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510(k) Data Aggregation
(28 days)
Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
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 five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities.
Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or systems.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Centricity PACS-IW device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not establish specific quantitative acceptance criteria or provide detailed numerical performance metrics for the Centricity PACS-IW. Instead, it relies on substantial equivalence to a predicate device and verification/validation testing.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Device functionality fits within 21 CFR 892.2050 (Picture Archiving and Communication Systems, Product Code LLZ) | Functionally equivalent to predicate device (K082318) in intended use and functionality. |
| Technological Equivalence | Same fundamental scientific technology as predicate device (K082318) with specified modifications (Windows server/database upgrade, JPEG lossless/non-wavelet compression support). | Modifications did not introduce adverse effects; device is as safe and effective as predicate. |
| Software Quality & Safety | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (moderate level of concern). Application of quality assurance measures. | All stated quality assurance measures applied. Verification and Validation testing demonstrated no adverse effects from differences. |
| Image Review Specifications | 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 five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. | Device adheres to these conditions as part of its intended use limitations and display requirements. |
| Clinical Performance | (No specific clinical performance criteria provided for this submission) | Clinical studies were not required to support substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket notification submission, Centricity PACS-IW, did not require clinical studies to support substantial equivalence."
Therefore, there is no clinical test set, sample size, or data provenance information provided for an evaluation of the device's diagnostic performance on medical images. The testing focused on software verification and validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical test set was used for performance evaluation, no experts were involved in establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states that clinical studies were not required. There is no mention of an MRMC study or an effect size for human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. The device is a PACS system, designed for human use in interpreting images. Its "performance" is primarily related to its ability to store, communicate, process, and display images reliably, rather than providing automated diagnoses.
7. Type of Ground Truth Used
For the software verification and validation testing, the "ground truth" would have been the expected behavior and outcomes defined by the software requirements and design specifications. For example, for a functional test, the ground truth would be that a specific image should display correctly or that a data transfer should complete without error.
8. Sample Size for the Training Set
Not applicable. This device is a PACS system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for diagnostic inference. The "training" here refers to software development and testing cycles, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set in the context of AI/ML for diagnostic inference. The development process likely involved thorough software engineering practices where expected behaviors and outputs were defined by system architects and engineers.
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