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 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

The provided text focuses on the 510(k) summary for the Preview Shoulder software, outlining its substantial equivalence to a predicate device and general non-clinical testing. However, it does not include detailed information about specific acceptance criteria for performance metrics, nor does it describe a study that explicitly proves the device meets such criteria with reported performance values.

The document states:

"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, 'Content of Premarket Submissions for Device Software Functions'."
"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)."
"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 was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device."

Given this, I cannot provide the requested information in full detail. Here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. While it mentions "Testing verified that the system performs as intended" and "measurement capabilities... were validated to be significantly equivalent to a benchmark tool," it does not specify what those performance metrics, acceptance criteria, or reported performance values are.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions "anonymized patient shoulder CT images" were used for validation testing, but the number of such images (sample size) is not given.
Data Provenance: "Anonymized patient shoulder CT images" were used. The country of origin and whether the data was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document states, "All user features have been validated by surgeons." It does not specify the number of surgeons or their qualifications or how they established "ground truth" for quantitative assessments.

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

The document mentions "All user features have been validated by surgeons" but does not detail any adjudication method.

5. 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, an 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 software is not an AI for diagnosis or interpretation but a surgical planning tool.

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

Not explicitly detailed as a standalone performance study in the context of typical AI performance evaluation. The document states that "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)." This suggests a comparison of the software's output with a benchmark, which could be considered a form of standalone validation for its measurement capabilities. However, specific metrics and results are not provided. The device itself is described as a "tool for orthopedic surgeons," implying human-in-the-loop operation.

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

The document implies that "benchmark tool with CT rendering measurement capabilities, Osirix MD (K101342)" served as a reference for validating measurement capabilities. For user features, "validation by surgeons" might have implicitly used their clinical judgment as a form of ground truth for usability and functionality, but this is not explicitly defined in terms of a formal ground truth process.

8. The sample size for the training set

This device is described as a "software application" for surgical planning and emphasizes its validation through comparison of measurement capabilities against a benchmark tool and user feature validation by surgeons. It does not explicitly state that it uses machine learning/AI models that require a "training set" in the conventional sense. If there are AI algorithms as implied by "Post-processing algorithm is added to further refine the 3D mesh quality" and "Algorithm is added to calculate humerus-side features," the training set size is not provided.

9. How the ground truth for the training set was established

As the existence of a "training set" is not confirmed or described, the method for establishing its ground truth is also not provided.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Genesis Software Innovations Matt Miller Director of Technology Development 2851 Charlevoix Dr. SE Suite 327 Grand Rapids, MI 49546

Re: K240172

April 4, 2024

Trade/Device Name: Preview Shoulder Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 7, 2024 Received: March 7, 2024

Dear Matt 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jessica Lamb

Jessica Lamb Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K240172

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.

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 features two interlocking squares on the left side. To the right of the squares is the word "GENESIS" in a bold, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.

510(k) Summary

Date Prepared:	March 7, 2024
Submitter:	Genesis Software Innovations2851 Charlevoix Dr. SE Suite 327Grand Rapids, MI 49546
Contact:	Matt MillerDirector of Technology DevelopmentGenesis Software Innovations(616) 294-1026 Ext. 5matt.miller@genesissoftwareinnovations.com
Proprietary Name:	Preview Shoulder
Common Name:	Pre-operative planning software
Classification Name:	Picture archiving and communications system
Regulation Number:	21 CFR Section 892.2050
Classification Code:	QIH
Review Panel:	Radiology
SubstantiallyEquivalent Device:	Genesis Software Innovations, Preview Shoulder (K210556)
Reference Device:	Pixmeo SARL, Osirix MD (K101342)

Device Description:

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

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Image /page/4/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two overlapping blue squares on the left, followed by the word "GENESIS" in blue, block letters. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in smaller, gray letters.

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.

Indications for Use:

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.

Comparison of Technological Characteristics:

The Preview Shoulder fundamental technological characteristics are similar to those of the predicate device as noted in the following table.

Characteristic	Proposed DeviceGenesis SoftwareInnovationsPreview Shoulder(K240172)	Predicate DeviceGenesis SoftwareInnovationsPreview Shoulder(K210556)	Significant Differences
Product Code	QIH	QIH	N/A
RegulationNumber	21 CFR 892.2050	21 CFR 892.2050	N/A
Intended Use	Preoperative planningsoftware for surgery	Preoperative planningsoftware for surgery	N/A
Indications for use	The Preview Shouldersoftware is intended to be	The Preview Shouldersoftware is intended to be	N/A
	used as a tool fororthopedic surgeons todevelop pre-operativeshoulder plans based ona patient CT imagingstudy.	used as a tool fororthopedic surgeons todevelop pre-operativeshoulder plans based ona patient CT imagingstudy.
	The import process allowsthe user to select aDICOM CT scan seriesfrom any location that theuser's computer sees asan available file source.3D digital representationsof various implant modelsare available in theplanning software.Preview Shoulder allowsthe user to digitallyperform the surgicalplanning by showing arepresentation of thepatient's shoulderanatomy as a 3D modeland allows the surgeon toplace the implant in thepatient's anatomy.The software allows thesurgeon to generate areport, detailing the outputof the planning activity.Experience in usage anda clinical assessment are	The import process allowsthe user to select aDICOM CT scan seriesfrom any location that theuser's computer sees asan available file source.3D digital representationsof various implant modelsare available in theplanning software.Preview Shoulder allowsthe user to digitallyperform the surgicalplanning by showing arepresentation of thepatient's shoulderanatomy as a 3D modeland allows the surgeon toplace the implant in thepatient's anatomy.The software allows thesurgeon to generate areport, detailing the outputof the planning activity.Experience in usage anda clinical assessment are
	necessary for a properuse of the software. It isto be used for adultpatients only and shouldnot be used for diagnosticpurposes.	necessary for a properuse of the software. It isto be used for adultpatients only and shouldnot be used for diagnosticpurposes.
Subspecialties	Preview Shoulder allowsthe surgeon to performthe pre-surgical planningfor the followingsubspeciality:Upper Limb: TotalShoulder Replacement	Preview Shoulder allowsthe surgeon to performthe pre-surgical planningfor the followingsubspeciality:Upper Limb: TotalShoulder Replacement	N/A
Type of Use	Prescription Only	Prescription Only	N/A
PatientPopulation	Adults	Adults	N/A
End User	Surgeons	Surgeons	N/A
Computer	Personal Computer orWorkstation	Personal Computer orWorkstation	N/A
OperatingSystem	Windows or MacOS	Windows or MacOS	N/A

DeviceAvailability	The software is installedand started from theuser's computer.	The software is installedand started from theuser's computer.	N/A
Images source	Receives medical imagesfrom various sourceslocally available to theuser's computer.	Receives medical imagesfrom various sourceslocally available to theuser's computer.	N/A
	Preview Shoulder doesnot communicate directlyto a PACS system.	Preview Shoulder doesnot communicate directlyto a PACS system.
Dataprocessing	The software processesthe CT image, whichallows the implant to beoverlapped/ placed inboth the original scanimages and/or the 3Dmodel reconstruction ofthe bone for surgicalplanning.	The software processesthe CT image, whichallows the implant to beoverlapped/ placed inboth the original scanimages and/or the 3Dmodel reconstruction ofthe bone for surgicalplanning.	SimilarPost-processing algorithmis added to further refinethe 3D mesh quality.Algorithm is added tocalculate humerus-sidefeatures used for implantselection, placement, andpre-surgical planning.
Digital overlapofprostheticmaterial	The software allows theimplant rendering to beoverlapped/placed in the3D model reconstructionof the bone that resultsfrom the processed CTimage(s).The software facilitatesthe placement andrendering of scapula andhumerus implants foranatomic partial or totalshoulder arthroplasty andreverse total shoulderarthroplasty.	The software allows theimplant rendering to beoverlapped/placed in the3D model reconstructionof the bone that resultsfrom the processed CTimage(s).The software facilitatesthe placement andrendering of scapulaimplants for anatomicpartial or total shoulderarthroplasty and reversetotal shoulderarthroplasty.	SimilarHumerus implants areadded to implant planninglibrary.
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	No	N/A
Pre-surgicalplanning	Yes	Yes	N/A
Contact withthe patient	No	No	N/A
Control of lifesupportingdevices	No	No	N/A
Humanintervention forimageinterpretation	Yes	Yes	N/A
Ability to addadditionalmodules whenavailable	Yes	Yes	N/A

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Image /page/5/Picture/0 description: The image shows the alphanumeric string "K240172" in a clear, sans-serif font. The characters are uniformly sized and spaced, making the string easily readable. The black text stands out against the white background, ensuring high contrast and visibility. The string appears to be a code or identifier, possibly a serial number or product key.

Image /page/5/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking blue 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.

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Image /page/6/Picture/0 description: The image contains the alphanumeric string "K240172" in a simple, sans-serif font. The text is black against a white background, and the letters and numbers are evenly spaced. The text appears to be a code or identifier.

Image /page/6/Picture/1 description: The image contains the logo for Genesis Software Innovations. The logo consists of two overlapping blue squares that are rotated 45 degrees. To the right of the squares is the word "GENESIS" in blue, and below that is the phrase "SOFTWARE INNOVATIONS" in a smaller font.

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Image /page/7/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking blue squares on the left, followed by the word "GENESIS" in large, bold, blue letters. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in smaller, gray letters.

Non-Clinical Testing Summary:

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, "Content of Premarket Submissions for Device Software Functions". The software is considered as a "basic documentation level" since a failure or latent design flaw would not present a hazardous situation with a probable risk of death or serious injury to either a patient, user of the device, or others in the environment of use, prior to the implementation of risk control measures. 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 Summary:

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

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Image /page/8/Picture/1 description: The image shows the logo for Genesis Software Innovations. The logo consists of two interlocking blue squares on the left, followed by the word "GENESIS" in blue, sans-serif font. Below the word "GENESIS" is the phrase "SOFTWARE INNOVATIONS" in a smaller, sans-serif font.

Overall Conclusio

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).