(98 days)
Climb-Mammography Viewer is intended to be used by radiologists for the reading, manipulation and interpretation of DICOM digital breast images including mammography. Radiologists are able to select, display, manipulate, quantify, mark-up, print and exchange images.
Lossy compressed mammographic images must not be reviewed for primary image interpretations. Images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA for digital mammography. All images must conform to regulatory requirements. Image quality must conform to applicable quality guidance.
Climb Mammography Viewer Software is breast imaging workstation software. The system allows for the display and manipulation of images that have been obtained from PACS or modalities. Source images are obtained as the recipient of push data for the images. The system can also automatically open images and the corresponding reporting page. The product includes features that allow the qualified medical professional to view patient medical images
The provided text contains information about the Climb Mammography Viewer Software and its FDA 510(k) clearance. However, it does not include the specific details required to answer all parts of your request regarding acceptance criteria, study methodologies, and performance metrics.
The document is a 510(k) clearance letter and a summary of the device for submission. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report.
Here's a breakdown of what can be extracted and what information is missing:
Information Available:
- Device Name: Climb Mammography Viewer Software
- Intended Use: Used by radiologists for reading, manipulation, and interpretation of DICOM digital breast images (mammography).
- Predicates: Cedara I-SoftView / Cedara-I ReadMammo (K040468) and WorkstationOne™ Breast Imaging Workstation (K073272).
- Conclusion: The device was found to be substantially equivalent to predicate devices in intended use, indications for use, technological characteristics, and labeling.
- Performance Data Mentioned: "All software verification and validation testing met or exceeded the requirements as established by the test protocol and applicable standards. The results demonstrated that the Subject device presents no new worst case for performance testing and the Subject device was therefore found to be substantially equivalent to the Predicate."
Information NOT Available in the Provided Text:
- Specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy).
- Reported device performance values against specific criteria.
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (beyond implying expert interpretation of DICOM images).
- Sample size for the training set.
- How ground truth for the training set was established.
Based on the available text, here's what can be provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) or report specific performance metrics for the Climb Mammography Viewer Software against such criteria. The focus of this 510(k) summary is on demonstrating substantial equivalence to predicate devices. The "Performance Data" section broadly states that "All software verification and validation testing met or exceeded the requirements as established by the test protocol and applicable standards." This indicates functional and safety performance, rather than diagnostic accuracy metrics.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| (Not specified in the document beyond meeting "requirements" and "standards") | (Not specified in the document. The filing emphasizes substantial equivalence to predicates for intended use, indications, and technological characteristics.) |
| Software Verification & Validation | Met or exceeded requirements as established by test protocol and applicable standards. |
| Functional Equivalence | Demonstrated substantial equivalence to predicate devices (Cedara I-SoftView / Cedara-I ReadMammo and WorkstationOne™ Breast Imaging Workstation) in intended use, indications for use, technological characteristics, and labeling. |
| Safety Profile | Presents no new worst case for performance testing compared to predicates, and deemed safe and effective for intended use. |
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The 510(k) summary focuses on general software verification and validation, and substantial equivalence, not a clinical performance study with a specific test set of patient cases.
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.
4. Adjudication method 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 an MRMC comparative effectiveness study or AI assistance in the provided text. The device is described as "breast imaging workstation software" for reading, manipulation, and interpretation of images by radiologists, implying it's a viewing and analysis tool, not necessarily an AI-driven CAD or decision support system that would typically be evaluated with MRMC studies comparing human performance with and without AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. Given the description as "Viewer Software" for radiologists to "interpret" images, a standalone algorithm performance study is unlikely to be relevant to this product's primary claim, as it is designed for human-in-the-loop use.
7. The type of ground truth used
This information is not explicitly stated. However, considering the device's function as a "Mammography Viewer" for radiologists to "interpret DICOM digital breast images," the implied ground truth would likely involve expert consensus, potentially linked to pathology or follow-up outcomes in a clinical validation study if one were described (which it is not here).
8. The sample size for the training set
This information is not provided in the document. A "training set" would typically be relevant for machine learning or AI-based devices, which this document does not present the Climb Mammography Viewer as. The software verification and validation mentioned would refer to testing the software's functional specifications, not a machine learning model's training.
9. How the ground truth for the training set was established
This information is not provided in the document, as a training set, as typically understood in AI/ML contexts, is not mentioned.
§ 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).