Quantib Prostate is image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images.

Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow.

Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.

Device Description

Quantib Prostate (QPR) is an extension to the Quantib AI Node (QBX) software platform that enables analysis of prostate MRI scans. QPR makes use of QBX functionality, and includes 3 specific QPR modules.

The three specific modules of QPR are as follows:

An automatic processing module that performs input checks, prostate (sub-region) segmentation, multi-parametric MRI (mpMRI) image registration, computation of a biparametric combination image, and optionally crops the images around the prostate.
A two-step user-interaction module in which the user can:
- edit the computed prostate segmentation (QBX functionality) and determine PSA density (QPR-specific functionality).
- view multi-parametric MRI images (QBX functionality), and segment (QBX functionality) and analyze potential lesions (QPR-specific functionality). This extension also shows the prostatic sub-region segmentation and biparametric combination image overlay. (QPR-specific functionality).
An automatic processing module that collects all results, and creates the report and DICOM output so that they can be exported back to the user.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for Quantib Prostate based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to the predicate device (Quantib Prostate v2.0) rather than presenting specific, quantitative acceptance criteria with corresponding performance metrics in a direct table format. However, based on the description, we can infer the performance expectations and the reported findings.

Acceptance Criteria Category	Specific Acceptance Criterion (Inferred)	Reported Device Performance
Prostate Segmentation	Accuracy at least as good as predicate device (Quantib Prostate v2.0)	"at least as accurate as that of the predicate device"
Subregion Segmentation (Standalone)	Acceptable Dice overlap and Mean Surface Distance compared to ground truth. Agreement comparable to interobserver variability.	Bench testing (quantitative metrics) did not reveal issues and showed agreement comparable to interobserver measurements.
Subregion Segmentation (Clinical Context)	Judged at least as accurate as predicate device by radiologists.	Radiologists judged sub-regions "at least as accurate as the predicate device was" using a 5-point Likert scale.
ROI Localization Initiation (Clinical Context)	Judged at least as accurate as predicate device by radiologists.	Radiologists judged ROI localizations "at least as accurate as the predicate device was" using a 5-point Likert scale.

2. Sample Size for Test Set and Data Provenance

Prostate and Subregion Segmentation Algorithm (Non-clinical / Bench Testing): While a specific test set sample size isn't explicitly stated for this part, the overall prostate and sub-region segmentation algorithms were improved by "updating the methodology and training it on over 400 scans." This suggests the test set for its validation would be drawn from a similar diverse dataset.
Clinical Performance Testing (Qualitative): The document does not specify the number of cases used in the clinical performance testing for the subregion segmentations and ROI localization initiation.
Data Provenance: Not explicitly stated for either the non-clinical or clinical performance testing. We cannot determine the country of origin or if the data was retrospective or prospective from this document.

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

Non-clinical Performance Testing (Prostate/Subregion Segmentation): Ground truth was established via "manual segmentation." The number and qualifications of the experts performing these manual segmentations are not specified in the document.
Clinical Performance Testing (Subregion Segmentation and ROI Localization Initiation): "Radiologists were asked to score the subregion segmentations and ROI initial localizations." The number of radiologists or their specific qualifications (e.g., years of experience, subspecialty) are not provided.

4. Adjudication Method for the Test Set

Non-clinical Performance Testing: The document mentions "comparing the automatic segmentations to their ground truth" and comparing results with "interobserver measurements." This suggests that the ground truth itself might have involved some form of consensus or a single expert's work, but a formal adjudication method (like 2+1 or 3+1) for the ground truth establishment is not described.
Clinical Performance Testing: A formal adjudication method is not mentioned. Radiologists scored segmentations and ROI localizations using a 5-point Likert scale, implying individual expert review rather than a consensus process for scoring during the test.

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

A formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not explicitly described for this submission. The clinical performance testing involved radiologists scoring the device's output, but it was not framed as a study to measure improvement in human reader performance with AI assistance. The focus was on demonstrating that the device's performance was at least as good as the predicate.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, standalone performance was done for the combined prostate-subregion segmentation algorithm. This is described under "Non-clinical performance testing," where the "stand-alone performance of the sub-region segmentation algorithm" was evaluated by comparing automatic segmentations to ground truth using Dice overlap and Mean Surface Distance.
The "semi-automatic clinical performance test of the prostate segmentation has not been repeated" as its accuracy was found to be at least as good as the predicate in non-clinical testing, suggesting that the initial predicate validation (K221106) would have covered this aspect, potentially including standalone evaluation.

7. Type of Ground Truth Used

Non-clinical Performance Testing: "Manual segmentation" was used to establish ground truth for prostate and subregion segmentation.
Clinical Performance Testing: The "ground truth" here is implied to be the expert judgment of radiologists based on a 5-point Likert scale score, rather than a definitive pathological or outcomes-based truth.

8. Sample Size for the Training Set

The improved prostate and sub-region segmentation algorithms were trained "on over 400 scans."

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

The document states the training involved "updating the methodology and training it on over 400 scans." It does not explicitly detail the process for establishing the ground truth for these 400+ training scans. However, given the context of segmentation algorithms, it is highly probable that manual segmentations by experts were used to create the ground truth annotations for training.

Summary

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April 17, 2023

Quantib BV % Floor van Leeuwen Quality & Regulatory Director Westblaak 130 Rotterdam, Zuid-Holland 3012 KM NETHERLANDS

Re: K230772

Trade/Device Name: Quantib Prostate Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: March 20, 2023 Received: March 21, 2023

Dear Floor van Leeuwen:

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,

D. Ray K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of 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) K230772

Device Name Quantib Prostate

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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Quantib Prostate Special 510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for Quantib. The logo consists of a blue icon on the left and the word "Quantib" in blue on the right. The icon is a network of blue circles connected by lines, with some of the circles being a lighter shade of blue.

SUBMITTER 1

Quantib B.V. Westblaak 130 3012 KM Rotterdam Phone: (+31) 108 41 17 49 Contact Person: Floor van Leeuwen Date Prepared: March 20th, 2023

Device 2

Name of Device:	Quantib Prostate – version 3.0
Common or Usual Name:	Quantib Prostate
Classification Name:	System, image processing, radiology (892.2050)
Regulatory Class:	II
Product Code:	Medical image management and processing system (formerPicture archiving and communication system) - LLZ

3 Predicate device

Device:	Quantib Prostate - version 2.0
Manufacturer:	Quantib B.V.
510(k) Reg. No:	K221106 - This predicate has not been subject to a design-related recall.
Classification Name:	System, image processing, radiology (892.2050)
Regulatory Class:	II
Product Code:	Medical image management and processing system (formerPicture archiving and communication system) - LLZ

Device description 4

Quantib Prostate (QPR) is an extension to the Quantib Al Node (QBX) software platform that enables analysis of prostate MRI scans. QPR makes use of QBX functionality, and includes 3 specific QPR modules.

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The three specific modules of QPR are as follows:

An automatic processing module that performs input checks, prostate (sub-region) . seqmentation, multi-parametric MRI (mpMRI) image registration, computation of a biparametric combination image, and optionally crops the images around the prostate.
A two-step user-interaction module in which the user can: .
- edit the computed prostate seqmentation (QBX functionality) and determine o PSA density (QPR-specific functionality).
- view multi-parametric MRI images (QBX functionality), and segment (QBX o functionality) and analyze potential lesions (QPR-specific functionality). This extension also shows the prostatic sub-region segmentation and biparametric combination image overlay. (QPR-specific functionality).
. An automatic processing module that collects all results, and creates the report and DICOM output so that they can be exported back to the user.

5 Indications for Use

INDICATIONS FOR USE - QUANTIB PROSTATE VERSION 3.0 AND 2.0 5.1

Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies, Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.

5.2 INDICATIONS FOR USE COMPARISON

The intended use of the device is equivalent to the intended use of the previously cleared predicate device [K221106]

6 Device modifications

Quantib Prostate 3.0 is an update of Quantib Prostate 2.0 (the predicate device) that includes a substantial change. The substantial difference is the following:

1. Improved prostate and sub-region segmentation algorithm The prostate and sub-region segmentation algorithms have been improved by updating the methodology and training it on over 400 scans. In addition, the two algorithms have been combined into one algorithm.

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7 Comparison of technological characteristics

The following technological characteristics are the same for Quantib Prostate 3.0 and its predicate device Quantib Prostate 2.0:

. Indications for use
Target users, anatomical site, and use environment .
Software Design ●
Design control activities and recognized standards .
Required input, reported measures
Deployment and compatibility with environment and other devices ●

The following technological characteristics are different:

. Human factors

The user can now switch between user interaction steps when editing and 2) the ROI drawing on the PI-RADS sketch is now initialized representing the ROI shape and size. This can be edited by the user.

. Algorithm Design and performance The algorithms for prostate segmentation and prostate subregion seqmentation are combined into a single algorithm. This algorithm has been retrained and re-validated. The performance measures of prostate and subregion segmentation are updated correspondingly.
Output files and formats . 3D segmentations of prostate including ROIs are generated and exported as secondary captures. Images of the 3D seqmentations are added to the PDF report.

7.1 QUALITY AND SAFETY

Quantib Prostate 3.0 was designed in compliance with the following US recognized consensus standards:

. ISO 14971 – Medical devices - Application of risk management to medical devices
. IEC 62304 - Medical device software - Software life cycle processes
. IEC 62366 - Medical devices - Application of usability engineering to medical devices

The following quality assurance measures were applied to Quantib Prostate 3.0 development:

. Risk and hazard analysis
Design reviews ●
Unit level testing
Integration testing ●
. System testing
. Performance testing
. Usability engineering
Software verification & validation activities ●
Cybersecurity and vulnerability analysis ●

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7.2 Performance Data

The following performance tests are done for the combined prostate- subregion segmentation algorithm:

Non-clinical performance testing

Bench testing of the software was done to show that the system is suitable for its intended use and to evaluate the stand-alone performance of the sub-region segmentation algorithm. This was done by comparing the automatic segmentations to their ground truth and calculating the Dice overlap and Mean Surface Distance. To place the agreement between the automatic method and the manual segmentation into context, the results are compared with the interobserver measurements using statistical tests. Bench testing did not reveal any issues with the system, demonstrating that the modified device is as safe and effective as the predicate device.

Clinical performance testing

With the results from the non-clinical performance testing of the prostate segmentation algorithm being at least as accurate as that of the predicate device, the semi-automatic clinical performance test of the prostate segmentation has not been repeated. The clinical performance test of the subregion segmentation and the ROI localization initiation as seen by the user in a clinical context is conducted in a qualitative manner. Radiologists were asked to score the subregion segmentations and ROI initial localizations using a 5-point Likert scale. It is concluded that sub-regions and ROI localizations are judged at least as accurate as the predicate device was.

7.2.1 Safety implications

The changes made in Quantib Prostate 3.0 do not affect the safety of the device.

യ CONCLUSIONS

By virtue of its intended use, design features, and technological characteristics, Quantib Prostate 3.0 is substantially equivalent to a device that has been approved for marketing in the United States. The performance data shows that Quantib Prostate 3.0 is as safe and effective as 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).