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The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS).

The Vital Sync™ Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data, waveforms, alarms and alerts routed through the Vital Sync™ Informatics Manager from supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals in a hospital or hospital-type facility for the following purposes:

• To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management.

• To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices.

• To access additional processed parameters to facilitate patient monitoring, assessment and clinical management.

• To set and adjust alert thresholds on supported devices where this capability is not available on the device itself.

• To access data, waveforms and alerts from supported devices where these capabilities are not enabled on the device itself.

WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are notification systems and are not replacements for direct patient observation, patient assessment or clinical judgment

The subject Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform VPMP) is a software only device that provides mobile and centralized remote monitoring. The Vital Sync™ Informatics Manager is intended to route and store medical device data from connected medical devices to the electronic medical record (eMR), clinical information system (CIS) and/or the Virtual Patient Monitoring Platform (VPMP). The Vital Sync™ Virtual Patient Monitoring Platform displays information received from the Informatics Manager on any webenabled device.

The subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform routes and displays parameters, waveforms and alarms for the connected medical devices in near-real time. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform allows users to set up a new default alarm priority across device types and allows for institutions to modify alarm priorities per their internal protocols. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform provides for the setting or adjusting of thresholds on supported devices where this capability is not available on the device itself; the platform can also act the primary display for patient data and alerts where this capability is not available of enabled on the device itself. Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform includes Turn Time functionality. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform allows the user the capability, via the software, to perform simple calculations from processed parameters, or from manual input by the user.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform:

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against specific acceptance criteria for a novel device. As such, direct acceptance criteria and detailed performance metrics are often not explicitly stated in the way a clinical trial report would. Instead, the document emphasizes verification and validation activities showing the new device functions similarly and safely to existing ones.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, direct, quantifiable acceptance criteria with numerical performance targets are not explicitly stated. The evaluation relies on demonstrating that the new functionalities and the overall system perform as intended and are safe and effective, similar to the predicate devices. The "reported device performance" is described qualitatively through the successful completion of various tests.

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

• Sample Size: This information is not provided in the FDA 510(k) summary. The document mentions "system level verification, user interface verification and usability validation" and "testing was also conducted to ensure data passes over communication networks," but does not specify the number of test cases, data points, or user participants for these activities.
• Data Provenance: This information is not provided. The document does not indicate the country of origin of the data or whether the data used in testing was retrospective or prospective. Given the nature of a software-only device routing data, simulated test data or internally generated data for verification and validation are common, but specifics are absent.

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

• This information is not provided. The document details "user interface verification and usability validation," which would typically involve end-users, but does not specify the number or qualifications of these users, nor explicitly state their role in establishing a "ground truth" for a test set. This type of information is usually part of detailed validation protocols, not typically summarized in a 510(k).

4. Adjudication Method for the Test Set:

• This information is not provided. Given the nature of system and usability testing for a data routing and display platform, formal adjudication methods like 2+1 or 3+1 consensus are less likely to be applicable compared to, for instance, a diagnostic AI device. The "verification and validation" would likely involve checking expected outputs against actual outputs, and usability findings based on user feedback.

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

• No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This type of study is more common for diagnostic devices where human readers interpret images or data with and without AI assistance. This device is a data management and display platform.

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

• The device itself, being software for routing and displaying data, operates primarily in a "standalone" or "algorithm only" fashion in its core function of data management. However, its purpose is to present data to a human-in-the-loop (clinician). The verification activities likely focused on the accuracy of this data routing, processing, and display as an "algorithm only" system. The subsequent usability validation assesses the human interaction. The document doesn't explicitly delineate "standalone performance" in the context of a diagnostic algorithm's performance metric, but the core functionalities (routing, storing, displaying, calculating parameters) would have been tested in an automated fashion before human interaction.

7. The Type of Ground Truth Used:

• For the technical verification of this device (data routing, display accuracy, alarm handling), the "ground truth" would likely be derived from:
  • Expected System Behavior/Specifications: The system's output (routed data, displayed waveforms, triggered alarms) is compared against pre-defined engineering and software requirements and technical specifications.
  • Reference Data/Simulated Data: Known input data (e.g., simulated patient physiological data, device diagnostic messages) would be fed into the system, and its output would be checked against the expected output based on the input.
  • Predicate Device Behavior: Some aspects might involve comparing the behavior or output of the new device to that of the predicate devices under similar conditions, to confirm "substantial equivalence."
• For usability validation, the "ground truth" would be established through user feedback, observations, and adherence to usability standards (e.g., IEC 62366-1).

8. The Sample Size for the Training Set:

• This information is not applicable/not provided. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is described as a data routing, storage, and display system. It does not appear to involve machine learning or artificial intelligence in a way that requires a "training set" for model development. The software performs defined functions based on established rules and programming, not learned patterns.

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

• Not applicable, as there is no mention of a training set for machine learning.

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The Vital Sync TM Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (eMR) and Clinical Information System (CIS).

The Vital Sync™ Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync™ Informatics Manager for supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes:

• To remotely consult regarding a patient's status

• To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform as the sole source of alarms.

The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is software that routes parameters, waveforms and alarms from connected devices and displays them on any device that is web-enabled. The Vital Sync™ IM & VPMP can utilize the hospital's network and existing hardware for installation and display or an optional server pre-loaded with the Vital Sync software and off the shelf operating system can be provided. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected.

The new features on the subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform include smart alarms, ADT connectivity and alarm forwarding to 30 party.

The provided document describes the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K140339). However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical evidence, primarily system-level verification, user interface verification, and usability validation. It explicitly states, "N/A - Clinical evidence was not necessary to show substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance tailored to the metrics typically found in efficacy studies (e.g., sensitivity, specificity, AUC), nor can I detail the specifics of a study proving those criteria, as such a study is not described in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document indicates that substantial equivalence was shown because the device successfully underwent "system level verification, user interface verification and usability validation." It does not provide specific quantitative performance metrics for these verifications.

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

• Test Set Sample Size: Not specified in the provided document.
• Data Provenance: Not specified in the provided document. The testing was non-clinical, implying internal testing and validation rather than clinical data sets.

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

• Not specified. Given the non-clinical nature of the evidence, this information is not expected to be present.

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

• Not specified. Given the non-clinical nature of the evidence, this information is not expected to be present.

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. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This implies no MRMC study or any clinical effectiveness study comparing human readers with and without AI assistance was performed or submitted.

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

• The device is software that routes and displays medical device data, waveforms, and alarms. Its "performance" is primarily related to its ability to accurately route, store, and display this information, and its new features (smart alarms, ADT connectivity, alarm forwarding). The "validation" performed (system, UI, usability) would assess functionality rather than a standalone diagnostic accuracy in the way an AI diagnostic algorithm might be evaluated. The documentation does not describe a standalone algorithm performance study.

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

• For the non-clinical tests (system, UI, usability), the ground truth would typically be defined by engineering specifications, software requirements, and usability standards rather than medical ground truth like pathology or expert consensus. Specific details are not provided.

8. The sample size for the training set:

• Not applicable. This device is an informatics manager and monitoring platform, not a machine learning model that requires a "training set" in the conventional sense for AI diagnostic or predictive tasks.

9. How the ground truth for the training set was established:
* Not applicable, as there is no "training set" for this type of device mentioned.

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The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (eMR) and Clinical Information System (CIS).

The Vital Sync™ Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync™ Informatics Manager for supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes:

• To remotely consult regarding a patient's status

• To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform as the sole source of alarms.

The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is software that routes parameters, waveforms and alarms from connected devices and displays them on any device that is web-enabled. The Vital Sync™ IM & VPMP can utilize the hospital's network and existing hardware for installation and display or an optional server pre-loaded with the Vital Sync software and off the shelf operating system can be provided. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform does not alter the parameters. waveforms and alarms displayed and does not control any of the medical devices connected.

This 510k is intended to add new features to the existing Vital Sync IM & VPMP:

Additional User Interface Additional Report Auto device Association Area (zone) Management Optional Off the Shelf Software/server

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

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform. The document describes a 510(k) submission for new features being added to an existing and legally marketed device. Therefore, the "acceptance criteria" discussed are primarily related to establishing substantial equivalence to the predicate device, rather than explicit performance metrics for a new, first-of-its-kind device.

• System level verification
• User interface verification
• System validation
• Device compatibility verification
  (The results of these tests showed that the subject device can be considered substantially equivalent to the legally marketed predicate.) |
  | Identical Indications for Use: The new device (with added features) must retain the same intended uses as the predicate device. | The subject device has "identical indications for use" as the predicate device. |
  | Does not alter parameters, waveforms, and alarms: The software must only route and display, not modify, the data from connected medical devices. | The device "does not alter the parameters, waveforms, and alarms displayed and does not control any of the medical devices connected." |
  | No new questions of safety and effectiveness: The introduction of new features should not raise new concerns beyond those addressed by the predicate. | "No new questions of safety and effectiveness have been raised." |
  | Substantial Equivalence: The overall determination that the subject device is as safe and effective as a legally marketed predicate device. | "Substantial equivalence is shown through systems level testing, user interface testing, and system validation." |

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

The document does not specify sample sizes for any test sets used in the verification or validation activities. It also does not mention an explicit "test set" in the context of clinical data or patient data. The studies described are primarily non-clinical engineering and software validation tests.

The data provenance is therefore internal to the manufacturer's testing and validation processes. No external or patient-related data provenance (e.g., country of origin, retrospective/prospective) is provided.

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

This information is not provided in the document. The studies mentioned are primarily non-clinical, focusing on system functionality and equivalence, rather than diagnostic accuracy requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant to the type of non-clinical testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving expert review of clinical cases to establish ground truth, which is not the nature of the studies detailed here.

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 comparative effectiveness study was not done. The device is software that routes and displays data; it is not an AI diagnostic tool and does not involve "human readers" in the context of an MRMC study. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence."

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

The device is a "Virtual Patient Monitoring Platform" that displays data for "healthcare professionals" to utilize for clinical decisions. Its very nature implies a human-in-the-loop interaction. Therefore, a standalone (algorithm only) performance assessment as typically understood for AI diagnostic algorithms was not done, nor would it be entirely applicable to this device's function. The "algorithm" here is the software's ability to accurately route and display data without alteration. The non-clinical tests (system level verification, user interface verification, system validation, device compatibility verification) confirm this core functionality.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that the studies are non-clinical engineering and software validation:

• The "ground truth" for system level verification would likely be the defined technical specifications and requirements of the software.
• The "ground truth" for user interface verification would be the design specifications and usability requirements.
• The "ground truth" for system validation would be that the system performs as intended and meets its functional requirements in a simulated or controlled environment.
• The "ground truth" for device compatibility verification would be the accurate transmission and display of data from connected predicate or representative medical devices.

No clinical "ground truth" (expert consensus, pathology, outcomes data) was used or needed for this 510(k) submission, as stated, "Clinical evidence was not necessary to show substantial equivalence."

8. The Sample Size for the Training Set

This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable and not provided.

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

As the device does not employ a training set (it's not an AI/ML algorithm), this information is not applicable and not provided.

Ask a specific question about this device

The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (eMR) and Clinical Information System (CIS).

The Vital Sync™ Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data, waveforms and alarms routed through the Vital Sync™ Informatics Manager for supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes:

• To remotely consult regarding a patient's status

• To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform as the sole source of alarms.

The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is software that routes parameters, waveforms and alarms from connected devices and displays them on any device that is web-enabled. The Vital Sync™ IM & VPMP utilize the hospital's network and existing hardware for installation and display. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected.

The provided 510(k) summary for the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K130796) does not describe specific acceptance criteria or a detailed study of device performance with reported metrics.

Here's a breakdown of the information available based on your request:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity). The document refers to "system level verification, user interface verification, system validation, and device compatibility verification" as methods to show safety, efficacy, and substantial equivalence. These are broad categories of testing, not specific performance criteria.
• Reported Device Performance: No quantitative performance metrics are reported. The document states that "The results of the tests show that the subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is safe and effective and can be considered substantially equivalent to the legally marketed predicate." This is a qualitative conclusion rather than a presentation of data against specific criteria.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document indicates "Non-Clinical Evidence" and states "N/A - Clinical evidence was not necessary to show substantial equivalence." This implies no patient data (clinical data) was used in the evaluation for substantial equivalence, focusing instead on system and usability testing.

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)

• Number of Experts & Qualifications: Not applicable. Since no clinical data or ground truth related to patient conditions was used, no experts were needed for this purpose. The device routes and displays data, it doesn't interpret or diagnose. "Summative usability testing" was mentioned, which would involve users, but details on their number or specific qualifications (beyond "healthcare professionals" as indicated in the Indications for Use) are not provided.

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

• Adjudication Method: Not applicable, as there's no mention of a ground truth established by experts for a test set.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a data routing and display platform, not an AI-powered diagnostic tool that assists human readers. No AI components are mentioned.

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

• Standalone Performance: Not applicable. This device is an "Informatics Manager & Virtual Patient Monitoring Platform" intended for "healthcare professionals" to remotely consult and review data. Its primary function is to route and display, explicitly stating it "does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected." It's an information display system for human use, not an automated algorithm for interpretation.

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

• Type of Ground Truth: Not applicable regarding patient conditions or diagnoses. The "ground truth" for this type of device would relate to the accuracy of data transmission, display fidelity, and system functionality. This would be established through engineering verification and validation (e.g., comparing displayed data to source data, ensuring alarms are routed correctly).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device does not appear to employ machine learning or AI that would require a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the 510(k) submission for K130796 emphasizes substantial equivalence to a predicate device based on non-clinical testing (system verification, user interface verification, system validation, and device compatibility verification). It does not present detailed quantitative performance metrics, clinical study data, or information regarding AI/ML-driven performance evaluation.

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