(424 days)
The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.
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.
Here's a breakdown of the acceptance criteria and study information for the Planmed Clarity 2D and Clarity S device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance (Subject Device) |
|---|---|---|
| System Performance | Sensitometric Response | Responds linearly to radiation exposure |
| Spatial Resolution (MTF) | Performs similarly to predicate | |
| Noise Analysis | Slightly better noise performance | |
| SNR | Slightly higher | |
| CNR | Slightly higher | |
| Dynamic Range | Higher DQE than predicate | |
| Repeated Exposures | Ghost tolerance similar | |
| AEC Performance (Organ Dose) | 1.23 mGy (for 40mm PMMA, W/Ag beam) | |
| Patient Radiation Dose | Within generally acceptable limits | |
| RMI Phantom Scores | Similar for all attributes | |
| CDMAM Test | Passes | |
| Image Quality | Acceptable for Mammographic Usage | All images rated good or excellent by MQSA radiologists |
Study Information
2. Sample Size and Data Provenance for Test Set:
- Sample Size: 6 patients
- Data Provenance: One site in Bulgaria. The cases selected also included diagnostic mammograms (spot and/or magnification images) in addition to routine screening images (BI-RADS score 1 or 2).
- Retrospective/Prospective: The text does not explicitly state if the study was retrospective or prospective. Given that "6 patients participated to routine breast cancer screening" and images were then selected for evaluation, it suggests a prospective acquisition for the purpose of the study.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
- Number of Experts: Two
- Qualifications: MQSA qualified experienced US radiologists.
4. Adjudication Method for Test Set:
- Method: The two MQSA qualified experienced US radiologists reviewed the images independently. There is no mention of a formal adjudication process (like 2+1 or 3+1) if their independent ratings differed. The statement "All images were rated good or excellent" suggests they either agreed or the individual assessments were sufficient.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No, a formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not performed as described in the provided text. The study focused on physician perception of image quality from the new device rather than reader performance with AI.
6. Standalone (Algorithm Only) Performance Study:
- Was it done?: No, a standalone algorithm-only performance study was not described. The evaluation focused on the overall system's image quality as reviewed by human experts.
7. Type of Ground Truth Used (Test Set):
- Type: The ground truth for the clinical image evaluation was based on expert consensus/review by two MQSA qualified experienced US radiologists, who rated the images as "good or excellent" for mammographic usage. The images themselves were selected based on BI-RADS scores 1 or 2 (indicating negative or benign findings), and some diagnostic mammograms.
8. Sample Size for Training Set:
- The provided text does not mention a training set or any machine learning/AI components requiring a training set. The descriptions relate to the hardware and software of a digital mammography system and its image quality validation.
9. How Ground Truth for Training Set was Established:
- Not applicable, as no training set for a machine learning model is mentioned.
§ 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.