The PtoleMedic System is an on-line orthopedic surgical planning software system. MRI images supply data sufficient to allow accurate modeling of anatomy for on-line surgical planning before knee joint replacement surgery. The surgeon preoperatively plans, reviews, adjusts and orients images to select implant size and create an idealized surgical plan for the first bony cuts only.

Device Description

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.

The ProleMedic System software described here utilized an FDA Guidance Document for industry called "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005". This guidance helped determine submission content and provided a determination of a "MODERATE" level of safety concern for the software. Improper use of software planning or processing could result in harm requiring medical intervention to correct.

The PtoleMedic System software access is only available via a web/cloud-based software interface. The program is a surgeon-directed surgical case Planning package primarily but not exclusively directed at total joint replacement and closely related orthopedic indications.

After completing secure log-in, the user registers, enters case information, requests MRI images, specifies implant size and parameters, sets orientation requirements, reviews expected outcome positioning, and ultimately authorizes the desired surgical plan.

Once the case is physician authorized, additional Lento Medical Innovation engineering review of the case requirements begin converting the physician recommended implant plan into personalized surgical instruments to reproduce the physician created plan. Only Lento Medical Innovation personnel may access engineering modules of the PtoleMedic System software. The engineering staff uses proprietary software to convert the plan parameters into manufacturing output. Manufacturing output means anatomically personalized models to help the surgeon visualize the bony cuts' physical orientation. Trained engineers then convert style/brand of implant, sizing requirements, component orientation, and limb alignments into output to make anatomically fitted models for exclusive use by the surgeon and the specifically named patient.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria related to numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the PtoleMedic System, nor does it describe a study specifically designed to quantify the device's performance against such criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Somersault Vault System) and a reference device (Materialise N.V., SurgiCase System) by detailing:

Its intended use and technological characteristics.
The software development and validation processes followed.
Confirmation that the software meets its defined requirements and specifications through various testing phases.

Here's an attempt to extract and present the information based on your request, highlighting what is implicitly or explicitly stated and what is missing from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Summary from text)
Functional Requirements Met: The device should fulfill all predefined functional requirements as outlined in the Software Requirement Specifications (SRS) and Software Design Specifications (SDS).	"The PtoleMedic System software meets its defined requirements and specifications. All identified test faults are corrected, mitigated, or eliminated as or if they occurred. No test variances remain. Final assessment using a software requirements matrix demonstrated software compliance within the scope of the testing. The PtoleMedic System meets all software requirements. All testing confirms system input equals system output."
Accuracy and Performance Consistent with Predicate: The planning accuracy and performance of the device should be consistent with the predicate device.	"The V&V testing results on the Vault System and the PtoleMedic System provided consistent planning accuracy and performance."
Compliance with Software Validation Guidance: The software development processes and validation activities should conform to FDA Guidance for "Content of Premarket Submissions for Software Contained in Medical Devices."	"Predefined Functional requirements, meeting PtoleMedic System Software Requirement Specifications (SRS), and Software Design Specifications (SDS) demonstrate all attributes and traceability activity, meet US-FDA General Principles of Software Validation and EU-MDR requirements for CE Marking. Software development processes conform with FDA Guidance; 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005'." Verification and Validation activities include accuracy, repeatability, and stress testing per FDA's Guidance for Software Contained in Medical Devices."
Safety and Risk Management: The device's safety concerns should be addressed according to ISO 14971:2017 and EN/ISO-13485:2016, and the FDA's level of concern determination (Moderate).	"Safety concerns identified during risk/hazard analysis follow ISO 14971:2017 and EN/ISO-13485:2016. The Food and Drug Administration cleared the Vault System with a "MODERATE" level of concern. The PtoleMedic System is identical. The risk/hazard analysis follows ISO 14971:2017 and EN/ISO-13485:2016 and the FDA guidance for the level of concern determination."
Accuracy, Repeatability, and Stress Testing: The device must undergo and pass tests for accuracy, repeatability, and stress.	"Verification and Validation activities include accuracy, repeatability, and stress testing per FDA's Guidance for Software Contained in Medical Devices." (The text states these activities were performed, implying they were passed, but specific results are not provided).
Absence of Test Variances: All identified test faults should be corrected, mitigated, or eliminated.	"All identified test faults are corrected, mitigated, or eliminated as or if they occurred. No test variances remain."
Imaging Modality Handling: The system should accurately process DICOM MRI images for surgical planning.	"The ProleMedic System provides restricted, secure web-based access for total joint replacement surgical planning. Both systems (PtoleMedic and Vault) use digital DICOM-based data from pre-operative MRI scans of the operative limb... All systems (PtoleMedic, Vault, Materialise) can utilize MRI-based images to size, orient, and position various implant components and locate the desired bony tissue resections. Each software system orients the distal femur and proximal tibia's primary bone cut to facilitate the chosen implants' placement. All systems use DICOM compliant digital image data for Planning, image display, overlay manipulation, and machine code processing to produce anatomic models if requested."

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

The document does not specify a sample size for a "test set" in the context of a clinical performance study using patient data. The testing mentioned refers to software verification and validation (V&V) activities against predefined functional requirements.

Test Set Sample Size: Not specified. The V&V activities involved "bench and phantom models" for software performance data.
Data Provenance: Not specified for any specific patient data used in performance evaluation. The "MRI images supply data" for general system functionality, but there's no mention of a specific dataset for performance testing.

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

This information is not provided. The V&V activities mentioned seem to be primarily software-centric (system requirements tests, unit tests, integration tests, functional tests, system tests), rather than clinical performance evaluation that would typically involve expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As no patient-based clinical "test set" requiring expert adjudication is described, no adjudication method is mentioned.

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

This information is not provided. The document focuses on demonstrating substantial equivalence through technological comparison and software V&V, not through a comparative effectiveness study involving human readers with and without AI assistance. Therefore, there is no effect size reported for human reader improvement.

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

The document describes the PtoleMedic System as an "on-line orthopedic surgical planning software system" where the "surgeon preoperatively plans, reviews, adjusts and orients images to select implant size and create an idealized surgical plan." This indicates a human-in-the-loop system. While the software has "consistent planning accuracy and performance" validated through V&V, a standalone algorithm-only performance study, independent of human interaction, is not described. The software's output, a "personalized surgical plan" and "anatomically personalized models," is directly derived from and used by human surgeons.

7. Type of Ground Truth Used

For the software verification and validation:

The "ground truth" implicitly used is the predefined software requirements and specifications (SRS and SDS). The testing aims to confirm that the software's output matches these requirements.
The text also mentions validation activities used "bench and phantom models". For these, the geometric accuracy or known properties of the phantom models would serve as ground truth for assessing measurements or planning.

There is no mention of ground truth established by expert consensus, histology/pathology, or outcomes data in the context of device performance claims.

8. Sample Size for the Training Set

This information is not provided. The document describes software validation and equivalence, not the development or training of an AI/ML model for which a "training set" would be typically used. It is possible the system uses rule-based logic or traditional image processing rather than machine learning requiring a training set, or if it does use ML, the training set details are not disclosed in this summary.

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

This information is not provided, as details about a "training set" are absent from the document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.

Lento Medical Innovation, Inc. % Mr. David Schlerf V.P., CQR 15110 Northwest Freeway, Suite 150 HOUSTON TX 77040

Re: K202521

Trade/Device Name: PtoleMedic System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: March 15, 2021 Received: March 19, 2021

Dear Mr. Schlerf:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

May 4, 2021

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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 medical devices and radiation-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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

Lento "PtoleMedic System"

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

EF PSC. Publishing Services (301) 443-6740

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510(k) Summary Per 21 CFR 807.92

SUBMITTER

Lento Medical Innovation, Inc. 15110 Northwest Freeway Suite 150 Houston, TX 77040 Phone: 510-413-7013 Fax: 510-413-7020

Contact Person: David W. Schlerf, V.P., CQR 925.768.0247 davidschlerf@lentomedical.com

Prepared: April 30, 2021

SUBMISSION DEVICE

Name of Device: PtoleMedic System, Release 1.3.x

Common or Usual Name: Surgical Planning Software

Product Name: PtoleMedic System - Surgical Planning Software

Regulatory Class: Class II

Product Code: LLZ.

PREDICATE DEVICE

Somersault Vault System, K124051 The predicate device was never the subject of a design-related recall.

REFERENCE DEVICE

A reference device was used in this submission, Materialise N.V., SurgiCase System, K 113599 The reference device was never the subject of a design-related recall.

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DEVICE DESCRIPTION

Per Code of Federal Regulation:

Sec. 892.2050 - Medical Image Management and Processing System

$ 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.

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INDICATIONS FOR USE

"The PtoleMedic System is an on-line orthopedic surgical planning software system. MRI images supply data sufficient to allow accurate modeling of anatomy for on-line surgical planning before knee joint replacement surgerv. The surgeon preoperatively plans, reviews, adjusts and orients implant images to select implant size and create an idealized surgical plan for the first bony cuts only."

The Indications for Use statement for the Somersault Vault System, while not identical in scope, includes surgical case planning and digital file output suitable for CNC machining. The Vault System provided planning for additional major joint locations, whereas Lento's PtoleMedic System is limited to total knee replacement procedures only and the creation of anatomic models representative of the planned bony resections for use as a visual aid.

The PtoleMedic System device, the predicate device, and the reference device share a common intended use. All are for orthopedic surgical joint replacement planning, and all systems are classified within ProCode; LLZ.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

As with the Somersault Vault System, the ProleMedic System provides restricted, secure webbased access for total joint replacement surgical planning. Both systems use digital DICOM-based data from pre-operative MRI scans of the operative limb, including the spatial location of the hip, knee, and ankle complex.

Both planning systems can create accurate anatomic models of the distal femur and tibia, representing the planned positioning of the bony cuts needed to align the implants the surgeon has chosen to use. Both systems are surgeon-controlled and directed. Both systems allow the surgeon to identify their preferred implant brand for use in Planning. Finally, the surgeon authorizes the plan and, if requested, a custom anatomic model of the resultant bone cuts may be supplied.

Both systems' software performance data are based upon current software development methodology, including defined bench and phantom models. Verification and Validation activities are identical and fully demonstrate planned objective test conditions are satisfactory. The V&V testing results on the Vault System and the PtoleMedic System provided consistent planning accuracy and performance.

Predefined Functional requirements, meeting PtoleMedic System Software Requirement Specifications (SRS), and Software Design Specifications (SDS) demonstrate all attributes and traceability activity, meet US-FDA General Principles of Software Validation and EU-MDR requirements for CE Marking.

Software development processes conform with FDA Guidance; "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005".

Level of Concern determination for both the Vault System and the PtoleMedic System is "MODERATE" as determined by FDA for the Vault System. Safety concerns identified during

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risk/hazard analysis follow ISO 14971:2017 and EN/ISO-13485:2016. Validation includes accuracy, repeatability, and stress testing per FDA's Guidance for Software Contained in Medical Devices. Software testing addressed the following areas of function as related to development engineers and users.

. Test Planning
. System Requirements Tests (SRS)
Acceptance Test Execution .
Structural Test Identification ●
Functional Test Identification ●
. Unit (Module) Tests (SDS)
. Integration Tests (High Level) (SDS)
Unit (Module) Testing
. System Integration Testing
. Functional Testing
. System Testing
. Test Result Evaluation
Error Evaluation/Resolution .
Traceability Review and Analysis .
Final Test Reports .

The PtoleMedic System software meets its defined requirements and specifications. All identified test faults are corrected, mitigated, or eliminated as or if they occurred. No test variances remain. Final assessment using a software requirements matrix demonstrated software compliance within the scope of the testing. The PtoleMedic System meets all software requirements. All testing confirms system input equals system output.

The PtoleMedic System software is to be marketed in the USA as surgical planning software. The predicate comparison software system (Vault System) and the other reference software system(s) offered by Materialise. NV. Both software systems take advantage of existing PC-type hardware. browsers, and internet access with high-resolution viewers. Both systems utilize digital DICOM images to view, plan, print, and produce models and physical representations of the planned bony resections.

The technology utilized in creating and controlling the PtoleMedic System software is well understood. Several orthopedic software companies. Somersault, in particular, promote a virtually identical product. The equivalent software systems also offer orthopedic surgical planning software wherein a digital CT/MRI data file provides the basis for a prescriptive order for patientspecific anatomic information (Personalized Surgical Plan). The ability to identify specific anatomic features and landmarks allows for accurate sizing, positioning, and marking tissue before cutting based on a patient's unique anatomy.

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System Similarities:

The PtoleMedic System and the equivalent Vault System use an image-based approach to interactive pre-operative Planning, visualization, printing with the potential creation of accurate patient-specific pre and post-resection models. The PtoleMedic System, the Vault System, and the Materialise software share the following fundamental characteristics and functions:

. Computer/browser/internet based
Support for orthopedic Total Knee Replacement (TKR) ●
. Utilize MRI DICOM based digital images for an accurate depiction of individual anatomy, incorporating a traditional mechanical axis alignment philosophy
An individualized plan for each patient ●
Comparable cyber-secure systems for enrollment, upload/download, presurgical ● Planning, visualizing, implant alignment and sizing, annotating and editing medical image data
. Controllable alignment variables include sizing, rotation (IR/ER), flexion, extension & varus/valgus angles
The surgeon created and approved plans to set the femoral and tibial resection locations ●

All systems can utilize MRI-based images to size, orient, and position various implant components and locate the desired bony tissue resections. Each software system orients the distal femur and proximal tibia's primary bone cut to facilitate the chosen implants' placement. All systems use DICOM compliant digital image data for Planning, image display, overlay manipulation, and machine code processing to produce anatomic models if requested.

System Differences:

Vault System supports all major joint Planning.
PtoleMedic System is focused on Total Knee Replacement procedures only ●
Materialise System is brand specific. .
PtoleMedic System and Vault System are brand agnostic. .
. Materialise System requires the creation of 3D models for Planning and whole image segmentation.
. PtoleMedic System utilizes multi-plane 2D slices to establish spatial orientation and resection angulation and location

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Substantial Equivalence Table

Feature	Lento PtoleMedic System	Somersault Vault System	Materialise Reference System	SE.
Intended Use:	The PtoleMedic System is an on-line orthopedic surgical planningsoftware system. MRI imagessupply data sufficient to allowaccurate modeling of anatomy foron-line surgical Planning beforejoint replacement surgery. Thesurgeon preoperatively plans,reviews, adjusts, and orientsimplant images to select implantsize and create an idealizedsurgical plan for the first bony cutsonly.	The Vault System is intended foruse as a software interface andimage manipulation system for thetransfer of imaging information froma medical scanner such asComputerized Axial Tomography(CT) or Magnetic ResonanceImaging (MRI). It is also intended aspre-operative software forsimulating/evaluating implantplacement and surgical treatmentoptions. The physician chooses theoutput data file for printing and/orsubsequent use in CAD modeling orCNC/Rapid-prototyping.	The SurgiCase System is intended foruse as a software interface and imagesegmentation system for the transfer ofimaging information from a medicalscanner such as a CT scanner or aMagnetic Resonance Imaging scanner.It is also intended as pre-operativesoftwarefor simulating/ evaluatingimplantplacementandsurgicaltreatment options.	Yes
Classification:	Class II	Class II	Class II	Yes
ProCode:	LLZ	LLZ	LLZ	Yes
Internetaccessrequired:	YES	YES	YES	Yes
Runs onCloudServer:	YES	YES	YES	Yes
DigitalOverlayImplants:	YES	YES	YES	Yes
Pre-operativePlanning:	YES	YES	YES	Yes
A plan created,reviewed &authorizedby surgeon:	YES	YES	YES	Yes
Imaging modality	DICOM	YES	YES	Yes
Cautions:	Uploaded images must pass QC forImage quality and anatomic detail	SAME	SAME	Yes
FemoralResectionLevel:	Based on anatomic features,mechanical alignment &posterior referencing	SAME	SAME	Yes
Tibial ResectionLevel:	Based on anatomic features,mechanical alignment	SAME	SAME	Yes
Flex, extension,tibial slope:	Based on anatomic features,mechanical alignment	SAME	SAME	Yes
Overall limbalignment:	Based on mechanical alignment	SAME	SAME	Yes
Alignment Options:	Mechanical Alignment & NeutralBoundary Alignment (NBA)	Mechanical Alignment	Mechanical Alignment	Yes
Implant sizing:	Based on anatomic features	SAME	SAME	Yes
Verification tools:	Intraoperative	SAME	SAME	Yes
ImplantTypes supported:	A physician identified, Non-customimplant	SAME	SAME	Yes
K-Number	K202521	K124051	K113599	Yes

CONCLUSION

Lento Medical Innovation, Inc. believes the documentation submitted demonstrates the PtoleMedic System is as safe and effective as the predicate systems. No new indications, uses, capabilities, or technological characteristics are proposed, suggested, or requested uses for the PtoleMedic System software are already available from other manufacturers offering legally marketed devices in the USA and EU.

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Software development processes conform with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005".

The Food and Drug Administration cleared the Vault System with a "MODERATE" level of concern. The PtoleMedic System is identical. The risk/hazard analysis follows ISO 14971:2017 and EN/ISO-13485:2016 and the FDA guidance for the level of concern determination.

Verification and Validation activities include accuracy, repeatability, and stress testing per FDA's Guidance for Software Contained in Medical Devices. Software testing addressed the following areas of function as related to development engineers and users.

Test Planning
System Requirements Tests (SRS)
Acceptance Test Execution ●
Structural Test Identification .
. Functional Test Identification
Unit (Module) Tests (SDS)
. Integration Tests (High Level) (SDS)
Unit (Module) Testing
System Integration Testing ●
. Functional Testing
System Testing
. Test Result Evaluation
Error Evaluation/Resolution .
Traceability Review and Analysis .
Final Test Reports .

The ProleMedic System software meets its defined requirements and specifications. All identified test faults are corrected, mitigated, or eliminated as or when they occurred. No test variances remain. Final assessment using a software requirements matrix demonstrated software compliance within the scope of the testing. The PtoleMedic System meets all software requirements. All testing confirms system input equals system output.

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).