(63 days)
The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/ screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
eContrast is an image post-processing algorithm applied to the DICOM "for processing" images in order to generate “for presentation" images. It consists in optimizing the local contrasts while reducing the overall dynamic range. This submission is proposing a software modification consisting of a new version of eContrast algorithm for Senographe Pristina platform to allow more flexibility for proposing different levels preserving/enhancing the visibility of the different structures present in the breast image. The first version of the eContrast image processing was previously cleared for Senographe Essential platform in the 510(k)# K131885. Then it was cleared with Senographe Pristina platform in the 510(k) # K162268. This design change is a software and labeling only option, compatible with Senographe Pristina installed base and does not require any hardware modification on the Senographe Pristina platform.
Here's a breakdown of the acceptance criteria and study information for the Senographe Pristina with the new version of eContrast, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The provided document describes a change to an existing cleared device (Senographe Pristina with eContrast K162268), specifically a new version of the eContrast post-processing algorithm. The core acceptance criteria revolve around demonstrating that the new version is substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Image Quality Performance: Images acquired with the new version of eContrast are of the same quality as images acquired with the predicate device (Senographe Pristina with eContrast as cleared in K162268) at similar dose levels. (Non-Clinical Data – Image Quality and Dose test) | "demonstrates that images acquired with Senographe Pristina with the new version of eContrast are of same quality as images acquired with Senographe Pristina with eContrast as cleared in K162268 at similar dose levels." |
| Clinical Image Acceptability: Clinical images generated with the new version of eContrast demonstrate acceptability by radiologists. (Clinical Data – Clinical image review by radiologists, with objective criteria defined) | "demonstrates the clinical image acceptability of images generated with Senographe Pristina with the new version of eContrast." |
| No Change in Intended Use and Indications for Use: The new algorithm does not alter the fundamental intended use or indications for use from the predicate device. | "The new version of eContrast algorithm for Senographe Pristina does not change the intended use and indications for use to its legally marketed predicate device, the Senographe Pristina with eContrast (K162268). ... Note: The intended use of Senographe Pristina cleared in K162268 is not changed. ... Note: The Indications for use of Senographe Pristina cleared in K162268 are not changed." |
| Fundamental Principles of Operation Unchanged: The core principles, functionalities, specifications, and technological characteristics of the Senographe Pristina itself remain unchanged. | "The fundamental principles of operation, functionalities, specifications and technological characteristics of Senographe Pristina remain unchanged." |
| Compliance with Quality Management System and Design Controls: The development and manufacturing adhere to GE Healthcare's quality management system, design controls, and relevant regulations (21CFR 820, ISO 13485). This includes risk analysis, design reviews, software development lifecycle, unit, integration, performance, safety, and simulated use testing. | "Senographe Pristina with the new version of eContrast has successfully completed required design control testing per GE Healthcare's quality management system. No unexpected test results were obtained. The design change was designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485. The following quality assurance measures were applied to the development of the system: - Risk Analysis - Design Reviews - Software Development Lifecycle - Testing on unit level (Module verification) - Integration testing (System verification) - Performance testing (Verification) - Safety testing (Verification) - Simulated use testing (Validation)" |
2. Sample Size and Data Provenance for Test Set (Clinical Data)
- Sample Size: Not explicitly stated for the clinical image review. The document mentions "clinical image review by radiologists" but does not specify the number of images or cases reviewed.
- Data Provenance: Not explicitly stated. It's likely retrospective as it involves reviewing existing images, but this is not confirmed. The country of origin is not mentioned.
3. Number of Experts and Qualifications for Ground Truth (Clinical Data)
- Number of Experts: "radiologists" (plural), but the exact number is not specified.
- Qualifications: "radiologists." Specific years of experience or sub-specialty are not provided.
4. Adjudication Method for Test Set (Clinical Data)
- Adjudication Method: Not explicitly stated. The document mentions "clinical image review by radiologists, with objective criteria defined," but does not detail how disagreements among radiologists, if any, were resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC Study was done. The study's purpose was to demonstrate substantial equivalence of a new version of an image processing algorithm, not to show improvement of human readers with AI assistance. It aimed to show that the new algorithm's output was "acceptable" and "same quality" as the previous version.
6. Standalone Performance Study (Algorithm Only)
- Yes, a standalone performance study was implicitly done through the "Non-Clinical Data – Image Quality and Dose test." This test would assess the direct output of the algorithm (image quality) without human intervention, comparing it to the previous version's output. The document states this test "demonstrates that images acquired with Senographe Pristina with the new version of eContrast are of same quality as images acquired with Senographe Pristina with eContrast as cleared in K162268 at similar dose levels."
7. Type of Ground Truth Used
- Non-Clinical Data (Image Quality): The ground truth for image quality comparison would likely be based on established image quality metrics, possibly evaluated against images from the predicate device as a reference standard. These are objective measures rather than expert consensus on disease.
- Clinical Data (Clinical Image Acceptability): The ground truth for clinical image acceptability was established via "objective criteria defined" by radiologists. This suggests a form of expert consensus or adherence to predefined quality standards for clinical interpretation, rather than pathology or outcomes data related to disease detection.
8. Sample Size for the Training Set
- Not applicable / Not disclosed. The document describes a modification to an existing algorithm (eContrast) rather than the development of a wholly new AI model that typically requires a separate training set. The new version of eContrast is an "extension of the current algorithm." If any internal parameter tuning or retraining occurred, the details of a training set are not provided. It's more of an algorithm update than a de novo AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not disclosed. As noted above, this appears to be an algorithm update rather than a new AI model requiring a separate training set with specific ground truth for learning.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.