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.

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.

[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.

AI/ML Overview

The provided text describes a 510(k) submission for the "United Orthopedic Knee Patient Specific Instrumentation" and highlights different performance tests conducted. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices and general software verification and validation, rather than a detailed acceptance criteria table with reported device performance specifically for an AI algorithm's diagnostic or predictive capabilities.

The AI components mentioned are:

Intelligent Surgery Knee CT Segmentation Engine / Intelligent Surgery Knee X-ray Segmentation Engine: Uses deep learning algorithms to detect and extract region of interest (ROI) information (femur and tibia) and generate 3D models.
Intelligent Surgery Knee Implant Recognition Engine: Uses an optimization algorithm as a treatment planning tool for total knee arthroplasty, assisting in implant selection and position.

The information provided about the study mainly focuses on general software testing and system verification, not a specific study proving the AI's diagnostic/predictive accuracy against a gold standard in a clinical context, which is typically what is asked for in such acceptance criteria discussions for AI/ML medical devices.

Therefore, I cannot fully complete all sections of your request based on the provided text, especially regarding specific performance metrics for the AI components and clinical study details (e.g., MRMC study, human reader improvement).

Here's what can be extracted and inferred, along with what's missing:

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

The document lists general testing categories and states that the device "passed the acceptance criteria and demonstrated satisfactory performance per the intended use" for each. It does not provide specific quantitative acceptance criteria or reported numerical performance metrics for the AI algorithms (e.g., sensitivity, specificity, Dice score for segmentation, or accuracy of landmark detection against a ground truth). It describes the type of testing but not the results in detail.

Acceptance Criteria Category	Reported Device Performance (as stated in document)
Segmentation System Testing	"The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use."
Model Verification Testing	"The device passed the acceptance criteria and demonstrated satisfactory performance per the intended use."
Software System Testing	"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	"The device passed the acceptance criteria of average weight loss and demonstrated satisfactory performance per the intended use."
System Verification and Validation Test	"The results demonstrated satisfactory performance per the intended use as in the predicate."

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

Sample Size: Not specified for any of the tests. The document generically mentions "specimens" and "cadaver specimens."
Data Provenance: Not specified (e.g., country of origin).
Retrospective or Prospective: Not specified. "Cadaver specimens" suggest an ex-vivo or lab-based study rather than a direct clinical study.

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

The document states "Full use simulations tests using cadaver specimens were performed by multiple surgeons to verify and validate the overall system performance."
Number of experts: "Multiple surgeons," but no specific number is given.
Qualifications: "Surgeons," but no specific experience or specialty (e.g., orthopedic surgeon, years of experience) is provided.
It's unclear if these surgeons established the ground truth or simply evaluated the system's performance in a simulated setting. For segmentation or landmark detection, ground truth typically involves more rigorous, independently verified annotations.

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

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study described. The focus appears to be on the system's accuracy in generating models and plans, rather than its impact on human reader performance in a diagnostic context. The "multiple surgeons" evaluating the system in the System V&V test is a system performance evaluation, not an MRMC study comparing human performance with and without AI assistance for a specific task.

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

The "Segmentation System Testing" and "Software System Testing" sections likely represent standalone algorithm testing, where the algorithm's output (segmentation masks, 3D models, landmark detection accuracy) was compared against a reference.
However, no specific performance metrics (e.g., accuracy, precision, recall, Dice score) are provided to quantify this standalone performance.

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

The document implies that the ground truth for "Segmentation System Testing," "Model Verification Testing," and "Software System Testing" was based on established benchmarks, comparisons to expected outputs, or potentially expert-derived ground truth for the "accuracy" claims. However, the specific method (e.g., expert consensus, manual measurements, etc.) for establishing this ground truth is not explicitly stated.
For the "System Verification and Validation Test" using cadaver specimens and surgeons, the "satisfactory performance" seems to imply that the surgeons found the system's output acceptable and accurate for surgical planning, but the method of establishing the "true" anatomical values or optimal plans as ground truth is not detailed.

8. The sample size for the training set

Not specified. The document mentions the use of "deep learning algorithms" but provides no details on the training data.

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

Not specified. The document mentions deep learning but no details about the ground truth creation for training.

In summary, the provided FDA 510(k) summary focuses on general validation of a device that includes AI components, but it does not provide the highly specific, quantifiable details often required for AI/ML device submissions regarding their specific performance metrics, test set characteristics, or the rigorous establishment of ground truth that one would expect for a diagnostic AI algorithm. This submission appears to be more focused on the overall system's functionality and its role in surgical planning rather than a detailed clinical validation study of the AI's diagnostic capabilities.

Summary

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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.

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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).

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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

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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)

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.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (6/20)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
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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 BoulevardHasbrouck Heights, NJ 07604Phone: (201) 771-2034
Official Correspondent:	Monica WilliamsQA/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) .

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5. DESCRIPTION OF THE DEVICE

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]

Note, these algorithms are static and non-adaptive; they do not alter their behavior over time based on user input.

[THE HARDWARE]

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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:

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. 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.

TechnologicalCharacteristics	Subject Device:United OrthopedicKnee Patient SpecificInstrumentation	PrimaryPredicate:Orthosoft X-PSIKnee System(K171269)	Predicate Device:3D Systems VSPOrthopedics System(K211244)	Predicate Device:United OrthopedicCorporation U2Total Knee System(K051640)	Comparison
Indications forUse (IFU)	The UnitedOrthopedic KneePatient SpecificInstrumentation isindicated as anorthopedic instrumentsystem to assist in thepositioning ofcompatible total kneearthroplasty systems. Itis comprised ofsurgical planningsoftware (IntelligentSurgery Knee CTSegmentationEngine/Knee X-raySegmentation Engine,and ImplantRecognition Engine)intended topreoperatively plan thesurgical placement of	The X-PSI KneeSystem is indicatedas an orthopedicinstrument systemto assist in thepositioning of kneereplacementcomponents. Itinvolves surgicalplanning softwareused pre-operatively to planthe surgicalplacement of thecomponents on thebasis of providedpatient radiologicalimages and 3-Dreconstructedbones withidentifiableplacementanatomicallandmarks, andsurgical instrument	The VSP®Orthopedics Systemis intended to be usedas a surgicalinstrument to assist inpreoperative planningand/or in guiding themarking of boneand/or in guidingsurgical instrumentsin non-acute, non-joint replacingosteotomies for adultpatients in the distalfemur, tibia, and non-sacrum pelvis.	This device isindicated in kneearthroplasty forreduction or relief ofpain and/or improvedknee function inskeletally maturepatients with severeknee pain anddisability due torheumatoid arthritis,osteoarthritis,primary andsecondary traumaticarthritis, polyarthritis,collagen disorders,avascular necrosis ofthe femoral condyleor pseudogout,posttraumatic loss ofjoint configuration,particularly when	SubstantiallyEquivalentAll fundamental aspectsof the indications foruse are the same (e.g.visualization ofradiological images, 3Dreconstruction of bonesand includes tools toimprove visualization,positioning of kneereplacementcomponents, use ofclinical judgement, usewith fixed bearing kneereplacement systems)
the UnitedOrthopedics Kneeimplants on the basisof provided patientradiological imagesand 3D reconstructionsof bones withidentifiable anatomicallandmarks, andsurgical instrumentcomponents thatinclude patient specificor customized guidesfabricated on the basisof the surgical plan toprecisely reference theplacement of theimplant componentsintra-operatively perthe surgical plan. TheUnited OrthopedicKnee Patient SpecificInstrumentation isindicated for patientswithout severe bonedeformities, such as aHKA greater than 15°or deformities due toprior fracture of thedistal femur orproximal tibia.The instruments areintended for use withthe U2 Total KneeSystem when theclinical evaluationcomplies with itscleared indications foruse. The instrumentsare intended for singleuse only.	components thatinclude patientspecific orcustomized guidesfabricated on thebasis of thesurgical plan toprecisely referencethe placement oftheimplantcomponents intra-operatively per thesurgical plan. TheX-PSI Kneesystem is indicatedfor patients withoutsevere bonedeformities, suchas a HKA greaterthan 15° ordeformities due toprior fracture of thedistal femur orproximal tibia.The X-PSI KneeSystem is to beused with thefollowing fixedbearing kneereplacementsystems inaccordance withtheir indicationsandcontraindications:NexGen® CR,NexGen CR-Flex,NexGen CR-FlexGender, NexGenLPS, NexGen LPS-Flex, NexGenLPS-Flex Gender,Persona® CR,Persona PS,Vanguard® CRand Vanguard PS.The patientspecific guidecomponents areintended for single-use only.	there ispatellofemoralerosion, dysfunctionor prior patellectomy,moderate valgus,varus, or flexiondeformities. Thisdevice may also beindicated in thesalvage of previouslyfailed surgicalattempts if the kneecan be satisfactorilybalanced andstabilized at the timeof surgery. Thisdevice system isdesigned forcemented use only.
Device Class	Class II		Same
Device Code	OOG, PBF, LLZ	OOG, IWH, MBH	PBF	IWH	Substantially
		LLZ			Equivalent
PatientPopulation	Adult patients	Patients withoutsevere bonedeformities	Adult patients	Skeletally maturepatients	SubstantiallyEquivalent
End User		Prespecified clinical users (orthopedic surgeons)			Equivalent
ImageModality	CT, X-ray	X-ray	CT	N/A	SubstantiallyEquivalent
SoftwareProcessing	Image segmentation,implant predictability,dimensioning ofdigital representationsof models, generationof PSI	Imagesegmentation,implantpredictability,dimensioning ofdigitalrepresentations ofmodels, generationof PSI	Image segmentation,dimensioning ofdigitalrepresentations ofmodels, generation ofPSI	N/A	SubstantiallyEquivalentSoftware processingfunctionality isconsistent
PreoperativePlanning	Provides tool toimprove visualization,generate 3D modelsand perform modelmeasurements tochoose, size, andposition the implant	Provides tool toimprovevisualization,generate 3Dmodels andperform modelmeasurements tochoose, size, andposition theimplant	Provides tool toimprovevisualization,generate 3D models	N/A	SubstantiallyEquivalentSubject device tools forpreoperative planningare consistent
Output	Patient specificanatomical models andguides (physicaloutputs); and patientspecific surgical plansand digital files(digital outputs)	Patient specificanatomical modelsand guides(physical outputs);and patient specificsurgical plans anddigital files (digitaloutputs)	Patient specificanatomical models,templates, and guides(physical outputs);and patient specificsurgical plans anddigital files (digital ordocumentationoutputs)	N/A	SubstantiallyEquivalentDevice outputs areconsistent

Table - Comparison Summary

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K230850 page 5 of 8

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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.

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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.

Regulation Number and Section

§ 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.