(83 days)
The Philips MicroDose L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Philips MicroDose L30 is intended to be used in the same clinical applications as traditional film/screen systems.
The Philips MicroDose L30 is a 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 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 Philips MicroDose L30 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 Philips MicroDose 130 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 Philips MicroDose 130 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.
The provided document (K120255) describes a 510(k) premarket notification for the Philips MicroDose L30 Full-Field Digital Mammography X-ray System. This submission focuses on obtaining clearance for a quantitative reduced dose claim for the MicroDose system based on supporting clinical data, as the device itself (including its indications for use and core technology) is substantially equivalent to a previously cleared predicate device (Sectra MicroDose Mammography L30, K110025).
Therefore, the document does not contain details about acceptance criteria or a study proving the device meets those criteria in the context of typical diagnostic performance (e.g., sensitivity, specificity, AUC for cancer detection). Instead, it refers to the original 510(k) (K110025) for performance data and highlights that the current submission is about the reduced dose claim.
However, based on the information provided, we can infer some aspects and acknowledge what is missing.
Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and explicitly stating when information is not provided:
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A table of acceptance criteria and the reported device performance
- Not explicitly provided in the context of diagnostic accuracy for cancer detection for this specific submission (K120255).
- The document states that the original 510(k) (K110025) for the Sectra MicroDose Mammography L30 did contain performance data from non-clinical testing. This included:
- Sensitometric response
- Spatial resolution
- Noise analysis
- Signal-to-noise-ratio transfer - DQE
- Dynamic range
- Automatic exposure control performance
- Phantom testing
- Patient radiation dose
- The predicate device demonstrated that it "performed as well as or better than the predicate devices in all relevant areas" for these technical parameters.
- For the reduced dose claim in K120255, the acceptance criteria would implicitly be related to demonstrating a reduction in patient radiation dose while maintaining image quality sufficient for the stated indications. The document mentions "consistent levels of dose reduction with the use of the MicroDose system compared to other FFDM and film screen systems" based on published studies. Specific numerical acceptance criteria for this dose reduction are not provided.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- For the original device performance (K110025) referred to, the document mentions "clinical evidence including published studies on various national mammography screening programs." This suggests prospective or retrospective data from real-world screening programs, but specific sample sizes, countries of origin, or detailed study designs are not provided in this document.
- For the reduced dose claim in K120255, no specific test set or study details like sample size or provenance are provided, beyond the general reference to "supporting clinical data" and "published studies."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. This information would typically be detailed in a clinical study report, which is not part of this summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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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 provided. This device is a digital mammography X-ray system, not an AI software for interpretation assistance. Therefore, an MRMC study comparing human readers with and without AI assistance is generally not applicable to this type of device itself. The clinical evidence referenced concerned the performance of the system for dose reduction and image quality (in K110025).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware device (X-ray system), not an algorithm for image interpretation. Its performance is evaluated on its ability to produce images, which are then interpreted by human readers.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided for the referenced "published studies" or previous clearance. For mammography screening, ground truth often involves a combination of imaging follow-up, biopsy/pathology results, and expert consensus (e.g., radiologists' final assessments over time).
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The sample size for the training set
- Not applicable/Not provided. This refers to a hardware system, not a machine learning algorithm that requires a training set. The system itself is "trained" through engineering and calibration processes, not data sets in the AI sense.
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How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).
Summary of what's described in the document:
The Philips MicroDose L30 obtained clearance through a 510(k) submission, asserting substantial equivalence to the Sectra MicroDose Mammography L30 (K110025). The current submission (K120255) specifically sought clearance for a quantitative reduced dose claim.
- Acceptance Criteria & Performance: For the initial device (K110025), non-clinical test data (sensitometric response, spatial resolution, noise, DQE, dynamic range, AEC performance, phantom testing, patient radiation dose) showed performance "as well as or better than the predicate devices." For the reduced dose claim, the device demonstrated "consistent levels of dose reduction" in comparison to other FFDM and film-screen systems, as supported by "published studies on various national mammography screening programs." The specific numerical acceptance criteria for this dose reduction are not detailed in this summary.
- Study Type: The evidence for the reduced dose claim comes from "supporting clinical data" and "published studies," indicating these were likely clinical evaluations focused on demonstrating dose reduction while maintaining diagnostic image quality. Details on these studies (e.g., sample size, provenance, ground truth, expert involvement) are not provided in this 510(k) summary.
- The device is a Full-Field Digital Mammography X-ray System, not an AI-powered diagnostic tool, so many questions regarding AI-specific evaluations (MRMC, standalone algorithm, training sets) are not applicable.
§ 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.