DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software and must not be used in isolation when making patient management decisions.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Megapixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists.

DeepLook PRECISE, is not intended for use on mobile devices.

Device Description

DeepLook PRECISE, is a software application that works embedded in PACS/EIS or OEM viewers. It provides automated measurement, replacing manual digital calipers currently used to measure objects in digital medical imaging.

It is a Windows OS service that uses XML messaging to receive Commands from the viewer application: it processes results independently and returns requested data to the viewer application via the same XML messaging. The software is not compiled within the viewer's application. As a result, integration is simplified and limited to establishing XML protocols for reciprocal Commands.

DeepLook PRECISE can operate on an individual workstation, local servers or in Cloudbased applications.

The software uses patented shape-recognition processes to analyze Regions of Interest (ROIs) identified by a trained medical user (i.e., imaging technologist, radiologist, phvsician or researcher). When requesting a measurement, the user triggers a set of XML Commands via the viewer interface. The primary Command is a request for a measurement of an object located within an ROI designated by the user using a mouse to click on the location of a suspected object.

DeepLook receives the Command, processes the area within the ROI and assembles the candidate shapes (and all relevant metrics) and returns a full set of displays (bundled and prioritized) that depict the possible boundaries of the object. To facilitate initial viewing, DeepLook PRECISE designates a default shape; this shape is recommended as the best depiction of the targeted margin of the object. The selection of the default shape from the display stack is determined by a set of deterministic algorithms that sort for the best candidate shape based on shape recognition ratios developed by DeepLook. Based on training and professional skill, a user can use simple keystroke Commands or a track ball or mouse wheel to move through the entire stack of alternative margins (shapes) and select the one that they conclude best represents the targeted object.

Once a candidate shape has been chosen, the user has the option to extend or contract any specific section of the margin in order to include or exclude a feature they deem relevant. Any alteration of the contours of the displayed margin will recalculate the overall measurement metrics (i.e., calculate two new axis measurements, and the area and estimated volume). The results will instantly appear with the modified margin.

The Commands to accept the default shape-display or select alternative shape-displays and any modification of selected shape-displays are all executed using keystroke or track ball functions that are initiated by the user through the viewer interface. Each resulting shape includes all relevant measurement metrics when displayed, allowing for quick comparison and selection.

For illustrative purposes, the software offers a colorization display of the internal shapes within a candidate margin: each of the shapes within the outer margin of a targeted object or anatomical structure is assigned a calibrated color. This is offered solely to assist the user in distinguishing the shape components when making a final selection. The colorization is not a decision-support or diagnostic tool.

The measurements and graphical display can be saved. Depending on the viewer configuration, this data can be saved 1) to the hard drive of the workstation; 2) to a server on the premises or in the Cloud; 3) in a structured report; or 4) configured to comply with DICOM data fields and saved to the PACS. The location of the saved display will be determined by the viewer manufacturer and/or the user.

The displays of DeepLook PRECISE described above offer the user consistent measurement of each shape. The modification functions provide the user with maximum flexibility to adjust the default shape or any other shapes in the display stack. The user can also decline all suggested shapes generated by DeepLook PRECISE and use standard mouse-operated digital calipers to measure the target object.

The final configuration of the user interface (i.e., keystrokes, track ball and hot-key Commands) will be determined by each vendor that integrates DeepLook PRECISE. To assist the vendor during integration, each XML Command and display option is illustrated separately in this manual. This provides the integrator with the option of selecting some or all the functions and to determine the best Commands to incorporate, consistent with its own user interface.

DeepLook PRECISE is stand-alone Windows OS service designed to permit maintenance and performance improvements without the need to modify established XML protocols used to send and receive Commands. This eliminates the need for additional vendor integrations when patches and/or updates are required to DeepLook PRECISE's Windows OS service.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the DeepLook PRECISE device, primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of the device's performance against specific acceptance criteria. While it mentions nonclinical testing and meeting "predetermined acceptance criteria," it does not explicitly list the acceptance criteria or present the quantitative results of the study in a way that directly maps to such criteria.

Therefore, I cannot fully complete the requested table of acceptance criteria and reported device performance or provide detailed answers to many of the questions regarding the specifics of the performance study based solely on the provided text.

However, I can extract and infer some information and highlight what is missing.

Here's an attempt to answer your questions based on the provided text:

Acceptance Criteria and Device Performance Study Information for DeepLook PRECISE

Based on the provided K202084 510(k) Premarket Notification document, the following observations can be made regarding acceptance criteria and the performance study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."

However, the specific "predetermined acceptance criteria" for performance (e.g., accuracy of measurements, precision, sensitivity, specificity, or inter-rater reliability metrics) and the quantitative results are NOT provided or detailed in the document. The document focuses on demonstrating substantial equivalence to a predicate device, and the nonclinical testing section broadly states that "all functions and has passed all predetermined testing criteria."

Therefore, a table of specific acceptance criteria and detailed reported device performance cannot be accurately constructed from the provided text.

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

The document does not explicitly state the sample size used for the test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly refers to "nonclinical testing results" provided in the 510(k) submission, but these are not included in the provided snippets.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. It mentions "trained professionals in measuring dimensions of objects" and "trained physicians and radiologists" as typical users, but not those involved in ground truth establishment for the testing itself.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The device is described as a "software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals," implying a human-in-the-loop use case, but the testing details for this specific interaction are not provided.

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

The description of the device's operation ("DeepLook receives the Command, processes the area within the ROI and assembles the candidate shapes... user can use simple keystroke Commands or a track ball or mouse wheel to move through the entire stack of alternative margins... Once a candidate shape has been chosen, the user has the option to extend or contract any specific section of the margin...") strongly suggests that the device is intended for human-in-the-loop use and not as a standalone diagnostic algorithm. The provided "Performance Data" section vaguely refers to "nonclinical testing," but does not distinguish between standalone and human-in-the-loop performance studies or provide data for either.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the device measures dimensions, common ground truth methods could include manual expert measurements with high precision, or potentially pathology if correlated with surgical removal. However, this is not detailed.

8. The Sample Size for the Training Set:

The document does not provide information regarding the sample size used for the training set.

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

The document does not provide information regarding how the ground truth for the training set was established.

Summary of what is present and what is missing:

Present:
- Confirmation that nonclinical testing was performed and that predetermined acceptance criteria were met.
- References to relevant standards (ISO 14971, NEMA PS 3.1-3.20 (DICOM), IEC 62304, FDA Guidance on Cyber Security, FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices).
- A high-level description of the device's function: assisting trained professionals in measuring dimensions (long-axis, short-axis, area, volume, margin) of user-identified ROIs in DICOM images.
- Acknowledgement that the device is not a decision-support tool and the information provided "must not be used in isolation when making patient management decisions."
Missing (Critical for understanding the performance study details):
- Quantitative acceptance criteria for performance metrics (e.g., accuracy, precision).
- Specific quantitative performance results against these criteria.
- Details on the test dataset (sample size, data characteristics, provenance).
- Details on ground truth establishment (number/qualifications of experts, adjudication methods).
- Information on training data.
- Specifics of any MRMC or standalone performance studies, including effect sizes.

This document serves as an FDA 510(k) clearance letter and summary, which typically focuses on demonstrating substantial equivalence rather than providing a comprehensive scientific publication of the device's performance study results. Detailed study reports would be contained within the full 510(k) submission, which is not publicly released in its entirety.

Summary

{0}------------------------------------------------

April 9, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

DeepLook Inc. % Mr. Carl Alletto Regulatory Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K202084

Trade/Device Name: DeepLook PRECISE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 5. 2021 Received: March 15, 2021

Dear Mr. Alletto:

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/cfpmn/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

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see 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-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Michael D. O'Hara
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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K202084

Device Name DeepLook PRECISE

Indications for Use (Describe)

DeepLook PRECISE, is not intended for use on mobile devices.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: March 29, 2011

510(k) Number: K202084

I. SUBMITTER

DeepLook Inc. 1220 Burton Street Silver Spring, MD 20910 TEL: 202.306.0808 Email: Steve.schwadron@DeepLookMedical.com

Contact Person: Mr. Steven Schwadron, Chief Operating Officer

II. DEVICE

Name of Device:	DeepLook PRECISE
Common or Usual Name:	Picture Archive and Communications System
Regulation Name:	System, Image Processing, Radiological
Regulation:	21 CFR 892.2050
Product Code:	LLZ
Regulatory Class:	II

III. PREDICATE DEVICE

Device Classification Name	System, Image Processing, Radiological
510(K) Number	K191530
Device Name	StoneChecker
Applicant	Imaging Biometrics, LLC13416 Watertown Plank Road, Suite 260Elm Grove, WI 53122
Regulation Number	892.2050
Regulation Medical Specialty	Radiology

IV. DEVICE DESCRIPTION

DeepLook PRECISE can operate on an individual workstation, local servers or in Cloudbased applications.

{4}------------------------------------------------

measurement of an object located within an ROI designated by the user using a mouse to click on the location of a suspected object.

V. INDICATIONS FOR USE

{5}------------------------------------------------

images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software is an initial estimate and must not be used in isolation when making patient management decisions.

Lossy compressed mammoqraphic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Mega-pixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists. DeepLook PRECISE, is not intended for use on mobile devices.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

Ref#	TechnicalCharacteristic	Subject Device -DeepLookPRECISE	Predicate -StoneCheckerK191530	Difference/Comments
	Indications for Use
1	Statement referencesa software onlydevice.	Yes	Yes	No significant difference
2	Statement referencesDICOM Standard.	Yes	Yes	No significant difference
3	Statement referencesthedisplay / view ofmedical images.	Yes	Yes	No significant difference
4	Statement referencesthe output ofinformation	Yes	Yes	No significant difference
5	Statement referencesthe user selection ofROIs	Yes	Yes	No significant difference
6	Statement referencesproviding the clinicianwith informationabout an ROI.	Yes	Yes	No significant difference
7	Statement referencesproviding the userwith informationrelated to kidneystones.	No	Yes	Yes, there is a difference. Thesubject device can measure anyobject within a ROI identified by theUser and is not intendedspecifically for kidney stones. Thedevice Intended Use is clearlydetailed in the device labeling anddoes not modify existing risks orraise any new potential safety risks.Therefore, we believe there is noimpact on safety or efficacy of thesubject device.
8	Intended Users	Trainedphysicians,radiologists.	Trained physicians,radiologists.	No Difference
9	Target population	No restrictions	Patients diagnosedwith	Yes, there is a difference. Thereare no restrictions with the subject device.
Ref#	TechnicalCharacteristic	Subject Device -DeepLookPRECISE	Predicate -StoneCheckerK191530	Difference/Comments
			kidney stones thatrequire medicalintervention.	device on the target population andis not intended for a specificpopulation as detailed in thelabeling. The subject device isapplied to DICOM Images and notspecific target populations. Targetpopulations are the responsibility ofthe modalities. This difference doesnot modify existing risks or raiseany new potential safety risks.Therefore, we believe there is noimpact on safety or efficacy of thesubject device.
10	Anatomical sites	No restrictions	Kidneys, ureters,and bladder (KUB)	Yes, there is a difference. Noanatomical sites are specified inthe subject device labeling. Thisdoes not modify existing risks orraise any new potential safety risks.Therefore, we believe there is noimpact on safety or efficacy of thesubject device.
11	Where used	No restrictions	No restrictions	No significant difference.
	Design
1	Software device thatoperates on off-the-shelf hardware.	Yes	Yes	No significant difference.
2	Software device usesa standard windowinguser interface.	Yes	Yes	No significant difference.
3	Software device usessoftware algorithmsfor image postprocessing analysis.	Yes	Yes	No significant difference. Thesubject device software is used formeasurement.
4	Conforms to DICOMstandards (PS 3.10)	Yes	Yes	No significant difference
	Features and Capabilities
5	Data loading of CTimage series usingDICOM standard	Yes	Yes	DeepLook PRECISE can handleany DICOM image and does notrestrictive to a specific modality.
6	2D image review	Yes	Yes	No significant difference
7	Image navigationtools (pan, zoom,scroll, window/level)	No	Yes	DeepLook PRECISE functions aremeasurement tools. Other imagemanagement functions are left tothe PACS OEM software which isnot part of DeepLook PRECISE.Therefore, it is our determinationthat this difference does not have anegative impact on safety orefficacy and there are no new
Ref#	TechnicalCharacteristic	Subject Device -DeepLookPRECISE	Predicate -StoneCheckerK191530	Difference/Comments
8	Measurement tools(ruler, ROI)	Yes	Yes	No significant difference
9	Size calculations(area, volume)	Yes	Yes	No significant difference
10	Statisticalcalculations	No	Mean, standarddeviation (SD),mean of positivepixels, skewness,kurtosis, entropy	Yes, there is a difference.DeepLook PRECISE functions aremeasurement tool related. Thegenerated information consists ofan initial estimated greatest long-axis and greatest short-axisdimensions, area, volume, andpositions of objects. Other imagemanagement functions are left tothe PACS OEM software which isnot part of DeepLook PRECISE.This does not modify existing risksor raise any new potential safetyrisks. Therefore, we believe there isno impact on safety or efficacy ofthe subject device.
11	CT texture analysiscalculations	No	Yes	Yes. There is a difference.DeepLook PRECISE functions aremeasurement tools and isintegrated with an OEM PACSsystem which is not part ofDeepLook PRECISE. The subjectdevice is applied to any DICOMimage and is not modality specific.This is explained in the deviceManual. This difference does notmodify existing risks or raise anynew potential safety risks.Therefore, we believe there is noimpact on safety or efficacy of thesubject device.
12	Display output ofmeasurements andinformation.	Yes	Yes	No significant difference
13	Report generation	No	Excel	Yes, there is a difference. Reportsare not generated by DeepLookPRECISE but are generated by theOEM PACS application which isnot part of the subject device. Thisdifference does not modify existingrisks or raise any new potentialsafety risks. Therefore, we believethere is no impact on safety orefficacy of the subject device.
Physical Characteristics
Ref#	TechnicalCharacteristic	Subject Device -DeepLookPRECISE	Predicate -StoneCheckerK191530	Difference/Comments
14	Post-processing(non-real-time, non-contacting, non-lifesupporting and notlife sustaining).	Yes	Yes	No significant difference

The following is a comparison of the subject device and the predicate device:

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

VII. PERFORMANCE DATA

Nonclinical Testing:

The subject device has been assessed and tested at the factory to assess all functions and has passed all predetermined testing criteria.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

The following Standards were used to test the system and DeepLook PRECISE, has met the applicable requirements:

ISO 14971 Third Edition 2019-12 Medical devices Application of risk management to . medical devices: FDA FR Recognition 5-125.
. NEMA PS 3.1 - 3.20 (2016, Digital Imaging and Communications in Medicine (DICOM) Set, FDA FR Recognition # 12-300.
. IEC 62304:2006/A1:2016, Medical device software - Software life cycle processes, FDA FR Recognition # 13-79.
FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of . Cybersecurity in Medical Devices Document Issued on: October 2, 2014.
. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005.

Conclusion:

The 510(k) Pre-Market Notification for DeepLook PRECISE, software device contains adequate information, data, and nonclinical test results to enable FDA -CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, DeepLook PRECISE, is substantially equivalent to the 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).