APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) by OMNLIFE SCIENCE

The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for uncemented fixation and single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.

Device Description

The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The shells are designed for cementless use. The two versions of the shells include a "no hole" and a "3 hole" version (plus an apical hole in both versions). The cup system includes titanium alloy cancellous bone screws (in separate sterile packaging) for optional supplemental fixation of the "3 hole" shell. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Interface Acetabular System, Acetabular Shell. For this type of device, the acceptance criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves non-clinical performance testing and a comparison of design features, materials, and intended use. Clinical studies, and thus the specific types of studies and criteria outlined in your request, are generally not performed for 510(k) submissions unless specifically deemed necessary by the FDA.

Based on the provided text, here's a breakdown of the information you requested, highlighting what is implicitly or explicitly stated:

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

For a 510(k) submission like this, "acceptance criteria" generally refers to demonstrating that the new device is as safe and effective as the predicate device. This is achieved through a combination of comparing design, materials, and non-clinical testing. The "reported device performance" is essentially the determination of substantial equivalence based on these comparisons.

Acceptance Criterion (Implied for 510(k))	Reported Device Performance (from document)
Premarket Substantial Equivalence	The Interface Acetabular System, Acetabular Shell, in our opinion, is substantially equivalent to the predicate device. The Apex Interface Acetabular System is manufactured, packaged, and sterilized using equivalent materials and processes. The subject device(s) is also substantially equivalent to its predicate(s) based on comparison of design features, intended use, and indications for use. The fundamental scientific technology of the modified device(s) has not changed relative to the predicate device(s). The safety and effectiveness of the devices has not changed relative to the predicate devices. The safety and effectiveness of the Interface Acetabular System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. (FDA's conclusion: "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...")
Material Equivalence	The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide. (Implicitly, these materials are equivalent to or acceptable for the predicate device's function).
Design Feature Equivalence	Comparison of design features (e.g., standard sizes 46-76mm and x-sizes 48x-58x mm; "no hole" and "3 hole" versions with apical hole; titanium alloy cancellous bone screws) against the predicate device (K031110 Apex Modular Acetabular Cup), demonstrating substantial similarity.
Intended Use and Indications for Use Equivalence	The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures... This prosthesis is intended for uncemented fixation and single use implantation... (These were found to be substantially equivalent to the predicate).
Non-Clinical Performance (if applicable)	No additional testing required per dFMEA. (This indicates that based on a design FMEA, existing test data, and comparison to the predicate, no new specific non-clinical tests were deemed necessary to prove substantial equivalence).

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

Sample Size: The document explicitly states: "No clinical studies were performed." Therefore, there is no "test set" in the context of human clinical data. The evaluation was based on non-clinical aspects and comparison to the predicate.
Data Provenance: Not applicable as no clinical data was used.

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)

Not applicable as no clinical studies were performed and thus no "ground truth" established by experts in a clinical test set. The substantial equivalence determination is made by the regulatory body (FDA) based on the manufacturer's submission and predicate comparison.

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

Not applicable as no clinical studies were performed.

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

Not applicable. This device is a passive implant (acetabular shell) and does not involve AI or human readers for diagnostic interpretation. No MRMC study was conducted.

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

Not applicable. This device is a passive implant; there is no algorithm or standalone performance in the context of AI.

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

Not applicable as no clinical studies were performed. The "ground truth" for a 510(k) in this context is implicitly the established safety and effectiveness of the predicate device, against which the new device is compared.

8. The sample size for the training set

Not applicable as no machine learning/AI training was involved for this passive implant device.

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

Not applicable as no machine learning/AI training was involved.

Summary

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Apex Interface Acetabular System, Acetabular Shell

26 October, 2011

Submitter	OMNIlife science, Inc.50 O'Connell WayE. Taunton MA 02718
Contact	Christine NassifDirector, Regulatory Affairs774-226-1871(508) 822-6030 (fax)
Preparation Date	26 October, 2011
Device Name	Apex Interface Acetabular System, Acetabular Shell
Sizes	Standard sizes, 46-76mm and x-sizes, 48x-58x mm.Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
Common name/Classification	Class II per 21 CFR § 888.3358
Regulatory Class	LPH
Product Code
Legally Marketed Predicate Device(s)	K031110 Apex Modular Acetabular Cup, May 22, 2003
Device Description	The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The shells are designed for cementless use. The two versions of the shells include a "no hole" and a "3 hole" version (plus an apical hole in both versions). The cup system includes titanium alloy cancellous bone screws (in separate sterile packaging) for optional supplemental fixation of the "3 hole" shell. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide.

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Indications for Use	The Apex Interface™ Acetabular System is intended for use in combination with the ApexModular Hip Stem in total hip replacement procedures. This acetabular cup is intended toarticulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesisis intended for uncemented fixation and single use implantation, and may be used for thefollowing conditions, as appropriate:Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.
Predicate DeviceComparison	The Apex Interface Acetabular System is manufactured, packaged, and sterilized usingequivalent materials and processes. The subject device(s) is also substantially equivalent toits predicate(s) based on comparison of design features, intended use, and indications foruse. The fundamental scientific technology of the modified device(s) has not changedrelative to the predicate device(s). The safety and effectiveness of the devices has notchanged relative to the predicate devices. The safety and effectiveness of the InterfaceAcetabular System is adequately supported by the substantial equivalence information,materials information, and analysis data provided within this Premarket Notification.
Non-Clinical TestSummary	No additional testing required per dFMEA.
Clinical TestSummary	No clinical studies were performed.
Conclusions	In summary, the Interface Acetabular System, Acetabular Shell, in our opinion, is substantiallyequivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters and is arranged in a circular fashion to match the shape of the circle.

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

Omni Life Science, Inc. % Chrstine Nassif 50 O'Connell Way Suite 10 East Taunton, MA 02718

·DEC - 2 2011

Re: K112779

Trade/Device Name: Apex Interface Acctabular System, Acetabular Shell 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 Dated: October 26, 2011 Received: November 2, 2011

Dear Ms. Nassif:

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.

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Christine Nassif

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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

Sincerely yours,

Erin L. Keith

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

Enclosure

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: K112779-S1 Apex Interface Acetabular Sys-Shell

510(k) Numbe

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

and Restorative Devices

AND/OR Over-The-Counter Use

on of Surgical, Orthopedic,

(21 CFR 801 Subpart C)

Prescription Use

(Part 21 CFR 801 Subpart D)

OMNIlife science, Inc.

Part 21 CFR 801 Subpart D)

Rheumatoid arthritis;

Correction of functional deformity;

Congenital dislocation;

Revision procedures where other treatments or devices have failed;

Femoral neck and trochanteric fractures of the proximal femur.

Device Name: Apex Interface Acetabular System, Acetabular Shell

510(k) Number (if known): 丝绸2779 (pg ١/١٦)

Indications for Use

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;

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.