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The intended use of the MX40 is to:

The device is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

Indications for Use

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals.

Rx only.

The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the litelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).

Previously cleared compatible Accessories are still in use, compatibility to additional Massimo accessories are documented in this filing. The MX40 is compatible with the legally marketed Philips CL SpO2 Pod and CL NBP Pod (K101600, K111905). The CL SpO2/NBP Pods are small battery powered devices that measure oxygen saturation, pulse rate and blood pressure, pulse rate, respectively. A list of all accessories is available in the Instructions for Use.

The provided text is a 510(k) summary for the Philips MX40 Release C.01, a physiological patient monitor. It describes the device, its intended use, and a comparison with a predicate device (Philips IntelliVue MX40 Release B.07).

However, this document does not contain the specific information required to answer your request regarding acceptance criteria and the study proving the device meets them.

The document states:

• "No performance standards have been issued under the authority of Section 514."
• "The MX40 Release C.01 was tested in accordance with Philips verification and validation processes."
• "Clinical Performance testing for MX40 Release C.01 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence."
• "Verification, validation, and testing activities, where required to establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate are performed. Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence."

This indicates that the submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing (system level tests, performance tests, and safety testing based on hazard analysis) and adherence to Philips' internal verification and validation processes, rather than conducting a new clinical study with specific acceptance criteria as one might expect for a novel device or a device with new clinical applications.

Therefore, I cannot provide the requested information from this document for the following reasons:

1. A table of acceptance criteria and reported device performance: This document explicitly states that "No performance standards have been issued." While it mentions "Pass/Fail criteria were based on the specifications cleared for the predicate device," these specific criteria and the detailed performance results are not provided in this summary.
2. Sample size used for the test set and data provenance: The document mentions "non-clinical performance testing" and "system level tests, performance tests, and safety testing," but does not specify sample sizes or data provenance (e.g., number of patients, records, or the nature of the test data).
3. Number of experts used to establish ground truth and qualifications: This information would typically be relevant for clinical studies or studies establishing ground truth, which were not performed for this 510(k) as per the document.
4. Adjudication method for the test set: Not applicable as a clinical study for establishing ground truth was not performed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: The document clearly states, "Clinical Production testing for MX40 Release C.01 was not performed." Therefore, no MRMC study was conducted.
6. Standalone (algorithm only without human-in-the-loop performance) study: This would typically refer to AI/ML device performance. The MX40 is a physiological monitor, not an AI/ML algorithm in the context typically discussed for standalone performance. Its functions are monitoring and alarm generation for vital parameters. The document focuses on hardware, software, and accessory changes.
7. Type of ground truth used: Not explicitly stated, as clinical performance testing was not performed. The "ground truth" for the non-clinical testing would be the established specifications and expected performance of the predicate device.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the typical sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) pertains to a modification of an existing physiological monitor, and its acceptance criteria and proof of performance are based on demonstrating substantial equivalence through non-clinical verification and validation against the predicate device's established specifications, rather than a new clinical study with the type of data points you are requesting.

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The intended use of the MX40 is to: The device is intended for monitoring and recording of and to generate alarms for, multiple physiological parameters of adults and pediatrics in a hospital environment and during patient transport inside hospitals. Not intended for home use. Intended for use by health care professionals.

Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. Rx only.

The MX40 is a multi-parameter, battery operated patient monitor that is small enough to be worn by the patient. Its multi-radio design enables device operation within existing Philips telemetry networks while providing compatibility to the IntelliVue Information Center solutions. Along with infrastructure radios, the MX40 integrates a short-range radio (SRR), enabling wireless connectivity to the IntelliVue family of monitors. Acquired physiological data, along with physiological alarms and technical alert information are provided to multiple monitoring systems (local, bedsides and /or information systems).

The provided document is a 510(k) summary for the Philips MX40 Release B.07, a physiological patient monitor. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria for a novel AI/software component within the device.

Therefore, many of the requested details about acceptance criteria, specific studies proving performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document as it pertains to a modification of an existing device rather than a new device with new clinical claims. Manufacturers typically demonstrate substantial equivalence through verification and validation testing, often against established standards and internal specifications, rather than large-scale clinical trials for minor modifications.

Here's an attempt to answer the questions based on the available information:

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

The document does not provide a table of specific acceptance criteria (e.g., sensitivity, specificity thresholds) or quantitative device performance metrics. Instead, it states:

• Acceptance Criteria (Implied): "Pass/Fail criteria were based on the specifications cleared for the predicate device." (Page 8)
• Reported Device Performance: "test results showed substantial equivalence." (Page 8) and "The MX40 Release B.07 meets all defined reliability requirements and performance claims." (Page 8)

The document lists changes to functionalities, such as:

• Heart Rate Alarm from Pulse, requiring PIC IX version C.01 or higher.
• Auto report battery inop (Technical Alert) when Standby is in low battery state.
• Support CI (Connection Indication) message transport using Unicast protocol for WLAN.
• Malfunc Inop for software license failure - Added self-test to MX40 to allow for confirmation of Software License version to assist users to identify compatibility to other systems.
• Claim IEC60601-1 3rd edition update IFU and Product Labeling appropriately.
• AAMI screen - A new portrait screen 1-wave and 2 numerics to support AAMI EC13 display, local control only & cannot default to this screen from PIC-iX.
• MCS PigTail and Block Adapter hardware to support Respiration measurements.

The "reported device performance" is broadly stated as meeting the specifications of the predicate device.

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

This information is not provided in the document. The document refers to "system level tests, performance tests, and safety testing from hazard analysis" (Page 8), but does not specify sample sizes or data provenance for these non-clinical tests.

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)

This information is not provided in the document, as clinical performance testing, which would typically involve expert ground truth, was not performed.

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

This information is not provided in the document.

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

No MRMC comparative effectiveness study was mentioned or performed, as the device is a physiological monitor and not an AI-assisted diagnostic tool.

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

The document states that "Clinical Performance testing for MX40 Release B.07 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required a clinical performance testing to support equivalence." (Page 8). Therefore, no standalone clinical performance study was done for this particular submission. The device itself is a standalone physiological monitor, but the nature of the submission (modifications to an existing device) did not necessitate a new standalone performance study against clinical ground truth.

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

For the non-clinical testing performed, the ground truth would have been based on established specifications, standards, and expected performance characteristics of the predicate device and the new functionalities, rather than clinical ground truth like pathology or expert consensus. The changes relate to hardware and software updates, not new diagnostic algorithms requiring clinical validation.

8. The sample size for the training set

This information is not applicable as the document does not describe the development or testing of an AI/machine learning algorithm with a training set. The device is a physiological monitor with specified functionalities.

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

This information is not applicable as there is no mention of an AI/machine learning component or a training set.

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The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSignsVS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.

The subject devices are SureSigns VS3 and SureSigns VS4 multi-parameter patient monitors. Modifications include adding connectivity to IntelliVue GuardianSoftware (IGS), adding Temporal Temperature measurement to VS3, and other enhancements such as additional title bar indicators, expanded patient records pane, display patient name or primary ID, expanded QuickCapture entries, default CO2 setting alignment (VS4 only), temperature high and low alarms color change, increased SpO2 alarm delay defaults, option to prevent inadvertently clearing NBP programs, and RFID patient ID entry.

This document describes the Philips SureSigns VS3 and VS4 Vital Signs Monitors, which are multi-parameter patient monitors. The submission is a 510(k) premarket notification for modifications to previously cleared devices.

Here's an analysis of the acceptance criteria and study information provided, focusing on what can be extracted from the text:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Pass/Fail criteria were based on the specifications cleared for the subject device." However, it does not explicitly list specific numerical acceptance criteria for performance metrics (e.g., accuracy ranges for NBP, SpO2, Temperature, CO2). Instead, it confirms that the device reportedly meets these implicit criteria.

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

The document does not provide details on the sample size used for the test set.
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be internal validation by Philips Medical Systems.

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 document. The testing described is verification, validation, and performance testing, which typically involves comparing device outputs to a known reference standard (e.g., calibration equipment, established measurement methods) rather than human expert-established ground truth in a clinical scenario.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the device (monitoring physiological parameters), "adjudication" in the sense of resolving discrepancies between human experts for a diagnostic task is unlikely to be relevant here. The testing would involve comparing device readings against a gold standard or reference measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices where human readers interpret images with and without AI assistance. The SureSigns VS3 and VS4 are vital signs monitors, not diagnostic imaging devices designed for human interpretation of complex data patterns in the same way. The modifications focus on software connectivity, a new temperature measurement accessory, and feature enhancements.

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

The document describes "system level tests, performance tests, and safety testing from hazard analysis." This strongly implies that standalone performance testing was done for the device's functions (e.g., accuracy of NBP, SpO2, Temperature measurements). The software verification and validation, along with compliance to specific standards for temperature measurement, suggest testing of the algorithms and hardware in a standalone capacity against reference standards. However, "standalone" in the context of an AI algorithm is typically for diagnostic or predictive AI, which this device, in its described modifications, does not appear to be. It's a measurement device.

7. The Type of Ground Truth Used

The ground truth used for these types of physiological parameter monitors would typically involve:

• Reference standard instruments: Highly accurate and calibrated devices used to establish the true value of parameters like NBP, SpO2, and Temperature.
• Known physical inputs: For example, precise temperature probes, blood pressure simulators, or SpO2 simulators with defined oxygen saturation levels.
• Compliance with industry standards: The mention of ISO 80601-2-56 for temperature indicates that the ground truth for temperature measurement accuracy would be established by following the specific protocols and reference measurements outlined in that standard.

The document does not explicitly state "expert consensus" or "pathology" as ground truth, which are more relevant for diagnostic AI applications.

8. The Sample Size for the Training Set

The document does not describe any "training set." This is because the device, based on the provided information, is a vital signs monitor and not an AI/ML-based diagnostic or predictive system that requires a training set for model development. The focus is on measurement accuracy and software functionality.

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

Since there is no mention of a training set, this information is not applicable/provided.

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