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.

Device Description

This application is to add functionality to the previously cleared MicroDose SI, Model L50, (K123995) that allows for breast density measurements. The L50 submission described that the detector electronics have been modified to do spectral imaging through the functionality to discriminate between high and low energy photons based on an energy threshold. The first application of this technology is Spectral Breast Density Measurement where breast glandularity and thickness is measured simultaneously by the spectral difference in X-ray attenuation between adipose and fibroglandular tissue. The MicroDose'Sl can thereby measure volumetric glandularity and breast thickness for each pixel in the image. Total breast volume is calculated by integrating the breast thickness over the breast region. taking pixel size and beam geometry into account. Fibroglandular thickness is calculated as the product of breast thickness and volumetric glandularity for each pixel. Total fibroglandular volume is then calculated by integrating the fibroglandular thickness over the breast region. The total breast volumetric glandularity is then given as the ratio of fibroglandular to breast volume. The correlation between the MicroDose Density Score and the radiologist's BI-RADS score has The following Information is sent as part of the content of a DICOM Structured Report, SR, to selected destinations (for example a PACS). Breast analysis information is also included as private attributes in the DICOM header of the acquired images.

AI/ML Overview

The Philips MicroDose SI (model L50) is an add-on functionality to a previously cleared full-field digital mammography (FFDM) system that allows for breast density measurements. The device measures volumetric glandularity, glandular volume, breast volume, and provides a breast density score correlated to BI-RADS categories.

Here's an analysis of its acceptance criteria and the study performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MicroDose SI Breast Density Measurement application were established by evaluating its parameters against industry standard breast tissue equivalent phantoms and a substantial clinical screening population dataset. The exact quantitative acceptance criteria (e.g., specific thresholds for correlation coefficients or agreement percentages) are not explicitly stated in the provided text. However, the study aimed to confirm several aspects:

Acceptance Criteria Category/Metric	Reported Device Performance (as indicated by the study)
Agreement with Radiologist's BI-RADS Score	Correlation between MicroDose Density Score and radiologist's BI-RADS breast composition score was evaluated and confirmed for a screening population.
Consistency across Views (CC & MLO) and Laterality (Left & Right)	Correlation between MicroDose Breast Density Measurements in CC and MLO views and left and right laterality was evaluated and confirmed to show consistent results.
Expected Decrease of Volumetric Glandularity with Age	Correlation between volumetric glandularity and age was evaluated and confirmed to show the expected decrease with age.
Expected Decrease of Volumetric Glandularity with Breast Volume	Correlation between volumetric glandularity and breast volume was evaluated and confirmed to show the expected decrease with volume.
Expected Increase of Volumetric Glandularity with BI-RADS Score	Correlation between volumetric glandularity and BI-RADS breast composition score was evaluated and confirmed to show the expected increase with BI-RADS score.
Comparison to Industry Standard Phantoms	Comparisons of MicroDose Breast Density Measurement parameters to industry standard breast tissue equivalent phantoms were performed. (Specific results not detailed).
Integration into Clinical Workflow	Validation that the Breast Density Measurement application can be easily incorporated into the clinical workflow of radiologists. (Specific results not detailed).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: "a substantial clinical screening population dataset"
Data Provenance: The document does not explicitly state the country of origin. It mentions "a substantial clinical screening population dataset," implying real-world clinical data. It is a retrospective study based on an existing dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated, but "MQSA qualified radiologists" were involved.
Qualifications of Experts: "MQSA qualified radiologists." MQSA (Mammography Quality Standards Act) qualification ensures radiologists are trained and certified to interpret mammograms in the United States.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It states "the BI-RADS breast composition score given by MQSA qualified radiologists," implying that the radiologists' scores were used as a reference for comparison, but doesn't detail how discrepancies among multiple radiologists would have been resolved if applicable.

5. Multi-Reader-Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, a traditional MRMC comparative effectiveness study, which typically evaluates human readers with and without AI assistance, was not explicitly described. The study focused on the correlation between the device's density scores and radiologists' BI-RADS scores, as well as internal consistency and expected biological correlations, rather than the improvement of human reader performance with AI assistance.
Effect size of human reader improvement: Not applicable, as an MRMC comparitive effectiveness study with human-in-the-loop performance measurement was not described.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, a standalone performance assessment was conducted. The MicroDose SI L50 Breast Density Measurement application's ability to measure and output volumetric glandularity, glandular volume, breast volume, and a breast density score is an inherent standalone function. The study evaluated these independent measurements against:

Industry standard breast tissue equivalent phantoms.
Correlation with radiologists' BI-RADS scores.
Internal consistency (across views, laterality).
Expected biological correlations (with age, breast volume).

7. Type of Ground Truth Used

The ground truth for the clinical correlation aspects of the test set was:

Expert Consensus: Specifically, "the BI-RADS breast composition score given by MQSA qualified radiologists." This implies expert interpretation of the mammograms.
Physiological/Biological Correlates: Age and breast volume were used to confirm expected biological relationships with volumetric glandularity.
Physical Phantoms: Used to validate density measurements against known standards.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions "a substantial clinical screening population dataset" for the evaluation (test set), but does not distinguish this from a training set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for any potential training set was established. The focus of the provided text is on the validation activities of the developed application.

Summary

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DEC 1 3 2013

K130704
Page 1 of 4

510(k) Summary (21 CFR 807.92)

A. SUBMITTER INFORMATION

Submitter's name	Philips Digital Mammography Sweden AB
Address	Smidesvägen 5
	SE-171 41 Solna
	Sweden
Establishment registration number	3009307584
Contact person	Mr. Gustav Lins
Telephone	+46-8-623 52 00
FAX	+46-8-623 52 01
Title	Manager Regulatory Affairs
Date of the summary preparation	2013-10-09

B. DEVICE IDENTIFICATION

Device trade name	MicroDose SI (model L50)
Device common name	Full-Field Digital Mammography X-ray System
Classification name	Full-Field Digital Mammography X-ray System
Classification product code	MUE, LLZ (secondary)
Device class	II
Regulation code	21 CFR 892.1715, 21 CFR 892.2050 (secondary)

C. DEVICE DESCRIPTION

This application is to add functionality to the previously cleared MicroDose SI, Model L50, (K123995) that allows for breast density measurements.

The L50 submission described that the detector electronics have been modified to do spectral imaging through the functionality to discriminate between high and low energy photons based on an energy threshold. The first application of this technology is Spectral Breast Density Measurement where breast glandularity and thickness is measured simultaneously by the spectral difference in X-ray attenuation between adipose and fibroglandular tissue. The MicroDose'Sl can thereby measure volumetric glandularity and breast thickness for each pixel in the image. Total breast volume is calculated by integrating the breast thickness over the breast region. taking pixel size and beam geometry into account. Fibroglandular thickness is calculated as the product of breast thickness and volumetric glandularity for each pixel. Total fibroglandular volume is then calculated by integrating the fibroglandular thickness over the breast region. The total breast volumetric glandularity is then given as the ratio of fibroglandular to breast volume. The correlation between the MicroDose Density Score and the radiologist's BI-RADS score has The following Information is sent as part of the content of a DICOM Structured Report, SR, to selected destinations (for example a PACS). Breast analysis information is also included as private attributes in the DICOM header of the acquired images.

Volumetric glandularity (%) �
Glandular volume (cm3) ●

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Breast volume (cm³) .
Breast density score (I, III, III, IV). The density score correlates to the BI-RADS categories. .

D. indications for use

E. SUBSTANTIAL EQUIVALANCE

The subject device is identical to the MicroDose SI (model L50) in regards to FFDM characteristics. Furthermore, with regards to the applications described in this submission, it is substantially equivalent to the software predicates Volpara and Quantra.

	MicroDose SI (modelL50)	MicroDose SI (modelL50)	VolparaK102556	QuantraK120472
	Subject device	K123995Predicate	Predicate	Predicate
Manufacturer	Philips DigitalMammographySweden AB	Philips DigitalMammographySweden AB	Matakina Technology Limited	Hologic, Inc.
Indication ForUse	The MicroDose SI(model L50) isindicated forgeneratingmammographicimages that can beused for screeningand diagnosis ofbreast cancer.	The MicroDose SI(model L50) isindicated forgeneratingmammographicimages that can beused for screeningand diagnosis ofbreast cancer.	Volpara is a software applicationintended for use with digitalmammography systems. Volparacalculates volumentric breastdensity as a ratio offibroglandular tissue and totalbreast volume estimates.Volpara provides these numericalvalues for each image to aidradiologists in the assessment ofbreast tissue composition.Volpara produces adjunctiveinformation. It is not aninterpretive or diagnostic aid.Volpara is a software applicationwhich runs on Windows or Linux-based computers.	QuantraTM is a softwareapplication intended for use withimages acquired using digitalbreast X-ray systems. Quantracalculates volumetric breastdensity as a ratio offibroglandular tissue area andtotal breast area estimates. Itsegregates breast density into BI-RADS-like breast compositioncategories, which may be usefulin the reporting of consistentbreast composition values foreach image, breast and subject,to aid radiologists in theassessment of breast tissuecomposition. Quantra producesadjunctive information, it is notan interpretive or diagnostic aid.Quantra runs on a Windowsplatform.
DeviceClassificationName	Full field digital,System, X-ray,Mammographic	Full field digital,System, X-ray,Mammographic	System, Image Processing,Radiological	System, Image Processing,Radiological
Device Class	II	II	II	II
Detectortechnology	Photon countingCrystalline siliconstrip detectorsRejection ofelectronic noise24 x 26 cm imagingarea	Photon countingCrystalline siliconstrip detectorsRejection ofelectronic noise24 x 26 cm imagingarea	N/A	N/A
ImageEvaluationSource	DigitalMammographyImages	Digital Mammography Images	Digital Mammography Images	Digital Mammography Images
AnatomicalAssessmentArea	Breast	Breast	Breast	Breast

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	MicroDose Si (model L50)Subject device	MicroDose Si (model L50)K123995Predicate	VolparaK102556Predicate	QuantraK120472Predicate
Assessmentoutput	Glandular volume (cm³)(volume of fibroglandular tissue)	N/A	Volume of fibroglandular tissue	Volume of fibroglandular tissue;
	Volumetric glandularity (%)(volumetric breast density)		Volumetric breast density	Volumetric breast density
	Breast volume (cm³)		Breast volume	Area breast density measure
	Breast density score (I, II, III, IV). The density score correlates to the Bi-RADS categories.			BI-RADS like breast composition measure
Image storageand reportgeneration	DICOM Structured report to send to PACS		Output to console	DICOM Structured report to send to PACS

E. PERFORMANCE/BENCH TESTING

The MicroDose SI L50 Breast Density Measurement application has been developed in accordance with Philips Digital Mammography Sweden AB's product development process. It has been verified and validated in accordance with the company's design control process. The design control process is divided into several levels of verification, unit, integration and system level. The results from the performance testing have been included in the application.

The bench testing and clinical validation of the MicroDose SI included:

Comparisons of MicroDose Breast Density Measurement parameters to industry standard . breast tissue equivalent phantoms;
. Validation that the Breast Density Measurement application can be easily incorporated into the clinical workflow of the radiologists;
. Based on a substantial clinical screening population dataset:
- The agreement between the MicroDose Density score and the BI-RADS breast 0 composition score given by MQSA qualified radiologists was evaluated for a screening population;
- Evaluation of the correlation between MicroDose Breast Density Measurements in o CC and MLO views and left and right laterality to confirm consistent results;
- Evaluation of the correlation between volumetric glandularity and age to confirm o the expected decrease with age;
- o Evaluation of the correlation between volumetric glandularity and breast volume to confirm the expected decrease with volume;
- Evaluation of the correlation between volumetric glandularity and BI-RADS breast O composition score to confirm the expected increase with BI-RADS score.

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K130704
page 4 of 4

The verification and validation activities confirm that the established acceptance criteria were met.

G. CONCLUSION

The breast density measurement functionality that is the subject of this application relies on the technology of a FFDM device which has already been cleared by the FDA (MicroDose SI, K123995). Breast density assessments have previously been introduced by Quantra (K120472) and Volpara (K102556). These devices provide information that is very similar to that generated by the MicroDose SI (Model L50), and are intended for the same purpose, i.e. to generate adjunctive information regarding breast density. Like the breast density functionality of the predicate devices Volpara and Quantra, the MicroDose Breast Density Measurement aids the clinician in the assessment of breast tissue composition. The Breast Density Measurement functionality is well characterized by the design control process and the physical laboratory tests show results that are comparative to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

December 13, 2013

PHILIPS DIGITAL MAMMOGRAPHY SWEDEN AB GUSTAV LINS MANAGER REGULATORY AFFAIRS SMIDESVAGEN 5, SOLNA, SW SE-171 41 SWEDEN

Re: K130704

Trade/Device Name: MicroDose SI Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE, LLZ Dated: October 29, 2013 Received: October 31, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mr. Lins

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR-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/McdicalDevices/Safety/ReportaProblem/dcfault.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.ida.gov/MedicalDevices/Resources/orYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K130704

Device Name

MicroDose SI (Model L50)

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Michael D. O'Hara
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FORM FDA 3881 (9/13)	Page 1 of 2
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ORM FUA 3681 (8/13)

178 Publisher Ser sam 1 100 : 441-4741 141-4741 EF

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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.