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The Spacelabs Medical Integrated Multiparameter Module 90496 is intended for use with the PCMS to acquire, monitor. and process various clinical parameters from adult or neonatal/infant populations in any type of clinical environment other than home use. Physiologic parameters that may be monitored include cardiac activity, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2), and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.

Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings.

In conjunction with clinical findings, a screening and diagnostic tool for use in:

• assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation, as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations:
• monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea:
• continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure;
• episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure;
• continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature;
• monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and
• noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.

The Integrated Multiparameter Module 90496 is a slim, lightweight singular modular unit that. when used in conjunction with a Spacelabs Medical Palient Care Management System (PCMS), provides the capability to acquire various common physiologic data in a clinical setting.

The Module is the primary interface to the patient being monitored. The Module is capable of acquiring and processing ECG, respiration, invasive and noninvasive blood pressure, temperature, cardiac output, and SpO2 parameters for a single patient. The Module accumulates the patient physiological data of interest and provides both waveform and digital data to a Spacelabs Medical monitor via SDLC communications. The monitor will provide the display capabilities for the care provider.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance, and study results in the format requested. The document is a 510(k) summary for a medical device (Spacelabs Medical Integrated Multiparameter Module 90496), which outlines:

• Submitter's Name and Company Information
• Device Name and Classification (Arrhythmia Detector and Alarm, Noninvasive Blood Pressure Measurement System, Oximeter, etc.)
• Predicate Device(s)
• Device Description
• Intended Use (acquiring, monitoring, and processing various clinical parameters)
• Comparison of Technological Characteristics (comparing to predicate devices, noting similarities in design, components, storage technology, and energy source, and differences in feature sets and hardware packaging)
• Testing (mentions extensive safety and performance testing, compliance to standards like IEC 601.1, ANSI/AAMI EC11 and EC13, AAMI ECAR-1987, and ANSI/AAMI SP-10 for accuracy testing)
• FDA Clearance Letter (K972502)
• Indications for Use (patient conditions indicated by abnormalities in various physiologic parameters)

While the document states that "Final testing for the system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications" and mentions compliance with specific standards for "accuracy testing" (e.g., ANSI/AAMI SP-10 for blood pressure), it does not provide:

1. A specific table of acceptance criteria and reported device performance values.
2. Details about sample sizes for test sets, data provenance (country, retrospective/prospective).
3. Number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Explicit confirmation or details of a standalone algorithm-only performance study.
7. The specific type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on demonstrating substantial equivalence to predicate devices under the 510(k) pathway, which typically involves showing that the new device is as safe and effective as a legally marketed device, often through a combination of design characteristics, intended use, and adherence to recognized performance standards, rather than disclosing detailed clinical study results with acceptance criteria and statistical performance metrics in this summary.

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