NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acetabular portions of the hip that are severely disabled and/or very painful as a result of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis or traumatic arthritis
Correction of functional deformity
Non-union femoral neck fracture
Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.
The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Device Description

The NovoHip Total Hip System is a non-cemented hip prosthesis that consists of a 4-part total hip replacement system including femoral head, acetabular liner, and acetabular shell components. The femoral head component articulates within the poly acetabular component. The acetabular liner snaps into the acetabular shell component. The design and sizing of the components correspond to natural hip anatomy to restore normal rotation, extension, and flexion.
The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "NovoHip Vitamin E liner." It describes the device, its intended use, technological characteristics, and importantly, the non-clinical performance data used for its clearance.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format alongside reported device performance. Instead, it lists numerous non-clinical tests performed on the device and concludes that, "Based on testing results and the comparisons provided, the NovoHip Vitamin E liner is considered substantially equivalent to the Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, DePuy Pinnacle Acetabular System, and Wright Medical Lineage Acetabular System in material, construction, and performance characteristics."

This indicates that the acceptance criterion for each test was likely that the NovoHip Vitamin E liner performed commensurately with, or acceptably against, the predicate devices based on the established standards/methods for those tests. The "reported device performance" is summarized by the overall statement of substantial equivalence rather than specific numerical results for each criterion.

Here's a conceptual representation of what such a table might look like, based on the provided information, if specific numerical criteria were explicitly listed:

Acceptance Criterion (Test Name)	Standard/Method	Expected Performance (Based on Predicate)	Reported Device Performance (NovoHip Vitamin E Liner)	Meets Criteria?
Thermal Properties (DSC) Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Small Punch Testing	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Oxidation Index Analysis	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Density Testing	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Trans-Vinylene Yield Index Analysis	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
In Situ Determination of Network Parameters	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Tensile Property Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Izod Impact Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Residual Free Radical Content	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Compressive Modulus	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Fatigue Crack Propagation	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Poisson's Ratio	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Exhaustive Extraction	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Consolidation Assessment	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Post-Wear Analysis	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Orbital Hip Wear	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Wear Particle Analysis at 1,000,000 Cycles	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Locking Mechanism Strength Evaluation	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Lever-Out Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Torque-Out Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Push-In Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Push-Out Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Rotational Stability Test	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Torsional Strength of Metallic Bone Screws	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Driving Torque of Metallic Bone Screws	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes
Axial Pullout Strength of Metallic Bone Screws	Implied standard	Commensurate with predicates	Performance demonstrated substantial equivalence	Yes

Study Details:

Sample size used for the test set and the data provenance:
The document lists 28 non-clinical performance tests. For each of these tests, a sample size of the device (NovoHip Vitamin E liners) would have been used. However, the specific sample sizes for each test are not detailed in this 510(k) summary. These would typically be found in the full test reports, which are not included here.
The data provenance is non-clinical bench testing, meaning the data was generated in a lab setting, not from human or animal subjects. Details like country of origin are not specified, but it's implied the testing was conducted by or for NovoSource Inc. to support regulatory submission in the U.S.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable as the studies were non-clinical (bench testing) rather than clinical studies requiring expert interpretation of medical images or patient outcomes. The "ground truth" for these tests would be the established scientific methods and engineering standards used to measure device properties.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable for non-clinical bench testing as there is no human interpretation of data requiring adjudication. The results are typically quantitative measurements against defined specifications.
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:
This question is not applicable. The device is an orthopedic implant (hip liner), not an AI-powered diagnostic or assistive tool. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is a physical implant; there is no AI algorithm involved in its function or assessment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For these non-clinical tests, the "ground truth" refers to the established scientific and engineering principles, measurement standards (e.g., ISO, ASTM), and the physical properties of the material and device components themselves. Performance was measured against these objective standards and compared to the performance of predicate devices.
The sample size for the training set:
This question is not applicable. This is not a machine learning or AI device that requires a training set. The device is a physical medical implant.
How the ground truth for the training set was established:
This question is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

K140701 (pg 1/3)

510(k) Summary NovoHip Vitamin E Liners NovoSource Inc.

JUN 2 7 2014

510(k) Summary

Submitter Information

Applicant/Sponsor: NovoSource, Inc. 714 E Monument Ave, Suite 220 Dayton, OH 45402

Contact Person: Allison Scott, RAC 317-228-8719 Allison.Scott@Navigant.com

Date of Preparation: June 27, 2014

Trade Name: NovoHip Vitamin E liner

Common Name: Hip prosthesis

Classification Name(s): Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis + Additive porous uncemented per 21 CFR 888.3358

Hip joint metal/polymer/metal semi-constrained porouscoated uncemented prosthesis per 21 CFR 888.3358

Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis per 21 CFR 888.3353

Device Produce Code(s): OQG, LPH, LZO Predicate Devices:

NovoHip Total Hip System (K132158)

Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (K120370)

DePuy Pinnacle Acetabular System (K001534)

Wright Medical Lineage Acetabular System (K002149)

{1}------------------------------------------------

510(k) Summary NovoHip Vitamin E Liners NovoSource Inc.

Device Description

The NovoHip Vitamin E liners are components to be used with the NovoHip Total Hip System, previously cleared via K132158. The Vitamin E poly acetabular component snaps into the metal acetabular components that were previously cleared with the NovoHip Total Hip System.

Intended Use(s)

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis or traumatic arthritis
Correction of functional deformity
Non-union femoral neck fracture
Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

Technological Characteristics

The NovoHip Total Hip System and NovoHip Vitamin E liner have the same intended use as the predicate devices. The NovoHip Total Hip System and NovoHip Vitamin-E liner have similar indications for use as the predicate devices. The NovoHip Vitamin E liner is manufactured from the same materials as the predicate devices. The range of sizes of the NovoHip Vitamin E liner is similar to the predicate devices.

{2}------------------------------------------------

510(k) Summary NovoHip Vitamin E Liners · NovoSource Inc.

K140701 (pg 3/3)

Non-Clinical Performance Data Summary

1. Thermal Properties (DSC) Test
1. Small Punch Testing
1. Oxidation Index Analysis
1. Density Testing
1. Trans-Vinylene Yield Index Analysis
1. In Situ Determination of Network Parameters
1. Tensile Property Test
1. Izod Impact Test
1. Residual Free Radical Content
1. Compressive Modulus
1. Fatigue Crack Propagation
1. Poisson's Ratio
1. Exhaustive Extraction
1. Consolidation Assessment
1. Post-Wear Analysis
1. Fatigue Crack Propagation
1. Analysis of Extraction Residue
1. Orbital Hip Wear
1. Wear Particle Analysis at 1,000,000 Cycles
1. Locking Mechanism Strength Evaluation
1. Lever-Out Test
1. Torque-Out Test
1. Push-In Test
1. Push-Out Test
1. Rotational Stability Test
1. Torsional Strength of Metallic Bone Screws
1. Driving Torque of Metallic Bone Screws
1. Axial Pullout Strength of Metallic Bone Screws

Clinical Performance Data Summary

No clinical testing was required.

Non-Clinical and Clinical Performance Data Conclusions

Based on testing results and the comparisons provided, the NovoHip Vitamin E liner is considered substantially equivalent to the Zimmer Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners, DePuy Pinnacle Acetabular System, and Wright Medical Lineage Acetabular System in material, construction, and performance characteristics.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002

June 27, 2014

NovoSource, Incorporated Navigant Consulting, Incorporated % Allison Scott, RAC Senior Consultant 9001 Weslevan Road, Suite 200 Indianapolis, Indiana 46268

Re: K140701

Trade/Device Name: NovoHip Vitamin E Liner 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: OQG, LPH, LZO Dated: May 27, 2014 Received: May 28, 2014

Dear Ms. Scott:

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. 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

{4}------------------------------------------------

Page 2 - Ms. Allison Scott

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K140701 (pg 1/1)

Device Name

NovoSource NovoHip Total Hip System

Indications for Use (Describe)

NovoHip Vitamin E liners are intended for use with the NovoSource NovoHip Total Hip System. NovoSource hip implant components are indicated for use in cementless reconstruction of the articulating surface of femoral and/or acctabular portions of the hip that are severely disabled and/or very painful as a result of:

Non-inflammatory degencrative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis or traumatic arthritis
Correction of functional deformity
Non-union femoral neck fracture
· Trochanteric fractures of the proximal femur with head involvement which is unmanageable using other techniques.

The components can be used for primary hip arthroplasty or for revision of a failed total hip arthroplasty.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabet际上 - Frank - S

Division of Orthopedic Devices

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."

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.