· A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, manageable by other techniques.
Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

Device Description

The Conformis BeneFIT Hip System is an uncemented, primary total hip replacement composed of femoral and acetabular components. All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fits through the acetabular shell screw holes and is driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.

AI/ML Overview

The ConforMIS BeneFIT Hip System is a medical device and its acceptance criteria are established through non-clinical laboratory testing. This is a hip implant system, not a software or AI-driven device, so the typical AI/software performance metrics, ground truth establishment, and expert adjudication as described in your prompt are not applicable.

Here's an overview of the acceptance criteria and the study as described in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Performed)	Reported Device Performance
Femoral Stem Fatigue Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Femoral Neck Fatigue Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Femoral Taper-CoCr Head Junction Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Femoral Taper-Ceramic Head Junction Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Acetabular Liner-Cup Disassembly Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Acetabular Liner Impingement Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Wear Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Acetabular Bone Screw Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
HA Coating Microstructure Characterization	Demonstrated acceptable performance; substantially equivalent to predicates.
HA Coating Static Fatigue Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
HA Coating Shear Fatigue	Demonstrated acceptable performance; substantially equivalent to predicates.
Range of Motion Testing	Demonstrated acceptable performance; substantially equivalent to predicates.
Chemical and Mechanical Characterization of iPoly XE	Demonstrated acceptable performance; substantially equivalent to predicates.
Cadaveric Evaluation	Demonstrated acceptable performance; substantially equivalent to predicates.

Note: The document states "Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use." This implies that the device met pre-defined performance thresholds, typically based on industry standards and comparison to the predicate devices, for each of these tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes for each non-clinical test. Clinical trials (human test subjects) for hip implants involve sample sizes that depend on the study design (e.g., pilot studies, pivotal studies), but this document focuses on non-clinical testing for 510(k) clearance, which typically involves mechanical testing of device samples.
Data Provenance: The data is generated from non-clinical laboratory testing conducted by ConforMIS, Inc. or its designated testing facilities. There is no information about country of origin of data in the sense of patient data, nor is it retrospective or prospective in a clinical study context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This is not applicable to the non-clinical laboratory testing described. The "ground truth" for the performance of a mechanical device like a hip implant is established by meeting predefined engineering specifications, adherence to ISO standards (e.g., for fatigue, wear), and demonstrating equivalence to predicate devices, rather than through expert consensus on interpreting patient data.

4. Adjudication Method for the Test Set

Not applicable. As this is non-clinical mechanical testing, there is no "adjudication method" in the sense of reconciling human expert opinions on cases. Test results are typically evaluated against pre-defined engineering criteria and scientific principles.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI algorithms where human interpretation plays a role. This document concerns a physical implant and its mechanical properties.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of non-clinical testing, is compliance with established engineering standards (e.g., ISO standards for orthopedic implants), predefined performance specifications, and demonstrated substantial equivalence to legally marketed predicate devices. This includes meeting specified thresholds for properties like fatigue strength, wear resistance, and component integrity.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a "training set." The design and manufacturing processes are refined through engineering, material science, and iterative testing, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the reasons stated in point 8.

Summary

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August 28, 2019

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.

ConforMIS, Inc. Emmanuel Nyakako Sr. Vice President, Regulatory and Quality Affairs 600 Technology Park Billerica, Massachusetts 01821

Re: K190904

Trade/Device Name: Conformis BeneFIT Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH, OQG Dated: July 29, 2019 Received: July 30, 2019

Dear Emmanuel Nyakako:

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/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.

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

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devices or postmarketing safety reporting (21 CFR 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 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 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).

Sincerely.

FOR Vesa Vuniqi Acting 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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Indications for Use

510(k) Number (if known) K190904

Device Name ConforMIS, Inc. BeneFIT Hip System

Indications for Use (Describe)

The ConforMIS BeneFIT Hip System is indicated for use in skeletally mature individuals undergoing total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
· Treatment of non-displaced non-unions of the hip, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement, manageable by other techniques.
Revision procedures for failed previous hip surgery (excluding situations where hardware is present). . The ConforMS BeneFIT Hip System implants are intended for cementless fixation using an anterior or posterior surgical approach.

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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6.0 510(K) SUMMARY (PAGE 1 OF 5)

510(K) SUMMARY (PAGE 1 OF 5)
Submitter's Name and Address:	ConforMIS, Inc.600 Technology ParkBillerica, MA 01821
Establishment Registration Number:	3009844603 and 3004153240
Date of Summary:	July 29, 2019
Contact Person:	Emmanuel Nyakako, Sr. Vice President, Regulatory and Quality Affairs
Telephone Number:	(781) 345-9164
Fax Number:	(781) 583-5006
Name of the Device:	ConforMIS BeneFIT Hip System
Common Name:	Total Hip Replacement System
Regulatory Status and Regulation Number:	Class II21 CFR 888.335821 CFR 888.3353
Classification Name:	Uncemented, primary total hip replacement composed of femoral and acetabular components.
Device Classification:	Product Code:LPH: Prosthesis, hip, semi-constrained, metal/polymer, porous uncementedLZO: Hip joint metal/ceramic/polymer semi constrained cemented or nonporous uncementedMEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calcium phosphate
Indications forUse:	The Conformis BeneFIT Hip System is indicated for use in skeletallymature individuals undergoing total hip replacement due to:• A severely painful and/or disabled joint from osteoarthritis,traumatic arthritis, rheumatoid arthritis, avascular necrosis, orcongenital hip dysplasia.• Treatment of non-displaced non-unions of the hip, femoralneck fractures, and trochanteric fractures of the proximal femur withhead involvement, unmanageable by other techniques.• Revision procedures for failed previous hip surgery(excluding situations where hardware is present).The Conformis BeneFIT Hip System implants are intended forcementless fixation using an anterior or posterior surgicalapproach.
Identification ofthe LegallyMarketedDevices(PredicateDevices):	Primary Predicate:
	Conformis iTotal Hip System
	Device Class:	II
	Product Code:	LPH, JDI, OQG, OQH
	Regulation Number:	21 CFR 888.3358
	510(k) Number:	K162719
	Secondary Predicates:
	Corail AMT Hip Prosthesis
	Device Class:	II
	Product Code:	LZO
	Regulation Number:	21 CFR 888.3353
	510(k) Number:	K042992
	Exactech Novation Crown Cup with InteGrip Acetabular ShellDevice
	Class:	II
	Product Code:
	Regulation Number:	21 CFR 888.3353
	510(k) Number:	K102795

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210(K) SUMMARY (PAGE 2 OF হা

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510(K) SUMMARY (PAGE 3 OF 5)

The Conformis BeneFIT Hip System is an uncemented, primary total Device hip replacement composed of femoral and acetabular components. Description: All components are provided sterile. The femoral component consists of a standard monoblock femoral stem body and neck, which mates with a standard femoral head. The stem and neck are manufactured as one piece and hence are not modular. The proximal neck surface with a 12/14 taper is highly polished and transitions to hydroxyapatite coating in the main stem body and is indicated for uncemented press fit fixation only. The femoral head is designed to connect to the femoral stem neck. All femoral heads are polished and have a 12/14 taper to match the femoral stem. The femoral heads are available in either cobalt chromium alloy (CoCr) or ceramic (Biolox® Delta). The acetabular component consists of a standard size shell in 1mm increments with standard screw hole placement, a mating polyethylene liner, and cancellous screws. The acetabular component is designed for uncemented use; initial implant fixation is achieved through press-fit design. The 6.5mm diameter cancellous screws with low profile head fits through the acetabular shell screw holes and is driven using a 3.5mm hex drive recess. The acetabular component has matching circumferential scallops on the shell and liner that rotationally secure the liner in the shell and allow for dialing the liner in a desired orientation. The liner is provided with an impactor made of a biocompatible nylon material.

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510(K) SUMMARY (PAGE 4 OF 5)

The Conformis BeneFIT Hip System, subject of this premarket Substantial notification is substantially equivalent to the Conformis iTotal Hip Equivalence: Replacement System (K162719, cleared June 14, 2017), the Corail AMT Hip Prosthesis (K042992, cleared February 11, 2005), and the Exactech Exactech Novation Crown Cup with InteGrip Acetabular ShellDevice (K102795, cleared February 2, 2011). Non-clinical testing was conducted in accordance with applicable FDA guidance documents to confirm that the Conformis BeneFIT Hip System is substantially equivalent to the predicate hip systems.

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510(K) SUMMARY (PAGE 5 OF 5)

510(K) SUMMARY (PAGE 5 OF 5)Description andAssessment ofNonclinicalTesting:	Nonclinical Testing: The determination of substantial equivalence forthis device was based on a detailed device description and non-clinicallaboratory testing. Testing on the Conformis BeneFIT Hip Systemincluded functional testing in compliance with the applicable FDAguidance documents.Specifically, the following tests were conducted to evaluate theperformance of the device:Femoral Stem Fatigue Testing Femoral Neck Fatigue Testing Femoral Taper-CoCr head Junction Testing Femoral Taper-Ceramic Head Junction Testing Acetabular Liner-Cup Disassembly Testing Acetabular Liner Impingement Testing Wear Testing Acetabular Bone Screw Testing HA Coating Microstructure Characterization HA Coating Static Fatigue Testing HA Coating Shear Fatigue Range of Motion Testing Chemical and Mechanical Characterization of iPoly XE Cadaveric Evaluation Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use.
Conclusion:	Based on the testing conducted, it is concluded that the ConformisBeneFIT Hip System is substantially equivalent to the predicatedevices: Conformis iTotal Hip Replacement System (K162719, clearedJune 14, 2017), the Corail AMT Hip Prosthesis (K042992, clearedFebruary 11, 2005), and the Exactech Exactech Novation Crown Cupwith InteGrip Acetabular ShellDevice (K102795, cleared February 2,2011)

510(K) SUMMARY (PAGE 5 OF 5)Description andAssessment ofNonclinicalTesting:

Nonclinical Testing: The determination of substantial equivalence forthis device was based on a detailed device description and non-clinicallaboratory testing. Testing on the Conformis BeneFIT Hip Systemincluded functional testing in compliance with the applicable FDAguidance documents.Specifically, the following tests were conducted to evaluate theperformance of the device:Femoral Stem Fatigue Testing Femoral Neck Fatigue Testing Femoral Taper-CoCr head Junction Testing Femoral Taper-Ceramic Head Junction Testing Acetabular Liner-Cup Disassembly Testing Acetabular Liner Impingement Testing Wear Testing Acetabular Bone Screw Testing HA Coating Microstructure Characterization HA Coating Static Fatigue Testing HA Coating Shear Fatigue Range of Motion Testing Chemical and Mechanical Characterization of iPoly XE Cadaveric Evaluation Test results demonstrated that the device can be considered substantially equivalent to the predicate devices for the specified intended use.

Conclusion:

Based on the testing conducted, it is concluded that the ConformisBeneFIT Hip System is substantially equivalent to the predicatedevices: Conformis iTotal Hip Replacement System (K162719, clearedJune 14, 2017), the Corail AMT Hip Prosthesis (K042992, clearedFebruary 11, 2005), and the Exactech Exactech Novation Crown Cupwith InteGrip Acetabular ShellDevice (K102795, cleared February 2,2011)

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.