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The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including:

• · Displaying DICOM compliant medical images and non-DICOM content using XDS
• · Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images
  · Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
• · Creating individually captured DICOM images that can be displayed and stored in a PACS
  • Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
  · Creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use.

The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

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 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks.

With no download or application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view exams and patient information including but not limited to the following content: Diagnostic Reports. Kev Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments.

IBM iConnect Access was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/ level, scroll, CINE, link series, line/ angle/ ROI measurements, and MPR.

The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.

When configured by an Administrator, patients can view their radiological information via portals that launch IBM iConnect Access and provide the ability to view clinical results, modality imaging, key images, scope/surgery videos, and associated clinical documentation. The role for patient access is limited to zooming the image, panning the image, and scrolling through a series of images.

The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project), MPR (multiplanar reconstruction), 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel and can employ advanced image processing and display from local or remote locations.

IBM iConnect Access provides advanced image segmentation and editing tools for the purpose of creating digital 3D anatomical models. These models can be exported as STL files for the purpose of fabricating physical replicas, such as 3D printing. Physical/3D printed models generated from the digital output files are not for diagnostic use.

IBM iConnect Access can be used to query and retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment.

IBM iConnect Suite is an offering that combines the image storage capability of IBM iConnect Enterprise Archive with the diagnostic viewer capability of IBM iConnect Access.

This 510(k) premarket notification describes the IBM iConnect Access (v8.0), a Picture Archiving and Communication System (PACS), which is substantially equivalent to a previously cleared version (IBM iConnect Access v7.0, K182290).

The primary focus of this submission revolves around the addition of new features related to 3D model manipulation and export for 3D printing. Because it is a PACS system and the changes are primarily functional enhancements to existing capabilities (e.g., image manipulation, 3D reconstruction, and data export), the submission states that clinical studies are not required to demonstrate safety and effectiveness.

Therefore, the following information, which would typically be found in a study demonstrating clinical performance, is not available in this document:

• A table of acceptance criteria and reported device performance (for clinical endpoints)
• Sample sizes for test sets and data provenance
• Number of experts and their qualifications for establishing ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used (for clinical validation)
• Sample size for the training set
• Ground truth establishment for the training set

The document does, however, provide information regarding non-clinical testing for the new features.

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

The document does not provide a formal table with acceptance criteria and reported device performance metrics in the way one would typically see for a diagnostic AI device. Instead, it describes compliance with voluntary standards and in-house testing for the new features.

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

The document mentions "in-house testing of de-identified CT and MRI DICOM images" but does not specify the sample size or the data provenance (country of origin, retrospective/prospective nature).

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 applicable, as clinical ground truth establishment by experts for specific diagnostic performance metrics was not part of this submission. The testing focused on technical functionality.

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

Not applicable, as no clinical adjudication of diagnostic findings from a test set is described.

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 study was conducted or reported. The device is a PACS system with added image manipulation and export features, not an AI-assisted diagnostic tool in the sense of providing specific interpretations.

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

The device's functionality is to provide tools for healthcare professionals; it does not operate in a standalone diagnostic manner. The document does not describe standalone algorithm performance.

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

For the non-clinical testing described, the "ground truth" was likely the expected technical output for the interactive segmentation and mesh generation features, rather than clinical ground truth (e.g., pathology confirmed disease presence). The document states: "in-house testing of de-identified CT and MRI DICOM images confirmed that interactive segmentation of digital 3D models and mesh generation for STL file creation was acceptable." This implies a verification against pre-defined technical specifications for the output.

8. The sample size for the training set

Not applicable. The description does not involve a training set for an AI model that performs diagnostic interpretation. The software's new features are based on algorithms for image manipulation and geometric processing, not typically requiring a distinct "training set" in the context of deep learning for image classification or detection.

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

Not applicable, as there is no mention of a training set for an AI model.

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The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including:

o Displaying DICOM compliant medical images and non-DICOM content using XDS

o Reformatting images. including creation of MPRs. MIPS. MinIPs. color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.

o Creating individually captured DICOM images that can be displayed and stored in a PACS

o Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.

The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

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 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.

IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks.

With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments.

IBM iConnect Access was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/ level, scroll, cine, link series, line/ angle/ ROI measurements, and MPR.

The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.

The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project). MPR (multiplanar reconstruction). 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel can employ advanced image processing and display from local or remote locations.

IBM iConnect Access can be used to query retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment.

IBM iConnect Access along with IBM iConnect Enterprise Archive comprise a cloud based solution marketed as iConnect Cloud Archive. The IBM iConnect Access 3D advanced imaging solution option is not available on iConnect Cloud Archive.

The provided text is a 510(k) Summary for the IBM iConnect Access device. It does not contain specific acceptance criteria or details of a study that proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of features and stating that internal verification and validation testing confirmed product specifications.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from this document.

However, I can provide what information is available:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of specific metrics (e.g., sensitivity, specificity, accuracy). It generally asserts that "product specifications have been met" based on internal verification and validation. The table in the "Comparison with Predicate" section outlines features and capabilities, and the rationale column often states "Substantially Equivalent."

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

This information is not provided in the document. The document states "Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that IBM iConnect Access product specifications have been met." It does not specify the sample size, type of data used (e.g., patient cases, synthetic data), or its provenance for these internal tests.

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 document does not describe the establishment of a "ground truth" using experts for the purpose of validating the device's performance against clinical outcomes.

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

This information is not provided in the document. No details on adjudication methods for a test set are mentioned.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the document. The IBM iConnect Access device is described as a Picture Archiving and Communication System (PACS) with advanced imaging capabilities, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement.

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

The document does not detail a standalone performance study in the way it might for an AI algorithm. It describes the device as providing "healthcare professional tools to aid in interpreting medical images," and explicitly states, "The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user." This indicates it's not a standalone diagnostic algorithm. The cardiac calcium scoring feature is described as "using tomographic medical image data and clinically accepted calcium scoring algorithms," suggesting it integrates existing, accepted algorithms rather than presenting a novel standalone algorithm for independent validation in this submission.

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

The document does not specify the type of ground truth used, as it does not detail a clinical study with a defined ground truth for device performance evaluation. The "ground truth" for the verification and validation largely refers to the device meeting its own design specifications and intended functionality, and demonstrating substantial equivalence to predicate devices.

8. The sample size for the training set

The document does not provide information about a training set since it focuses on a PACS system and its comparison to predicate devices, not on a machine learning model 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, this information is not applicable/provided.

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