(37 days)
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.
The MicroDose SI (model L50) 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 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 MicroDose SI (model L50) 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 MicroDose SI (model L50) 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 MicroDose SI (model L50) 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 changes compared to the L30 model involves a minor modification to the collimator, such that the range of breast thickness that can be imaged on the device is slightly expanded.
The provided 510(k) summary for the PHILIPS MicroDose SI (model L50) does not contain a detailed study proving device performance against specific acceptance criteria. This document focuses on demonstrating substantial equivalence to a predicate device (Philips MicroDose L30) rather than presenting a performance study with acceptance criteria.
However, based on the information provided, we can infer some aspects and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred/Missing) | Reported Device Performance (Inferred from document) |
|---|---|---|
| Intended Use | Device can generate mammographic images for screening and diagnosis of breast cancer, usable in the same clinical applications as traditional film/screen systems. | Device's intended use is identical to the predicate device (MicroDose L30): "indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems." |
| Technical Equivalence | Minor modifications (collimator change for expanded breast thickness range) do not negatively impact fundamental technology or performance. | "The MicroDose SI (model L50) is based on the same fundamental technology as the predicate L30 model and there is no change in intended use." |
| "The configuration of silicon strip detectors for converting the X-ray quanta to electrical pulses is identical for the two models and there are merely slight modifications to the pulse counting electronics." | ||
| "modifications to the device...are minor in nature and are well characterized by the design control process and the physical laboratory test results showing the comparative performance of the modified device to the predicate device." | ||
| Safety and Effectiveness | (Specific performance metrics like image quality, diagnostic accuracy, dose reduction relative to predicate) - MISSING | "The equivalence in performance is supported through the performed verification and validation activities." (No specific data provided in this document). |
| The predicate device (L30) had a cleared claim for "quantitative reduced dose." While not explicitly stated for L50, the document implies this characteristic is maintained. | ||
| Regulatory Compliance | Meets all applicable general controls for Class II devices. | FDA found the device substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document states "The equivalence in performance is supported through the performed verification and validation activities" and "physical laboratory test results," but it does not detail the nature, sample size, or provenance of these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given 510(k) summary. Given the focus on technical equivalence through minor modifications, it's possible that clinical ground truth establishment with expert readers was not deemed necessary for this specific submission, relying instead on the predicate's prior approvals.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence based on technical characteristics and minor modifications, not on a direct comparison of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study of the algorithm is not discussed in the provided 510(k) summary. The device is a "Full-Field Digital Mammography X-ray System," implying it generates images for human interpretation, not an AI-only diagnostic tool.
7. Type of Ground Truth Used
The specific type of ground truth used for any "verification and validation activities" related to the L50's performance is not explicitly stated in this document. Given that it's an imaging device for breast cancer screening and diagnosis, typical ground truth would involve pathology reports or long-term follow-up for cancer detection, often assessed by expert consensus on image interpretation. However, this is not detailed here.
8. Sample Size for the Training Set
The provided 510(k) summary describes a physical imaging device, not an AI algorithm that requires a training set. Therefore, this information is not applicable in the context of this specific submission.
9. How the Ground Truth for the Training Set Was Established
Since the device itself is not an AI algorithm with a training set, this information is not applicable.
Summary of Missing Information:
This 510(k) summary is for a hardware device (mammography system) that has undergone minor modifications compared to a cleared predicate. As such, it primarily focuses on demonstrating technical equivalence and that the changes do not introduce new safety or effectiveness concerns.
It does not provide details about:
- Specific quantitative performance acceptance criteria (e.g., image quality metrics, diagnostic accuracy).
- Clinical study designs (sample sizes, provenance, expert qualifications, adjudication methods).
- AI algorithm training or testing data (as it's not an AI diagnostic device).
- MRMC studies.
The "study" mentioned vaguely as "verification and validation activities" and "physical laboratory test results" is implied to support the claim of equivalence, but no specifics are provided in this regulatory document.
§ 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.