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CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.

Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alarm notification is the device or system producing the alarm or event. This device is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

CareAware Event Management™ is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does CareAware Event Management™ come into direct contact with patients.

CareAware Event Management™ is a software application intended to provide healthcare professionals with supplemental information about events and alarms originating from medical devices, or other event or alarm producing systems within a clinical setting. This device can route notifications including all or a subset of the event or alarm information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points.

This document is an FDA 510(k) clearance letter for the Cerner CareAware Event Management™ device. It does not contain information about a study proving the device meets acceptance criteria.

The letter explicitly states:

• "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..."
• "Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria for the new device as would be seen in a clinical trial.

Therefore, I cannot provide the requested information because the provided document does not contain a description of a study with acceptance criteria and reported device performance.

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Cerner FetaLink+ is a software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms in one view. FetaLink+transforms the ongoing measurements into a visual wave display which conveys the frequency, duration and relative strength of uterine contractions combined with the patient data of pregnant women in the antepartum and/or intrapartum phases of pregnancy.

Cerner FetaLink+ is the software application that runs on the user's iPhone or iPad. The application displays patient clinical waveform data including maternal heart rates, maternal oxygen saturation, maternal blood pressure, and uterine contractions. Within the application, the user can view annotations associated to waveform data.

The provided text describes the Cerner FetaLink+ device, its intended use, and a comparison to a predicate device (AirStrip OB®). However, it does not contain information about specific acceptance criteria, a study proving the device meets these criteria, or a detailed breakdown of performance metrics and ground truth establishment typically found in a clinical performance study.

The document refers to various types of internal testing but none of these are presented as a formal study with acceptance criteria and reported performance metrics.

Here is a breakdown of what can be extracted and what information is missing based on your request:

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

No specific quantitative acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity) are provided in the document for the FetaLink+ device. The document states:

"Cerner's validation demonstrated that all functional requirements and hazard analysis software mitigations for Cerner FetaLink+ were executed and the expected results achieved. Based on the results of the testing performed, Cerner FetaLink+ was evaluated to be a safe and effective device for use in a live patient environment."

This is a general statement rather than a specific performance metric against a defined acceptance criterion.

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

This information is not provided in the document. The text mentions "functional testing," "formative and summative usability," and "interference testing," but does not specify the sample size of data or patients used for these tests, nor the provenance of any data if it were used in performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The document describes the device as displaying data, not making diagnoses or interpretations that would require expert ground truth for performance evaluation in the typical sense of AI/CADe devices.

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

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device is described as a display tool, not an AI-driven diagnostic aid in the traditional sense that would typically involve a MRMC study for AI assistance.

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

The device itself is a "software-only application intended for use on iOS mobile devices by obstetrical healthcare clinicians to view near real time the simultaneous measurement of fetal heart rate(s) and uterine contractions waveforms." It is an information display tool, not an algorithm that performs standalone analysis or makes diagnoses. Therefore, the concept of "standalone performance" for an algorithm that operates without human-in-the-loop is not directly applicable in the way it would be for a CADe/AI device. The "performance" here relates to the accurate display of data, which was likely covered by the "functional testing."

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

As the device's primary function is to display waveform data, the "ground truth" for its performance would likely refer to the accuracy of the displayed data compared to the source data from the monitoring devices. This type of ground truth (e.g., accuracy of data transmission and display) is implied by "functional testing" but not explicitly detailed with specific methods like expert consensus or pathology.

8. The sample size for the training set

This information is not applicable/not provided. The device, as described, is a data display application. There is no indication that it utilizes machine learning or AI models that would require a "training set" in the context of typical AI device development.

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

This information is not applicable/not provided for the same reason as point 8.

Summary of what is present:

The document focuses on:

• Description of the Device: FetaLink+ displays continuous fetal heart rate, uterine contraction waveforms, and other maternal vital signs and clinical data on iOS devices.
• Intended Use: For obstetrical healthcare clinicians to view near real-time and historical waveform data.
• Comparison to Predicate Device: Detail similarities in functionality with AirStrip OB®.
• Performance Testing (General): Mentions "functional testing," "hazard analysis," "unit testing," "regression testing," "exploratory testing," "assembly testing," "formative and summative usability," and "interference testing."
• Conclusions: States that all functional requirements were met, usability issues were mitigated, and the device was found to be "adequately safe and effective."

In conclusion, while the document confirms that testing was conducted and the device was deemed safe and effective, it lacks the specific, quantifiable acceptance criteria and detailed study results (including sample sizes, ground truth methods, and expert involvement) that would be expected for a comprehensive performance study of a device making diagnostic-type claims or using advanced AI. The device appears to be a data display tool, and its "performance" testing likely centered on accurate data presentation and application functionality, rather than diagnostic accuracy against a clinical ground truth.

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Cerner iBus is a software application intended for use in the transportation, aggregation and derivation of data between medical devices and external systems used in a clinical setting for the purpose of automating data collection and clinical information management.

Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Cerner iBus come into direct contact with patients.

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The provided text is a 510(k) summary for the Cerner CareAware™ iBus, an FDA medical device clearance letter. It describes the device's regulatory status and indications for use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance and not on the technical and clinical validation studies that would involve such details.

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Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.

Cerner FetaLink is a software application intended for use in both hospital and clinic settings by obstetrical healthcare professionals providing care to pregnant women in the antepartum and/or intrapartum phases of pregnancy. Cerner FetaLink can be used at the bedside, the central nursing station, or at remote locations to help the clinician monitor the labor of patients by displaying data sent from fetal monitoring devices, providing a graphical display of the relationship between uterine contractions and fetal heart rate, and alerting the clinician to out-of-reference-range data trends.

The provided document is a 510(k) clearance letter from the FDA for the Cerner FetaLink™ device. It primarily focuses on the regulatory approval of the device based on substantial equivalence to predicate devices and outlines the device's indications for use.

Crucially, this document does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The FDA clearance letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a legally marketed device or has different technological characteristics but does not raise different questions of safety and effectiveness. This determination is primarily based on a comparison to predicate devices, not typically on a new, comprehensive clinical study with specific performance metrics and acceptance criteria that would be detailed in the submission.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the FDA clearance letter.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not 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: Not present. The Cerner FetaLink™ is described as a software application that displays data and alerts clinicians, implying it's a monitoring and information-display system, not necessarily an AI-powered diagnostic tool that would typically undergo MRMC studies for improved human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. Given its description as displaying data and alerting clinicians, it's inherently a human-in-the-loop system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

To obtain this information, you would need to consult the original 510(k) submission document (if publicly available in a more detailed form than the clearance letter), or technical documentation provided by Cerner Corporation for FetaLink™.

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The Cerner ProVision Workstation is a software application intended for the rendering. visualization and manipulating of medical images to support the image display needs of clinicians, diagnosticians and technologists.

Application capabilities enable primary diagnostic review, interpretation and distribution viewing for physician review.

The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA

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This document is a 510(k) clearance letter for the Cerner ProVision™ Workstation, dating back to 2007. It's important to note that 510(k) clearances typically do not require specific clinical study data to demonstrate safety and effectiveness beyond substantial equivalence to a predicate device. The focus is on showing the new device is as safe and effective as a legally marketed device, not necessarily on proving absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Premarket Approval) application.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is generally not included in a 510(k) clearance letter unless it was part of the substantial equivalence argument, which is rare for devices like a PACS workstation whose primary function is displaying images. The letter confirms substantial equivalence but doesn't detail the performance testing that might have been part of the manufacturer's internal verification and validation.

Based on the provided text, I can extract the following information relevant to the device and its intended use:

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

This information is not present in the 510(k) clearance letter. The letter focuses on regulatory clearance for substantial equivalence, not detailed performance metrics.

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

This information is not present in the 510(k) clearance letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not present in the 510(k) clearance letter.

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

This information is not present in the 510(k) clearance letter.

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 present in the 510(k) clearance letter. Given the device is a PACS workstation, not an AI diagnostic tool, a MRMC study focused on AI impact would not be expected.

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

The letter states: "The Cerner ProVision Workstation can be utilized in a standalone implementation, not interfaced or integrated to a Radiology Information System, or as component of a unified RIS/PACS solution." This indicates the workstation itself can operate in a standalone manner, meaning it's a complete system for image handling. It does not refer to a standalone algorithm without a human-in-the-loop for image interpretation. The device is a display and manipulation tool for clinicians.

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

This information is not present in the 510(k) clearance letter.

8. The sample size for the training set:

This information is not present in the 510(k) clearance letter.

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

This information is not present in the 510(k) clearance letter.

Summary of what can be gleaned from the document:

• Device Name: Cerner ProVision™ Workstation
• Regulation Number: 21 CFR 892.2050
• Regulation Name: Picture archiving and communications system (PACS)
• Regulatory Class: II
• Product Code: LLZ
• Indications for Use: The software application is intended for rendering, visualization, and manipulating medical images to support the image display needs of clinicians, diagnosticians, and technologists. Application capabilities enable primary diagnostic review, interpretation, and distribution viewing for physician review.
• Important Caveat for Mammography: "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." This is a crucial safety control related to the display of mammographic images.
• Intended Use Environment: Can be used standalone or as part of a unified RIS/PACS solution.

The letter's purpose is to confirm that the device is substantially equivalent to legally marketed predicate devices, not to detail the performance studies typically associated with novel diagnostic algorithms or AI.

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