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.

Device Description

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.

AI/ML Overview

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:

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.
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."
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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).
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.
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).
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.
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.

Summary

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120255

510(k) Summary (21 CFR 807.92)

APR 1 9 2012

A. SUBMITTER INFORMATION

· Philips Digital Mammography Sweden AB Submitter's name Address Smidesvägen 5 SE-171 41 Solna Sweden Establishment registration 3009307584 number Contact person Gustav Lins Telephone +46-8-623 52 00 FAX +46-8-623 52 01 Title Manager Regulatory Affairs Date of the summary preparation 2012-01-24

B. DEVICE IDENTIFICATION

Device trade name Device common name Classification name Classification product code Device class Regulation code

Philips MicroDose L30 Full-Field Digital Mammography X-ray System Full-Field Digital Mammography X-ray System MUE = 21 CFR 892.1715

C. DEVICE DESCRIPTION

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.

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D. INDICATIONS FOR USE

E. PREDICATE DEVICE

	Predicate device
Device ClassificationName	Full Field Digital, System, X-ray,Mammographic
510(k) Number	K110025
Device Name	Sectra MicroDose Mammography
Model	L30
Applicant	Sectra Imtec AB
Product Code	MUE
Advisory Committee	Radiology

E TECHNICAL CHARACTERISTICS

As described in K110025, the Philips MicroDose L30 System employs photon counting technology; x-ray photons are captured in the detector and ultimately converted to an electrical signal, forming a digital image. All system components, hardware, and system features of the subject device are identical to the predicate MicroDose System. This 510(k) premarket notification is to obtain FDA clearance for the quantitative reduced dose claim for the MicroDose system based on the supporting clinical data. There is no change in the indications for use of the MicroDose system. The principle of operations of the MicroDose system is not affected, since there is no change to the device including image acquisition, X-ray generation, user interface, etc.

As described in the original 510(k), K110025, performance data from non-clinical testing of the Sectra MicroDose Mammography L30 covering Sensitometric response, Spatial resolution, Noise analysis. Signal-to-noise-ratio transfer - DQE. Dynamic range, Automatic exposure control performance, Phantom testing, Patient radiation dose was compared with data from the predicate devices. This comparison showed that the Sectra MicroDose Mammography L30 device performed as well as or better than the predicate devices in all relevant areas. The testing was performed in accordance with generally accepted test methods, e.g. using IEC standards, published factors for dose calculations etc. In addition, clinical evidence including published studies on various national mammography screening programs demonstrated consistent levels of dose reduction with the use of the MicroDose system compared to other FFDM and film screen systems.

G. CONCLUSION

The Philips MicroDose L30 described in this submission is substantially equivalent to the predicate device in indication for use, principle of operation, technology and materials. Performance data demonstrate that the devices are substantially equivalent.

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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Gustav Lins Manager Regulatory Affairs Philips Digital Mammography Sweden AB Smidesvagen 5 SE-171 41 SOLNA SWEDEN

Re: K120255

Trade/Device Name: Philips MicroDose L30 Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: January 24, 2012 Received: January 27, 2012

APR 1 9 2012

Dear Mr. Lins:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28. 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K |2025

Device Name:

Philips MicroDose L30

Indications for Use:

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K120255
510K

Page 4-1

Regulation Number and Section

§ 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.