(55 days)
Yes
The document explicitly states that the device "utilizes an Al algorithm for reconstructing 3D bone model from the image data."
No
The device is described as surgical planning software, a tool for orthopedic surgeons to develop pre-operative plans. It does not directly treat or diagnose a disease or condition, which are characteristic functions of a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states "should not be used for diagnostic purposes." Additionally, the "Device Description" states "Preview Shoulder does not provide a diagnosis or surgical recommendation."
Yes
The device is explicitly described as a "standalone software application" and its functions are entirely software-based, processing digital images and providing digital planning tools. While it uses CT images as input, it does not include or require any specific hardware beyond a standard computer system for its operation.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the software is a "tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study." It also clearly states that it "should not be used for diagnostic purposes."
- Device Description: The description reinforces that the software "assists the surgeon in planning reverse and anatomic shoulder arthroplasty" and "does not provide a diagnosis or surgical recommendation."
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility of transfusions, or to monitor therapeutic measures.
This software operates on medical images (CT scans) and assists in surgical planning, which is an in vivo procedure. It does not analyze biological specimens in vitro for diagnostic purposes.
While it uses patient data and involves image processing, its function is to aid in surgical planning, not to diagnose a condition or provide information about a physiological or pathological state based on in vitro analysis.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section for "Control Plan Authorized (PCCP) and relevant text" is explicitly marked "Not Found".
Intended Use / 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.
Product codes
QIH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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.
Input Imaging Modality
CT imaging study
Anatomical Site
Shoulder
Indicated Patient Age Range
Adults
Intended User / Care Setting
Orthopedic surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
All validation testing was performed on a fully configured system using anonymized patient shoulder CT images to emulate intended use.
Summary of Performance Studies
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 was not necessary to demonstrate substantial equivalence of the Preview Shoulder to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
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
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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.
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) | |
|---|---|
| ☑ 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 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.
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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:
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).
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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 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 | 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/7/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/8/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/9/Picture/0 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, and the words "SOFTWARE INNOVATIONS" in smaller letters below the word "GENESIS". The logo is simple and modern, and the use of blue gives it a professional look.
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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/12/Picture/0 description: The image contains the logo for Genesis Software Innovations. The logo consists of two interlocking squares on the left, followed by the word "GENESIS" in a large, bold, 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.