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 is an extension to the Quantib Al Node software platform and enables analysis of prostate MRI scans. Quantib Prostate makes use of Quantib Al Node functionality, and includes the following specific Quantib Prostate modules:

An automatic processing module that performs prostate and prostate sub-reqion segmentation and multi-parametric MRI image registration and computation of a biparametric combination image.
A user-interaction module in which the user can edit and approve the computed prostate segmentation and determine PSA density.
A user-interaction module in which the user can view multi-parametric MRI images. segment and analyze potential lesions and set and view PI-RADS properties. This module also shows the prostatic sub-region segmentation and biparametric combination image overlav.
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

The provided text does not contain a detailed study specifically proving the device meets acceptance criteria, nor does it specify acceptance criteria in a quantifiable table format. It describes the modifications made to the device (Quantib Prostate 2.0 from 1.0) and mentions performance testing to demonstrate substantial equivalence to its predicate.

However, based on the information provided about the non-clinical and clinical performance testing, we can infer the intent of the acceptance criteria and the nature of the studies conducted. I will reconstruct the table and study description based on the available information, noting where specific quantifiable acceptance criteria are not explicitly stated in the document.

Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (Inferred)	Acceptance Threshold (Inferred)	Reported Device Performance
Non-Clinical Performance (Sub-Region Segmentation)	Dice Overlap Coefficient	Sufficiently high (compared to inter-observer variability)	Not explicitly quantified, but reported that "Bench testing did not reveal any issues with the system, demonstrating that the modified device is as safe and effective as the predicate device."
	Mean Surface Distance	Sufficiently low (compared to inter-observer variability)	Not explicitly quantified, but reported that "Bench testing did not reveal any issues with the system, demonstrating that the modified device is as safe and effective as the predicate device."
	Statistical comparison to inter-observer measurements	Comparable to inter-observer variability	"results are compared with the inter-observer measurements using statistical tests." (Specific results not given)
Clinical Performance (Sub-Region Segmentation & ROI Initialization)	Qualitative Assessment (Likert Scale)	High quality (e.g., majority of scores at the higher end of the 5-point Likert scale)	"It is concluded that sub-regions and ROI localizations are judged to be of high quality." (Specific scores not given)
General Safety and Effectiveness	Absence of significant issues	No issues identified	"Bench testing did not reveal any issues with the system..." and "By virtue of its intended use and physical and technological characteristics, Quantib Prostate 2.0 is substantially equivalent to a device that has been approved for marketing in the United States. The performance data show that Quantib Prostate 2.0 is as safe and effective as the predicate device."

Study Information Pertaining to Device Performance:

Sample sizes used for the test set and the data provenance:
- Sub-region segmentation (non-clinical testing): The exact sample size for the image dataset used for comparing automatic sub-region segmentation to ground truth is not specified.
- Clinical performance test: The exact sample size (number of cases or radiologists) for the qualitative assessment is not specified.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth for Sub-region Segmentation: Established by "manual segmentation." The number of experts and their qualifications (e.g., "radiologist with 10 years of experience") are not specified. The text mentions "inter-observer measurements" for context of the Dice overlap and Mean Surface Distance, implying multiple human experts were involved in generating or evaluating "manual segmentations."
- Ground Truth for Clinical Performance (Likert Scale): The "radiologists were asked to score." The number of radiologists and their specific qualifications are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document implies ground truth for quantitative metrics was manual segmentation, presumably from one or more experts. For the qualitative clinical assessment, radiologists scored the output, but there is no mention of a formal adjudication process (e.g., arbitration for discrepancies) if multiple radiologists rated the same case. It is likely a consensus or averaged score was used for "high quality" judgment, but no specific method is detailed.
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:
- No MRMC comparative effectiveness study involving human readers with vs. without AI assistance is explicitly described. The testing focuses on the performance of the algorithm additions themselves (sub-region segmentation, ROI localization initiation) and their qualitative assessment by radiologists, rather than a comparative study of radiologist performance. The software is described as "assisting" in interpretation, but no data on improved human reader performance with the assistance is provided in this document.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, for the sub-region segmentation algorithm, "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 sub-region segmentation to a ground truth and calculating the Dice overlap and Mean Surface Distance." This is a standalone performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical quantitative performance of sub-region segmentation, the ground truth was manual segmentation (presumably by experts).
- For the clinical qualitative performance, the ground truth for "high quality" was based on radiologist scoring/judgment (Likert scale).
The sample size for the training set:
- Not specified within this document. This document focuses on the performance testing of the modified device, not its development or training data.
How the ground truth for the training set was established:
- Not specified within this document as training set details are not provided.

Summary

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May 13, 2022

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

Quantib BV % Arnault Massink Quality & Regulatory Manager Westblaak 106 3012 KM Rotterdam, Zuid-Holland NETHERLANDS

Re: K221106

Trade/Device Name: Quantib Prostate (version 2.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 4, 2022 Received: April 15, 2022

Dear Arnault Massink:

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

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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-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.

For

Thalia T. Mills, Ph.D. Division Director DHT8B: Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221106

Device Name Quantib Prostate (version 2.0)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Quantib Prostate 2.0 Special 510(k) Summary

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SUBMITTER 1

Quantib B.V. Westblaak 106 3012 KM Rotterdam Phone: (+31) 108 41 17 49 Contact Person: Floor van Leeuwen Date Prepared: April 4th, 2022

Device 2

Name of Device: Quantib Prostate - version 2.0 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 (former Picture archiving and communication system) - LLZ

Predicate device 3

Device: Quantib Prostate - version 1.0 Manufacturer: Quantib B.V. 510(k) Reg. No: K202501 This predicate has not been subject to a design-related recall. Classification Name: System, image processing, radiology (892.2050) Requlatory Class: II Product Code: Medical image management and processing system (former Picture archiving and communication system) - LLZ

4 Device Description

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. An automatic processing module that performs prostate and prostate sub-reqion segmentation and multi-parametric MRI image registration and computation of a biparametric combination image.
A user-interaction module in which the user can edit and approve the computed . prostate segmentation and determine PSA density.
A user-interaction module in which the user can view multi-parametric MRI images. . segment and analyze potential lesions and set and view PI-RADS properties. This module also shows the prostatic sub-region segmentation and biparametric combination image overlav.
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

Quantib Prostate - version 1.0 and version 2.0

Indications for use comparison

The intended use of the device is equivalent to the intended use of the previously cleared predicate device [K202501]

රි DEVICE MODIFICATIONS

Quantib Prostate 2.0 is the first update of Quantib Prostate 1.0 that includes a substantial change. The substantial changes are the following:

1. Division of prostate seqmentation into prostatic sub-regions
  The semi-automatic prostate segmentation is extended with an algorithm to divide the prostate segmentation into sub-regions (central gland, peripheral zone, and urethra), without impacting the original prostate segmentations are displayed in the mpMRI analysis user interaction step and can be exported as a secondary capture series that also includes the ROI segmentations. Internal boundaries of subregions cannot be edited, but user edits of the outer prostate segmentation are reflected in the sub-region outer boundaries. Individual volumes of sub-regions are not provided.

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1. Initialization of ROI location on PI-RADS sector map
  For an annotated ROI the location on the PI-RADS sector map is now initialized with a cross, based on the sub-region segmentation input when the PI-RADS scoring window is opened. Inspecting, editing and confirming the location should be done manually.

7 Comparison of technological characteristics

The following technological characteristics are the same for Quantib Prostate 2.0 and its predicate device Quantib Prostate 1.0:

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

The following technological characteristics are different:

. Software Design: addition of ROI localization initiation on PI-RADS sector map.
Algorithm design and performance: prostate sub-region segmentation added as . seqmentation output.
. Output formats: additionally presented in a PDF report, DICOM RT structure set and DICOM segmentation storage.

7.1 QUALITY AND SAFETY

Quantib Prostate 2.0 is designed in compliance with the following process standards:

ISO 14971 Medical devices Application of risk management to medical devices ●
IEC 62304 Medical device software Software life cycle processes ●
IEC 62366-1 Medical devices part 1 Application of usability engineering to medical ● devices

The following quality assurance measures were applied to Quantib Prostate 2.0 development:

Risk and hazard analysis .
. Design and code reviews
Software verification & validation activities
Performance testing ●
Usability engineering ●
Cybersecurity and vulnerability analysis ●

PERFORMANCE DATA 7.2

The prostate segmentation algorithm and performance are unchanged. For the sub-region segmentation and ROI localization initiation the following performance tests are added:

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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 seqmentation algorithm. This was done by comparing the automatic sub-region segmentation to a 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 inter-observer 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:

The clinical performance test of the sub-region prostate 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 sub-region segmentations and ROI initial localizations using a 5-point Likert scale. It is concluded that sub-regions and ROI localizations are judged to be of high quality.

8 CONCLUSIONS

By virtue of its intended use and physical and technological characteristics, Quantib Prostate 2.0 is substantially equivalent to a device that has been approved for marketing in the United States. The performance data show that Quantib Prostate 2.0 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).