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The Early Vue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.

The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)): Non-invasive BP--NBP (Adult, Pediatric, Neonatal); SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal); Pulse Rate -- PR -- derived from SpO2 or NBP (Adult, Pediatric, Neonatal); Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal); end tidal CO2--etCO2 (Adult, Pediatric, Neonatal); Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal); Respiration Rate: acoustic respiration--RRa (Adult, Pediatric);

Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric)

Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.

The subject device EarlyVue VS30 is a platform redesigned from the predicate device Suresign VS4 to provide the measurement of the same physiological parameters. It is a multi-parameter compact, portable monitor, offering several configurations and optional features that are intended to meet the customer's needs. The VS30 is designed with a simple, intuitive user interface for ease of operation. It is used to measure or monitor NBP, SpO2, SpHb, RRa, CO2 and optional temperature primarily in non-acute settings.

The subject VS30 also provides the wireless option. The wireless functions for VS30 are for the monitors to communicate with the hospital EMR system or to communicate with Philips IGS software over the hospital's wireless infrastructure.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: EarlyVue VS30 Vital Signs Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EarlyVue VS30 are implied by its comparison to the predicate device, Philips SureSigns VS4. The document asserts that the VS30 has the "same fundamental technological characteristics" and that "performance data demonstrates the subject device Early Vue VS30 is as safe and effective as the predicate device for all the measurements." Therefore, the predicate device's specifications serve as the de facto acceptance criteria for each measurement parameter.

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The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital signs monitors) for multiple patients. It provides secondary operator notification of alarms from other networked medical devices. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients. The intended use of the printer, when present, is to provide hardcopy text, graphics, and wave data. The Efficia CMS200 may provide for connection and information exchange to external systems. The Efficia CMS200 is intended for use in hospitals and out-of-hospital patient care settings (such as clinics, outpatient surgery facilities, long-term care facilities and physician offices) in which care is administered by healthcare professionals.

The subject Efficia CMS200 Central Monitoring System is comprised of medical device software, model S863352, which is installed on a PC platform. The subject Efficia CMS200 includes S863352, the PC and peripherals. The Efficia CMS200 software is not marketed separately.

The subject Philips Efficia CMS200 Central Monitoring System is a central station. It provides continuous remote monitoring of up to 32 beds. It obtains data from networked patient monitors and provides centralized viewing of waveric data and alarms from all the connected beds. It is providing secondary alarm notification. It allows for retrospective data review. It can transfer data to an electronic medical record system (EMR).

Here's a breakdown of the acceptance criteria and study information for the Philips Efficia CMS200 Central Monitoring System, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics (e.g., specific accuracy rates, sensitivity, specificity, or error margins) with corresponding reported device performance values. Instead, it relies on demonstrating substantial equivalence to a predicate device and compliance with relevant standards.

The "Performance Data" section indicates that:

• "Performance data supports that the subject device performances to the same level of performance as the predicate device."
• "The clinical preference testing supports that the customer requirements are met."
• The device is in compliance with various international standards (IEC 62304, IEC 62366, IEC 60601 series, ISO 80601 series, ANSI/AAMI EC-13).

Therefore, the acceptance criteria are implicitly tied to meeting the same performance level as the predicate device (Philips SureSigns Central K131032) and compliance with relevant safety and performance standards. The "reported device performance" is that it meets these criteria.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: The document mentions a "clinical user preference study" but does not specify the sample size (number of users or cases) involved in this study.
• Data Provenance: Not explicitly stated, but the device is marketed in various countries, suggesting a broader provenance. The document indicates that for countries where the Efficia CMS200 is already marketed, there have been no reported adverse events. This implies some form of real-world use data contributes to the assessment, but it's not a formal "test set" in the context of a controlled study.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not detail the use of experts to establish ground truth for a quantitative test set in the traditional sense (e.g., for diagnostic accuracy). The "clinical user preference study" involved "users" or "healthcare professionals," but their specific qualifications or number are not provided for establishing "ground truth," as this study was more focused on user acceptance and identifying enhancement requests rather than diagnostic accuracy.

4. Adjudication Method (Test Set)

Not applicable, as a formal quantitative test set requiring adjudication of diagnostic outcomes is not described in the provided document. The clinical user preference study was likely qualitative feedback.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or at least not described in this document. The device is a central monitoring system for displaying physiological data and alarms, not an AI-powered diagnostic tool for interpretation. The "AI" component (if any in the context of this document) would be in the algorithms for processing physiological data, which are not detailed as AI in the modern sense.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the algorithm without human-in-the-loop performance is not explicitly described in terms of specific performance metrics (e.g., accuracy of alarm detection). However, the document states:

• "Performance data supports that the subject device performances to the same level of performance as the predicate device."
• It complies with various IEC and ISO standards that likely include requirements for the standalone performance of physiological monitoring systems.

The core technology (S863352 software) is assessed for compliance with standards applicable to medical device software (IEC 62304) and usability (IEC 62366), and its ability to meet system requirements when connected to compatible patient monitors (IEC 60601 series, ISO 80601 series, ANSI/AAMI EC-13). This implies that the software's functional performance itself was evaluated to ensure it operates correctly in a standalone context, though specific performance metrics are not given.

7. Type of Ground Truth Used

• For demonstrating substantial equivalence: The primary "ground truth" or reference point for establishing the device's acceptability is the predicate device (Philips SureSigns Central K131032). The document extensively compares the functionalities, software, hardware, and performance against this predicate to assert substantial equivalence.
• For compliance: Compliance with various international standards (IEC, ISO, ANSI/AAMI) serves as a ground truth for safety, effectiveness, and performance.
• For the clinical user preference study: "Customer requirements" and "enhancement requests" from healthcare professionals served as the qualitative ground truth for user acceptance.
• For the "no adverse events" claim: Real-world outcomes data (absence of reported adverse events) from countries where the device is already marketed functions as a form of ground truth for safety.

8. Sample Size for Training Set

The document is a 510(k) submission for a central monitoring system, which is a re-branding and enhancement of an existing product. It does not describe an "AI algorithm" in the modern sense that would require a distinct "training set" for machine learning. Therefore, a sample size for a training set is not applicable as described in this document. The software development process likely involved traditional verification and validation on various test cases, but these are not referred to as a "training set."

9. How Ground Truth for Training Set Was Established

As noted above, the concept of a "training set" for AI is not applicable here. The "ground truth" for the software's functionality and performance would have been established through a combination of:

• Engineering specifications and requirements: Defining how the system should operate.
• Predicate device's established performance: The SureSigns Central's proven functionality and safety.
• Relevant regulatory standards: Defining required performance characteristics (e.g., alarm accuracy, data display integrity).
• Clinical validation related to patient monitors: The linked patient monitors (e.g., SureSigns VM Series, Efficia CM Series) would have their own established performance and accuracy for physiological measurements, which the CMS200 then displays and processes.

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