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The intended use of the Philips Patient Information Center iX software application is to:

• Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than ● at the patient, for multiple patients.
• . Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.
  • Algorithms present in the software are limited to the ST/AR ECG (for arthythmia, ST Segment and QT Segment — Monitoring) and SpO2.
• Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.
• Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved ● medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.
• Provide review and trend application data, designed to contribute to the screening of patient condition. All information or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.
• Provide connection to other systems not associated with active patient monitoring, such as information systems. The software ● performs the action to transfer, store, convert from one format to another according to preset specifications, or to display medical device data.

The Information Center Software is intended for use in professional healthcare professionals. The Information Center Software is not intended for home use.

Indicated for use when monitoring adult and/or specified pediatic subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data.

Rx only.

The Philips Information Center uses off-the-shelf Windows PCs and servers, combined with the M3290B Patient Information Center iX software Release C.03 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Patient Information Center iX software Release C.03 provides for the retrospective review of alarms, physiologic waves and parameters from its database.

Additionally, the M3290B Patient Information Center iX software Release C.03 provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Compatible Accessories include: Mobile Caregiver - a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate device.

The provided text describes the Philips M3290B Patient Information Center iX Release C.03 and its substantial equivalence to a predicate device. However, it explicitly states that no clinical performance testing was performed for the new device. Therefore, the specific information requested regarding acceptance criteria, reported device performance metrics, sample sizes, expert qualifications, and ground truth establishment for a study proving the device meets acceptance criteria cannot be extracted from this document.

The document primarily focuses on non-clinical performance and a comparison of technical characteristics with the predicate device to argue for substantial equivalence.

Here's the breakdown based on the information provided and not provided in the document:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated with quantifiable metrics for clinical performance. The document mentions "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." This suggests internal performance and functionality goals were met, but specific clinical acceptance criteria are not detailed.
• Reported Device Performance: Not reported as no clinical performance testing was done.

2. Sample sized used for the test set and the data provenance:

• Not provided. No clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. No clinical test set requiring expert ground truth was used.

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

• Not provided. No clinical test set requiring adjudication was used.

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, an MRMC study was NOT done. The document states: "Clinical Performance testing for M3290B Philips Patient Information Center iX software Release C.03 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."

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

• While the device includes algorithms (ST/AR ECG for arrhythmia, ST Segment and QT Segment Monitoring, and SpO2), the document does not detail any standalone performance studies for these algorithms. Its focus is on the overall "Patient Information Center iX software application" and its substantial equivalence to the predicate. The changes primarily relate to a user-adjustable QRS detection threshold, which was a feature already cleared on another Philips product (K014261).

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

• Not provided for clinical performance. For internal verification and validation, the ground truth would typically be based on product specifications and risk analysis, but this is not clinical ground truth.

8. The sample size for the training set:

• Not applicable/Not provided. As no new clinical performance testing was performed, details about training sets for algorithms are not discussed in this document.

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

• Not applicable/Not provided.

Summary of Device Changes and Justification for No Clinical Study:

The primary change in the M3290B Patient Information Center iX Release C.03 compared to its predicate (Release C.01) is the addition of a user-adjustable minimum QRS detection threshold. This feature was previously cleared on Philips ST/AR, ST and Arrhythmia Algorithm Software (K014261). The manufacturer argues that this, along with other non-significant changes (such as system scalability increases, cybersecurity improvements, and OS updates), does not introduce new clinical features or risks that would necessitate new clinical performance testing. Therefore, "Clinical Performance testing... 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."

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The intended use of the Philips Patient Information Center iX software application is to:

Receive, aggregate, process, distribute and display physiologic waves, parameters, alarms and events at locations other than at the patient, for multiple patients.

Determine alarm conditions and generate alarm signals for Philips approved medical devices, that send physiological data and do not have the ability to determine the alarm condition.

• Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2.

Generate alarm signals for user notification, based on the alarm signal determined and sent by Philips approved medical devices.

Perform diagnostic 12-Lead analysis and interpretation based on raw ECG data samples provided from Philips approved medical devices. Result may be displayed, printed and/or distributed to Philips approved medical devices.

Provide review and trend application data, designed to contribute to the screening of patient condition or visual indications provided are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making, thus these applications are not intended for diagnoses or active patient monitoring where immediate action is required.

Provide connection to other systems not associated with active patient monitoring, such as information systems. The software performs the action to transfer, store, convert from one format to another according to to display medical device data.

The Information Center Software is intended for use in professional healthcare facilities by trained healthcare professionals. The Information Center Software is not intended for home use.

Indicated for use when monitoring adult and/or specified pediatric subgroups (Newborn (neonate), Infant, Child, Adolescent) patients as indicated by labeling of the medical device providing the data. Rx only.

The Philips Patient Information Center uses off-the-shelf Windows PCs and servers, combined with the Patient Information Center iX M3290B software Release C.01 to provide centralized display of physiologic waves, parameters, and trends, format data for strip chart recordings printed reports, and secondary annunciation of alarms from other networked medical devices. The M3290B Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. Additionally, the M3290B Software provides primary annunciation of alarms and configuration and control access for networked telemetry monitors.

Compatible Accessories include: Mobile Caregiver – a medical device data system, viewing only, mobile application associated with the Enhanced Web Viewing feature cleared in the predicate. This is not a new mobile application, and it has no changes that introduce significant risks for the PIC iX C.01 release.

The provided document, a 510(k) premarket notification for the Philips Medical Systems "M3290B Patient Information Center iX Release C.01," primarily focuses on establishing substantial equivalence to a predicate device (M3290B Philips IntelliVue Information Center iX software Revision C.0). The document asserts that the changes in the new device do not introduce significant risks or new clinical applications requiring clinical performance testing. Therefore, it does not describe a clinical study in the traditional sense, particularly one involving an AI algorithm that would have specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or human-AI reader performance.

The device described is a patient information center software, which functions to receive, aggregate, process, distribute, and display physiological data, determine alarm conditions, generate alarm signals, and perform diagnostic 12-Lead analysis and interpretation. The algorithms mentioned (ST/AR ECG for arrhythmia, ST Segment, and QT Segment Monitoring) are present in the software but the performance evaluation described focuses on system-level testing and verification/validation to ensure it functions as intended and is as safe and effective as its predicate.

Based on the provided text, here is an analysis of the requested information:

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

The document does not provide a table of acceptance criteria in the form of specific performance metrics (like sensitivity, specificity, accuracy) for a new clinical application or AI algorithm, nor does it present reported device performance against such metrics. Instead, the acceptance criteria are implicitly tied to the system-level functional and safety requirements, and the reported performance is that the device "meets all defined reliability requirements and performance claims" and "test results showed substantial equivalence."

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

The document states: "Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software 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."

Therefore, there is no specific test set or clinical data (sample size, provenance) described for evaluating the performance of the integrated algorithms. The testing was non-clinical, focusing on system-level verification and validation.

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)

Since no clinical performance study was conducted to evaluate the algorithms' diagnostic performance, there was no ground truth established by experts for a test set. The validation was against the defined specifications and the performance of the predicate device.

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

Not applicable, as no clinical test set requiring expert adjudication was used.

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. The document explicitly states that clinical performance testing was not performed. This device is an information center, not an AI-powered diagnostic tool intended to directly assist human readers in image interpretation or a similar task where MRMC studies are typically conducted.

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

The document alludes to "Algorithms present in the software are limited to the ST/AR ECG (for arrhythmia, ST Segment and QT Segment Monitoring) and SpO2," and "Perform diagnostic 12-Lead analysis and interpretation". However, it does not describe a standalone performance study for these algorithms. The testing described is system-level verification and validation. The 12-lead analysis is stated to be "based on raw ECG data samples provided from Philips approved medical devices" and the "Result may be displayed, printed and/or distributed". The output data (e.g., from 12-lead analysis) is explicitly stated to "not be the sole source of information for decision making," indicating a human-in-the-loop context, but no study of this combined performance is presented.

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

Not applicable, as no clinical performance study requiring ground truth was conducted. The assessment relied on verifying that the system's output aligned with predefined functional specifications and matched the performance of the predicate device in a non-clinical testing environment.

8. The sample size for the training set

Not applicable. This document describes a software update for a patient information center, not a machine learning model requiring a training set. The existing algorithms are presumed to be validated from prior predicate device clearances.

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

Not applicable, as no training set for a machine learning model is described.

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Intended Use

The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database.

An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors.

This product is intended for use in health care facilities by trained healthcare professionals. This product is not intended for home use.

Indications for Use

Indicated for central monitoring of multiple adult and all pediatric subgroups (Newborn (neonate). Infant, Child, Adolescent) patients; and where the clinician decides to monitor cardiac arthythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The Philips IntelliVue Information Center iX Software Revision C.O is central station software that runs on off-the-shelf Windows PCs and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.

The provided FDA 510(k) summary for the Philips IntelliVue Information Center iX (K153702) discusses software changes but does not contain detailed information about specific acceptance criteria, device performance, or a study rigorously proving the device meets new acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K143057) through non-clinical testing of design, functionality, and reliability, rather than clinical performance for new applications.

The document explicitly states: "Clinical Performance testing for M3290B Philips IntelliVue Information Center iX software Release C.0 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."

Therefore, I cannot populate the requested tables and sections with specific acceptance criteria and performance data for this particular 510(k) application, as such detailed information is not present in the provided text. The submission relies on demonstrating that the software updates do not introduce new safety or effectiveness concerns compared to the already cleared predicate device.

However, based on the non-clinical testing performed and the general approach of a 510(k) summary seeking substantial equivalence, I can describe what would typically be the nature of the acceptance criteria and study in such a scenario, by interpreting the information given and stating what is not present.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The provided 510(k) summary for the Philips IntelliVue Information Center iX (K153702) focuses on demonstrating substantial equivalence to a predicate device (K143057) for software updates. It explicitly states that clinical performance testing was not performed because no new clinical applications or significant new hazards/risks were introduced that would necessitate it. Therefore, the "acceptance criteria" here are primarily tied to verifying that the updated software maintains the safety, effectiveness, functionality, and reliability characteristics of the predicate device, as confirmed through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given that no clinical performance study was conducted for new clinical applications, specific numerical performance metrics (e.g., sensitivity, specificity for arrhythmia detection) are not reported for this particular 510(k) submission. The acceptance criteria and "performance" are framed around maintaining equivalence to the predicate device.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: Not specified in the provided document. The testing was non-clinical, likely involving various software modules and integration points rather than a "test set" of patient data in the conventional sense for clinical performance.
• Data Provenance: Not applicable in the context of clinical patient data for this submission, as the testing was non-clinical (engineering verification and validation).

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

• Number of Experts: Not applicable, as the testing was non-clinical. Ground truth for software functionality, reliability, and safety is typically established against design specifications, recognized standards, and hazard analyses, rather than clinical expert consensus on patient data.
• Qualifications of Experts: Not specified. Testing would have been conducted by Philips' internal engineering, quality assurance, and regulatory teams.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no clinical ground truth requiring adjudication was established for this submission.

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

• MRMC Study Done: No. An MRMC study is a clinical study involving multiple human readers interpreting cases to assess diagnostic performance. This submission explicitly states "Clinical Performance testing... was not performed."

6. Standalone Performance Study (Algorithm only)

• Standalone Performance Study Done: No, not in the sense of a new clinical algorithm being evaluated for its standalone diagnostic performance. The document mentions "Release C.0 allows data previously gathered by the algorithm [ST/AR] to be displayed. No changes to the algorithm are present." This indicates that existing algorithms (like ST/AR for arrhythmia/ST segment analysis) were unchanged, and their performance would have been established in previous 510(k) clearances for the predicate device. The focus here is on the information center's ability to process and display that data.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical testing performed, the ground truth was based on:
  • Product Specifications: Meeting defined requirements.
  • Design Specifications: Adherence to engineered design.
  • Hazard Analysis: Ensuring risks are mitigated and safety maintained.
  • Predicate Device Specifications: Ensuring equivalence in performance and functionality to the device previously cleared.
  • International and FDA-recognized Consensus Standards: Compliance with industry benchmarks.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This submission concerns software updates to a central monitoring system, not the development of new machine learning algorithms requiring a training set of data. Existing algorithms (like ST/AR) maintain their previously established performance and would have been "trained" (or validated) in earlier submissions if they involved such methodologies.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as no new training set was used for this submission.

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Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The Philips IntelliVue Information Center iX Software Revision B.01 is central station software that runs on off-the-shelf Windows PCs and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.

This 510(k) premarket notification for the M3290B Philips IntelliVue Information Center iX Software Release B.01 does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The document primarily focuses on establishing substantial equivalence to a predicate device (M3290B IntelliVue Information Center software, Release A.0, marketed pursuant to K102495) based on shared indications for use and technological characteristics.

Instead, the document states:
"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 internal testing was conducted against existing specifications (presumably for the predicate device) to verify performance. However, the specific acceptance criteria, the detailed results, and the methodology of these tests are not provided in this summary.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be gathered, with limitations:

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

• Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection). The document generalizes: "Pass/Fail criteria were based on the specifications cleared for the predicate device."
• Reported Device Performance: Not explicitly provided with specific numbers. The document states: "test results showed substantial equivalence. The M3290B IntelliVue Information Center Software meets all defined reliability requirements and performance claims."

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

• Not specified in the document.

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)

• Not specified in the document. The general nature of a "central station software" suggests the ground truth for internal performance testing might be based on established medical standards or reference equipment, rather than direct expert labeling for each data point in the way an AI diagnostic algorithm might.

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

• Not specified 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, an MRMC study is not mentioned. This device is a central station software for displaying physiological data and generating alarms, not an AI-assisted diagnostic tool in the typical sense that would undergo MRMC studies for improved human reader performance.

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

• The document implies standalone testing was performed to verify "system level tests, performance tests, and safety testing," but details on what constitutes "standalone performance" in this context (e.g., specific event detection accuracy) are not provided. Given it's a central monitoring system with alarm functions, its "standalone" performance would likely relate to its ability to correctly process and display data and trigger alarms according to predefined thresholds.

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

• Not specified. For a physiological monitor, ground truth would typically come from known calibrated inputs, reference measurements, or established medical standards for event detection.

8. The sample size for the training set

• Not applicable as this is a software update to an existing monitoring system, not a new AI algorithm that uses a "training set" in the machine learning sense. The testing likely involved verification and validation against functional specifications.

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

• Not applicable (see point 8).

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The intended use of the M300 & M400 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.

M300 & M400 Powered Wheelchair is battery powered, center wheel motor driven and is controlled by the PG power wheelchair VR-2 90 amp or R-net 120 amp controller. The user interface is a joystick. M300 & M400 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 25km (15,5 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two center drive wheels with drive units (motor, gear, brake), batteries and front and rear pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.

The Permobil M300 & M400 powered wheelchairs were assessed for substantial equivalence to the predicate device Permobil C350 (K071650). The performance data indicates that the M300 & M400 functioned as intended in all instances based on various ISO and RESNA standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" but lists various characteristics and their values for both the new device and the predicate device, implying these are the performance metrics against which substantial equivalence is judged. The "reported device performance" are the values for the M300 & M400.

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size for a "test set" in the context of human subjects or a specific data set. The performance testing was based on compliance with various international and national standards for wheelchairs (ISO and RESNA). These standards typically involve testing a representative sample of the devices. The data provenance is derived from the testing conducted by Permobil AB, based in Timrå, Sweden. The testing described is likely prospective, as it's part of the premarket notification for a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided in the document. The device is a powered wheelchair; its performance is evaluated against engineering and safety standards, not against "ground truth" established by medical experts in diagnosing conditions.

4. Adjudication method for the test set:

This information is not applicable and not provided in the document. As mentioned above, the evaluation is against established engineering and safety standards, not expert consensus requiring adjudication.

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:

This information is not applicable and not provided in the document. The device is a powered wheelchair; it is not an AI-assisted diagnostic tool involving human readers.

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

This information is not applicable and not provided in the document. The device is a physical powered wheelchair, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the fulfillment of requirements outlined in the specified international and national standards (ISO 7176 series and RESNA WC-1/WC-2). These standards define objective performance thresholds and test methodologies for characteristics like climatic resistance, power and control systems, electromagnetic compatibility, weight bearing capacity, speed, braking, etc.

8. The sample size for the training set:

This information is not applicable and not provided in the document. The development of a powered wheelchair does not typically involve a "training set" in the way that machine learning algorithms do. The design and engineering process is iterative, based on established mechanical and electrical engineering principles, and validated through testing against standards.

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

This information is not applicable and not provided in the document for the reasons stated in point 8.

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The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is intended to be used upon prescription of a licensed physician or authorized healthcare provider by patients as a means to automatically collect and transmit medical information, such as weight, blood pressure, and non-diagnostic ECG, over normal residential telephone lines or cellular connectivity, between a patient, typically at home, and a health care professional at the authorized provider. The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

The M3810A Philips TeleMonitoring System with eDevice BridgeD130 is indicated for patients at home, who are capable and willing to self administrate this device, upon the prescription of their healthcare provider, to collect and transmit medical information such as weight, blood pressure (including pulse rate) and non-diagnostic ECG rhythm strip to the healthcare provider at another location. The patient takes these measurements, typically once per day, and the information is transmitted automatically via normal telephone lines or cellular connectivity to the healthcare provider. The device may be used for the management of congestive heart failure, hypertension, ischemic heart disease, weight management, cardiovascular risk management, post cardiovascular surgery, post myocardial infarction, and other post cardiac events. The device does not send any real time alarms. Clinical judgment and experience are required to check and interpret the information delivered.

The M3810A Philips Telemonitoring System with eDevice BridgeD130 is a system that automatically collects and transmits medical information such as weight, blood pressure, and non-diagnostic ECG from a patient at home to a healthcare professional. The eDevice BridgeD130 is an external wireless communication device that transmits data to the backend clinical server.

The provided text describes a 510(k) premarket notification for the "M3810A Philips Telemonitoring System with eDevice BridgeD130". The primary modification is the addition of a wireless communication option (eDevice BridgeD130) to transmit data.

Based on the provided information, I can answer some of your questions, but it's important to note that this document is a 510(k) summary for a modification of an existing device. As such, the performance data presented focuses on demonstrating that the modified device maintains substantial equivalence to the predicate device, rather than providing an exhaustive de novo performance study.

Here's the breakdown of the information you requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states: "Acceptance criteria were based on the specification cleared for the predicate device, the specifications of the subject device and test results showed substantial equivalence." It does not provide a specific table with quantitative acceptance criteria and corresponding performance metrics for individual parameters (like blood pressure accuracy or ECG interpretation accuracy).

Instead, it refers to broad categories of testing and general compliance:

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing focused on functional verification and validation of the hardware and software changes, not a clinical trial with a patient population.

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

This information is not provided. The study described is a technical verification and validation, not a clinical study requiring expert ground truth for interpretation of physiological data in a clinical context. The device collects non-diagnostic ECG and other physiological data, which are then interpreted by a healthcare professional.

4. Adjudication Method for the Test Set

This information is not provided because the testing described is not a clinical study involving human interpretation needing adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document describes technical verification and validation, not a comparative effectiveness study involving human readers with and without AI assistance. The device is for data collection and transmission, not for automated interpretation or diagnosis.

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

The device itself is a data collection and transmission system. The "algorithm" in this context refers to the system's ability to accurately acquire and transmit data. The performance claims are related to the accuracy of the measurements and the reliability of the transmission, which are evaluated in a standalone manner (device functioning correctly) but don't involve an "algorithm" in the sense of AI for image or signal interpretation. The document states: "The device does not send any real-time alarms. Clinical judgment and experience are required to check and interpret the information delivered." This clearly indicates it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

For the instrumentation itself (weight, blood pressure, ECG signal acquisition), the "ground truth" would be established by reference standards or highly accurate laboratory equipment during calibration and functional testing. For example, blood pressure monitors are often tested against mercury sphygmomanometers, or using pressure simulators. ECG acquisition would be verified against known signal inputs. The document generally refers to "specifications," implying that performance was measured against predetermined engineering or regulatory benchmarks.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this device. This is not an AI/machine learning device that learns from a training set. It is a physiological monitoring and transmission system.

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

Not applicable, as there is no training set for this device.

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Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The IntelliVue Information Center Software is central station software that runs on off-the-shelf Wir interest and servers which can connect to recorders for waveform printing. It displays physiologic waves and parameters from multiple patient connected monitors and telemetry devices in summary or detailed format, and generates alarm signals. It provides retrospective review applications and a variety of data import and export functions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips M3290B IntelliVue Information Center Software:

Based on the provided text (K102495), the device in question is the M3290B IntelliVue Information Center Software release A.0.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics in a table format. Instead, it refers to a qualitative assessment against predicate device specifications.

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

The document does not specify the sample size used for any test set (e.g., number of patients, number of cases).
The data provenance (country of origin, retrospective/prospective) is not mentioned.

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

The document does not mention the use of experts to establish a ground truth for a test set. This type of study does not appear to have been conducted based on the provided information.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned as a specific test set requiring expert adjudication is not described.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence to predicate devices, not on comparing performance with and without AI assistance for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The entire device is an "algorithm only" (software) system that provides information to human users. The testing described is for the standalone software performance, not in comparison to human-in-the-loop performance. The verification and validation activities were for the software itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The concept of "ground truth" as typically understood in AI/ML validation (e.g., pathology, expert labels) is not explicitly detailed. Instead, the document states that "Pass/Fail criteria were based on the specifications cleared for the predicate device." This implies that the 'ground truth' for the software's functions (e.g., displaying physiological waves, parameters, generating alarms) was adherence to the established performance and functional specifications of the previous, cleared versions of the software.

8. The Sample Size for the Training Set:

The document does not mention a training set sample size. This is likely because the device is a software update (release A.0) to an existing, cleared product (IntelliVue Information Center Software) and not presented as a machine learning model that requires a distinct "training set" for its development. The testing focused on verification and validation of the new release against established specifications, not on training a new algorithm.

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

As no training set is mentioned, the method for establishing its ground truth is not applicable/not provided.

Summary of Findings:

The K102495 submission for the M3290B IntelliVue Information Center Software is a 510(k) premarket notification asserting substantial equivalence to previously cleared predicate devices. The study detailed is not a clinical performance study involving patient data, expert adjudication, or AI model training. Instead, it describes a series of verification and validation (V&V) activities (system level tests, performance tests, safety testing, hazard analysis) to demonstrate that the new software release meets the specifications and reliability requirements of its predicate. The "acceptance criteria" were essentially the specifications already cleared for the predicate device, and the "study" was the V&V process that confirmed the new release met these existing criteria.

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The intended use of the M3 Monitor is for the non- invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration, blood flow and gaseous emboli in an extracorporeal circuit.

The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarms.

The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and five active measuring channels mounted into a flat panel unit. Sensor cables are used to connect the active measuring channels to the external surface of extracorporeal blood line tubing. Two active measuring channels are used to measure venous and arterial oxygen saturation. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the blood. The reflected spectra is collected by a fibre optic cable and quantified by a photo detector contained within a spectrometer. These spectra are compared to reference spectra by the monitor's software to determine the oxygen saturation of the blood. The third active measuring channel is used to measure bematocrit or haemoglobin concentration. The sensor cable head contains a light emitting diode that transmits near-infra-red light through the extracorporeal tube. A photo diode measures a received light level. The level of signal attenuation is used to calculate hematocrit or haemoglobin concentration.

Three further active and optional measuring channels (i.e. the fourth, fifth and sixth channels) are used to measure simultaneously blood flow and the presence of emboli. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers. Emboli is measured by detecting reductions in the amplitude of the ultrasonic signal.

Parameter values are displayed in both a digital and trended format. The M3 Monitor has been designed to self-detect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to set parameter specific alarms and to select either the display of hematocrit or haemoglobin concentration. Session data can be stored to a memory card supplied with the system, via a RS232 link or wirelessly to a remote computer.

The M3 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.

The provided text describes a 510(k) submission for the Spectrum Medical M3 Monitor, but it does not contain specific acceptance criteria or a study detailed enough to directly create the requested table and answer all questions.

The document states that "Performance data has been provided to show that the revised M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration, the flow of blood and gaseous emboli in an extracorporeal circuit to an equivalent or improved accuracy when compared to the predicate devices." However, it does not provide the actual performance data, acceptance criteria values, or details of the study methodology.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or answer specific questions about sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

Based on the information available, here's what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be generated. The document states that performance data "has been provided" to the FDA, but the data itself and the specific acceptance criteria (e.g., accuracy +/- X%) are not included in this summary.

2. Sample size used for the test set and the data provenance:

• Cannot be determined. This information is not provided in the text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be determined. This information is not provided in the text.

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

• Cannot be determined. This information is not provided in the text.

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:

• Cannot be determined. The device is a "Blood Gas Monitor" for objective physiological measurements (oxygen saturation, hematocrit, hemoglobin, blood flow, emboli). The concept of "human readers improving with AI assistance" is typically relevant for interpretative tasks (e.g., radiology image interpretation), not for direct physiological monitoring. This type of study would likely not be applicable to this device.

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

• Yes, implicitly. The device is a monitor that provides continuous measurements. The performance comparison mentioned ("can measure...to an equivalent or improved accuracy when compared to the predicate devices") refers to the device's inherent measurement capabilities, which would be a standalone assessment.

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

• Implied, but not explicitly stated. For physiological monitors, ground truth is typically established by:
  • Comparison to a gold standard laboratory instrument (e.g., a co-oximeter for oxygen saturation, a hematology analyzer for hematocrit/hemoglobin).
  • Highly accurate flow measurement systems for blood flow.
  • Controlled experimental setups for emboli detection.
    The document does not specify which gold standards were used.

8. The sample size for the training set:

• Cannot be determined. The document does not mention details about training data for the device's software.

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

• Cannot be determined. The document does not mention details about training data or its ground truth establishment.

Summary based on available information:

The document is a 510(k) summary for the M3 Monitor. It focuses on establishing substantial equivalence to predicate devices (K072131 Spectrum Medical - M3 Monitor and K940651 Sarns - Ultrasonic Air Sensor). The "study" mentioned is a general statement that "Performance data has been provided to show that the revised M3 Monitor can measure...to an equivalent or improved accuracy when compared to the predicate devices." This implies a standalone performance study was conducted, comparing the device's measurements to a reference, but the specifics of that study (e.g., acceptance criteria, test set size, ground truth details) are not included in this public summary.

Without the actual performance data and detailed study report, a comprehensive answer to your questions cannot be provided.

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Indicated for central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

M3290A IntelliVue Information Center Software, Release L.0

This Philips Medical Systems 510(k) submission (K081983) for the M3290A IntelliVue Information Center Software, Release L.0, primarily focuses on demonstrating substantial equivalence to predicate devices based on modifications that add new features and integrations. The document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that statistically proves the device meets such criteria in terms of analytical or clinical performance (e.g., sensitivity, specificity, accuracy for arrhythmia detection or ST-segment monitoring).

Instead, the submission emphasizes that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate. 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. The results demonstrate that M3290A IntelliVue Information Center Software, Release L.0 meets all defined reliability requirements and performance claims."

This statement indicates that the testing performed was primarily to ensure the new software release maintained equivalence to the previously cleared versions and met established internal specifications and safety requirements, rather than presenting a de novo clinical performance study against specific, quantifiable acceptance criteria for diagnostic accuracy.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test/training sets, expert qualifications, and comparison studies are not available in the provided document.

Here's a breakdown of what is and is not present, based on the input:

Acceptance Criteria and Device Performance

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

  • Not provided. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device," but these specific criteria and the corresponding performance results (e.g., accuracy, sensitivity, specificity for arrhythmia detection) are not detailed.

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

  • Not provided. The document mentions "system level tests, performance tests, and safety testing," but does not specify sample sizes for any test sets or the origin/nature of the data used in these 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):

  • Not provided. Given that specific performance metrics and test sets are not detailed, information about expert ground truth establishment is absent.

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

  • Not provided.

• 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 provided and not applicable for this type of device. The device is a patient monitoring information center software, not an AI-assisted diagnostic tool that would typically involve human readers. The mention of "Integration of the ST/AR J.0 algorithm (K080461)" suggests algorithmic processing within the device itself, not necessarily for human interpretation improvement in an MRMC study context.

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

  • Likely yes, implicitly, but no specific study details are provided. The testing mentioned (system level, performance, safety) for the "ST/AR J.0 algorithm" integration would imply standalone performance evaluation against specifications, but no data is presented.

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

  • Not provided. The document states "Pass/Fail criteria were based on the specifications cleared for the predicate device." For physiological monitoring, ground truth often involves expert review of raw physiological waveforms or correlation with other established diagnostic methods, but specifics are missing here.

• 8. The sample size for the training set:

  • Not provided. This information is typically relevant for machine learning algorithms, and while an "ST/AR J.0 algorithm" is mentioned, no details about its development or training are included in this 510(k) summary.

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

  • Not provided.

Summary Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices by detailing new features and stating that "Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the new device with respect to the predicate." It indicates that "Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence." However, it does not provide the specific acceptance criteria, reported performance metrics, or the detailed study design elements requested in the prompt, such as sample sizes, data provenance, expert qualifications, or ground truth establishment methods for a clinical performance study. The submission appears to rely on the established performance of its predicate devices and internal verification activities for the new software release.

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The M3 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit / haemoglobin concentration and the flow of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to alarm to set parameter specific alarms.

The Spectrum M3 Monitor consists of a 10.4 inch high definition touch screen and four active measuring channels mounted into a flat panel unit. Sensor cables are used to connect the active measuring channels to the external surface of extracorporeal blood line tubing. Two active measuring channels are used to measure venous and arterial oxygen saturation. The sensor cable head contains a light emitting diode that sends light through the extracorporeal tube, which illuminates the blood. The reflected spectra is collected by a fibre optic cable and quantified by a photo detector contained within a spectrometer. These spectra are compared to reference spectra by the monitor's software to determine the oxygen saturation of the blood. The third active measuring channel is used to measure hematocrit or haemoglobin concentration. The sensor cable head contains a light emitting diode that transmits near-infra-red light through the extracorporeal tube. A photo diode measures a received light level. The level of signal attenuation is used to calculate hematocrit or haemoglobin concentration. The fourth active measuring channel is used to measure blood flow using Transonic proprietary technology. Flow measurement is accomplished by measuring the difference in transit time between a pair of upstream and down stream ultrasonic transducers. Parameter values are displayed in both a digital and trended format. The M3 Monitor has been designed to self-detect the selected sensor and to automatically configure the required parameter display screens. The device can be configured by the trained clinician to set parameter specific alarms and to select either the display of hematocrit or haemoqlobin concentration. Session data can be stored to a memory card supplied with the system or via a RS232 link to a remote computer. The M3 Monitor is powered from the AC Mains supply and also incorporates a battery back-up that automatically switches on in the event of an interruption to the mains power supply. The system weighs 4.5 kg and is supplied with a pole mount clamp.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lacks a specific, quantitative "acceptance criteria" table with corresponding numerical performance targets. Instead, the justification for substantial equivalence relies on the device having "equivalent accuracy" to predicate devices.

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

The document does not provide any specific information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The statement "Performance data has been provided to show that the M3 Monitor can measure the oxygen saturation, hematocrit / haemoglobin concentration and flow of blood in extracorporeal blood tubing to an equivalent accuracy of the predicate devices" is the extent of the information.

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

The document does not mention the use of human experts to establish ground truth for a test set. The focus is on technical equivalence to existing devices and "gold-standard" flow sensors.

4. Adjudication Method:

Given that there's no mention of human experts or a test set requiring adjudication, there is no information about an adjudication method (e.g., 2+1, 3+1, none) in the provided text.

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

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is a "Blood Gas Monitor" and not an imaging or diagnostic device that would typically involve human readers for interpretation. The evaluation focuses on the device's measurement accuracy compared to predicate devices.

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

The provided text implicitly describes a "standalone" evaluation of the device's technical performance. The "performance data" mentioned is focused on the device's ability to measure parameters accurately, independent of human interaction beyond initial setup and configuration. This is not explicitly called a "standalone study" in the modern sense of AI algorithms, but the nature of the device's function implies its core measurement capabilities were assessed independently.

7. Type of Ground Truth Used:

• Oxygen Saturation and Hematocrit/Hemoglobin Concentration: The document does not explicitly state how "ground truth" was established for these parameters during the "performance data" collection. It only states that the proposed device has the "same technological characteristics" as its predicate and aims for "equivalent accuracy." This often implies comparison against more established laboratory methods or reference instruments, but this is not detailed.
• Flow Measurement: For flow, the ground truth is established using a "gold-standard" flow sensors, which are tested by timed fluid collection using NIST traceable stopwatch and volume standards.

8. Sample Size for the Training Set:

The provided text does not mention a "training set" or "sample size for the training set." This device, a Blood Gas Monitor, operates on established biophysical principles and algorithms, likely calibrated during its manufacturing process. It does not appear to employ machine learning that would necessitate a distinct "training set" in the context of typical AI/ML medical devices.

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

As there is no mention of a "training set" (see point 8), there is no information on how its ground truth would have been established. The device relies on physical principles and calibration, not a machine learning model trained on a dataset with established ground truth.

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