(283 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.
Patient-assisted compression (Self-Compression) is an option of the Senographe Pristina Full Field Digital Mammography system. It consists of a handheld wireless remote control to allow patient to adjust the compression force during breast positioning. The remote transmits the compression command to the Senographe Pristina. Senographe Pristina executes the command by raising or lowering the compression paddle, if conditions for motion are met.
Patient-assisted compression is designed to minimize patients perceived pain and discomfort by giving them an active role in the application of compression. The technologist positions the patient and initiates compression. The technologist then guides the patient while she operates the remote to gradually increase compression until she reaches adequate compression.
The provided text describes the Senographe Pristina Full-Field Digital Mammography System and an optional patient-assisted compression feature. However, the text does not contain acceptance criteria or a detailed study that proves the device meets specific performance criteria related to the image quality or diagnostic accuracy of the mammography system itself.
The "Performance Testing" section primarily focuses on the patient-assisted compression option and its impact on image quality compared to technologist-applied compression. It states that patient-assisted compression produced images of similar quality.
Here's an attempt to answer your questions based only on the provided text, acknowledging that many questions cannot be fully answered due to limited information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the mammography device's diagnostic performance (e.g., sensitivity, specificity for cancer detection). The performance testing described is for the patient-assisted compression feature, not the core mammography system's diagnostic ability.
| Acceptance Criteria (for Patient-Assisted Compression) | Reported Device Performance (for Patient-Assisted Compression) |
|---|---|
| Image quality comparable to technologist-applied compression | Patient-assisted compression produced images of similar quality (assessed by MQSA qualified radiologists). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 30 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be prospective as it's a "clinical evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The text states "MQSA qualified radiologists" assessed image quality. It does not specify the number of radiologists or their years of experience.
- Ground Truth for Image Quality: Radiologist assessment of image quality based on criteria set in the "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System." This is an expert opinion/consensus on image quality, not disease presence.
4. Adjudication method for the test set
Not specified. The text only mentions "Image quality was assessed by MQSA qualified radiologists." It does not indicate if multiple radiologists assessed each image and how disagreements were resolved.
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
No. This document does not mention an MRMC study or any AI assistance. The "performance testing" was a clinical evaluation of the patient-assisted compression feature, comparing image quality between two compression methods.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical imaging device, not an algorithm being tested in standalone mode.
7. The type of ground truth used
For the patient-assisted compression clinical evaluation, the "ground truth" was expert assessment/opinion of image quality by MQSA qualified radiologists. It was not pathology, outcomes data, or expert consensus on disease diagnosis.
8. The sample size for the training set
Not applicable/mentioned. The document describes a medical device, not a machine learning algorithm that requires a training set in the typical sense. If the "design and test" phase involved iterative development, the "training" would be part of the engineering and testing process rather than a distinct dataset for an algorithm.
9. How the ground truth for the training set was established
Not applicable/mentioned. See answer to question 8.
§ 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.