The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.

The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.

3D digital representations of various implant models are available in the planning software. Preview Shoulder allows the user to digitally perform the surgical planning by showing a representation of the patient's shoulder anatomy as a 3D model and allows the surgeon to place the implant in the patient's anatomy.

The software allows the surgeon to generate a report, detailing the output of the planning activity.

Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Device Description

The Preview Shoulder, a 3D total shoulder arthroplasty (TSA) surgical planning software, is a standalone software application which assists the surgeon in planning reverse and anatomic shoulder arthroplasty. Preview Shoulder includes 3D digital representations of implants for placement in images used for surgical planning. Preview Shoulder is a secure software application used by qualified or trained surgeons and is accessed by authorized users.

The primary function of Preview Shoulder is to receive and process DICOM CT image(s) of patients. Preview Shoulder can be used to place an implant in the original CT image and place an implant in the 3D model of reconstructed bone. The Preview Shoulder allow the user to perform surgical planning and generate an output surgical report. Preview Shoulder does not provide a diagnosis or surgical recommendation. The surgeon is responsible for selecting and placing the implant model for pre-surgical planning purposes.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study information for the "Preview Shoulder" device, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., minimum accuracy percentages, specific error margins). Instead, the bench testing section describes the goals of validation as:

"assess the safety and effectiveness of the device"
"demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon"
"demonstrate the safety and efficacy of the device to meet its intended use and specifications"
"measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)"
"All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use. All user features have been validated by surgeons."

Given this, the table for reported performance will focus on the qualitative outcomes described:

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Effectiveness demonstrated	"Software Verification and Validation testing was performed... to assess the safety and effectiveness of the device." "The software has been verified via code reviews and automated and manual testing." "All validation testing was performed on a fully configured system... to emulate intended use."
Accurate and repeatable 3D reconstructed bones and surgical coordinates	"Testing verified that the system performs as intended." "The measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)."
Device meets intended use and specifications	"demonstrate the safety and efficacy of the device to meet its intended use and specifications." "All user features have been validated by surgeons."
Measurement capabilities equivalent to benchmark tool (Osirix MD K101342)	"The measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)." (No specific metrics or quantitative equivalence reported in this document, only that it was "significantly equivalent" - this likely implies pre-defined bounds were met).
Performance on anonymized patient shoulder CT images reflecting intended use and adult population	"All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use." "Preview Shoulder has been validated using adult patient images."
Validation of user features by surgeons	"All user features have been validated by surgeons."

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

Test Set Sample Size: Not explicitly stated. The text only mentions "anonymized patient shoulder CT images" were used.
Data Provenance: "anonymized patient shoulder CT images". The country of origin is not specified, nor is whether the data was retrospective or prospective.

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

Number of Experts: Not explicitly stated for ground truth establishment. However, the document notes that "All user features have been validated by surgeons." This implies at least some surgeons were involved in testing, but doesn't specify if they established the ground truth for measurements or just validated features.
Qualifications of Experts: The experts who validated user features are identified as "surgeons." No further qualifications (e.g., years of experience, subspecialty) are provided in this document.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or resolving discrepancies in the test set.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device." The validation focused on equivalence to a benchmark tool (Osirix MD) rather than human readers, or comparing human readers with and without AI assistance.
Effect Size: Not applicable as no such study was performed or reported.

6. Standalone Performance

Yes, a standalone performance evaluation was done. The device itself is described as a "standalone software application." The "Bench Testing" section details verification and validation tests indicating the algorithm's performance in reconstructing 3D bone models and its measurement capabilities. The validation comparing its measurement capabilities to Osirix MD (K101342) is a form of standalone performance evaluation.

7. Type of Ground Truth Used

The ground truth for validating "measurement capabilities" was established by comparison to a "benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)." For "3D reconstructed bones and surgical coordinates," the ground truth implicitly refers to the accuracy and repeatability against accepted standards or the output of the benchmark tool. Implicitly, the accuracy and repeatability would be compared to a derived ground truth based on the CT images themselves or measurements obtained from the benchmark. It is not explicitly pathology or outcomes data.

8. Sample Size for the Training Set

Not stated. The document mentions the use of an "AI algorithm" for 3D model reconstruction but does not provide any information about the training set size, composition, or how it was used to train the AI.

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

Not stated. As the training set size and details are not provided, the method for establishing its ground truth is also not mentioned in this document.

Summary

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April 21, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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. The words "U.S. FOOD & DRUG" are in a larger font than the word "ADMINISTRATION".

Genesis Software Innovations % Mr. Matt Miller Director of Technology Development 220 Lyon St NW Suite 500 GRAND RAPIDS MI 49503

Re: K210556

Trade/Device Name: Preview Shoulder Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH Dated: February 16, 2021 Received: February 25, 2021

Dear Mr. Miller:

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

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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

510(k) Number (if known) K210556

Device Name Preview Shoulder

Indications for Use (Describe)

The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.

The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.

The software allows the surgeon to generate a report, detailing the output of the planning activity.

Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

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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Image /page/3/Picture/0 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking squares on the left, followed by the word "GENESIS" in large, blue, sans-serif font. Below the word "GENESIS" are the words "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.

510(k) Summary K210556

Date Prepared:	February 16, 2021
Submitter:	Genesis Software Innovations220 Lyon St NW Suite 500Grand Rapids, MI 49503
Contact:	Matt MillerDirector of Technology DevelopmentGenesis Software Innovations616-294-1026 Ext. 5matt.miller@genesissoftwareinnovations.com
Proprietary Name:	Preview Shoulder
Common Name:	Pre-operative planning software
Classifications:	21 CFR Section 892.2050 – Picture archiving andcommunications system; Class IIProduct Code: QIH
Classification Panel:	Radiology
SubstantiallyEquivalent Devices:	Peek Health, S.A. PeekMed (K182464)
Reference Device:	Pixmeo SARL, Osirix MD (K101342)

Intended Use / Indications:

The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study.

The import process allows the user to select a DICOM CT scan series from any location that the user's computer sees as an available file source.

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Image /page/4/Picture/0 description: The image is a logo for Genesis Software Innovations. The logo consists of two interlocking squares on the left, followed by the word "GENESIS" in large, blue, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font, also in blue.

The software allows the surgeon to generate a report, detailing the output of the planning activity.

Experience in usage and a clinical assessment are necessary for a proper use of the software. It is to be used for adult patients only and should not be used for diagnostic purposes.

Device Description:

Substantial Equivalence Discussion:

The proposed Preview Shoulder and its predicate device, PeekMed (K182464), are similar with regards to their intended use, clinical indications, principle of operation and fundamental technology. In conclusion, Genesis Software Innovations believes that the Preview Shoulder does not introduce any new potential safety and/or effectiveness issues and is comparable to the identified predicate device, PeekMed (K182464).

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Image /page/5/Picture/0 description: The image shows the logo for Genesis Software Innovations. The logo consists of two overlapping squares on the left, followed by the word "GENESIS" in large, blue, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.

Property orCharacteristic	Proposed DevicePreview Shoulder	Peek Health, S.A. PeekMed(K182464)	Significant Differences
Product Code	QIH	LLZ	The QIH device definition appliesto picture archiving andcommunications systems thatimplement artificial intelligence(AI) including nonadaptivemachine learning algorithms.Preview Shoulder utilizes an Alalgorithm for reconstructing 3Dbone model from the image data.
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050	N/A
Intended Use	Preoperative planning softwarefor surgery	Preoperative planning softwarefor surgery	N/A
Indications foruse	The Preview Shoulder software isintended to be used as a tool fororthopedic surgeons to developpre-operative shoulder plansbased on a patient CT imagingstudy.The import process allows theuser to select a DICOM CT scanseries from any location that theuser's computer sees as anavailable file source.	PeekMed is a software systemdesigned to help surgeons'specialists carry out the pre-operative planning in a promptand efficient manner for severalsurgical procedures, based ontheir patients' imaging studies.The software imports diagnosticsimaging studies such as x-rays,CT or magnetic resonance image(MRI). The import process can	The indications for use are similarbetween the Preview Shoulderand the predicate device.

	3D digital representations ofvarious implant models areavailable in the planningsoftware. Preview Shoulderallows the user to digitallyperform the surgical planning byshowing a representation of thepatient's shoulder anatomy as a3D model and allows the surgeonto place the implant in thepatient's anatomy.The software allows the surgeonto generate a report, detailing theoutput of the planning activity.Experience in usage and aclinical assessment arenecessary for a proper use of thesoftware. It is to be used for adultpatients only and should not beused for diagnostic purposes.	retrieve files from a CD ROM, alocal folder or the PACS. Inparallel, there is a database ofdigital representations related toprosthetic materials supplied bytheir producing companies.PeekMed allows healthprofessional to digitally performthe surgical planning withoutadding any additional steps tothat process. This softwaresystem requires no imaging studyacquisition specification (noprotocol). Experience in usageand a clinical assessment arenecessary for a proper use of thesoftware.
Subspecialties	Preview Shoulder allows thesurgeon to perform the pre-surgical planning for the followingsubspeciality:Upper Limb: Total ShoulderReplacement	PeekMed allows the surgeon toperform the pre-surgical planningefficiently in the followingsubspecialties:- Hip- Knee- Spine- Upper Limb- Foot and Ankle	Both devices are designed forpre-surgical planning of totalshoulder replacement surgeries.The predicate device is designedfor additional pre-surgicalplanning procedures beyond totalshoulder replacement.
	- TraumaFor each subspecialty, there areseveral procedures:	Preview Shoulder has beenvalidated for pre-surgicalplanning of total shoulderreplacement surgeries.
	-Hip: Hip Dysplasia Correction,Limb Length Discrepancy, Centerof Rotation - Ranawat method,Acetabular Angle, Total HipArthroplasty
	-Knee: Leg Deformity Correction,AP Knee Resection, AP Full Legresection, High Tibial Osteotomy,ACL Tunnel Reconstruction,Medial Patellofemoral Ligament	The limitation of pre-surgicalplanning subspecialties does notraise new questions of safety oreffectiveness.
	-Spine: Single Cobb Angle,Thoracic Kyphosis Angle, LumbarLordosis Angle, Sagittal VerticalAxis, Pelvic Angles, CoronalBalance, Sacrofemoral Angle,Sagittal Balance, Smith-PetersenOsteotomy, Pedicle SubtractionOsteotomy
	-Upper Limb: Total ShoulderReplacement, Clavicular Angle,Shoulder Resurfacing
	-Foot and Ankle: Talar Tilt, HalluxValgus, Moreau-Costa-BertaniInternal Angle, MoreauCosta-
		Bertani External Angle, Maestro Formula-Trauma: Diaphyseal Shaft Fracture Angle, MetaphysealShaft Fracture Angle, Roof Arc
Type of Use	Prescription Only	Prescription Only	N/A
PatientPopulation	Adults	Adults and pediatrics	The Preview Shoulder is intendedfor use with adult patient imagesonly.Preview Shoulder has beenvalidated using adult patientimages.Preview Shoulder's measurementimage processing andmeasurement capabilities of adultCT images does not raise newquestions on safety oreffectiveness.
End User	Surgeons	Surgeons	N/A
Computer	Personal Computer orWorkstation	Personal Computer orWorkstation	N/A
OperatingSystem	Windows or MacOS	Windows or OS X	N/A
DeviceAvailability	The software is installed andstarted from the user's computer.	It can be set to start from aworkstation or standalone forplanning procedures.	Both the Preview Shoulder andpredicate device are accessedthrough the surgeon's computersystem.
Images source	Receives medical images fromvarious sources locally availableto the user's computer.Preview Shoulder does notcommunicate directly to a PACSsystem.	Receives medical images fromvarious sources (including PACS)	Both devices import image filesfrom multiple data locations. Thepredicate retrieves files from CDROM, local file storage, or PACS.The Preview Shoulder does notcommunicate directly to a PACSsystem but can retrieve files fromany file storage locationaccessible by the surgeon'scomputer in DICOM format.The file storage and retrievallocation does not raise newquestions of safety oreffectiveness as the DICOMimages can be stored andtransferred utilizing any filesharing systems.
Dataprocessing	The software processes the CTimage, which allows the implantto be overlapped/ placed in boththe original scan images and/orthe 3D model reconstruction ofthe bone for surgical planning.	The software processes data inorder to provide an overlap anddimensioning of digitalrepresentations of the prostheticmaterial	Both the Preview Shoulder andpredicate device process patientimages in order for the surgeonto overlap (place) 3D digitalrepresentations of implantmodels and dimension anatomicfeatures.

Digital overlapofprostheticmaterial	The software allows the implantrendering to beoverlapped/placed in the 3Dmodel reconstruction of the bonethat results from the processedCT image(s).	Allows the overlap of models andthe intersection of the models	The Preview Shoulder CT imageprocessing has been validated.Both the Preview Shoulder andpredicate device allow the 3Ddigital representations of implantmodels representations to beoverlapped (placed) in theprocessed images.The Preview Shoulder does notinclude functionality to intersect3D models of reconstructedbone. Intersection functionality isnot necessary for planning oftotal shoulder replacementsurgery.The Preview Shoulderfunctionality to place 3D digitalrepresentations of implantmodels has been validated.
Interactivemodelpositioning	Yes	Yes	N/A
Interactivemodeldimensioning	Yes	Yes	N/A
Model rotation	Yes	Yes	N/A
Support fordigitalprostheticmaterialsprovided bythemanufacturers	Yes	Yes	N/A
AutomaticCalibration	No	Yes	Automatic Calibration refers tothe predicate's capability to usestandard markers placed in X-rayimages to determine scale.Preview Shoulder does not allowsingle X-ray images for planningand the presence of scalingmarkers are not used for 3Dimaging modalities.
Pre-surgicalplanning	Yes	Yes	N/A
Contact withthe patient	No	No	N/A
Control of lifesupportingdevices	No	No	N/A
Humaninterventionfor imageinterpretation	Yes	Yes	N/A
Ability to addadditionalmodules whenavailable	Yes	Yes	N/A

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Image /page/6/Picture/0 description: The image shows the logo for Genesis Software Innovations. The logo consists of two overlapping squares on the left, followed by the word "GENESIS" in large, blue, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.

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Image /page/10/Picture/0 description: The image shows the logo for Genesis Software Innovations. The logo consists of two overlapping squares on the left, followed by the word "GENESIS" in large, blue, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.

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Image /page/13/Picture/0 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking squares on the left, followed by the word "GENESIS" in a bold, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font. The logo is blue in color.

Bench Testing:

Software Verification and Validation testing was performed on the Preview Shoulder, and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software is considered as a "moderate level of concern" since a failure or latent design flaw could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

The Verification and Validation testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon. Testing verified that the system performs as intended. The software has been verified via code reviews and automated and manual testing. The measurement capabilities of the Preview Shoulder were validated to be significantly equivalent to a benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342). All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use. All user features have been validated by surgeons.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device.

Overall Conclusion:

Based on the information presented in this submission, Genesis Software Innovations concludes that the Preview Shoulder is similar to the predicate devices in regard to indications, principles of operation, and technological characteristics. Additionally, verification and validation tests demonstrate the safety and efficacy of the device to meet its intended use and specifications. Genesis Software Innovations believes that the proposed device, Preview Shoulder, is similar to its identified predicate device and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

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).