Libby IAAA is intended to review and analyze Intravascular optical coherence tomography (OCT) images in raw OCT file format. IAAA enables quantification of artery and/or stent dimensions. The software is intended to be used by or under supervision of a Cardiologist.

Device Description

The Libby IAAA v1.0 platform is a web-accessible post-processing analysis device used for viewing and quantifying intravascular OCT images. The device is intended to visualize and quantify OCT pullback data in raw OCT file format. The device enables lumen, stent, and stent strut detection and has features for loading, saving, and report generation of aggregated quantitative data. The device allows for analysis of raw Intravascular optical coherence tomography (OCT) files obtained from the Abbott Laboratories C7-XR system and compatible imaging catheters.

The web-based platform can be used in common desktop web browsers. A user opens an intravascular image pullback file using the platform and has the ability to use various modules to perform image analysis on areas of interest. The platform includes the following module panels for visualization, quantification, and report generation:

Visualization:

2D cross-sectional view
2D longitudinal view
Image navigation tools
Measurement and annotation tools
Bookmark areas of interest

Quantification:

Distance and area measurements
Guidewire detection
Lumen and Stent area quantification
Stent and strut detection (pullback level and frame level)
Strut classification (covered versus uncovered, apposed, and malapposed)

Data Reporting:
Study information, lumen areas, stent areas, reference areas, percent stenosis, along with usercreated annotations are displayed to the user within the software automatically saves all data and the user has the option to generate a report in .xlsx format.

The product is intended to be used by or under supervision of a board-certified Cardiologist.

AI/ML Overview

Here's an analysis of the acceptance criteria and study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes a standalone performance test where the device's output was compared against analyses performed by expert cardiologists. The conclusion states that the device "raises no different questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance," implying that the device's performance was deemed acceptable relative to expert cardiologists.

Based on the text, the acceptance criteria implicitly involve the device's automated quantification of artery and/or stent dimensions aligning sufficiently with expert manual analysis.

Acceptance Criteria (Implicit)	Reported Device Performance
Device's automated quantification of artery and/or stent dimensions should be comparable to expert manual analysis.	Standalone performance testing consisted of a "head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm." The conclusion states the device "raises no different questions of safety and effectiveness."
Software specifications, applicable performance standards, and regulatory guidance documents (e.g., ANSI/AAMI/IEC 62304, FDA Guidance).	"evaluated and verified in accordance with software specifications, applicable performance standards through software verification and validation testing, in addition to the FDA Guidance documents..."

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

Sample Size for Test Set: The document mentions "a generalized dataset" but does not provide a specific number for the sample size used in the standalone performance test.
Data Provenance: Not explicitly stated. The term "generalized dataset" suggests it might be diverse, but there's no mention of country of origin or whether it was retrospective or prospective.

3. Number of Experts and Qualifications

Number of Experts: The document refers to "expert cardiologists" (plural), but does not specify the exact number of experts used to establish the ground truth for the test set.
Qualifications of Experts: The document states "expert cardiologists." It doesn't provide specific details like years of experience, subspecialty certifications, or affiliations.

4. Adjudication Method for the Test Set

The document describes the test as a "head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm." This implies that the experts' manual analyses served as the reference against which the algorithm was compared. However, it does not explicitly mention an adjudication method (e.g., 2+1, 3+1 consensus) among the experts themselves if multiple experts were involved in the manual analysis. It's possible each expert's analysis was independently compared, or a consensus was reached, but this detail is missing.

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

Was an MRMC study done? No. The document describes a "standalone performance test" comparing the algorithm against expert manual analysis. It does not mention a comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.
Effect size of human reader improvement: Since an MRMC study was not described, there is no information on the effect size of human readers improving with AI assistance.

6. Standalone Performance

Was standalone (algorithm-only) performance done? Yes. The document explicitly states: "Standalone performance testing consisted of a head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm." This confirms an algorithm-only evaluation.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the standalone performance test was established through expert consensus/manual analysis ("manually analyzed by expert cardiologists").

8. Sample Size for the Training Set

The document does not provide any information about the sample size for the training set. It focuses solely on the performance testing.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information about how the ground truth for the training set was established, as it does not discuss the training process or dataset.

Summary

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December 17, 2021

Dyad Medical, Inc. Rory Carrillo Quality & Regulatory 215 Brighton Avenue, Suite 203 Boston, Massachusetts 02134

Re: K210931

Trade/Device Name: Libby IAAA v1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 12, 2021 Received: November 18, 2021

Dear Rory Carrillo:

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

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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices 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) K210931

Device Name Libby IAAA v1.0

Indications for Use (Describe)

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)

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510(k) Summary

1. General Information

510(k) Sponsor	Dyad Medical, Inc.
Address	215 Brighton Avenue, Suite 203Boston, MA 02134
Correspondence Person	Rory A. CarrilloQuality and Regulatory ConsultantRAC Medical Consulting, LLC
Contact Information	Email: rory@cosmhq.comPhone: 562-533-7010
Date Prepared	March 29, 2021

2. Proposed Device

Proprietary Name	Libby IAAA v1.0
Premarket Notification	K210931
Common Name	Libby IAAA
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Regulation Name	Picture archiving and communication system
Product Code	LLZ
Regulatory Class	II

3. Predicate Device

Proprietary Name	Pie Medical CAAS Intravascular
Premarket Notification	K123970
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Regulation Name	Picture archiving and communications system
Product Code	LLZ
Regulatory Class	II

Device Description 4.

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Image /page/4/Picture/1 description: The image contains the logo for DYAD MEDICAL. The logo consists of a blue graphic on the left and the text "DYAD MEDICAL" on the right. The graphic is a stylized representation of connected circles or spheres, with a gradient of blue shades. The text "DYAD" is in a larger, bolder font, while "MEDICAL" is in a smaller font below it.

quantitative data. The device allows for analysis of raw Intravascular optical coherence tomography (OCT) files obtained from the Abbott Laboratories C7-XR system and compatible imaging catheters.

Visualization:

2D cross-sectional view
2D longitudinal view ●
Image navigation tools
Measurement and annotation tools ●
Bookmark areas of interest ●

Quantification:

Distance and area measurements ●
Guidewire detection
Lumen and Stent area quantification ●
Stent and strut detection (pullback level and frame level) ●
Strut classification (covered versus uncovered, apposed, and malapposed) ●

Data Reporting:

Study information, lumen areas, stent areas, reference areas, percent stenosis, along with usercreated annotations are displayed to the user within the software automatically saves all data and the user has the option to generate a report in .xlsx format.

The product is intended to be used by or under supervision of a board-certified Cardiologist.

ನ. Intended Use

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6. Substantial Equivalence

Feature/Function	Proposed Device:Libby IAAA v1.0(K210931)	Predicate Device:Pie Medical CAAS Intravascular(K123970)
Intended Use& Indicationsfor Use	Libby IAAA is intended to reviewanalyzeopticalandcoherencetomography(OCT)images in raw OCT file format.IAAA enables quantification ofartery and/or stent dimensions. Thesoftware is intended to be used by orunder supervision of a Cardiologist.	CAAS IntraVascular has beendeveloped to review and analyzeintravascular images. The software isused by or under supervision of acardiologist or radiologist.Based on intravascular ultrasound(IVUS) and/or optical coherencetomography (OCT) images CAASIntraVascular enables quantificationof artery and/or stent dimensions.
Intended Users	The software is used by or undersupervision of a Cardiologist.	The software is used by or undersupervision of a cardiologist orradiologist.
IntendedEnvironment	Healthcare facilities such ashospitals and clinics	Healthcare facilities such as hospitalsand clinics
Device Class	II	II
Data Type	Raw OCT data	IVUS and OCT data in DICOMformat (vendor independent)
Import ofPatient Data	-Manual through keyboard-Automatic import with image file-Study List creation	-Manual through keyboard-Automatic import with image file-Study List creation
Image Display	- 2D OCT reconstruction- Cross-sectional views- Longitudinal reconstruction	-3D OCT reconstruction- Cross-sectional views- Longitudinal reconstruction
ContourDefinition	Lumen and stent contour-Automatic-Manual	Lumen, EEM and stent contour-Automatic-Manual
Vessel Analysis	- Stenosis analysis- Stent analysis	- Stenosis analysis- Plaque analysis- Stent analysis

ImageAssessment	- Linear (length and diameter),angular and ROI measurements- Volume measurements	- Linear (length and diameter),angular and ROI measurements- Volume measurements
Storage ofResults	- Digital report (.xlsx)	-Printout-Reanalysis-Digital PDF report-XML export-DICOM PDF report
OperatingSystem	Web Browser	MS Windows

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Image /page/6/Picture/0 description: The image contains the logo for DYAD MEDICAL. On the left side of the logo, there is a blue graphic that looks like three cells connected together. On the right side of the logo, the words DYAD MEDICAL are written in bold, blue letters.

7. Performance Data

Safety and performance of the Libby IAAA v1.0 has been evaluated and verified in accordance with software specifications, applicable performance standards through software verification and validation testing, and a standalone performance test. Standalone performance testing consisted of a head to head analysis of a generalized dataset manually analyzed by expert cardiologists and compared to the performance of the Libby IAAA algorithm. The software system testing activities were performed in accordance with ANSI/AAMI/IEC 62304:2006/A1:2016 - Medical device software - Software life cvcle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices. "

8. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the Libby IAAA v1.0 raises no different questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.

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).