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Comprehensive software package for visualization and analysis of thoracic CT datasets, which is intended to help the reading physician to analyze regions of the lung, such as nodules and other lung parameters, and to generate an automatic report.

The Acculmage PrimeLung software module is an additional software option to K990241, AccuView Diagnostics Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plug-ins. The AccuShade plug-in is not currently marketed, the AccuMIP plug-in is currently marketed with the name ProjectorPro. The Acculmage PrimeLung plug-in provides visualization and analysis tools for viewing regions of the lung, and generating reports with patient information, images, results and recommendations.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

Evaluation of Acceptance Criteria and Device Performance for PrimeLung (K024149)

Based on the provided 510(k) summary for PrimeLung (K024149), the information regarding acceptance criteria and performance studies is limited and primarily focuses on functional verification rather than clinical accuracy for diagnostic tasks.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity for nodule detection or characterization). Instead, the "test results" section describes functional verification.

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

The document states: "The testing performed showed that auto-matching comparison tool provides very reliable results with 100% of matching accuracy on the specified data sets."

• Sample Size: The exact sample size used for the "specified data sets" is not provided.
• Data Provenance: The country of origin and whether the data was retrospective or prospective is not specified.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth for any of the testing. The "100% matching accuracy" for the comparison tool implies that there was a reference standard, but how that standard was derived is not detailed.

4. Adjudication Method for the Test Set

• The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

• No, an MRMC comparative effectiveness study that assesses human reader improvement with AI assistance versus without AI assistance was not mentioned or reported in this 510(k) summary. The summary focuses on the device's functional equivalence to predicate devices and its own functional performance.

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

• The reported performance for the "auto-matching comparison tool" achieving "100% matching accuracy on the specified data sets" seems to be a standalone algorithm performance metric. However, this is a very specific function and not a comprehensive diagnostic standalone claim (e.g., for nodule detection or characterization).
• The overall context of the device as "intended to help the user to analyze lung nodules" suggests it's an assistive tool, not a standalone diagnostic. Therefore, a comprehensive standalone performance study for diagnostic tasks was not explicitly stated or reported.

7. The Type of Ground Truth Used

• For the "auto-matching comparison tool," the ground truth was likely established by manual matching performed by a human expert or a pre-defined reference, against which the automated matching was compared. The exact nature of this ground truth (e.g., consensus, pathology, follow-up) for general nodule analysis is not specified.
• For other functionalities like GUI conformity and report generation, the "ground truth" is simply adherence to the functional specification.

8. The Sample Size for the Training Set

• The document does not mention any training set or its sample size. This is consistent with the era of the submission (2002-2003) where deep learning and large-scale training datasets were not standard practice for medical device submissions of this type. The device's functionality appears to be based on more traditional image processing algorithms rather than machine learning requiring a distinct training phase.

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

• As no training set is mentioned (see point 8), the method for establishing its ground truth is also not applicable/provided.

Summary of Study Limitations and Nature:

The "study" described in the 510(k) summary is primarily a functional verification test (also known as verification and validation testing) rather than a clinical performance study. It confirms that the software's user interface works as designed, its features perform their intended actions, and a specific "auto-matching comparison tool" achieves high accuracy for matching tasks on limited, unspecified data. It does not provide clinical performance metrics like sensitivity, specificity, or reader agreement for diagnostic tasks such as nodule detection or characterization, which are common in more recent AI/CADe submissions. The submission relies on substantial equivalence to predicate devices that also provided visualization and analysis tools.

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Heart calcium scoring for gated CT images to minimize effects of heart movements.

The Acculmage Smartgate Upgrade for AccuScore 1.0 is an additional The Accumlage Onlangate Openalic Imaging Workstation with AccuScore, AccuAnalyze, AccuShade, AccuVRT and AccuMIP plugwin 7 locaboore, Accuring is not currently marketed, and the AccuMIP ins. The Accuremade play ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . play-in-15-ourrently-our-en-in-stating Tool enhancement for AccuScore Accumage Onlangulo Opgrado Stimas scoring for gated images, thus minimizing adverse effects of heart movement.

The provided text is a 510(k) Summary for the AccuImage SmartGate Upgrade. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description, intended use, and general safety considerations.

The document does NOT contain information regarding:

• Specific acceptance criteria for device performance.
• A detailed study proving the device meets acceptance criteria.
• Reported device performance metrics.
• Sample sizes for test sets or their data provenance.
• Number of experts or their qualifications for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone performance study results.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the document states:

• Substantial Equivalence: The AccuImage Smartgate Upgrade Option is substantially equivalent to GE Medical Systems HiSpeed Lxi with SmartScore and the Vital Images Vscore with Gating options. This is the primary method of validation presented.
• Performance Testing: "All software testing specified in the Software Product Development Plan will be successfully completed prior to market release." However, no details of this testing or its results are provided.
• Software Development: The software was "designed, developed, verified and validated according to which procedure for developing and approving product organizations, software colling and testing, validation testing and field maintenance." Again,
  no specifics on the results of these processes are given.
• Hazard Analysis: Performed throughout development, concluding that the "Level of Concern" is "Minor" and that no failures are expected to materially contribute to patient death or injury.

In summary, the provided text does not contain the specific information requested in your prompt regarding acceptance criteria, study details, and performance metrics. It's a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

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The product is an image processing workstation software package designed to run on standard PC hardware. The hardware is all "off-the-shelf" standard supplied by and may be purchased independently by the end user or from AccuImage. The AccuImage, AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receives image files from medical scanning devices, such as CT or MRI and performs real time viewing, image manipulation, 3D and 4D visualization, communication, and archiving.

The AccuView Diagnostic Imaging Workstation Software Package with Plug-ins receive image files from medical scanning devices, such as CT or MRI and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving. All of the functions are supported on standard communication, and them for ease of cost and maintenance. The use of Microsoft Windows 95/98/NT operating system makes the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins easy to use and capable of being integrated with other computer needs.

This document is a 510(k) Summary for the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins. It is a pre-market notification to the FDA to demonstrate substantial equivalence to legally marketed devices. As such, it describes the device and its intended use but does not include detailed acceptance criteria or a study proving the device meets those criteria in the way a performance study report would.

Here's an analysis based on the provided text, highlighting what is included and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on functional comparisons and technical specifications rather than quantitative performance metrics against predefined acceptance criteria. The tables provided compare the features and technical specifications of the AccuView components with their respective predicate devices.

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

This information is not provided. As this is a 510(k) submission for a diagnostic imaging workstation software package, the focus is on functional equivalence and safety, not on a clinical performance study with a test set of patient cases.

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

This information is not provided. No clinical performance study is described that would involve expert review and ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set or clinical performance study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided. The device is an imaging workstation and software package, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or aiding human readers in a way that would be assessed by an MRMC study measuring reader improvement.

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

This information is not provided. The device is a workstation for human interpretation and manipulation of medical images; it's not a standalone algorithm for diagnosis.

7. The Type of Ground Truth Used

This information is not provided as no clinical performance study requiring ground truth is described.

8. The Sample Size for the Training Set

This information is not provided. The document describes software development and testing procedures but not the training of a machine learning model, which would involve a training set.

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

This information is not provided as no training set for a machine learning model is mentioned.

Summary of what is present in the document relevant to device description and regulatory process (but not detailed performance outcomes):

The document outlines:

• Device Name: AccuImage Diagnostics Corporation, AccuView Diagnostic Imaging Software Package with AccuScore, AccuAnalyze, AccuScope, AccuShade, AccuVRT and AccuMIP Plug-ins.
• Intended Use: Receives image files from medical scanning devices (CT or MRI) and performs real-time viewing, image manipulation, three and four dimensional visualization, communication, and archiving.
• Software Development and Testing: "AccuImage Diagnostics Corporation certifies that the AccuView Diagnostic Imaging Workstation Software Package with Plug-ins are designed, developed, tested and validated according to written procedures." These procedures cover product specifications, coding, testing, validation testing, and field maintenance.
• Hazard Analysis: Performed throughout the definition, design, coding, and testing phases. Concluded that the "Level of Concern" is "Minor," as failures are primarily related to computer system components and "None of these failures are expected to materially contribute to patient death or injury."
• Substantial Equivalence: Demonstrated by comparing the device's characteristics and functions (e.g., computer platform, communication, image format, display, processing, specific plug-in functionalities like calcium scoring, and virtual endoscopy) against predicate devices (AIDP, Imatron Ultra Access, InSight Diagnostic Imaging Workstation, and Picker Voxel Q/Voyager) via detailed tables. This comparison forms the basis of the FDA's clearance, indicating that the new device is as safe and effective as existing legally marketed devices.

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