(267 days)
Not Found
Yes
The device description explicitly states that the Intelligent Surgery Knee CT Segmentation Engine and X-ray Segmentation Engine use "deep learning algorithms" to detect and extract ROI information from medical imaging data. Deep learning is a subset of machine learning.
No.
The device is an orthopedic instrument system, including software and surgical instrument components, intended to assist in the positioning of compatible total knee arthroplasty systems. It does not directly perform a therapeutic function on the patient.
No
Explanation: The device is an orthopedic instrument system for surgical planning and guiding implant placement, not for diagnosing a disease or condition. While it uses radiological images and creates 3D reconstructions, these are for operative purposes, not diagnostic ones.
No
The device description explicitly states that the system is comprised of both software components (segmentation and implant recognition engines) and hardware components (surgical guides and anatomical models). The performance studies also include testing of the hardware components (Guide Wear Testing).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use 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 concerning a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.
- Device's Intended Use: The intended use of the United Orthopedic Knee Patient Specific Instrumentation is to assist in the positioning of compatible total knee arthroplasty systems during surgery. It uses patient radiological images to plan the surgical placement of implants and provides surgical instrument components (guides) to reference this placement intra-operatively.
- Lack of Specimen Examination: The device does not examine any specimens derived from the human body (like blood or tissue samples) in vitro. It processes medical images (CT and X-ray) which are representations of the patient's anatomy, not biological specimens.
- Purpose is Surgical Planning and Guidance: The primary purpose is to aid in surgical planning and provide physical guidance during the surgical procedure, not to provide diagnostic information about a physiological or pathological state based on in vitro examination of specimens.
While the device uses medical images and software to process information about the patient's anatomy, this processing is for the purpose of surgical planning and execution, not for in vitro diagnosis.
No
The document states "Control Plan Authorized (PCCP) and relevant text Not Found", indicating no explicit mention of PCCP approval or clearance.
Intended Use / Indications for Use
The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia.
The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
OOG, PBF, LLZ
Device Description
The United Orthopedic Knee Patient Specific Instrumentation is comprised of: United Orthopedics (UO) surgical guides (hardware), anatomical models (physical replica), Intelligent Surgery Knee CT Segmentation Engine / Intelligent Surgery Knee X-ray Segmentation Engine (software), and Intelligent Surgery Knee Implant Recognition Engine (software). Enhatch is responsible for design and development of all three components of the system.
The subject device is intended to facilitate the implantation of the U2 Knee protheses under the U2 Knee System developed and distributed by United Orthopedics Corporation: U2 Total Knee System.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, X-ray
Anatomical Site
Knee, distal femur, proximal tibia
Indicated Patient Age Range
Adult patients / Skeletally mature patients
Intended User / Care Setting
Prespecified clinical users (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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety and performance of United Orthopedic Knee Patient Specific Instrumentation has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Verification & Validation Procedures (ISO 14971, IEC 62304:2006 & A1:2016), User Requirements, and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "FDA Guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The software contained in this device is considered to be of "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.
United Orthopedic Knee Patient Specific Instrumentation has been evaluated through the following non-clinical testing:
- Segmentation System Testing
- This testing was performed to verify and validate the accuracy of the software generated segmentation masks for CT and X-ray based DICOM data. The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use.
- Model Verification Testing
- This testing was performed to verify and validate the accuracy of the software generated 3-dimensional models from CT and X-ray based DICOM data. The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use.
- Software System Testing
- This testing was performed to verify and validate the accuracy of landmark detection, system usage and accuracy. All specimens were within the bounds of the acceptance criteria. The resulting output measurements from the system were within the bounds of the input parameters (input values produced expected output values). The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use.
- Guide Wear Testing
- This testing was performed to verify and validate the amount of wear debris generated from use of the surgical guides. The device passed the acceptance criteria of average weight loss and demonstrated satisfactory performance per the intended use.
- System Verification and Validation Test
- This testing was performed to verify and validate the amount overall system performance in terms of system usage, and accuracy. Full use simulations tests using cadaver specimens were performed by multiple surgeons to verify and validate the overall system performance. The results demonstrated satisfactory performance per the intended use as in the predicate.
In conclusion, United Orthopedic Knee Patient Specific Instrumentation performance testing has demonstrated the subject device's safety and effectiveness and meets its intended use statement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 20, 2023
Enhatch, Inc. Monica Williams QA/RA Manager 226 Boulevard Hasbrouck Heights, New Jersey 07604
Re: K230850
Trade/Device Name: United Orthopedic Knee Patient Specific Instrumentation Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: OOG, PBF, LLZ Dated: March 24, 2023 Received: March 28, 2023
Dear Monica Williams:
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.
1
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).
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 mediation-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).
2
Sincerely,
Lixin Liu -S
Lixin Liu, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No, 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Indications for Use
510(k) Number (if known) K230850
Device Name
United Orthopedic Knee Patient Specific Instrumentation
Indications for Use (Describe)
The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the surgical plan to precisely reference the placement of the implant components intra-operatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia.
The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its evaluation complies with its cleared indications for use. The instruments are intended for single use only.
| 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) | ||
|---|---|---|---|
| -- | ---------------------------------------------- | -- | --------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (6/20) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 EF |
|---|---|---|
| ---------------------- | ------------- | ------------------------------------------- |
4
510(k) Summary
1. INTRODUCTION
This document contains the 510(k) summary for the United Orthopedic Knee Patient Specific Instrumentation. The content of this summary is based on the requirements of 21 CFR 807.92.
2. SUBMITTER
| Name: | Enhatch, Inc. |
|---|---|
| Address: | 226 Boulevard |
| Hasbrouck Heights, NJ 07604 | |
| Phone: (201) 771-2034 | |
| Official Correspondent: | Monica Williams |
| QA/RA Manager | |
| Date Prepared: | November 20, 2023 |
| DEVICE | |
| Trade Name: | United Orthopedic Knee Patient Specific Instrumentation |
| Regulation Number: | 21 CFR 888.3560 |
| Regulation Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- |
| constrained cemented prosthesis | |
| Regulatory Class: | Class II |
| Product Code: | OOG, PBE, LLZ |
4. PREDICATE DEVICES
Primary predicate device:
-
X-PSI Knee System, Orthosoft (K171269) .
Secondary predicate devices: -
VSP Orthopedics System, 3D Systems (K211244) ●
-
United Orthopedic Corporation U2 Total Knee System (K051640) .
5
5. DESCRIPTION OF THE DEVICE
The United Orthopedic Knee Patient Specific Instrumentation is comprised of: United Orthopedics (UO) surgical guides (hardware), anatomical models (physical replica), Intelligent Surgery Knee CT Segmentation Engine / Intelligent Surgery Knee X-ray Segmentation Engine (software), and Intelligent Surgery Knee Implant Recognition Engine (software). Enhatch is responsible for design and development of all three components of the system.
The subject device is intended to facilitate the implantation of the U2 Knee protheses under the U2 Knee System developed and distributed by United Orthopedics Corporation: U2 Total Knee System.
[THE SOFTWARE]
The Intelligent Surgery Knee Segmentation Engine consists of two imaging modalities, CT (Knee CT Segmentation) and X-ray (Knee X-ray Segmentation). The Intelligent Surgery Knee CT Segmentation Engine and X-ray Segmentation Engine are web applications that use deep learning algorithms to detect and extract region of interest (ROI) information (femur and tibia) from medical imaging data (DICOM). The segmentation engines generate 3D models which can be used for treatment planning of Total Knee Arthroplasty (TKA), design of surgical guides, or generation of 3D printed anatomical models.
The Intelligent Surgery Knee Implant Recognition Engine is a web application that uses an optimization algorithm as a treatment planning tool for total knee arthroplasty. It assists in selecting implant size and position, from a range of implants of a total knee implant system, using a range of run parameters based upon the TKA surgical technique of that system. The software identifies anatomical landmarks of the patient's bony anatomy and articular surface topographies to reference the position and alignment of the femoral and tibial implant components. This positioning and alignment in turn allows for design of surgical guides and of the United Orthopedic Knee Patient Specific Instrumentation .
Note, these algorithms are static and non-adaptive; they do not alter their behavior over time based on user input.
[THE HARDWARE]
The UO surgical guides and anatomical models are patient-specific instruments designed to facilitate the implantation of the United Orthopedics Knee protheses. The UO surgical guides are designed based on preoperative plan generated by the software Intelligent Surgery Knee Implant Recognition Engine.
6
6. INDICATIONS FOR USE
The United Orthopedic Knee Patient Specific Instrumentation is indicated as an orthopedic instrument system to assist in the positioning of compatible total knee arthroplasty systems. It is comprised of surgical planning software (Intelligent Surgery Knee CT Segmentation Engine/Knee X-ray Segmentation Engine, and Implant Recognition Engine) intended to preoperatively plan the surgical placement of the United Orthopedics Knee implants on the basis of provided patient radiological images and 3D reconstructions of bones with identifiable anatomical landmarks, and surgical instrument components that include patient specific or customized guides fabricated on the basis of the surgical plan to precisely reference the placement of the implant components intraoperatively per the surgical plan. The United Orthopedic Knee Patient Specific Instrumentation is indicated for patients without severe bone deformities, such as a HKA greater than 15° or deformities due to prior fracture of the distal femur or proximal tibia. The instruments are intended for use with the U2 Total Knee System when the clinical evaluation complies with its cleared indications for use. The instruments are intended for single use only.
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technical features of United Orthopedic Knee Patient Specific Instrumentation are substantially equivalent to the primary predicate, Orthosoft X-PSI Knee System (K171269), and secondary predicate devices. 3D Systems VSP Orthopedics System (K211244) and United Orthopedic Corporation U2 Total Knee System (K051640). The subject device has similar indications for use as compared to the predicates. At a high level, the subject and predicate devices are based on the following same technological elements:
- . Includes software as a medical device component
- . Image transfer and manipulation via software to be used for 3D printing of anatomical models and guides for surgical planning
- . Visualization of radiological images (CT and X-ray), image segmentation, and 3D reconstruction of bones
- Display and measurement evaluations of anatomical landmarks that must be viewed, . accepted, or rejected by a clinician
- . For use by prespecified clinical users
The following technological differences exists between the subject and predicate devices:
7
- . Internal facing versus external user interface, United Orthopedic Knee Patient Specific Instrumentation software follows a SaaS preoperative planning workflow where Enhatch technicians interface directly with the software and provide end user outputs
- Segmentation edge detection versus manual outlining of patient contours, United . Orthopedic Knee Patient Specific Instrumentation has the ability to semiautomatically identify bony contours for the alignment of the final algorithmic model using deep learning algorithms whereas predicate device
- Implant sizing / placement with an optimization algorithm versus manual user controls, United Orthopedic Knee Patient Specific Instrumentation does not allow end user to perform measurements in software but uses an optimization algorithm to find the approximate location of implant size / position approved by surgeon via a preoperative plan
The following table provides details of the United Orthopedic Knee Patient Specific Instrumentation as compared to the primary and secondary predicates.
| Technological
Characteristics | Subject Device:
United Orthopedic
Knee Patient Specific
Instrumentation | Primary
Predicate:
Orthosoft X-PSI
Knee System
(K171269) | Predicate Device:
3D Systems VSP
Orthopedics System
(K211244) | Predicate Device:
United Orthopedic
Corporation U2
Total Knee System
(K051640) | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use (IFU) | The United
Orthopedic Knee
Patient Specific
Instrumentation is
indicated as an
orthopedic instrument
system to assist in the
positioning of
compatible total knee
arthroplasty systems. It
is comprised of
surgical planning
software (Intelligent
Surgery Knee CT
Segmentation
Engine/Knee X-ray
Segmentation Engine,
and Implant
Recognition Engine)
intended to
preoperatively plan the
surgical placement of | The X-PSI Knee
System is indicated
as an orthopedic
instrument system
to assist in the
positioning of knee
replacement
components. It
involves surgical
planning software
used pre-
operatively to plan
the surgical
placement of the
components on the
basis of provided
patient radiological
images and 3-D
reconstructed
bones with
identifiable
placement
anatomical
landmarks, and
surgical instrument | The VSP®
Orthopedics System
is intended to be used
as a surgical
instrument to assist in
preoperative planning
and/or in guiding the
marking of bone
and/or in guiding
surgical instruments
in non-acute, non-
joint replacing
osteotomies for adult
patients in the distal
femur, tibia, and non-
sacrum pelvis. | This device is
indicated in knee
arthroplasty for
reduction or relief of
pain and/or improved
knee function in
skeletally mature
patients with severe
knee pain and
disability due to
rheumatoid arthritis,
osteoarthritis,
primary and
secondary traumatic
arthritis, polyarthritis,
collagen disorders,
avascular necrosis of
the femoral condyle
or pseudogout,
posttraumatic loss of
joint configuration,
particularly when | Substantially
Equivalent
All fundamental aspects
of the indications for
use are the same (e.g.
visualization of
radiological images, 3D
reconstruction of bones
and includes tools to
improve visualization,
positioning of knee
replacement
components, use of
clinical judgement, use
with fixed bearing knee
replacement systems) |
| the United
Orthopedics Knee
implants on the basis
of provided patient
radiological images
and 3D reconstructions
of bones with
identifiable anatomical
landmarks, and
surgical instrument
components that
include patient specific
or customized guides
fabricated on the basis
of the surgical plan to
precisely reference the
placement of the
implant components
intra-operatively per
the surgical plan. The
United Orthopedic
Knee Patient Specific
Instrumentation is
indicated for patients
without severe bone
deformities, such as a
HKA greater than 15°
or deformities due to
prior fracture of the
distal femur or
proximal tibia.
The instruments are
intended for use with
the U2 Total Knee
System when the
clinical evaluation
complies with its
cleared indications for
use. The instruments
are intended for single
use only. | components that
include patient
specific or
customized guides
fabricated on the
basis of the
surgical plan to
precisely reference
the placement of
the
implant
components intra-
operatively per the
surgical plan. The
X-PSI Knee
system is indicated
for patients without
severe bone
deformities, such
as a HKA greater
than 15° or
deformities due to
prior fracture of the
distal femur or
proximal tibia.
The X-PSI Knee
System is to be
used with the
following fixed
bearing knee
replacement
systems in
accordance with
their indications
and
contraindications:
NexGen® CR,
NexGen CR-Flex,
NexGen CR-Flex
Gender, NexGen
LPS, NexGen LPS-
Flex, NexGen
LPS-Flex Gender,
Persona® CR,
Persona PS,
Vanguard® CR
and Vanguard PS.
The patient
specific guide
components are
intended for single-
use only. | there is
patellofemoral
erosion, dysfunction
or prior patellectomy,
moderate valgus,
varus, or flexion
deformities. This
device may also be
indicated in the
salvage of previously
failed surgical
attempts if the knee
can be satisfactorily
balanced and
stabilized at the time
of surgery. This
device system is
designed for
cemented use only. | | | |
| Device Class | Class II | | Same | | |
| Device Code | OOG, PBF, LLZ | OOG, IWH, MBH | PBF | IWH | Substantially |
| | | LLZ | | | Equivalent |
| Patient
Population | Adult patients | Patients without
severe bone
deformities | Adult patients | Skeletally mature
patients | Substantially
Equivalent |
| End User | | Prespecified clinical users (orthopedic surgeons) | | | Equivalent |
| Image
Modality | CT, X-ray | X-ray | CT | N/A | Substantially
Equivalent |
| Software
Processing | Image segmentation,
implant predictability,
dimensioning of
digital representations
of models, generation
of PSI | Image
segmentation,
implant
predictability,
dimensioning of
digital
representations of
models, generation
of PSI | Image segmentation,
dimensioning of
digital
representations of
models, generation of
PSI | N/A | Substantially
Equivalent
Software processing
functionality is
consistent |
| Preoperative
Planning | Provides tool to
improve visualization,
generate 3D models
and perform model
measurements to
choose, size, and
position the implant | Provides tool to
improve
visualization,
generate 3D
models and
perform model
measurements to
choose, size, and
position the
implant | Provides tool to
improve
visualization,
generate 3D models | N/A | Substantially
Equivalent
Subject device tools for
preoperative planning
are consistent |
| Output | Patient specific
anatomical models and
guides (physical
outputs); and patient
specific surgical plans
and digital files
(digital outputs) | Patient specific
anatomical models
and guides
(physical outputs);
and patient specific
surgical plans and
digital files (digital
outputs) | Patient specific
anatomical models,
templates, and guides
(physical outputs);
and patient specific
surgical plans and
digital files (digital or
documentation
outputs) | N/A | Substantially
Equivalent
Device outputs are
consistent |
Table - Comparison Summary
8
K230850 page 5 of 8
9
10
8. SUMMARY OF PERFORMANCE TESTING
Safety and performance of United Orthopedic Knee Patient Specific Instrumentation has been evaluated and verified in accordance with software specifications and applicable performance standards through Software Development and Verification & Validation Procedures (ISO 14971, IEC 62304:2006 & A1:2016), User Requirements, and Federal Regulations and Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "FDA Guidance on Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The software contained in this device is considered to be of "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.
United Orthopedic Knee Patient Specific Instrumentation has been evaluated through the following non-clinical testing:
- . Segmentation System Testing
- o This testing was performed to verify and validate the accuracy of the software generated segmentation masks for CT and X-ray based DICOM data. The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use.
- . Model Verification Testing
- This testing was performed to verify and validate the accuracy of the software o generated 3-dimensional models from CT and X-ray based DICOM data. The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use.
- Software System Testing
- This testing was performed to verify and validate the accuracy of landmark o detection, system usage and accuracy. All specimens were within the bounds of the acceptance criteria. The resulting output measurements from the system were within the bounds of the input parameters (input values produced expected output values). The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use.
- Guide Wear Testing ●
- This testing was performed to verify and validate the amount of wear debris o generated from use of the surgical guides. The device passed the acceptance criteria of average weight loss and demonstrated satisfactory performance per the intended use.
11
- System Verification and Validation Test
- This testing was performed to verify and validate the amount overall system O performance in terms of system usage, and accuracy. Full use simulations tests using cadaver specimens were performed by multiple surgeons to verify and validate the overall system performance. The results demonstrated satisfactory performance per the intended use as in the predicate
In conclusion, United Orthopedic Knee Patient Specific Instrumentation performance testing has demonstrated the subject device's safety and effectiveness and meets its intended use statement.
CONCLUSION
The result of the comparison of the intended use/indications and technological characteristics of United Orthopedic Knee Patient Specific Instrumentation as compared to the primary predicate and secondary predicates demonstrate that United Orthopedic Knee Patient Specific Instrumentation is substantially equivalent to the chosen predicate devices. Additionally, the results of testing demonstrate that United Orthopedic Knee Patient Specific Instrumentation is as safe and effective as the predicate device and does not raise different questions relating to safety and/or effectiveness.