The Aspire CR for Mammography (CRm) System is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Fuji Aspire CRm System is intended to be used in the same clinical applications as traditional film/screen systems.

Device Description

The FCR Aspire CRm is Fuji's newest reader to join our CR for mammography (FCRm) line of mammography readers (ClearView CSm and ClearView 1-m). The Aspire CRm system is composed of an Aspire CRm image reader, a new 50 micron HR VI single sided image plate (IP), and the same Fuji Flash Plus IIPm acquisition workstation as our approved FCRMS. In addition, any cleared dedicated mammographic x-ray machine may be used with the Aspire CRm system to generate digital mammographic images for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a 5 megapixel 510(k) cleared for mammography soft copy review station, and optionally printed on a 510(k) cleared for mammography printer.

AI/ML Overview

Here's an analysis of the provided text regarding the Aspire CR for Mammography (CRm) FFDM System, focusing on acceptance criteria and supporting studies:

It's important to note that this 510(k) summary is for a substantial equivalence determination, not an approval based on specific performance criteria demonstrated against a disease state. The primary goal is to show that the new device performs "as well as" or "similarly to" legally marketed predicate devices, especially regarding physical image quality parameters. Therefore, the "acceptance criteria" here are more about demonstrating comparable technical performance than clinical outcome thresholds.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative clinical acceptance criteria a typical medical device would have (e.g., AUC > X, Sensitivity > Y at Specificity Z). Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical performance studies and an image attribute evaluation. The implied "acceptance criteria" for the preclinical studies are that the Aspire CRm's performance should be comparable or equivalent to the predicate devices in the listed parameters.

Acceptance Criteria (Implied: Comparable to predicate devices)	Reported Device Performance (Summary)
Preclinical Studies	The results demonstrate that our proposed device is substantially equivalent to our cleared predicate devices.
Sensitometric Response	Aspire CRm performed as well as the predicate devices.
Spatial Resolution	Aspire CRm performed as well as the predicate devices.
Noise Analysis	Aspire CRm performed as well as the predicate devices.
Detective Quantum Efficiency (DQE)	Aspire CRm performed as well as the predicate devices.
Dynamic Range-NEQ	Aspire CRm performed as well as the predicate devices.
Dynamic Range-DQE	Aspire CRm performed as well as the predicate devices.
Image Erasure and Fading Test	Aspire CRm performed as well as the predicate devices.
Image Fogging Test	Aspire CRm performed as well as the predicate devices.
ACR Phantom Scoring (2cm, 4.2cm, 6cm)	Aspire CRm performed as well as the predicate devices.
CD MAM Scoring	Aspire CRm performed as well as the predicate devices.
MTF Comparison (Aspire CRm vs. Kodak DirectView CR)	Performance is comparable (explicitly stated "Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) MTF Comparison").
DQE Comparison (Aspire CRm vs. Kodak DirectView CR)	Performance is comparable (explicitly stated "Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) DQE Comparison").
Clinical Image Studies	Images were of sufficiently acceptable quality for clinical mammographic usage.

Study Details

Sample sizes used for the test set and the data provenance:
- Preclinical Studies: The document does not specify the exact sample size for each individual preclinical test (e.g., number of measurements, number of phantoms used). It states these tests were performed in accordance with Section 8 of the Class II Special Controls Guidance Document: Full-Field Digital Mammography System.
- Clinical Image Studies: The document mentions "An image attribute evaluation was conducted." It does not specify the number of images or cases included in this evaluation.
- Data Provenance: Not explicitly stated for either preclinical or clinical image studies (e.g., country of origin). The studies appear to be prospective or experimental studies conducted by the manufacturer, rather than retrospective analysis of existing clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the "Image attribute evaluation," the document does not specify the number of experts or their qualifications. However, for mammography, these would typically be board-certified radiologists experienced in mammography interpretation.
- For preclinical phantom studies, "ground truth" is established by the known physical properties of the phantoms and the objective measurements of the device's performance.
Adjudication method for the test set:
- The document does not specify an adjudication method for the image attribute evaluation. If multiple experts were involved, a consensus or majority read often serves as adjudication, but this is not detailed here. For preclinical objective measurements, adjudication is not typically relevant as the results are quantitative.
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:
- No, an MRMC comparative effectiveness study was not done.
- The document describes an "image attribute evaluation," which assesses image quality for clinical usage, but not a study comparing human reader performance with and without AI assistance. The device in question is a Full-Field Digital Mammography (FFDM) System (hardware and associated processing), not an AI-assisted interpretation product. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this submission.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in essence, standalone performance was evaluated for the physical image acquisition and processing system. The preclinical studies (e.g., DQE, MTF, noise, sensitometric response, phantom scoring) are evaluations of the system's inherent image quality performance, which is a form of standalone testing for the image generation algorithm and hardware. The "image attribute evaluation" also assesses the quality of images produced solely by the system before human interpretation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Preclinical Studies: The ground truth for these studies is based on controlled phantom measurements and objective physical parameters (e.g., known object sizes in phantoms, defined input X-ray dosages, standard test patterns).
- Clinical Image Studies: For the "image attribute evaluation," the ground truth for "sufficiently acceptable quality for clinical mammographic usage" would implicitly come from expert readers' subjective assessment of image quality (e.g., clarity of structures, presence of artifacts, visibility of clinical features). It does not reference pathology or outcomes data to establish ground truth for individual cases.
The sample size for the training set:
- The document does not provide information on a training set sample size. This device is an image acquisition and processing system, not typically an AI/machine learning algorithm that requires a distinct "training set" in the context of diagnostic decision-making. The system's processing parameters are likely tuned and optimized during development, but this is not described as a "training set" in the common AI sense.
How the ground truth for the training set was established:
- As no "training set" is described for an AI/ML algorithm, this question is not applicable in the context of this 510(k) submission. Parameters of the image processing pipeline would be tuned based on engineering principles and optimization for image quality metrics, often against known physical phantom data or expert assessment of image appearance, rather than a labeled clinical training set for disease detection.

Summary

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K111646

DEC - 8 2011

Section 5

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510(k) Summary

Aspire CR for Mammography (CRm) FFDM System

This Section contains:

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510(k) Summary

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KIII646

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510(k) Summarv Aspire CR for Mammography (CRm) FFDM System

Date: June 10, 2011

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut, 06902, U.S.A.

Contact Person:

Name:	Debra Peacock
Title:	Regulatory Affairs Manager
Telephone:	(203) 602-3774
Facsimile:	(203) 363-3813

Identification of the Proposed Device:

Proprietary/Trade Name:	Aspire CR for Mammography (CRm) FFDM System
Classification Name:	Full Field Digital Mammography System
Regulations Number:	21 CFR 892.1715
Product Codes:	MUE
Device Class:	Class II
Review Panel:	Radiology
Common Name:	Full Field Digital Mammography System

1. INDICATIONS FOR USE

2. DEVICE DESCRIPTION

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megapixel 510(k) cleared for mammography soft copy review station, and optionally printed on a 510(k) cleared for mammography printer.

The requirements for the dedicated mammographic x-ray machine are as follows:

An x-ray machine specifically designed and 510(k) cleared for mammography . should be used.
The X-ray tube should have as a minimum a molybdenum target and . molybdenum filter
(Mo/Mo) combination for calibration of the Aspire CRm image reader and . optionally any of the following anode target and filter combinations: molybdenum target with rhodium filter (Mo/Rh), rhodium target with rhodium filter (Rh/Rh), and tungsten target with rhodium filter (W/Rh).
The x-ray system should have both manual exposure control and automatic . exposure control (AEC). The AEC may be of the type controlling mAs only, or mAs and kVp, or mAs, kVp and filter, or mAs. kVp. filter, and target.

	Proposed FujifilmAspire CRm	Predicate Kodak DirectViewCR Mammography System(P080018)	Predicate Fuji CR for MammographySystem (FCRMS) (P050014)
Detector-only FFDMSystem	Yes	Yes	Yes
AcquisitionWorkstation	Fujifilm Flash PlusIIPm (CR-IR348 CL)MammographyWorkstationspecifically designedfor viewing andstoring images anddata. Fuji proprietarysoftware.	Yes. CARESTREAM(KODAK)MammographyWorkstationspecifically designed forviewing and storingimagesand data. Carestream(Kodak) proprietarysoftware.	Same. Fujifilm Flash PlusIIPm (CR-IR348 CL)Mammography Workstationspecifically designed forviewing and storing imagesand data. Fuji proprietarysoftware.
ImageReader	Aspire CRm (CR-IR359) single slotreader can be usedfor bothmammography andgeneral radiography.	Yes. Single slotreader(s) can be usedfor both mammographyand generalradiography.	ClearView CSm (CR-IR363)multi slot reader andClearView-1m (CR-IR368)single slot reader can beused for both mammographyand general radiography.
Detector	Flexible, Single SidedImaging Plate (IP)	Rigid, Single Sided IP	Flexible, Dual Sided IP

3. PREDICATE DEVICES

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4. SUMMARY OF STUDIES

Preclinical Studies:

The following Preclinical tests were performed in accordance with Section 8 of the Class II Special Controls Guidance Document: Full-Field Digital Mammography System Document issued on: November 5, 2010,

� Sensitometric Response
. Spatial resolution of Aspire CRm
. Aspire CRm Noise Analysis
Aspire CRm Detective Quantum Efficiency .
. Dynamic Range-NEQ
Dynamic Range-DQE .
Image Erasure and Fading Test for Aspire CRm .
. Image Fogging Test for Aspire CRm
. ACR Phantom (2cm, 4.2cm, and 6cm). Scoring
CD MAM Scoring .
Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) MTF Comparison .
Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) DQE Comparison .

The results of the tests demonstrate that our proposed device is substantially equivalent to our cleared predicate devices. The Aspire CRm system performed as well as the predicate devices in all relevant areas. As recommended by FFDM Guidance Document, and where appropriate, tests were performed in accordance with IEC 62220-1-2 and The Addendum on Digital Mammography: The European Protocol for the Quality Control of the physical and technical aspects of mammography screening, version 1.0, November 2003.

Clinical Images Studies:

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

5. SUBSTANTIAL EQUIVALENCE

The Aspire CRm FFDM System is substantially equivalent to the predicate device, Kodak DirectView CR Mammography System (P080018) and our own Fuji CR for Mammography System (FCRMS). The Aspire CRm uses the same acquisition workstation as our currently approved FCRMS. Our FCRMS uses a dual sided 50 micron high resolution image plate. The Aspire CRm uses a new, single sided 50 micron, high resolution image plate (HR VI). Kodak's also uses a single sided 50 micron image plate. All systems are a detector-only FFDM (Computed Radiography for Mammography) system, using any cleared dedicated x-ray mammography system.

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6. CONCLUSION

The Aspire CRm FFDM System is substantially equivalent to the predicate devices in respects to indication for use, technology, similar materials and image quality. All three systems are CR for mammography systems utilizing an imaging plate and CR image reader. All systems demonstrate comparable safety and effectiveness features, and are similar in design and construction.

All collected performance data demonstrate that the devices are substantially equivalent. Our conclusion is that the Aspire CRm FFDM System is as safe and effective as the legally marketed predicate devices.

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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

DEC - 8 2011

Ms. Debra A. Peacock Regulatory Affairs Manager FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CT 06902

Re: K111646

Trade/Device Name: Aspire CR for Mammography (CRm) System Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: November 11, 2011 Received: November 14, 2011

Dear Ms. Peacock:

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 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.

Mary S Pastel

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: "Aspire CR for Mammography (CRm) System

Indications for Use:

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 In Vitro Diagnostic Device (OIVD)

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

510K. K111646

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.