(17 days)
The NeuColonCARE is a soft-copy reading workstation intended for clinical review of CT abdominal (gastrointestinal) images which allows easy acquisition, transmission and review of the medical images and supports VC (Virtual Colonoscopy) function. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis.
NeuColonCARE software product is a soft-copy reading workstation used to clinically evaluate the CT abdominal (gastrointestinal) images. It is a self-contained software package, providing the functions of patient information management, image viewer (2D view, standard MPR views and 3D visualization view), and the analysis and processing of the gastrointestinal system, especially the colon. It allows the user to conduct air segmentation based on a customized threshold value, extract the centerline automatically and interactively, view the colon lumen structure in the manner of virtual colonoscopy or virtual dissection along the centerline, view the ROI, and finally acquire useful clinical information by marking and measuring the ROI (3D distance and CT value).
The provided text is a 510(k) summary for the Neusoft NeuColonCARE device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria and a study proving those criteria are met.
Here's an analysis of what can and cannot be answered based on the provided text:
Acceptance Criteria and Study (Cannot be fully answered):
The document states:
- "The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. A summary of the software design description, risk management, level of concern and verification&validation testing information can be found in the attached submission."
- "It is further verified for system compatibility with the devices with which it communicates, including conformance to DICOM 3.0 standard."
- "Neusoft Medical Systems considers the NeuColonCARE software product to be as safe, as effective, and performance is substantially equivalent to the predicate devices."
This broadly indicates that some form of "verification and validation testing" was performed to show conformance to design specifications and industry standards. However, the document does not provide specific acceptance criteria (e.g., a certain sensitivity/specificity threshold for polyp detection, or accuracy of measurements) nor does it describe any specific study that quantitatively measures the device's performance against such criteria. The basis for clearance is substantial equivalence to predicate devices, not a demonstration of specific performance metrics against pre-defined acceptance criteria.
Therefore, the table of acceptance criteria and reported device performance cannot be generated from the provided text. The subsequent questions (#2-9) regarding sample sizes, ground truth, experts, etc., are also not addressed because there is no description of a performance study in the provided text.
Summary of available information:
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Table of acceptance criteria and the reported device performance:
- N/A. The document does not provide specific acceptance criteria or reported device performance metrics from a clinical study. It relies on a comparison to predicate devices for substantial equivalence.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- N/A. No such details are provided as no specific performance study is detailed.
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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):
- N/A. No such details are provided as no specific performance study is detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No such details are provided as no specific performance study is detailed.
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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:
- N/A. The document does not mention any MRMC comparative effectiveness study or AI assistance. The device is described as a "soft-copy reading workstation" and focuses on visualization and analysis tools, not AI-driven improvement for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. The document describes the device as a "soft-copy reading workstation" intended for "clinical review of CT abdominal (gastrointestinal) images" where "Images may be interpreted by a trained physician." This implies a human-in-the-loop system. No standalone algorithm performance is described.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No such details are provided as no specific performance study is detailed.
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The sample size for the training set:
- N/A. No such details are provided as no specific training of a machine learning algorithm is discussed.
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How the ground truth for the training set was established:
- N/A. No such details are provided as no specific training of a machine learning algorithm is discussed.
Conclusion from the document:
The Neusoft NeuColonCARE device was cleared based on substantial equivalence to its predicate devices (Voxar 3D Entreprise with ColonMetrix K070831 and Philips ViewForum 2003 K032096). The text outlines that the device shares similar technological characteristics and functions (e.g., standard MPR, Virtual Endoscopy, Virtual Dissection, ROI bookmarking and measurement) with the predicate devices. It states that the device "employs the same or similar fundamental technology as its predicate devices and dose not introduce any new potential safety risks," leading to the conclusion that it is "as safe, as effective, and performance is substantially equivalent to the predicate devices."
The description of "non-clinical tests" refers to conformance to design specifications, industry standards (DICOM 3.0), software design description, risk management, and verification & validation—these are general software development and regulatory compliance activities, not a detailed clinical performance study with specific acceptance criteria and outcome metrics.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).