. Osteoarthritis
. Femoral neck fracture
Dislocation risk ●
Osteonecrosis of the femoral head
. Revision procedures where other treatments or devices have failed and if bone reconstruction so permits

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use

Device Description

The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is made of cross-linked Ultra-High-Molecular-Weight Polyethylene which meet the strength requirements of the ASTM F648 and the testing listed in the ASTM F2565. The liner is mobile (free) in the NOVAE® metallic shell (clearance K111572) and retained on the prosthetic femoral head. Liners can be used with Ø22.2 or 28 mm prosthetic femoral heads.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.

The document is a 510(k) premarket notification letter from the FDA regarding a medical device called "CI../..X liner for NOVAE® Dual Mobility Acetabular Cup." While it mentions that "Acceptance criteria were met for each test," it does not explicitly state what those acceptance criteria are nor does it provide a detailed description of the study that proves the device meets those criteria.

Specifically, the following information you requested is missing from the provided text:

A table of acceptance criteria and the reported device performance: The text only generally states that "Acceptance criteria were met."
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth and their qualifications: Not applicable for this type of mechanical testing.
Adjudication method: Not applicable for this type of mechanical testing.
Multi reader multi case (MRMC) comparative effectiveness study: The document explicitly states "No clinical studies were performed."
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an AI algorithm.
Type of ground truth used: For mechanical tests, the ground truth would be the physical measurements themselves against established standards, but details are not provided.
Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm.
How the ground truth for the training set was established: Not applicable.

The document only lists the types of non-clinical tests performed:

Dimensional analysis
Head insertion force
Head lever out force
Wear analysis

And states that these tests were conducted to demonstrate substantial equivalence to predicate devices, focusing on design, materials, and mechanical performance according to ASTM standards. It concludes that the device is substantially equivalent based on these non-clinical tests.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.

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

January 15, 2015

Gloster Biomedical International Ms. Catherine Gloster Founder and Principal Consultant 577 North Hope Avenue Santa Barbara, California 93110

Re: K142675 Trade/Device Name: CI../..X liner for NOVAE® Dual Mobility Acetabular Cup Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, MEH Dated: October 20, 2014 Received: October 21, 2014

Dear Ms. Gloster:

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

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Page 2 - Ms. Catherine Gloster

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Section 4

Indications for Use Statement

510(k) Number (if known): K142675

Device Name: Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup

Indications For Use:

NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:

Osteoarthritis
Femoral neck fracture
Dislocation risk
Osteonecrosis of the femoral head
Revision procedures where other treatments or devices have failed and if bone reconstruction so permits

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Section 5 510(k) Summary

Date: January 15th, 2015

Company name and address:	SERF85 avenue des Bruyères69153 Décines CedexFRANCEPhone: +33 4 72 05 60 10Fax: +33 4 72 02 19 18
Contact person:	Jean-Luc AURELLEGeneral Manager / Industrial Manager
Date prepared:	July 25th, 2014
Trade name:	CI../..X liner for NOVAE® Dual Mobility Acetabular Cup
Common name:	Total hip prosthesis – Acetabular component

Classification name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353, Product Code LZO/MEH)

Device description

Substantial equivalence claimed to predicate devices

The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to the Cl../..E liner for NOVAE® Dual Mobility Acetabular Cup (K111572, SERF) in terms of intended use, design, range of sizes, mechanical safety and performances.

The Cl../..X liner for NOVAE® Dual Mobility Acetabular Cup is substantially equivalent to ApeX-LNK Poly™ Acetabular Cup Liner (K100555, OMNIlife science) in terms of intended use, material and manufacturing and sterilization processes.

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Device	CI../..X liner for NOVAE®Dual Mobility AcetabularCup	NOVAE® Dual MobilityAcetabular Cup	ApeX-LNK PolyTMAcetabular Cup Liners
510(k) number	/	K111572	K100555
Intended use
Total hipreplacement	Yes	Yes	Yes
Cementless/cemented	Yes/Yes	Yes/Yes	Unknown
Primary/Revision	Yes/Yes	Yes/Yes	Yes/Yes
Design
Dual mobility	Yes	Yes	No
Liner is retainedon the head	Yes	Yes	No
Materials
Liner	Cross-linked UHMWPE	UHMWPE	Cross-linked UHMWPE

Intended use

Cl../..X liner for NOVAE® Dual mobility Acetabular Cup is indicated for total hip replacement, which includes:

. Osteoarthritis
. Femoral neck fracture
Dislocation risk ●
Osteonecrosis of the femoral head
. Revision procedures where other treatments or devices have failed and if bone reconstruction so permits

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use

Non-clinical Test Summary

The following tests were conducted:

. Dimensional analysis
. Head insertion force
Head lever out force .
. Wear analysis

Acceptance criteria were met for each test above.

Clinical Test Summary

No clinical studies were performed

Conclusions Nonclinical and Clinical

Cl../..X liner for NOVAE® Dual mobility Acetabular Cup is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and performances.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.