The Sectra MicroDose Mammography L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Sectra MicroDose Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.

Device Description

The Sectra MicroDose Mammography L30 is a type of 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 Sectra MicroDose Mammography 130 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 Sectra MicroDose Mammography L30 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 Sectra MicroDose Mammography L30 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC. SmartAEC continuously adjusts the exposure based on measured transmission from the leading detector edge.

AI/ML Overview

This 510(k) premarket notification describes the Sectra MicroDose Mammography L30, a full-field digital mammography system. The submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristic comparisons and non-clinical performance data, rather than specific acceptance criteria from a clinical study for an AI-powered device. Therefore, a direct table of acceptance criteria and reported device performance related to AI is not available in the provided text.

Based on the provided information, I can extract the following relevant details that loosely align with your request regarding how the device meets acceptance criteria, though it's important to note this is not an AI device and the evaluation process differs significantly from what you might expect for AI-driven systems:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing and Predicate Comparison):

Acceptance Criteria (inferred from predicate comparison)	Reported Device Performance (Sectra MicroDose Mammography L30)
Sensitometric Response (related to image density/contrast)	Performed as well as or better than predicate devices.
Spatial Resolution (related to image sharpness/detail)	Performed as well as or better than predicate devices.
Noise Analysis (related to image clarity/graininess)	Performed as well as or better than predicate devices.
Signal-to-Noise Ratio Transfer – DQE (related to image quality efficiency)	Performed as well as or better than predicate devices.
Dynamic Range (related to ability to capture a wide range of x-ray intensities)	Performed as well as or better than predicate devices.
Automatic Exposure Control Performance (related to consistent image quality)	Performed as well as or better than predicate devices.
Phantom Testing (general image quality assessment using standardized objects)	Performed as well as or better than predicate devices.
Patient Radiation Dose (safety criteria)	Performed as well as or better than predicate devices.
Image Erasure, Fading, and Repeated Exposure (image stability)	Performed as well as or better than predicate devices.
Clinical Mammographic Usage Quality (overall image acceptability for diagnosis)	Images were of sufficiently acceptable quality.

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

Test Set Sample Size: Not explicitly stated as a number of images or patients for clinical testing using a test set. The document refers to "Performance data from non-clinical testing," which typically involves phantoms and laboratory measurements, not patient images in a "test set" in the context of AI evaluation.
Data Provenance: The non-clinical testing was performed in line with generally accepted test methods (e.g., IEC standards). No specific country of origin for a clinical test set is mentioned because a clinical test set for performance comparison was not detailed. This was a 510(k) submission based on technical equivalence and non-clinical data.

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

Not applicable in the context of this 510(k) submission. The evaluation was based on non-clinical performance data compared to predicate devices, and an "image attribute evaluation" was conducted, but the number and qualifications of experts establishing a "ground truth" for a test set (as would be done for an AI model) are not provided. The image attribute evaluation "concluded that the images were of sufficiently acceptable quality for clinical mammographic usage," implying expert review, but details are absent.

4. Adjudication Method for the Test Set:

Not applicable. No formal adjudication method for a clinical "test set" is described for this submission.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or described. This device is a mammography system (hardware and basic processing), not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a mammography imaging system, not a standalone AI algorithm. Its performance is inherent in the image acquisition and primary processing, not as an independent diagnostic algorithm.

7. Type of Ground Truth Used:

For the non-clinical performance evaluation, the "ground truth" was established by comparison against established standards and predicate device performance. For the "image attribute evaluation," the ground truth was expert consensus on the acceptability of image quality for clinical mammographic usage, as per the FDA Guidance for Industry and FDA Staff. No pathology or outcomes data are mentioned for this particular evaluation of the system's image quality.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware system with integrated image acquisition and processing. There is no concept of a "training set" in the context of how this device was evaluated for its 510(k) submission.

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

Not applicable, as there is no training set for this type of device.

Summary of the Study:

The study described is primarily a technical comparison and non-clinical performance evaluation to demonstrate substantial equivalence of the Sectra MicroDose Mammography L30 system to two legally marketed predicate devices (FUJI'S COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE and SENOGRAPHE 2000D).

Study Design: The manufacturer performed non-clinical testing covering various image quality and dose parameters (sensitometric response, spatial resolution, noise analysis, DQE, dynamic range, AEC performance, phantom testing, patient radiation dose, image stability). The results of these tests were then compared to the data available from the PMA Summaries of Safety and Effectiveness of the predicate devices.
Evaluation Standard: The testing was done "in accordance with generally accepted test methods, e.g. using IEC standards, published factors for dose calculations etc." An "image attribute evaluation" was also conducted as per the "Class II Special Controls Guidance Document: Full-Field Digital Mammography System," concluding the images were of "sufficiently acceptable quality for clinical mammographic usage."
Conclusion of the Study: The study concluded that the Sectra MicroDose Mammography L30 device performed "as well as or better than the predicate devices in all relevant areas" and that the technical differences did not raise new questions of safety and effectiveness, thus demonstrating substantial equivalence.

Summary

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510(k) Summary (21 CFR 807.92)

APR 2 8 2011

A. SUBMITTER INFORMATION

Submitter's name	Sectra Imtec AB
Address	Teknikringen 20SE-583, 30 LinköpingSweden
Establishment registrationnumber	9615992
Contact person	Alexander Asklöv
Telephone	+46-13-23 52 00
FAX	+46-13-21 21 85
Title	Chief Quality Officer of product divisionmammography at Sectra Imtec AB
Date of the summary preparation	2010-12-30

B. DEVICE IDENTIFICATION

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

Sectra MicroDose Mammography L30 Full-Field Digital Mammography X-ray System Full-Field Digital Mammography X-ray System MUE ll

21 CFR 892.1710 ﮐ

C. DEVICE DESCRIPTION

The Sectra MicroDose Mammography L30 provides three exposure modes; manual, automatic (parameters predefined based on compressed breast thickness), and SmartAEC. SmartAEC

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continuously adjusts the exposure based on measured transmission from the leading detector edge.

D. INDICATIONS FOR USE

E. PREDICATE DEVICES

	Predicate device #1	Predicate device #2
Trade Name	FUJI'S COMPUTED RADIOGRAPHYMAMMOGRAPHY SUITE (FCRMS)	SENOGRAPHE 2000D
ClassificationName	Full Field Digital, System, X-ray,Mammographic	Full Field Digital, System, X-ray,Mammographic
Generic Name	Fuji CR-IR348CL Image Console WithFCRMS Software	Digital Mammographic X-ray System
PMA Applicant	FUJIFILM MEDICAL SYSTEM U.S.A.,INC.	GE HEALTHCARE
PMA Number	P050014	P990066
Product Code	MUE	MUE
AdvisoryCommittee	Radiology	Radiology

ப TECHNICAL CHARACTERISTICS

The Sectra MicroDose Mammography L30 System does not employ exactly the same type of detector as the predicate devices and the readout methods are different, however the fundamental process of digital full field mammographic image creation remains the same for all three devices; x-ray photons are captured in the detector and ultimately converted to an electrical signal, forming a digital image.

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, and Image erasure, fading and repeated exposure was compared with data from the PMA Summary of Safety and effectiveness of 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.

An image attribute evaluation was conducted in accordance with the Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Full-Field Digital Mammography System [issued: November 5, 2010] which concluded that the images were of sufficiently acceptable quality for clinical mammographic usage.

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G. conclusion

The Sectra MicroDose Mammography L30 described in this substantially equivalent to the predicate devices in respects of indication for use and image quality. The proposed and predicate devices utilize similar technology and materials, comparable safety and effectiveness features, and are similar in design and construction. The information submitted in this application shows that none of the technical differences between the systems raises new questions of safety and effectiveness. All collected performance data demonstrate that the devices are substantially equivalent. Our conclusion is that Sectra MicroDose Mammography L30 is as safe and effective as the legally marketed predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle 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. Alexander Asklöv Chief Quality Officer Sectra Imtec AB - Product Division Mammography Teknikrigen 20 Linköping SE-58330 SWEDEN

APR 2 8 2011

Re: K110025

Trade/Device Name: Sectra MicroDose Mammography L30 Regulation Number: 21 CFR 892.1715 Regulation Name: Mammographic x-ray system Regulatory Class: II Product Code: MUE Dated: April 15, 2011 Received: April 19, 2011

Dear Mr. Asklöv:

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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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 wification. 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 11 you don't openice as not 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,

Mary Patel

Mary S. Pastel, Sc.D. 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): ____________________________________________________________________________________________________________________________________________________

Device Name:

Sectra MicroDose Mammography L30

Indications for Use:

The Sectra MicroDose Mammography L30 is indicated for The Sectra MicroDoso Mic images that can be used for screening and diagnosis of breast cancer.

and Glaghosis of Steast Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.

Prescription Use __ X (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)

Mury S. Potts
(Division Sign-Off)

..............................................................................................................................................................................

(Division Sign Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

610K. K1100.25

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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.