CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use:

Calculate the dimensions of cardiovascular structures;
Quantify stenosis in coronary vessels;
Determine C-arm position for optimal imaging of cardiovascular structures;
Quantify pressure drop in coronary vessels;
Enhance stent visualization and measure stent dimensions;
CAAS Workstation is intended to be used by or under supervision of a cardiologist.

Device Description

CAAS Workstation is an image post-processing software package for advanced visualization and ysis in the field of cardiology or radiology and offers functionality to view X-Ray angiographic images, to segment cardiovascular structures in these images, to analyze and quantify these cardiovascular structures and to present the results in different formats.
CAAS Workstation is a client-server solution intended for usage in a network environment or standalone usage and runs on a PC with a Windows operating system. It can read DICOM X-ray images from a directory, or receive DICOM images from the X-ray or PACS system.
CAAS Workstation is composed out of the following analysis workflows: StentEnhancer and vFFR for calculating dimensions of coronary vessels, quantification of stenosis and calculating the pressure drop and vFFR value based on two 2D X-Ray angiographic images. Semi-automatic contour detection forms the basis for the analyses.
Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CAAS Workstation, a software package for advanced visualization and analysis in cardiology and radiology. However, it does not contain specific details about acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics for AI/ML components.

The document states: "Performance testing demonstrated that the numerical results for the analysis workflows StentEnhancer and vFFR, as already available in predicate device K180019, were comparable." This is a qualitative statement of comparability to a predicate device, not a detailed presentation of acceptance criteria and the results of a study designed to meet them.

Therefore, I cannot fulfill all parts of your request with the provided input. I will outline what can be extracted and note what information is missing.

Summary of Device and Approval:

Device Name: CAAS Workstation
Applicant: Pie Medical Imaging B.V.
FDA K-Number: K232147
Regulation Name: Angiographic X-Ray System
Regulatory Class: Class II
Product Codes: QHA, LLZ
Predicate Device: CAAS Workstation (K180019) – an earlier version of the same product.
Basis for Clearance: Substantial Equivalence to the predicate device.

Indications for Use (Key Features):
CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use:

Calculate the dimensions of cardiovascular structures;
Quantify stenosis in coronary vessels;
Determine C-arm position for optimal imaging of cardiovascular structures;
Quantify pressure drop in coronary vessels;
Enhance stent visualization and measure stent dimensions;

Missing Information:

The provided text focuses on the regulatory clearance process through 510(k) substantial equivalence. This pathway often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with specific acceptance criteria as you've requested for an AI/ML component. The document mentions "Performance testing," but it does not provide the details required to answer your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for a new AI/ML model's performance.

The "AI" mentioned appears to refer more to automated image processing algorithms (semi-automatic contour detection, vFFR workflow involving pressure drop quantification, StentEnhancer workflow) rather than a novel, deep learning-based AI/ML algorithm that would typically necessitate the detailed performance study described in your prompt. The emphasis is on comparability of "numerical results" to the predicate, implying validation of existing algorithms, possibly with minor improvements, not a new AI/ML model with distinct performance criteria.

Based on the provided text, here's what can be inferred or explicitly stated, and what remains unknown:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in quantitative terms in the provided text. The document broadly indicates that "numerical results for the analysis workflows StentEnhancer and vFFR...were comparable" to the predicate. This implies the acceptance criterion was "comparability" to the predicate's performance, but no specific thresholds (e.g., accuracy > X%, ROC AUC > Y) are given.
Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) are provided in the text. The statement is qualitative: "numerical results...were comparable."

Criterion Type	Acceptance Criterion (as described)	Reported Device Performance (as described)
Numerical Results	Comparability to predicate device (K180019) for StentEnhancer and vFFR workflows.	"Numerical results...were comparable" to the predicate.
Safety & Effectiveness	As safe and effective as predicate device (K180019).	Demonstrated through verification and validation results.
Usability	Conformance to IEC 62366-1 standard.	User is able to use CAAS Workstation for its purpose.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions reading DICOM X-ray images, but not the source of the test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The device is intended for use by or under the supervision of a cardiologist, suggesting expert cardiac imaging knowledge would be relevant, but details about ground truth establishment are absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

5. 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:

Not described. The focus is on the device's standalone performance compared to a predicate, not on a human-in-the-loop MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, implicitly. The "Performance testing demonstrated that the numerical results for the analysis workflows StentEnhancer and vFFR...were comparable" indicates an evaluation of the algorithm's output. This is consistent with a standalone performance assessment, as the comparison is about the output of the software itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not explicitly stated. Given the functionalities (quantifying stenosis, dimensions, pressure drop), the ground truth for these "numerical results" would likely involve comparison against a gold standard derived from established imaging methods, potentially quantitative measurements from calibrated imaging devices, or expert consensus measurements, but the document does not elaborate.

8. The sample size for the training set:

Not specified. The document mentions "semi-automatic contour detection forms the basis for the analyses" for the vFFR workflow, which could imply a training process, but no details are given.

9. How the ground truth for the training set was established:

Not specified.

In conclusion, the K232147 FDA clearance document for the CAAS Workstation confirms its regulatory pathway via substantial equivalence to a predicate device. While it mentions "Performance testing" and "comparable numerical results," it does not provide the detailed quantitative acceptance criteria, study methodology, or specific performance metrics that would typically be found in an in-depth clinical validation study for a novel AI/ML device. The information provided is sufficient for a 510(k) submission based on predicate equivalence but lacks the granularity for the specific technical and clinical performance questions asked.

Summary

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April 9, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Pie Medical Imaging B.V. % Annemiek Bouts Regulatory Affairs Coordinator Philipsweg 1 Maastricht, Limburg 6227 AJ NETHERLANDS

Re: K232147

Trade/Device Name: CAAS Workstation Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic X-Ray System Regulatory Class: Class II Product Code: QHA, LLZ Dated: March 7, 2024 Received: March 7, 2024

Dear Annemiek Bouts:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232147

Device Name CAAS Workstation

Indications for Use (Describe)

· Calculate the dimensions of cardiovascular structures;
· Quantify stenosis in coronary vessels;
· Determine C-arm position for optimal imaging of cardiovascular structures;
· Quantify pressure drop in coronary vessels;
· Enhance stent visualization and measure stent dimensions;

CAAS Workstation is intended to be used by or under supervision of a cardiologist.

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

CAAS Workstation

Pie Medical Imaging BV

I – General Information
Submitter/Owner Name	Pie Medical Imaging BV
Address	Philipsweg 1, 6227 AJ Maastricht, The Netherlands
Phone Number	+31 43 32 81 328
Contact Person	Annemiek Bouts, Regulatory Affairs Coordinator
Email Address	reg@pie.nl
Date	08-Apr-24
Trade/Device Name	CAAS Workstation
Classification	Common Name:	Radiological Image Processing Software
	Regulation Class:	Class II
	Regulation Description:	Angiographic X-Ray System
	Regulation number:	21 CFR 892.1600
	Classification Product Code:	QHA
	Additional Product Code:	LLZ
Predicate Device	CAAS Workstation (K180019, Angiographic X-ray System, 21 CFR 892.1600, QHA, LLZ)

Il - Device Description

CAAS Workstation is a client-server solution intended for usage in a network environment or standalone usage and runs on a PC with a Windows operating system. It can read DICOM X-ray images from a directory, or receive DICOM images from the X-ray or PACS system.

CAAS Workstation is composed out of the following analysis workflows: StentEnhancer and vFFR for calculating dimensions of coronary vessels, quantification of stenosis and calculating the pressure drop and vFFR value based on two 2D X-Ray angiographic images. Semi-automatic contour detection forms the basis for the analyses.

Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.

III - Intended Use and Indications for Use

Intended Use

CAAS Workstation is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading and interpreting cardiovascular X-Ray images to support diagnoses and for assistance during intervention of cardiovascular conditions.

Indications for Use

Calculate the dimensions of cardiovascular structures;
Quantify stenosis in coronary vessels;
Determine C-arm position for optimal imaging of cardiovascular structures;
Quantify pressure drop in coronary vessels;
Enhance stent visualization and measure stent dimensions;

CAAS Workstation is intended to be used by or under supervision of a cardiologist.

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IV - Substantial equivalence

CAAS Workstation (K180019) is selected as a predicate device has technological features and characteristics comparable to the new CAAS Workstation and is intended to be used by or under supervision of a cardiologist or radiologist to support clinical decision making of cardiovascular conditions.

Predicate device, CAAS Workstation (K180019), is an earlier version of the new CAAS Workstation product. It provides similar functionalities by means of the analysis workflows StentEnhancer and vFFR for calculating dimensions of cardiovascular structures, quantify stenosis in coronary vessels, determine C-arm position for optimal imaging of cardiovascular structures, quantify pressure drop in coronary vessels (all part of vFFR workflow) and enhance stent visualization and measure stent dimensions (StentEnhancer workflow). All these functionalities are also supported in the new CAAS Workstation product. Other technological features available in predicate device K180019: the analysis workflows QCA, QVA, QCA3D, LVA, RVA and IV-LINQ are not present in the new CAAS Workstation product.

The other differences in technological characteristics between the predicate device K180019 and the device CAAS Workstation are that the new CAAS Workstation runs from a browser and the server-side installation can be on the system itself (standalone usage) or on a server accessible through the intranet (network environment). Predicate device K180019 is only a standalone usage device. Additionally, CAAS Workstation can be operated using keyboard, mouse and touchscreen while predicate device K180019 could only be operated using the keyboard and mouse.

New technological characteristics in the vFFR workflow in CAAS Workstation include a change in the default lesion location from minimum diameter location towards the largest percentage stenosis location and a correction for the hydrostatic pressure as a function of elevation in the pressure drop quantification.

The basic features and technology of the new CAAS Workstation are the same in terms of intended use and indications for use and have the similar technological characteristics as the predicate device CAAS Workstation (K180019). The cardiovascular functions supported by the new CAAS Workstation are also provided by the predicate device K180019. Both software applications use the same types of data and operating principles for the user and technology regarding data import, contour definition, image display and storage of results.

V - Performance Data

Verification and validation of the new CAAS Workstation showed that the system requirements – derived from the intended use and indications for use – as well as risk control measures were implemented correctly and that the device meets its specifications including conformance to the following international standards (i.e., ISO13485, ISO14971, IEC 62304, IEC 62366-1, IEC 82304-1, and ISO 15223-1).

Performance testing demonstrated that the numerical results for the analysis workflows StentEnhancer and vFFR, as already available in predicate device K180019, were comparable.

Usability testing is performed in accordance with the IEC 62366-1 standard and demonstrated that the user is able to use CAAS Workstation for the purpose it was developed for.

All verification and validation results demonstrate the safety and effectiveness of CAAS Workstation in relation to its intended use and therefore CAAS Workstation can be considered as safe and effective as its predicate device.

VI - Conclusion

Based on the application of risk management and performance testing inherent to PMI's QA system (compliant with recognized standards as stated above) CAAS Workstation is as safe and effective as its predicate device in terms of intended use, indications for use, technological characteristics, measurements and does not raise any new issues related to safety and effectiveness compared to the predicate device.

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.