PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.

Device Description

PowerLook Density Assessment 4.0 is a software application intended for use with mammography exams containing synthetic 2D images generated from Digital Breast Tomosynthesis (DBT) data. The PowerLook Density Assessment software assesses breast tissue composition and provides a breast density category aligned with BI-RADS® 5th Edition density lexicon. The PowerLook Density Assessment 4.0 algorithm is designed to be used with cases containing up to four synthetic 2D views. When exams contain only DBT and synthetic 2D images generated from DBT, the 4.0 algorithm is used. The PowerLook Density Assessment software is designed to work in conjunction with iCAD's PowerLook DICOM server platform, which is a Class I exempt medical device. The PowerLook Density Assessment 4.0 utilizes data management capabilities of PowerLook for controlling input to and output from the PowerLook Density Assessment algorithm. Results of the PowerLook Density Assessment software application can be displayed on a mammography review workstation, mammography reporting application or radiology information system (RIS), or printed case report.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details for the PowerLook Density Assessment V4.0.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for PowerLook Density Assessment V4.0 (K211506) does not explicitly state numerical acceptance criteria in terms of metrics like accuracy, sensitivity, or specificity. Instead, it refers to a qualitative acceptance criteria: "The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data."

However, based on the nature of breast density assessment devices, the implicit acceptance criteria would typically involve a high level of agreement between the device's output and expert-determined ground truth, particularly concerning the assignment of ACR BI-RADS breast density categories. While specific percentages are not provided, the claim of "accurately calculates" suggests that substantial agreement was achieved.

Acceptance Criteria (Implicit from "accurately calculates BI-RADS breast density category")	Reported Device Performance
High agreement with expert-assigned BI-RADS breast density categories	"The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data." (Specific metrics like accuracy, sensitivity, or specificity are not provided in the document)

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

Sample Size for Test Set: The document does not specify the exact number of cases (images/patients) used in the test set. It mentions "Hologic C-View, GE V-Preview V3 and GE V-Preview V4.1 cases were run through Density Assessment 4.0."
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

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

The document does not specify the number of experts used or their qualifications (e.g., years of experience as a radiologist) for establishing the ground truth for the test set. It implicitly refers to "BI-RADS® 5th Edition density lexicon," suggesting that expert radiologists were involved in the ground truth labeling process, as this lexicon is used by radiologists.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set ground truth.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is an effect size for human readers improving with AI assistance. The device is intended to provide "adjunctive information" to aid healthcare professionals, rather than directly assisting in a diagnostic reading task where reader performance would be measured.

6. Standalone Performance

Yes, a standalone performance study was done. The document states: "The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data." This indicates that the algorithm's performance was evaluated independently in calculating the breast density categories.

7. Type of Ground Truth Used

The ground truth used is based on the ACR BI-RADS Atlas 5th Edition breast density category. This strongly implies expert consensus or expert-assigned categories, as radiologists are trained to use this lexicon.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. It primarily focuses on the validation of the device.

9. How Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. However, given the device's function and the ground truth used for validation (BI-RADS 5th Edition), it is highly probable that the training data's ground truth was also established by expert radiologists adhering to the same BI-RADS lexicon.

Summary

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July 12, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

iCAD, Inc. % Ms. Heather Reed Vice President, Quality Assurance and Regulatory Affairs 98 Spit Brook Rd. Suite 100 NASHUA NH 03062

Re: K211506

Trade/Device Name: PowerLook Density Assessment V4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH Dated: May 6, 2021 Received: May 14, 2021

Dear Ms. Reed:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211506

Device Name PowerLook Density Assessment V4.0

Indications for Use (Describe)

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)

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510k Summary K211506

Date Prepared: May 7, 2021

Submitter:

iCAD, Inc. 98 Spit Brook Road Suite 100 Nashua, NH 03062

Contact Person:

Heather Reed Vice President, Quality Assurance and Regulatory Affairs Email: hreed@icadmed.com Phone: (603) 309-1945 Fax: (603) 880-3043

Device Name:

Trade Name:	PowerLook Density Assessment V4.0
Common Name:	Medical Imaging Software
Classification:	Medical Image Management and Processing System
Product Code:	QIH
Regulation Number:	21 CFR 892.2050
Review Panel:	Radiology

Predicate Device:

510k Number:	K180125
Manufacturer:	iCAD, Inc.
Device Name:	PowerLook Density Assessment, V3.4

Device Description

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software application can be displayed on a mammography review workstation, mammography reporting application or radiology information system (RIS), or printed case report.

Technical Characteristics:

PowerLook Density Assessment V4.0 contains a new custom software application specifically designed to run on the PowerLook AMP, which is a Class I exempt medical device. The PowerLook Density Assessment utilizes data management capabilities of the PowerLook AMP for controlling input and output to the PowerLook Density Assessment. This functionality was validated to support the addition of GE V-Preview V4.1. This custom software application is new and independent from PowerLook Density Assessment V3.4 cleared in K180125.

Supported Digital Breast Tomosynthesis Systems

The following Digital Breast Tomosynthesis systems have been tested and are compatible with PowerLook Density Assessment V4.0 software:

Hologic Selenia Dimensions/3Dimensions (C-View)
GE Senographe Essential with SenoClaire (V-Preview)
GE Senographe Pristina (V-Preview) ●

Intended Use / "Indications for Use"

PowerLook Density Assessment is a software application intended for use with digital breast tomosynthesis synthesized 2D images from tomosynthesis exams. PowerLook Density Assessment provides an ACR BI-RADS Atlas 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment produces adjunctive information. It is not a diagnostic aid.

	UNMODIFIED DevicePowerLook Density Assessment	MODIFIED DevicePowerLook Density Assessment V4.0
Manufacturer	iCAD, Inc.	iCAD, Inc.
Classification Name	System, Image Processing,Radiological	Medical Image Management andProcessing System
Regulation Number	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	QIH
510(k) #	K180125	Pending
	UNMODIFIED DevicePowerLook Density Assessment	MODIFIED DevicePowerLook Density Assessment V4.0
Intended Use / Indication forUse	PowerLook Density Assessment is asoftware application intended for usewith digital breast tomosynthesissynthesized 2D images fromtomosynthesis exams. PowerLookDensity Assessment provides an ACRBI-RADS Atlas 5th Edition breastdensity category to aid health careprofessionals in the assessment ofbreast tissue composition. PowerLookDensity Assessment producesadjunctive information. It is not adiagnostic aid.	PowerLook Density Assessment is asoftware application intended for usewith digital breast tomosynthesissynthesized 2D images fromtomosynthesis exams. PowerLookDensity Assessment provides an ACRBI-RADS Atlas 5th Edition breastdensity category to aid health careprofessionals in the assessment ofbreast tissue composition. PowerLookDensity Assessment producesadjunctive information. It is not adiagnostic aid.
End User	Radiologists	Radiologists
Patient Population	Symptomatic and asymptomatic womenundergoing mammography.	Symptomatic and asymptomatic womenundergoing mammography.
Image Source Modalities	Synthetic views from tomosynthesissystems	Synthetic views from tomosynthesissystems
Input: Image Data Format	DICOM synthetic 2D images generatedfrom breast tomosynthesis data	DICOM synthetic 2D images generatedfrom breast tomosynthesis data
Output Format	DICOM structured report or DICOMsecondary capture.	DICOM structured report or DICOMsecondary capture.
Output Data	For each patient:ACR BI-RADS® Atlas 5thEdition breast densitycategoryFractional indication ofdistance inside breast densitycategory	For each patient:ACR BI-RADS® Atlas 5thEdition breast densitycategoryFractional indication ofdistance inside breast densitycategory
Deployment	Standalone computer	Standalone computer
Supported Digital BreastTomosynthesis Systems	Hologic SeleniaDimensions/3Dimensions(C-View)GE Senographe Essentialwith SenoClaire (V-Preview)GE Senographe Pristina (V-Preview)	Hologic SeleniaDimensions/3Dimensions(C-View)GE Senographe Essentialwith SenoClaire (V-Preview)GE Senographe Pristina (V-Preview)

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Summary of Indications for Use:

The "Indications for Use" remain unchanged from the Predicate UNMODIFIED Device PowerLook Density Assessment.

Summary of Technological Characteristic

Many technological characteristics of Modified PowerLook Density Assessment V4.0 remain unchanged from Unmodified Device PowerLook Density Assessment as the predicate. PowerLook Density Assessment V4.0 contains a new custom software application specifically designed to run on the PowerLook AMP, which is a Class I exempt medical device. PowerLook Density Assessment utilizes data management capabilities of the PowerLook AMP for controlling input and output to the PowerLook Density Assessment. This functionality was validated to support the addition of GE V-Preview V4.1. This custom software application is new and independent from PowerLook Density Assessment V3.4 cleared in K180125.

These changes do not raise different questions of safety and effectiveness.

General Safety and Effectiveness Concerns

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis which is used to identify and mitigate potential hazards. Any potential hazards are controlled via software development, verification, and validation testing.

Assessment of Non-Clinical Performance Data

PowerLook Density Assessment V4.0 has been verified and validated according to iCAD's design control processes. All supporting documentation has been included in this 510(k) Premarket Notification. Verification activity included unit, integration testing was performed. Hologic C-View, GE V-Preview V3 and GE V-Preview V4.1 cases were run through Density Assessment 4.0, results were compiled into confusion matrices and then summarized. The performance of the system on all three datasets were above the desired performance, demonstrating that PowerLook Density Assessment 4.0 accurately calculates the BI-RADS breast density category for Hologic C-View and GE V-Preview data.

Conclusion:

Based upon the information presented in this submission, it is concluded that PowerLook Density Assessment V4.0 is substantially equivalent to the named predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).