qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of qp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.

Device Description

qp-Prostate is a medical image viewing, processing and analyzing software package for use by a trained user or healthcare professional, including radiologists specialized in prostate imaging, urologists and oncologists. These prostate MR images, when interpreted by a trained physician, may yield clinically useful information.

qp-Prostate consists of a modular platform based on a plug-in software architecture. Apparent Diffusion Coefficient (ADC) post-processing and Perfusion - Pharmacokinetics post-processing (PKM) are embedded into the platform as plug-ins to allow prostate imaging quantitative analysis.

The platform runs as a client-server model that requires a high-performance computer installed by QUIBIM inside the hospital or medical clinic network. The server communicates with the Picture Archiving and Communication System (PACS) through DICOM protocol, qp-Prostate is accessible through the web browser (Google Chrome or Mozilla Firefox) of any standard "off-the-shelf" computer connected to the hospital/center network.

The main features of the software are:

Query/Retrieve interaction with PACS;
Apparent Diffusion Coefficient (ADC) post-processing (MR imaging);
Perfusion Pharmacokinetics (PKM) post-processing (MR imaging);
DICOM viewer; and
Structured reporting.

The software provides MR imaging analysis plug-ins to objectively measure different functional properties in prostate images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the qp-Prostate device, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance. Instead, it describes performance testing conducted to demonstrate functional equivalence and safety and effectiveness compared to a predicate device. The performance data generally aims to show the device functions as intended and is comparable to the predicate.

The closest we can get to a "table of acceptance criteria and reported device performance" is by looking at the types of tests done and the general conclusions.

Implicit Acceptance Criteria (Inferred from testing and purpose):

Accuracy of Diffusion-ADC and Perfusion-Pharmacokinetics (PKM) calculations: The device should accurately compute these parameters.
Accuracy of algorithmic functions: The Spatial Smoothing, Registration, Automated Prostate Segmentation, Motion Correction, and automated AIF selection algorithms should perform correctly.
Equivalence to Predicate Device: The performance of qp-Prostate should be comparable to the Olea Sphere v3.0, especially in quantitative outputs.
Functionality as intended: All listed features (Query/Retrieve, DICOM viewer, Structured reporting, etc.) should work correctly.

Reported Device Performance (from the document):

Diffusion-ADC and Perfusion-Pharmacokinetics (PKM) analysis modules: Evaluated using QIBA's Digital Reference Objects (DROs), including noise modeling, for technical performance. The document concludes that the "tests results demonstrate that qp-Prostate functioned as intended."
Algorithmic functions (Spatial Smoothing, Registration, Automated Prostate Segmentation, Motion Correction, AIF selection): Tested using a dataset of prostate clinical cases. The document states "performance testing with prostate MR cases" was conducted.
Comparison to Predicate Device: Performed using 157 clinical cases, demonstrating that the device is "as safe and effective as its predicate device, without introducing new questions of safety and efficacy."
Overall Conclusion: "Performance data demonstrate that qp-Prostate is as safe and effective as the OLEA Sphere v3.0. Thus, gp-Prostate is substantially equivalent."

Since no specific numerical thresholds for accuracy or performance metrics are provided in the document, a quantitative table cannot be generated. The acceptance is based on successful completion of the described performance tests and demonstrating substantial equivalence.

Study Details

Here's the detailed information regarding the studies:

1. Sample sized used for the test set and the data provenance:

Digital Reference Object (DRO) Analysis (Bench Testing):
- Sample Size: Not explicitly quantified as "sample size" in terms of number of patient cases, but rather refers to universally accepted digital reference objects from QIBA.
- Provenance: These are synthetic or standardized digital objects designed for technical performance evaluation, not originating from specific patients or countries.
Clinical Testing of Algorithms (Motion Correction, Registration, Spatial Smoothing, AIF Selection, Prostate Segmentation):
- Motion Correction algorithm: 155 DCE-MR and DWI-MR prostate sequences from 155 different patients.
- Registration algorithm: 112 T2-Weighted MR, DCE-MR, and 108 DWI-MR prostate sequences from different patients.
- Spatial Smoothing algorithm: 51 transverse T2-weighted, DCE-MR, and DWI-MR prostate sequences from 51 different patients.
- AIF selection algorithm: 242 DCE-MR prostate sequences from 242 different patients.
- Prostate Segmentation algorithm: 243 transverse T2-weighted MR prostate sequences from 243 different patients.
- Provenance for these clinical cases: The document states they were "acquired from different patients in different machines with multiple acquisition protocols" and from "different three major MRI vendors: Siemens, GE and Philips, magnetic field of 3T and 1.5T cases." There is no explicit mention of the country of origin or whether the data was retrospective or prospective, though "clinical cases" used for validation often imply retrospective use of existing data.
Comparison to Predicate Device:
- Sample Size: 157 T2-weighted MR, DCE-MR, and 141 DWI-MR prostate sequences from different patients.
- Provenance: Similar to the algorithmic clinical testing, from "different patients in different machines with multiple acquisition protocols" and from "different three major MRI vendors: Siemens, GE and Philips, magnetic field of 3T and 1.5T cases."

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

The document does not explicitly state the number of experts used or their specific qualifications (e.g., years of experience as radiologists) for establishing ground truth for the clinical test sets.
For the Digital Reference Object (DRO) analysis, the "ground truth" is inherent to the design of the DROs themselves (proposed by QIBA), rather than established by human experts for each test.

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

The document does not specify any adjudication method used for establishing ground truth or for resolving discrepancies in the test sets.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study assessing human reader improvement with AI assistance was not performed or reported in this document. The study compared the device's technical performance and its output with that of a predicate device, not with human readers or human readers assisted by AI.

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

Yes, the performance testing described is primarily standalone. The "bench testing" with DROs and the "clinical testing" of the algorithms (Motion Correction, Registration, etc.) evaluate the device's inherent performance without a human-in-the-loop scenario. The comparison to the predicate device also assesses the algorithm's output directly against the predicate's output. The device itself is described as "an image processing software package to be used by trained professionals" and "does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data," which points to it being a tool that supports human interpretation rather than replacing it.

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

Bench Testing (DWI & DCE): Digital Reference Objects (DROs) proposed by QIBA, which serve as a synthetic, known ground truth for quantitative accuracy.
Clinical Testing of Algorithms & Comparison to Predicate: The document does not explicitly define the ground truth for these clinical performance tests. Given that it's comparing the outputs of image processing algorithms, the ground truth would likely involve:
- Reference standard values: For quantitative parameters like ADC, Ktrans, kep, ve, it would likely involve comparing the device's calculated values against a recognized reference standard or the predicate's output considered as a benchmark.
- Visual assessment/Expert review: For the performance of segmentation, registration, and motion correction, expert radiologists would visually assess the accuracy of the algorithm's output to determine if it "functioned as intended."
- The statement "comparison against the predicate device" implies the predicate's output is used as a reference point.

7. The sample size for the training set:

The document does not provide any information on the sample size used for the training set of the algorithms. It focuses solely on the validation and verification performed post-development.

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

Since no information on the training set or its sample size is provided, there is also no information on how the ground truth for the training set was established.

Summary

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February 4, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.

QUIBIM S.L. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20005

Re: K203582

Trade/Device Name: qp-Prostate Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 7, 2020 Received: December 7, 2020

Dear Dr. Smith:

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. 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

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510(k) Number (if known) K203582

Device Name

ap-Prostate

Indications for Use (Describe)

gp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of qp-Prostate. gp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY QUIBIM's qp-Prostate

K203582

CONTACT DETAILS

Submitter

QUIBIM, S.L.

Avenida Aragón 30, 12th floor, Office I, 46021 Valencia (Spain)

Phone:

+34 961 243 225 .
+34 686 784 484 .

Contact Person:

. Ángel Alberich Bayarri, CEO and Founder of QUIBIM (angel@quibim.com)
. Belén Fos Guarinos, Quality Assurance and Regulatory Affairs Manager (belenfos@quibim.com)

Date Prepared:

January 28, 2021

DEVICE INFORMATION

Name of Device: qp-Prostate

Common or Usual Name: PACS

Classification Name: 892.2050 Picture archiving and communications system (LLZ)

Regulatory Class: Class II

Classification Panel: Radiology

LEGALLY MARKETED PREDICATE DEVICE

Manufacturer's name: OLEA Medical (93 avenue des Sorbiers, Zone Athelia IV La Ciotat 13600, France)
Device's trade name: Olea Sphere v3.0
. 510(k) number: K152602
Product code: LLZ ●

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INTENDED USE / INDICATIONS FOR USE

qp-Prostate is an image processing software package to be used by trained professionals, including radiologists specialized in prostate imaging, urologists and oncologists. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing and analysis of prostate MR images. Data and images are acquired through DICOM compliant imaging devices and modalities. Patient management decisions should not be based solely on the results of gp-Prostate. qp-Prostate does not perform a diagnostic function, but instead allows the users to visualize and analyze DICOM data.

DEVICE DESCRIPTION

gp-Prostate is a medical image viewing, processing and analyzing software package for use by a trained user or healthcare professional, including radiologists specialized in prostate imaging, urologists and oncologists. These prostate MR images, when interpreted by a trained physician, may yield clinically useful information.

The platform runs as a client-server model that requires a high-performance computer installed by QUIBIM inside the hospital or medical clinic network. The server communicates with the Picture Archiving and Communication System (PACS) through DICOM protocol, gp-Prostate is accessible through the web browser (Google Chrome or Mozilla Firefox) of any standard "off-the-shelf" computer connected to the hospital/center network.

The main features of the software are:

1. Query/Retrieve interaction with PACS;
1. Apparent Diffusion Coefficient (ADC) post-processing (MR imaging);
1. Perfusion Pharmacokinetics (PKM) post-processing (MR imaging);
1. DICOM viewer; and
1. Structured reporting.

The software provides MR imaging analysis plug-ins to objectively measure different functional properties in prostate images:

The software can communicate with any Picture Archiving Communications System (PACS) through the DICOM standard. This communication includes standard Query/Retrieve DICOM operations in order to receive prostate MR image studies in qp-Prostate. Once the complete prostate MR study has been received, qp-Prostate will check the available sequences. For a successful launch of qp-Prostate, the study must include at least:

-the T2-weighted MR sequence and the Diffusion Weighted Imaging (DWI) or -the T2-weighted MR sequence and the Dynamic Contrast Enhanced (DCE) or

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-the T2-weighted MR sequence, the DWI and the DCE.

If the DWI sequence is available and it complies with the required acquisition protocol, the Diffusion ADC analysis will be launched. Imaging processing steps, such as spatial smoothing and motion correction between the different b-values are proposed before applying the monoexponential model for ADC calculation. The Diffusion-ADC post-processing and analysis plugin for prostate MR imaging calculates a parameter related to the degree of water molecules mobility in tissues. The Apparent Diffusion Coefficient (ADC)[s/mm²] is given in order to evaluate the diffusion signal decay in regions. The ADC is calculated by applying the mono-exponential model of the diffusion signal, assessing the signal attenuation that occurs at least at two different b values. The final result of the DWI workflow includes ADC parametric maps, which represent the ADC value for each voxel of the image.
If the DCE sequence is available and it complies with the required acquisition protocol, the Perfusion analysis will be launched. Imaging processing steps, such as spatial smoothing, motion correction and Arterial Input Function (AIF) selection are proposed before applying the standard Tofts model with one input and two compartments for Kirans, kep and ve calculation. The Perfusion - Pharmacokinetics post-processing and analysis plugin for prostate MR imaging calculates parameters related to the vascular environment of the tissue, which are based on the quantitative pharmacokinetic assessment of Dynamic Contrast-Enhanced Magnetic Resonance Images (DCE-MRI). The transfer constant (K(fans)[min']), extraction rate (kep) [min-1] and extra-vascular and extra-cellular volume (ve) [%] are given in order to evaluate the leakage of injected contrast media from intra-vascular to interstitial space. The final results of the DCE workflow include Ktrans, kep and ve parametric maps, which represent perfusion for each voxel of the image.
The software includes a DICOM viewer to improve the review process of a single study and its related image sequences. The viewer has basic image manipulation and segmentation capabilities and advanced segmentation ones for prostate.
The software includes a Structured Reporting option for filling a standard PI-RADS® v2.1 template [Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. American College of Radiology].

qp-Prostate does not perform a diagnostic function, but instead allows the radiologist to visualize and analyze DICOM data with the possibility of verifying the quality and editing the output of each step of the process.

COMPARISON TO PREDICATE DEVICE

The subject and predicate devices are based on the following same technological elements:

Both devices work with DICOM 3.0 images retrieved from PACS systems, and can . export data back to those PACS systems.
Both have integrated slice views with MPR, segmentation and ROI tools, and . image filtering.
. Both devices perform study management and structured report generation.

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Both uniquely identify users and maintain audit trails of user actions. ●
. Both have a modular architecture for analysis tools and include modules for perfusion and diffusion for MR cases.

The following technological differences exist between the subject and predicate devices:

Olea Sphere can import and export to the local file system, whereas qp-Prostate ● does not.
. Olea Sphere can perform perfusion calculations for both MR and CT, whereas qp-Prostate only does so for MR data.
. qp-Prostate software only includes two analysis modules for perfusion (Perfusion – Pharmacokinetics, PKM) and diffusion (Diffusion - ADC) calculations, whereas Olea Sphere includes more modules.
qp-Prostate software is indicated only for prostate MR images whereas OLEA covers more anatomical areas, including prostate.

Taken individually and together, these differences do not affect the substantial equivalence; both products are still using the same technological basis. Software validation and verification testing, as well as performance data, confirm that the qp-Prostate functionalities do not raise different questions of safety or effectiveness compared to the predicate, and support substantial equivalence.

A table comparing the key features of the subject and predicate devices is provided below.

Table 1. Comparison of key features of the subject (qp-Prostate, QUIBIM) and the predicatedevice (OLEA Sphere 3.0, OLEA Medical)
FEATURE	qp-Prostate	Olea Sphere V3.0

FEATURE	qp-Prostate	Olea Sphere V3.0K152602
REGULATORY DATA
Regulatory Class	II	II
Regulation name	Picture archiving andcommunicationssystem (PACS)	Picture archiving andcommunications system (PACS)
Regulation number	21 CFR 892.2050	21 CFR 892.2050
Classification Panel	Radiology	Radiology
Product code	LLZ	LLZ
Manufacturer	QUIBIM	Olea Medical
FDA clearance	-	K152602
INTENDED USE
Indications for use	qp-Prostate is an image processingsoftware package to be used bytrained professionals, including	Olea Sphere V3.0 is an imageprocessing software package tobe used by trained professionals
FEATURE	qp-Prostate	Olea Sphere V3.0K152602
	radiologists specialized in prostateimaging, urologists and oncologists.The software runs on a standard"off-the-shelf" workstation and canbe used to perform image viewing,processing and analysis of prostateMR images. Data and images areacquired through DICOM compliantimaging devices and modalities.Patient management decisionsshould not be based solely on theresults of qp-Prostate. qp-Prostatedoes not perform a diagnosticfunction, but instead allows theusers to visualize and analyzeDICOM data.	including, but not limited to,physicians and medicaltechnicians. The software runs ona standard "off-the-shelf"workstation and can be used toperform image viewing,processing, image collage andanalysis of medical images. Dataand images are acquired throughDICOM compliant imagingdevices and modalities.
CHARACTERISTICS
Supported imageformat	DICOM 3.0	DICOM 3.0
Type of scans	MR	MR, CT
Data import	PACS	PACS or file system
Data export	PACS	PACS or file system
Image loading andsaving	Yes	Yes
Integrated slice viewer	Yes	Yes
Multi-planar	Yes	Yes
MPR/3D	Yes	Yes
Segmentation tools	Yes	Yes
ROI tools	Yes	Yes
Image Processing	Yes	Yes
Study Managementtools	Yes	Yes
Structured reportgeneration	Yes	Yes
License ManagementSystem	Yes	Yes
Unique user log-in andpassword	Yes	Yes
User audit trails	Yes	Yes
Modular analysis plug-in	Yes	Yes
FEATURE	qp-Prostate	Olea Sphere V3.0K152602
Intended useenvironment	Hospitals / imaging centers orclinics	Hospitals / imaging centers orclinics
Intended user	Radiologists specialized inprostate imaging, urologists andoncologists.	Trained professionals includingbut not limited tophysicians and medicaltechnicians
Intended patientpopulation	Any patient for which PACS MRprostate data exists.	Any patient for which PACS dataexists.
Image post-processingand analysis plugins	Not included	DCE (for MR Imaging) Kinetics -semi quantitative maps(AUC, Peak enhancement map,Peak percentage enhancement,Time to maximum enhancement,Washin, Washout, Relativewashout,Signal Enhancement Ratio)
	DCE (for prostate MRimaging) Perfusion –PharmacokineticsModelling( $K^{trans}$ [min-1], $k_{ep}$ [min-1], $v_e$ [%])	DCE (for MR imaging) Permeability– Quantitative parameter maps( $K^{trans}$ , $k_{ep}$ , $V_p$ , $v_e$ , signal toconcentration time curveconversion with fixed bloodand tissue T1 values)
	Not included	DWI (for MR Imaging) Intra - VoxelIncoherent Motion IVIM(ADC, D, D*, f)
	DWI (for MR Imaging) ApparentDiffusionCoefficient (ADC [mm2/s])	DWI (for MR Imaging) ApparentDiffusion Coefficient(ADC)
	Not included	Yes (T1 and T2 Mapping)
	Not included	Metabolic (hepatic fat fraction FF)

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Thus, qp-Prostate device is substantially equivalent to the Olea Sphere V3.0 (K152602) from OLEA Medical.

PERFORMANČE DATA

PERFORMANCE TESTING - BENCH

The following bench testing was performed on the subject device per the following draft guidance: "Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions" (April 19, 2019) for the unitary validation of the different parts that constitute qp

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Prostate. qp-Prostate is aimed for diffusion and perfusion analysis of prostate MR cases, providing quantitative information useful to assist the professional in completing the prostate structured report template.

One of tests is the analysis of digital reference objects (DROs) proposed by QIBA, available for DWI and DCE, considered as ground truth. For both Perfusion-Pharmacokinetics (PKM) and Diffusion-ADC analysis modules, DROs, including presence and absence of noise modeling, are used for technical performance evaluation.

Modules
qp-Prostatefunctionality	Test type	Dataset
Diffusion - ADCanalysis module	Digital ReferenceObject Analysis(Diffusion - ADC)	QIBA's DiffusionWeighted Imaging(DWI) DigitalReference Object(DRO)
Perfusion -Pharmacokineticsanalysis module	Digital ReferenceObject Analysis(Perfusion –Pharmacokinetics)	QIBA's DynamicContrast-Enhanced(DCE) MR perfusionDRO

Table 2. qp-Prostate's Performance Bench Testing for Diffusion and Perfusion Analysis Modules

PERFORMANCE TESTING - CLINICAL

A dataset of prostate clinical cases was used for the validation of the algorithms integrated in qp-Prostate v1.0.0 such as Spatial Smoothing algorithm, Registration algorithm, Automated Prostate Segmentation algorithm, Motion Correction algorithm and automated AIF selection algorithm.

The other assessment is the comparison against the predicate device (OLEA Sphere, v3.0, K152602), using 157 clinical cases of prostate MRI. The dataset includes cases from different three major MRI vendors: Siemens, GE and Philips, magnetic field of 3T and 1.5T cases and different technical parameters that make up the broad spectrum of cases allowed in our recommended protocol (T2w + DWI + DCE).

Table 3. qp-Prostate's Performance Clinical Testing and Comparison with the Predicate Device

qp-Prostatefunctionality	Test type	Dataset
Motion Correctionalgorithm	Performancetesting withprostate MRcases	155 DCE-MR and DWI-MRprostate sequences acquired form155 different patients in differentmachines with multiple acquisitionprotocols
Registration algorithm	Performancetesting with	112 T2-Weighted MR, DCE-MRand 108 DWI-MR prostatesequences acquired from different

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	prostate MR	patients in different machines with
	cases	multiple acquisition parameters
Spatial Smoothingalgorithm		51 transverse T2-weighted, DCE-
	Performance	MR and DWI-MR prostate
	testing with	sequences acquired from 51
	prostate MR	different patients in different
	cases	machines with multiple acquisition
		protocols
AIF selectionalgorithm	Performance	242 DCE-MR prostate sequences
	testing with	acquired from 242 different
	prostate MR	patients in different machines with
	cases	multiple acquisition protocols
ProstateSegmentationalgorithm	Performance	243 transverse T2-weighted MR
	testing withprostate MRcases	prostate sequences acquired from
		243 different patients in different
		machines with multiple acquisition
		protocols.
Comparison to thePredicate Device(OLEA Sphere, v3.0,K152602)		157 T2-weighted MR, DCE-MR
	Comparison to	and 141 DWI-MR prostate
	predicate	sequences acquired form different
	device	patients in different machines with
		multiple acquisition protocols

SOFTWARE VERIFICATION & VALIDATION

gp-Prostate software was developed according to FDA recognized consensus standards for software development. Software verification and validation was performed following V&V plans and protocols verifying that product specifications were met.

The tests results demonstrate that qp-Prostate functioned as intended, is acceptable for clinical use, and is as safe and effective as its predicate device, without introducing new questions of safety and efficacy.

CONFORMANCE STANDARDS

The qp-Prostate complies with the following FDA recognized consensus standards:

ISO 62304:2006/A1:2016 Medical device software - Software life cycle processes
ISO 14971 Medical devices Applications of risk management to medical devices ●
ISO 82304:2016 Health software Part 1: General requirements for product safety ●
IEC 60601-1 Medical electrical equipment -- Part 1-2: General requirements for basic ● safety and essential performance -- Collateral Standard: Electromagnetic disturbances -- Requirements and tests
. IEC 62366 Medical devices - Part 1: Application of usability engineering to medical devices
ISO 80002 Medical device software Part 1: Guidance on the application of ISO 14971 ● to medical device software

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In addition, the device also complies with the following consensus standards:

. ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes

CONCLUSIONS

qp-Prostate is as safe and effective as the Olea Sphere v3.0. qp-Prostate has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. In addition, the minor technological differences between qp -Prostate and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that qp-Prostate is as safe and effective as the OLEA Sphere v3.0. Thus, gp-Prostate is substantially equivalent.

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).