Who is the manufacturer of Preview Shoulder?

Genesis Software Innovations filed the 510(k) submission for Preview Shoulder (K210556).

What is the FDA product code for Preview Shoulder?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Preview Shoulder?

510(k) clearance (submission type: Traditional).

Does Preview Shoulder use AI or machine learning?

Yes. Preview Shoulder (K210556) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like Preview Shoulder?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like Preview Shoulder get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

Preview Shoulder

Q: What are the predicate devices for Preview Shoulder?

Peek Health, S.A. PeekMed (K182464).

K210556 · Genesis Software Innovations · QIH · Apr 21, 2021 · Radiology

Device Facts

Record ID	K210556
Device Name	Preview Shoulder
Applicant	Genesis Software Innovations
Product Code	QIH · Radiology
Decision Date	Apr 21, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
3D bone model reconstruction	AI algorithm for reconstructing 3D bone model	—	—	—	—	—	—

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.

Device Story

Preview Shoulder is a standalone software application for pre-operative planning of total shoulder arthroplasty. It accepts DICOM CT scans as input. The software uses an AI algorithm to reconstruct 3D bone models from CT data. Surgeons use the software on a PC or workstation to visualize patient anatomy in 3D, place digital representations of implant models, and perform surgical planning. The device generates a surgical report detailing the planning activity. It is used by orthopedic surgeons in a clinical setting. The output assists the surgeon in pre-surgical planning; the surgeon remains responsible for final implant selection and placement. The device does not provide a diagnosis or surgical recommendation.

Clinical Evidence

No clinical testing was performed. Substantial equivalence was demonstrated through bench testing, including software verification and validation. Validation confirmed the accuracy and repeatability of 3D bone reconstruction and surgical coordinate generation. Measurement capabilities were validated against the reference device, Osirix MD (K101342). Testing was conducted on a fully configured system using anonymized patient shoulder CT images to emulate intended use, with all features validated by surgeons.

Technological Characteristics

Standalone software application for Windows or MacOS. Utilizes an AI algorithm for 3D bone model reconstruction from DICOM CT images. Features include 3D visualization, interactive model positioning, rotation, and dimensioning. Does not interface directly with PACS but imports files from local/networked sources. Classified as moderate level of concern software.

Indications for Use

Indicated for adult patients requiring pre-operative planning for total shoulder arthroplasty (TSA), including reverse and anatomic shoulder arthroplasty. Intended for use by orthopedic surgeons as a planning tool; not for diagnostic purposes.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Peek Health, S.A. PeekMed (K182464)

Reference Devices

Pixmeo SARL, Osirix MD (K101342)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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. 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------|----------------------------------------------------------| | <div>☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | #### 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." {3}------------------------------------------------ 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 Innovations 220 Lyon St NW Suite 500 Grand Rapids, MI 49503 | | Contact: | Matt Miller Director of Technology Development Genesis Software Innovations 616-294-1026 Ext. 5 matt.miller@genesissoftwareinnovations.com | | Proprietary Name: | Preview Shoulder | | Common Name: | Pre-operative planning software | | Classifications: | 21 CFR Section 892.2050 – Picture archiving and communications system; Class II Product Code: QIH | | Classification Panel: | Radiology | | Substantially Equivalent 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. 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. {4}------------------------------------------------ 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: 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. ### 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). {5}------------------------------------------------ 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 or Characteristic | Proposed Device Preview Shoulder | Peek Health, S.A. PeekMed (K182464) | Significant Differences | |------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | QIH | LLZ | The QIH device definition applies to picture archiving and communications systems that implement artificial intelligence (AI) including nonadaptive machine learning algorithms. Preview Shoulder utilizes an Al algorithm for reconstructing 3D bone model from the image data. | | Regulation Number | 21 CFR 892.2050 | 21 CFR 892.2050 | N/A | | Intended Use | Preoperative planning software for surgery | Preoperative planning software for surgery | N/A | | 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. | PeekMed is a software system designed to help surgeons' specialists carry out the pre- operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies. The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can | The indications for use are similar between the Preview Shoulder and the predicate device. | | | | | | | | 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. | retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies. PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software. | | | Subspecialties | Preview Shoulder allows the surgeon to perform the pre- surgical planning for the following subspeciality: Upper Limb: Total Shoulder Replacement | PeekMed allows the surgeon to perform the pre-surgical planning efficiently in the following subspecialties: - Hip - Knee - Spine - Upper Limb - Foot and Ankle | Both devices are designed for pre-surgical planning of total shoulder replacement surgeries. The predicate device is designed for additional pre-surgical planning procedures beyond total shoulder replacement. | | | - Trauma For each subspecialty, there are several procedures: | Preview Shoulder has been validated for pre-surgical planning of total shoulder replacement surgeries. | | | | -Hip: Hip Dysplasia Correction, Limb Length Discrepancy, Center of Rotation - Ranawat method, Acetabular Angle, Total Hip Arthroplasty | | | | | -Knee: Leg Deformity Correction, AP Knee Resection, AP Full Leg resection, High Tibial Osteotomy, ACL Tunnel Reconstruction, Medial Patellofemoral Ligament | The limitation of pre-surgical planning subspecialties does not raise new questions of safety or effectiveness. | | | | -Spine: Single Cobb Angle, Thoracic Kyphosis Angle, Lumbar Lordosis Angle, Sagittal Vertical Axis, Pelvic Angles, Coronal Balance, Sacrofemoral Angle, Sagittal Balance, Smith-Petersen Osteotomy, Pedicle Subtraction Osteotomy | | | | | -Upper Limb: Total Shoulder Replacement, Clavicular Angle, Shoulder Resurfacing | | | | | -Foot and Ankle: Talar Tilt, Hallux Valgus, Moreau-Costa-Bertani Internal Angle, MoreauCosta- | | | | | | Bertani External Angle, Maestro Formula -Trauma: Diaphyseal Shaft Fracture Angle, Metaphyseal Shaft Fracture Angle, Roof Arc | | | Type of Use | Prescription Only | Prescription Only | N/A | | Patient Population | Adults | Adults and pediatrics | The Preview Shoulder is intended for use with adult patient images only. Preview Shoulder has been validated using adult patient images. Preview Shoulder's measurement image processing and measurement capabilities of adult CT images does not raise new questions on safety or effectiveness. | | End User | Surgeons | Surgeons | N/A | | Computer | Personal Computer or Workstation | Personal Computer or Workstation | N/A | | Operating System | Windows or MacOS | Windows or OS X | N/A | | Device Availability | The software is installed and started from the user's computer. | It can be set to start from a workstation or standalone for planning procedures. | Both the Preview Shoulder and predicate device are accessed through the surgeon's computer system. | | Images source | Receives medical images from various sources locally available to the user's computer. Preview Shoulder does not communicate directly to a PACS system. | Receives medical images from various sources (including PACS) | Both devices import image files from multiple data locations. The predicate retrieves files from CD ROM, local file storage, or PACS. The Preview Shoulder does not communicate directly to a PACS system but can retrieve files from any file storage location accessible by the surgeon's computer in DICOM format. The file storage and retrieval location does not raise new questions of safety or effectiveness as the DICOM images can be stored and transferred utilizing any file sharing systems. | | Data processing | The software processes the CT image, which allows the implant to be overlapped/ placed in both the original scan images and/or the 3D model reconstruction of the bone for surgical planning. | The software processes data in order to provide an overlap and dimensioning of digital representations of the prosthetic material | Both the Preview Shoulder and predicate device process patient images in order for the surgeon to overlap (place) 3D digital representations of implant models and dimension anatomic features. | | | | | | | Digital overlap of prosthetic material | The software allows the implant rendering to be overlapped/placed in the 3D model reconstruction of the bone that results from the processed CT image(s). | Allows the overlap of models and the intersection of the models | The Preview Shoulder CT image processing has been validated. Both the Preview Shoulder and predicate device allow the 3D digital representations of implant models representations to be overlapped (placed) in the processed images. The Preview Shoulder does not include functionality to intersect 3D models of reconstructed bone. Intersection functionality is not necessary for planning of total shoulder replacement surgery. The Preview Shoulder functionality to place 3D digital representations of implant models has been validated. | | Interactive model positioning | Yes | Yes | N/A | | Interactive model dimensioning | Yes | Yes | N/A | | Model rotation | Yes | Yes | N/A | | Support for digital prosthetic materials provided by the manufacturers | Yes | Yes | N/A | | Automatic Calibration | No | Yes | Automatic Calibration refers to the predicate's capability to use standard markers placed in X-ray images to determine scale. Preview Shoulder does not allow single X-ray images for planning and the presence of scaling markers are not used for 3D imaging modalities. | | Pre-surgical planning | Yes | Yes | N/A | | Contact with the patient | No | No | N/A | | Control of life supporting devices | No | No | N/A | | Human intervention for image interpretation | Yes | Yes | N/A | | Ability to add additional modules when available | Yes…

Preview Shoulder

Device Facts

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Preview Shoulder

Device Facts

AI Performance

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Reference Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps