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Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.

Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.

Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow networkbased applications to open windows and display information on other networked monitors.

Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders.

Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

The Spacelabs Medical Patient Monitors are a component of the Spacelabs Medical Patient Monitoring System. The four (4) monitor models 91367, 91369 and 91370 and the stationary monitor model 91387; are all similar in that they are all employ the same software and all accept inputs from the family of Spacelabs Parameter Modules. The monitors accept and display parameter information, waveform and numeric data, and alarm conditions including arrhythmia information received from the same family of modules modules.

The portable monitors are capable of operating independent of or connected to the Spacelabs Patient monitoring Network. As independent, portable monitors these devices operate from either AC or battery power. All alarm information received from the parameter modules is visually and audibly available at each monitor. When networked, either physically or wirelessly, these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the network.

The stationary monitor, model 91387, can be configured at installation as either a bedside or central station. As an independent bedside monitor the device operates from AC and. presents waveform, numeric data, and alarm conditions, including arrhythmia information, received from parameter modules. When physically networked these monitors are able to share their information with a central station or with other monitors on the network according to conditions establish by the user/system administrator. They are also able to connect, via the healthcare institution's network, through Dynamic Network Access (DNA) to other applications available on the newt6work.

The model 91387 central station monitor provides full monitoring control of remote parameters, including displays and alarms with both visual and audible annunciation for up to 16 patients. All waveform and current numeric data, arrhythmia, ST segment, and trends are available are available at the central station.

The provided text describes the Spacelabs Patient Monitors (models 91367, 91369, 91370, and 91387) and their substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or a detailed study report with performance metrics in the format usually associated with a medical device's performance evaluation against predefined criteria.

Instead, the document states that the devices were validated through "rigorous testing" to ensure compliance with standards and accurate presentation of parameter data, but it does not quantify this performance or present it in a table of acceptance criteria vs. reported performance.

Therefore, for aspects like "Table of acceptance criteria and reported device performance," "Sample sized used for the test set," etc., the information is not present in the provided text.

Here's an analysis based on the information available in the text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document mentions "test programs" but does not give the number of cases, patients, or data points used.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No. The document describes patient monitors that display data from other modules and communicate alarm conditions. It does not involve human readers interpreting data that could be assisted by AI.
• Effect size of human readers with vs. without AI assistance: Not applicable, as no MRMC study or AI assistance is mentioned in this context.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done? The device itself (the monitor) is not an "algorithm" in the sense of making diagnostic interpretations. It's a display and communication device for physiological parameters. The "rigorous testing" mentioned was for the monitor's ability to accurately present data and interface. This aligns more with functional and system integration testing rather than an AI algorithm's standalone performance. No specific standalone performance metrics for an algorithm are provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated for specific performance metrics. The phrasing "parameter data provided by parameter modules...could be accurately presented" suggests that the ground truth for "accuracy" would be the direct output from the source parameter modules or a reference standard for those parameters. For clinical workflow, the "ground truth" would be the subjective assessment of meeting user needs.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a patient monitor displaying data, not an AI/ML algorithm that is "trained" on a dataset.

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

• How Ground Truth Established: Not applicable. This device is a patient monitor displaying data, not an AI/ML algorithm that is "trained" on a dataset.

Summary of Device and Study Information:

This 510(k) submission is for patient monitors that display and communicate physiological data and alarms from other external modules. The "study" described is a general validation of the monitors' ability to accurately present data, support clinical workflows, and comply with unspecified software standards. There are no detailed performance metrics, test set sizes, expert qualifications, or AI-related study components typically found in submissions for AI/ML-driven devices. The focus is on the functional equivalence and safety of the monitors as display and communication interfaces.

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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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