(115 days)
The Sectra MicroDose Mammography L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Sectra MicroDose Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.
The Sectra MicroDose Mammography L30 is a type of full-field digital mammography system comprised of an image acquisition system, a gantry and an acquisition workstation computer equipped with a keyboard, a keypad, a mouse, and a monitor. The image acquisition system includes a digital detector of photon counting technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression paddle(s), and multi-slit collimator. The acquisition workstation is the user interface for preparing and initiating image acquisition, image processing, and image transfer to the desired destination (e.g. PACS) for diagnosis and archiving.
The Sectra MicroDose Mammography 130 detector is based on photon counting technology and consists of a large number of crystalline silicon strip detectors. The technology enables high detection efficiency of photons and efficient rejection of electronic noise. The Sectra MicroDose Mammography L30 uses a multi-slit scanning technique that prevents image degradation caused by scattered radiation by removing photons scattered in the breast and not directed towards the detector. These factors combine into a dose efficient system.
The Sectra MicroDose Mammography L30 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC. SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.
This 510(k) premarket notification describes the Sectra MicroDose Mammography L30, a full-field digital mammography system. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and non-clinical performance data, rather than specific acceptance criteria from a clinical study for an AI-powered device. Therefore, a direct table of acceptance criteria and reported device performance related to AI is not available in the provided text.
Based on the provided information, I can extract the following relevant details that loosely align with your request regarding how the device meets acceptance criteria, though it's important to note this is not an AI device and the evaluation process differs significantly from what you might expect for AI-driven systems:
1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing and Predicate Comparison):
| Acceptance Criteria (inferred from predicate comparison) | Reported Device Performance (Sectra MicroDose Mammography L30) |
|---|---|
| Sensitometric Response (related to image density/contrast) | Performed as well as or better than predicate devices. |
| Spatial Resolution (related to image sharpness/detail) | Performed as well as or better than predicate devices. |
| Noise Analysis (related to image clarity/graininess) | Performed as well as or better than predicate devices. |
| Signal-to-Noise Ratio Transfer – DQE (related to image quality efficiency) | Performed as well as or better than predicate devices. |
| Dynamic Range (related to ability to capture a wide range of x-ray intensities) | Performed as well as or better than predicate devices. |
| Automatic Exposure Control Performance (related to consistent image quality) | Performed as well as or better than predicate devices. |
| Phantom Testing (general image quality assessment using standardized objects) | Performed as well as or better than predicate devices. |
| Patient Radiation Dose (safety criteria) | Performed as well as or better than predicate devices. |
| Image Erasure, Fading, and Repeated Exposure (image stability) | Performed as well as or better than predicate devices. |
| Clinical Mammographic Usage Quality (overall image acceptability for diagnosis) | Images were of sufficiently acceptable quality. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of images or patients for clinical testing using a test set. The document refers to "Performance data from non-clinical testing," which typically involves phantoms and laboratory measurements, not patient images in a "test set" in the context of AI evaluation.
- Data Provenance: The non-clinical testing was performed in line with generally accepted test methods (e.g., IEC standards). No specific country of origin for a clinical test set is mentioned because a clinical test set for performance comparison was not detailed. This was a 510(k) submission based on technical equivalence and non-clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable in the context of this 510(k) submission. The evaluation was based on non-clinical performance data compared to predicate devices, and an "image attribute evaluation" was conducted, but the number and qualifications of experts establishing a "ground truth" for a test set (as would be done for an AI model) are not provided. The image attribute evaluation "concluded that the images were of sufficiently acceptable quality for clinical mammographic usage," implying expert review, but details are absent.
4. Adjudication Method for the Test Set:
- Not applicable. No formal adjudication method for a clinical "test set" is described for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described. This device is a mammography system (hardware and basic processing), not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a mammography imaging system, not a standalone AI algorithm. Its performance is inherent in the image acquisition and primary processing, not as an independent diagnostic algorithm.
7. Type of Ground Truth Used:
- For the non-clinical performance evaluation, the "ground truth" was established by comparison against established standards and predicate device performance. For the "image attribute evaluation," the ground truth was expert consensus on the acceptability of image quality for clinical mammographic usage, as per the FDA Guidance for Industry and FDA Staff. No pathology or outcomes data are mentioned for this particular evaluation of the system's image quality.
8. Sample Size for the Training Set:
- Not applicable. This device is a hardware system with integrated image acquisition and processing. There is no concept of a "training set" in the context of how this device was evaluated for its 510(k) submission.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
Summary of the Study:
The study described is primarily a technical comparison and non-clinical performance evaluation to demonstrate substantial equivalence of the Sectra MicroDose Mammography L30 system to two legally marketed predicate devices (FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE and SENOGRAPHE 2000D).
- Study Design: The manufacturer performed non-clinical testing covering various image quality and dose parameters (sensitometric response, spatial resolution, noise analysis, DQE, dynamic range, AEC performance, phantom testing, patient radiation dose, image stability). The results of these tests were then compared to the data available from the PMA Summaries of Safety and Effectiveness of the predicate devices.
- Evaluation Standard: The testing was done "in accordance with generally accepted test methods, e.g. using IEC standards, published factors for dose calculations etc." An "image attribute evaluation" was also conducted as per the "Class II Special Controls Guidance Document: Full-Field Digital Mammography System," concluding the images were of "sufficiently acceptable quality for clinical mammographic usage."
- Conclusion of the Study: The study concluded that the Sectra MicroDose Mammography L30 device performed "as well as or better than the predicate devices in all relevant areas" and that the technical differences did not raise new questions of safety and effectiveness, thus demonstrating substantial equivalence.
§ 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.