(409 days)
The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D and S systems are intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity 2D and S systems may also be used for additional diagnostic workup of the breast. Additionally, the Planmed Clarity 2D and S systems can be used to provide digital x-ray images of breast biopsy specimens.
The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data.
The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
Acceptance Criteria and Study for Planmed Clarity 2D and S
This response synthesizes the information provided about the Planmed Clarity 2D and S mammography systems, focusing on the acceptance criteria and the studies conducted to demonstrate compliance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily details performance testing rather than explicitly stated acceptance criteria with numerical targets. However, based on the descriptions, we can infer the acceptance criteria. The device's performance is deemed acceptable if it meets these inferred criteria and demonstrates clinical image quality comparable to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Image Quality (Physical Laboratory Testing): | |
| Sensitometric response, linearity | Testing performed, results deemed satisfactory (no specific numerical values provided but system complies with standards) |
| Spatial resolution, MTF | Testing performed, results deemed satisfactory |
| Noise analysis, DQE | Testing performed, results deemed satisfactory |
| Dynamic range | Testing performed, results deemed satisfactory |
| Repeated exposures, ghosting and lag performance | Testing performed, results deemed satisfactory |
| Automatic Exposure Control (AEC) performance | Compliance with EUREF reference values |
| Phantom test: RMI phantom scores, CDMAM contrast detail performance | Testing performed, results deemed satisfactory |
| Patient radiation dose | Compliance with EUREF reference level |
| Breast compression system functionality | Testing performed, results deemed satisfactory |
| Clinical Image Quality: | |
| Sufficiency for mammographic usage when reviewed by MQSA qualified experienced interpreting physicians. | All images rated "good" or "excellent" by three MQSA qualified experienced US interpreting physicians. Overall image quality acceptable for all cases and image types. |
| Comparability to predicate device (K192317) in terms of safety and effectiveness. | Clinical image evaluation shows devices equipped with the new software perform comparably to the predicate device. |
| Safety and Regulatory Compliance: | |
| Biocompatibility | Previously performed biocompatibility testing for predicate device is still valid as no new patient-contacting parts or materials. |
| Electrical, mechanical and radiation safety | Compliance with ANSI/AAMI ES60601-1, CSA CAN/CSA-C22.2 NO. 60601-1:14, IEC 60601-1-Ed3.1:2012, IEC 60601-1-3-Ed2.1:2013, IEC 60601-2-45-Ed3.1:2015, IEC 62304 Ed1.1:2015, IEC 60601-1-6-Ed3.1:2013, IEC 62366-1_Ed1.0:2015 |
| Electromagnetic compatibility (EMC) | Compliance with IEC 60601-1-2-Ed4:2014. |
| Software Verification and Validation | Conducted according to FDA's guidance, considered "Moderate" level of concern. |
| Risk Management | Updated to include new image processing software (CORE) risks and other identified hazards. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 6 patients particpated in routine breast cancer screening. The clinical evaluation used images from these 6 patients, with some cases also including diagnostic mammograms (spot and/or magnification images).
- Data Provenance: The data was obtained from two sites: one in Belgium and one in Bulgaria. The study appears to be prospective in nature, as images were "taken at one site in Belgium and one site in Bulgaria where altogether 6 patients participated to routine breast cancer screening."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Three
- Qualifications: "MQSA qualified experienced US interpreting physicians independently."
4. Adjudication Method for the Test Set
The document states, "The images were then reviewed by three MQSA qualified experienced US interpreting physicians independently." This indicates that there was no formal adjudication method (e.g., 2+1 or 3+1 consensus) described. Each expert provided an independent assessment, and the aggregate finding (all images rated good or excellent) was reported.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not described in the provided text. The study primarily focused on the standalone performance of the image processing algorithm and its impact on image quality for human interpretation. The clinical image evaluation assessed if the image quality produced by the new software was acceptable for human readers, not whether AI assistance improved human performance.
6. Standalone Performance Study
Yes, a standalone performance evaluation of the new image processing algorithm (CORE) was implicitly performed. While not in the context of a "standalone algorithm" in isolation from the hardware, the "Clinical image evaluation" aimed to determine if the images processed with the new Planmed CORE software algorithm were of "sufficiently acceptable quality for mammographic usage when reviewed by MQSA qualified experienced interpreting physicians." This assesses the algorithm's output quality as a standalone component contributing to the overall system's diagnostic utility. The physical laboratory testing also evaluates the image chain, including the processing, in a standalone manner from actual diagnostic human interpretation.
7. Type of Ground Truth Used
For the clinical image evaluation, the "ground truth" used for assessing image quality was expert consensus on image quality acceptability. The experts rated images as "good" or "excellent," and the overall judgment ("acceptable for all cases and image types") served as the ground truth criterion. The selection of cases with BI-RADS score 1 or 2 suggests that the intent was to evaluate images from non-cancerous breasts (or breasts with benign findings) to assess general image clarity, rather than a diagnostic accuracy study where pathology or outcomes data would be directly compared.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size for a training set for the CORE image processing algorithm. The algorithm is described as "developed by Planmed in-house," but details on its development data (training, validation, testing) are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
As no information is provided about a training set, the method for establishing its ground truth is not described in the document.
§ 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.