complex technology, intended for use only as an adjunct to clinical judgment and training.

The BIS may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.

The Spectrum Monitor has the capability of interfacing with Datascope's Intra Aortic Balloon Pumps, Central Stations, and Gas Module products.

The Spectrum Monitor, which is the subject of this submission, is a modified version of the Datascope Spectrum Monitor, which was previously cleared by FDA under K031849, on September 9, 2003. There have been no significant changes to the Spectrum Monitor since its clearance. At this time, Datascope Corp. has added a new parameter to the device's monitoring capabilities, the measurement of Bispectral Index (BIS) via an interface to the Aspect Medical System's BISx™ module (K040183).

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 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® and Oximax® SpO2, a 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, CO, CO2, and BIS. The optional internal recorder provides hard copies of all digital data and waveforms, as well as trend information.

Bispectral Index (BIS) is continuous measure of the effects of certain anesthetic and sedative agents on a patient's brain. The Aspect BISx module monitors the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes the raw EEG signal to produce Aspect's proprietary BIS Index, a single value that is correlated with the patient's level of hypnosis. The BISx mates on one side with a patient interface cable, which attaches to Aspect's BIS sensors, and on the other side with the Spectrum Monitor, where the BIS Index is displayed on the integrated display.

The provided text is a 510(k) Summary of Safety and Effectiveness for the Datascope Spectrum™ Monitor, dated February 2, 2007. It describes a modified version of an existing monitor with the addition of Bispectral Index (BIS) monitoring capabilities via an interface to Aspect Medical System's BISx™ module.

However, the document does not contain specific acceptance criteria or performance data in terms of quantifiable metrics (e.g., sensitivity, specificity, accuracy, error rates) for any of the monitored parameters, including the newly added BIS. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to design control processes.

Therefore, many of the requested items cannot be extracted from this document.

Here's an analysis of what information is available and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document states that "Datascope's product development process required that the following activities be completed during the development of the Spectrum Monitor: Requirements specification review, Software testing, Code design and code reviews, EMC testing, Safety testing, Software validation." And concludes that "The results of all testing demonstrate that the Spectrum Monitor is as safe, as effective, and performs as well as the predicate devices."

However, it does not provide any specific performance metrics or acceptance criteria that were used to evaluate the device and compare it to predicate devices. For example, it does not state "BIS accuracy must be +/- X points" or "Arrhythmia detection sensitivity must be Y%."

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

Missing. No details on sample size, data provenance, or study design (retrospective/prospective) are provided for any testing mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. No information on experts or ground truth establishment for testing is included.

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

Missing. No adjudication methods are described.

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 multi-parameter patient monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" or be evaluated in an MRMC comparative effectiveness study in the context of improving human interpretation. The BIS functionality is presented as an aid to clinical judgment, but not as an AI system that improves human "reading" of data in a comparative effectiveness study.

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

Missing. The document does not provide performance data for any component, standalone or otherwise. The BISx module is described as providing a "single value that is correlated with the patient's level of hypnosis," but no performance metrics for this correlation are given.

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

Missing. No ground truth types are described for any testing.

8. The sample size for the training set

Missing. There is no mention of a "training set" as this is a medical device submission based on substantial equivalence, and the new BIS parameter is integrated via Aspect Medical System's BISx™ module, which is a previously cleared device (K040183). The submission for the Spectrum Monitor's modification primarily focuses on the integration and safety/effectiveness of the combined system, rather than de novo algorithm development and training.

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

Missing. As no training set is mentioned, naturally, its ground truth establishment is also not discussed.

In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to predicate devices and adherence to design control processes. It does not present detailed performance data, acceptance criteria, or clinical study results in the format requested, which would be typical for a submission involving novel algorithms or significant performance claims for a new diagnostic or assistive AI feature. The addition of BIS is achieved by integrating a pre-cleared module, and the focus of this submission is on the safety and effectiveness of the combined system.

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