(447 days)
Helianthus is intended to produce two dimensional digital mammographic images of the breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy.
Helianthus is a mammography solution composed of equipment and software for different examination types and optimized for digital imaging.
Helianthus is a digital mammography system also called full-field digital mammography (FFDM) system. It is an integrated system that includes both the X-ray delivery system and integrated detector. It consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. The image receptor system consists of a built-in full-filed solid state detector, acquisition software, acquisition work station (AWS), and accessories. It includes an optional stereotactic biopsy device (BYM 3D DMD) with its respective Operator's Manual.
Helianthus is intended to produce two-dimensional digital mammographic images of the breast for diagnosis of breast cancer. Its intended use is for diagnosis, screening, or for needle localization in case of stereotactic biopsy
Based on the provided text, the document describes the substantial equivalence determination for the Helianthus full-field digital mammography system, comparing it to the predicate device, Planmed Clarity. However, the text does not contain detailed information about acceptance criteria or a specific study proving the device meets these criteria in the format requested.
The document states that:
- Non-Clinical Performance Data (Section 9) demonstrates that "Results confirm that the design inputs and performance specifications for the device are met." This section lists various tests (e.g., electrical safety, software verification, imaging characteristics through physical laboratory testing).
- Clinical Performance Data (Section 10) states: "A clinical image evaluation as required by the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full-Field Digital Mammography System issued on April 4, 2012 (Section 9 Clinical Image Evaluation) was conducted with the Helianthus and determined that the images, reviewed by expert radiologists, were of sufficiently acceptable quality for mammographic usage and that the images are substantially equivalent to those from a predicate device."
Therefore, the full details required to populate all fields of your request (e.g., specific acceptance criteria values, sample sizes for test/training sets, exact number and qualifications of experts, adjudication methods, MRMC study details, types of ground truth) are NOT present in the provided text.
Below, I will fill in what can be inferred or explicitly stated from the provided text, and clearly mark where information is not provided.
Acceptance Criteria and Device Performance (Inferred/Stated from Text)
| Acceptance Criteria Category | Acceptance Criteria (Specific Values) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | ||
| Biocompatibility (Breast Support Material) | Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-5 (Irritation), ISO 10993-10 (Sensitization) | Passed all specified ISO 10993 tests. |
| Biocompatibility (Compression Paddles) | Compliance with ISO 10993-5 (Cytotoxicity), ISO 10993-5 (Irritation), ISO 10993-10 (Sensitization); Demonstrated chemical stability | Passed all specified ISO 10993 tests; Demonstrated chemical stability. |
| Electrical Safety | Compliance with IEC 60601-1 | Passed. |
| Electromagnetic Disturbance (EMD) | Compliance with IEC 60601-1-2 | Passed. |
| Photobiological Safety | Compliance with IEC 62471 | Passed. |
| Software Verification & Validation | Compliance with IEC 62304 / FDA Guidance; Software system met its specification and fulfilled its purpose. | Software system met its specification and fulfilled its purpose. |
| Imaging Characteristics (Physical Lab) | As required by FDA Guidance (April 4, 2012, Section 8): Sensitometric response, spatial resolution, noise analysis, DQE, dynamic range, image erasure and fading, repeated exposure test, Automatic Exposure Control performance, phantom testing, patient radiation dose, breast compression system. Specific quantitative acceptance values are not provided in this text. | Performed as intended and established to be substantially equivalent in terms of safety and effectiveness to the predicate device. |
| Stereotactic Biopsy Device Accuracy | Compliance with IEC 60601-2-45 (Positioning accuracy of the biopsy needle) | Passed. |
| Mechanical/Environmental Testing | Compliance with EN 60721-3-2 (Vibrations, shock, fall) for mammography unit and accessories, AWS Monitor (ISTA 1A), and detectors. | Demonstrated package integrity maintained for all tested components (mammography unit/accessories, AWS Monitor, detectors). |
| Clinical Performance | ||
| Image Quality - Mammographic Usage | Images determined to be "sufficiently acceptable quality for mammographic usage" and "substantially equivalent to those from a predicate device" (per FDA Guidance, April 4, 2012, Section 9) | Images, reviewed by expert radiologists, were of sufficiently acceptable quality for mammographic usage and were substantially equivalent to those from a predicate device. |
Study Details:
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A table of acceptance criteria and the reported device performance: Included above. (Note: Specific quantitative values for imaging acceptance criteria are not provided, only that they were assessed per FDA guidance and found equivalent.)
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided. The text only states "A clinical image evaluation... was conducted."
- Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided. The text states "images, reviewed by expert radiologists."
- Qualifications: "expert radiologists" - Further specific qualifications (e.g., years of experience, subspecialty) are not provided.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided. The text only states images were "reviewed by expert radiologists."
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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: Not applicable / Not provided. The document describes a traditional 510(k) for a Full-Field Digital Mammography System (the imaging device itself), not an AI-assisted interpretation or CAD device. The clinical study was to demonstrate image quality equivalence rather than reader performance with/without AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an FFDM system, meaning it produces images for human interpretation, not an algorithm that performs diagnosis standalone. The physical laboratory tests (Section 9) could be considered "standalone" evaluation of the system's technical image quality parameters.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For clinical image evaluation, the ground truth for acceptability and equivalence was based on the review by expert radiologists. The text implies a subjective assessment of image quality for mammographic usage and comparison to the predicate. It does not mention pathology or outcomes data as "ground truth" for the image evaluation itself, though such data would underpin the overall purpose of mammography.
- For non-clinical performance tests, the ground truth was based on compliance with established international standards (e.g., ISO, IEC) and internal requirements.
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The sample size for the training set: Not applicable/Not provided. This device is a traditional imaging system, not an AI model requiring a "training set" in the machine learning sense. The testing (non-clinical and clinical) is for verification and validation.
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How the ground truth for the training set was established: Not applicable. As above, there's no mention of a "training set" for an AI model.
§ 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.