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The Mac-Lab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from a hemodynamic procedure. Mac-Lab may be used in a variety of hospital and clinical settings to record hemodynamic data and measurements, which may then be displayed, filtered, digitized, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.

The CardioLab system is indicated for use on patients of all ages when a physician determines that a patient would benefft from an electrophysiology procedure. CardioLab may be used in a variety of hospital and clinical settings to record electrophysiology data and measurements, which may then be displayed filtered, amplified, measured, and calculated and/or transmitted for storage, analysis and viewing at distributed locations.

The ComboLab system is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. ComboLab may be used in a variety of hospital and clinical settings to record hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.

The MLCL Client Software is indicated for use on patients of all ages when a physician determines that a patient would benefit from either a hemodynamic or electrophysiology procedure. MLCL Client Software may be used in a variety of hospital and clinical settings to record, document and/or review hemodynamic and electrophysiology data and measurements, which may then be displayed, filtered, digitized, amplified, measured, calculated and/or transmitted for storage, analysis and viewing at distributed locations.

Mac-Lab and CardioLab are hemodynamic and electrophysiology (EP) recording systems, respectively. A third configuration, ComboLab, allows the user to access both CardioLab and Mac-Lab functions, though only one application may be accessed at a time.

These devices are used during interventional and related procedures to process, display and record hemodynamic and electrophysiology (EP) data depending on the type of procedure performed. The data is acquired and displayed real-time for multiple physiological parameters to allow the user to view the data. The data may be entered manually through the use of a dedicated keyboard/mouse/barcode scanner or acquired via procedural information devices, imaging devices and interfaced data devices, and may then be displayed, filtered, digitized, amplified, measured, and calculated.

A fourth configuration, called the MLCL Client Software, is the core Mac-Lab and CardioLab application software which is available for installation on a stand-alone workstation (i.e. outside of the Mac-Lab/CardioLab/ComboLab acquisition systems described above). The MLCL Review Software may be used to record, document, analyze, store and transmit data, including data from supported patient monitors.

Mac-Lab, CardioLab, ComboLab and the MLCL Client Software provide the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity but may also be used stand-alone (not connected to a network).

Mac-Lab, CardioLab, ComboLab and the MLCL Client Software are not intended to be used as a patient monitor and are not intended to alert the licensed health care practitioner of a change in patient status.

The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Mac-Lab Recording Systems, CardioLab Recording Systems, ComboLab Recording Systems, and MLCL Client Software.

Here's a breakdown of the requested information:

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

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. The overall reported device performance is that the device is "as safe, as effective, and performs as well as the legally marketed predicate device."

Summary of Reported Device Performance and Equivalence Claims:

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 explicitly states: "The subject of this premarket submission, Mac-Lab, CardioLab and ComboLab AltiX, did not require clinical studies to support comparability to the predicate device." Therefore, there is no sample size for an external "test set" and no direct data provenance related to a clinical study. The evaluation primarily relied on non-clinical testing and comparison to the predicate device.

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 studies were performed to establish a "test set" with ground truth from experts, this information is not applicable and not provided in the document.

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

As no clinical test set requiring expert ground truth or adjudication was conducted, this information is not applicable.

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

No MRMC comparative effectiveness study was done. The device is a recording system for hemodynamic and electrophysiology data and measurements, not an AI-assisted diagnostic tool for human readers.

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

The document describes "Performance testing (Verification)" and "System performance testing (Verification)" as part of the non-clinical tests. These would likely involve evaluating the algorithm's performance in isolation or as part of the system. However, specific standalone performance metrics or a detailed description of "algorithm-only" performance is not provided beyond the general statement of performing "as well as" the predicate. The device's primary function is data acquisition, display, and processing, not automated diagnosis that would typically warrant a standalone algorithmic performance study distinct from the system's overall function.

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

For the non-clinical testing, the "ground truth" for verification and validation would be established by reference to engineering specifications, established standards (e.g., IEC 60601 series), and the performance of the legally marketed predicate device. This is primarily technical or functional ground truth, rather than clinical ground truth (like pathology or outcomes data).

8. The sample size for the training set

The document does not mention any "training set" as part of an AI/machine learning model. The device is described as a recording system, and the changes primarily involve hardware updates (new EP amplifier) and inclusion of existing technology (DFR technology). There is no indication of machine learning components that would require a distinct training set.

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

As there is no mention of a training set for an AI/machine learning component, this information is not applicable.

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Centricity AW Suite is an optional software package that provides an interface between the Centricity PACS Workstation and Volume Viewer such that both applications can run on a single platform while maintaining common patient & exam context. Optional advanced analysis extensions of the Volume Viewer application include: AutoBone, Advanced Vessel Analysis, CT Colonography, CardIQ Analysis, and Advanced Lung Analysis.

Volume Viewer allows the processing, review, analysis and communication of 3D reconstructed images and their relationship to originally acquired images from CT, MR, X-Ray Angio, NM and PET Scanning devices. The combination of acquired images, reconstructed images, annotations and measurements performed by the clinician are intended to provide to the referring physician clinically relevant information for diagnosis, surgery and treatment planning.

Advanced Vessel Analysis can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

CardIQ Analysis allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionality for 20/30 rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician to process, render, review, archive and visualize cardiac anatomy and coronary vessels.

CT Colonography allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of the 2D. 3D and 360 dissection views, and an object oriented endoluminal display. In comparison to Colonoscopy, this tool has an advantage of depth penetration due to its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive and distribute colon image studies.

AutoBone is intended to facilitate segmentation of bony structures from abdominal and extremity CT Angiography data.

Advanced Lung Analysis is intended to provide an optimized non-invasive application to measure abnormalities in the lung (for example, nodules, lesions, etc.) from a set of Computed Tomography (CT) images. The software is designed to support the physician in confirming the presence of physician identified lung lesions (e.g. nodules). The software allows measurement of volume over time using a consistent standardized measurement protocol, thus providing an estimation of the volume doubling time. ALA software allows andlysis and displays statistics for nodule characterization all the different nodule types. ALA optional Digital Contrast Agent (DCA) module is an automated highlight feature for the visual identification of possible lesions. Digital Contrast Agent (DCA) is a 3D filter that produces images that highlight spherical (S) and cylindrical (C) anatomical regions, such as nodules, cysts, scars, and vessels. Images are made available to the physician to aid in characterization of suspicious nodules and thus, the patient management care decision process. ALA provides additional information to the physician and is intended to compliment diagnosis based on classical techniques.

Centricity AW Suite is a software option that provides an interface between the Centricity Workstation (on a Windows platform) and Volume Viewer with advanced analysis options such that both these applications can run on a single platform while maintaining common patient and exam context.

Volume Viewer is a previously FDA cleared image analysis software option. Optional advanced analysis extensions of the Volume Viewer application have been previously cleared by FDA and include AutoBone, Advanced Vessel Analysis, CT Colonography, CardiQ Analysis and Advanced Lung Analysis.

The provided document (K061372) is a 510(k) summary for the GE Healthcare Information Technologies' Centricity AW Suite Option, which is a software option providing an interface between the Centricity PACS Workstation and Volume Viewer with advanced analysis options.

The document does NOT explicitly describe specific acceptance criteria and a detailed study proving the device meets these criteria in the typical format of a performance study with quantitative results against specific criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The "Test Summary" section describes the quality assurance measures applied during development, which are standard software development and quality control practices rather than a specific performance study against defined acceptance metrics.

Therefore, the following information, as requested, cannot be fully extracted or is explicitly stated as not applicable based on the provided text.

Acceptance Criteria and Device Performance Summary for K061372

Since specific performance acceptance criteria and a detailed study proving the device meets them are not presented in the provided 510(k) summary, the table below reflects what can be inferred or explicitly stated from the document regarding its equivalence claim rather than a direct performance report.

Additional Study Information:

1. Sample sizes used for the test set and the data provenance:

   • Not explicitly stated. The document mentions "Testing on unit level (Module verification)", "Integration testing (System verification)", and "Final acceptance testing (Validation)" as part of general quality assurance, but no specific test set sample sizes or data provenance (e.g., country of origin, retrospective/prospective) are provided for these activities in the summary.

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

   • Not explicitly stated, and likely not applicable in the context of this 510(k). This 510(k) focuses on the substantial equivalence of a software application integrating existing functionalities and adding minor enhancements. It does not describe a clinical performance study requiring expert ground truth for diagnostic accuracy where primary endpoints are evaluated. The "ground truth" here would relate more to the software performing its intended functions accurately and reliably, which is verified through software testing processes.

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

   • Not applicable / Not explicitly stated. Adjudication methods are typically used in clinical studies for establishing ground truth, which is not detailed in this 510(k) summary focused on substantial equivalence of software functionality.

4. 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 explicitly mentioned or performed as described. The device is presented as an interface with advanced analysis options that are extensions of previously cleared applications (Volume Viewer, AutoBone, etc.). The 510(k) focuses on the equivalence of these combined functionalities and the technological approach, not on improving human reader performance with new AI algorithms. The "Advanced Lung Analysis" description mentions the software "is designed to support the physician in confirming the presence or absence of physician identified lung lesions" and "provides additional information... and is intended to compliment diagnosis based on classical techniques," but this is a statement of intended use, not a result from an MRMC study.

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

   • Not explicitly described as a standalone performance study in the document. The software is presented as supporting physicians and providing tools, implying a human-in-the-loop context. General "Performance testing" is mentioned as part of quality assurance but without specifics of standalone algorithmic performance metrics.

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

   • Not explicitly stated. Given the nature of the device (software integration and advanced visualization tools building on predicate devices), the "ground truth" for its acceptance would primarily revolve around the accuracy of its software functions in processing, rendering, and measuring images as intended, consistent with its predicate devices. This would typically be established through validation against known good data, software specifications, and expected outputs, rather than a clinical ground truth like pathology for diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable / Not explicitly stated. This device is described as an "optional software package" and advanced analysis extensions, employing "the same functional scientific technology as its predicate devices." It is not presented as an AI/ML algorithm that requires a distinct training dataset in the modern sense. The "training set" concept is not relevant to this type of traditional software submission.

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

   • Not applicable. As a training set for an AI/ML algorithm is not described, the establishment of its ground truth is also not applicable.

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