The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat 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

ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 40 mm diameter, with various offsets.
Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Analysis based on the provided document:

The provided document is a 510(k) premarket notification for ApeX-LNK Poly™ Acetabular Cup Liners and Apex Modular Heads. It is a regulatory submission for medical devices, primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance acceptance criteria through clinical studies in the way an AI/software device would.

Therefore, the requested information categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable in the context of this medical device submission. These categories are typically relevant for AI/ML-based diagnostic or screening devices where performance is measured against a ground truth from human expert interpretation or pathology.

This document demonstrates equivalence through design, materials, manufacturing processes, and in some cases, performance testing (often mechanical bench testing) to ensure safety and effectiveness are comparable to legally marketed devices. It does not involve "performance metrics" in the sense of diagnostic accuracy (sensitivity, specificity) or human reader improvement with AI.

Here's a breakdown of the relevant information from the document, acknowledging the difference in context:

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance

For this type of device, "acceptance criteria" are primarily established by the requirements for demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is judged by meeting these equivalence criteria and by ensuring the device functions as intended and is safe.

Acceptance Criterion (for Substantial Equivalence to Predicate)	Reported Device Performance (as presented in the submission)
Intended Use (Apex Hip System for primary & revision THA, uncemented fixation, single use implantation, specific articulating components and conditions)	Meets Predicate: "Same indicated use: (see indications statement)" - ApeX-LNK Poly™ Acetabular Cup Liners: Used with Apex Modular Acetabular Cup, with Apex Modular, Apex K2 Hip, articulating with metal (cobalt chromium) or ceramic (alumina) femoral head for conditions like degenerative joint disease, rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, and fractures. - Apex Modular Heads: Used in total hip replacement, compatible with various acetabular cups.
Operating Principle ("ball-in-socket" cobalt chromium-UHMWPE articular bearing components)	Meets Predicate: "Same operating principle: 'ball-in-socket' cobalt chromium-UHMWPE articular bearing components"
Materials (UHMWPE for liners, wrought cobalt chromium for heads as per specific ASTM standards)	Meets Predicate: "Same materials as predicates: the ApeX-LNK Acetabular Cup Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648) with identical specifications and processing parameters as the predicate ApeX-LNK Acetabular liners; the Apex Modular Heads are manufactured from the same material as the predicate Apex Modular Heads (wrought cobalt chromium per ASTM F1537)"
Basic Design (UHMWPE liners, cobalt chromium heads, identical modular interface dimensions, surface finish, taper dimensions, locking features)	Meets Predicate: "Same basic design: UHMWPE liners, cobalt chromium heads; identical modular interface dimensions and specifications as the predicates, including surface finish, taper dimensions, and locking features" - Liner Engagement: 19° taper and PE locking ring (same as ApeX-LNK predicate K073150). - Liner Options: Neutral and 10° hooded (same as ApeX-LNK predicate K073150). - Taper Design (Heads): Identical (size "N" bore in ASTM F1636-95) (same as Apex Modular Femoral Heads predicate K000788). - Offsets (Heads): -3.5, +0, +3.5, +7 (same as Apex Modular Femoral Heads predicate K000788).
Shelf Life (5 years from date of manufacture)	Meets Predicate: "Same shelf life: 5 years from date of manufacture."
Packaging & Sterilization (ETO, SAL 10^-6^)	Meets Predicate: "Packaged and sterilized using the same materials and processes: ETO, SAL 10^-6^*." - Packaging: Paper board box, Foil outer pouch, Double Tyvek inner pouch (same as ApeX-LNK predicate K073150 and Apex Modular Femoral Heads predicate K000788).
Functional Equivalence (demonstrated via performance testing, design comparisons, functional analysis)	Meets Predicate: "Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices." (Specific details of any new performance testing are not provided in this summary, but would typically involve mechanical tests for wear, fatigue, static strength, etc., to support the safety and effectiveness of the new sizes, not a clinical study comparing outcomes to a "ground truth" established by experts). The modifications are limited to the addition of a 40mm size head and a 40mm ID liner.

Regarding the other requested points:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a medical device 510(k) submission, not a study evaluating an AI/ML diagnostic algorithm. "Test sets" in the context of this document refer to mechanical testing of physical device components, not data for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth from experts is not applicable here. Mechanical tests typically compare physical measurements or observed failures against engineering specifications, often established by material science experts or engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for a device 510(k) submission.
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:
- N/A. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a physical medical device (hip implants), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A in the context of AI. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science data from ASTM standards, and performance characteristics (e.g., strength, wear resistance) that are comparable to previously approved, equivalent predicate devices.
8. The sample size for the training set:
- N/A. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. This is not an AI/ML device.

In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates substantial equivalence to predicate devices based on design, materials, intended use, manufacturing processes, and fundamental operating principles. The concepts of "acceptance criteria" and "studies" as typically applied to AI/ML software performance (e.g., diagnostic accuracy, reader studies) are not relevant to this document. The "study" here is the entire 510(k) submission process, which involves demonstrating that the new device is as safe and effective as a legally marketed one, often supported by detailed engineering and mechanical testing data (which is not fully detailed in this summary document).

Summary

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MAR 2 9 2010

ApeX-LNK Poly™ Acetabular Cup Liners Apex Modular Heads

March 09, 2010

Submitter: OMNI life science™, Inc. 50 O'Connell Way, Suite#10 E. Taunton,MA 02718

Contact: Radhika Pondicherry, Regulatory Affairs 774-226-1842 (508) 822-6030 (fax)

2. Device Name: The device trade names and common/classification names are-

Device Trade Name	Common/Classification name
ApeX-LNK Poly™ Acetabular Cup Liners	Hip joint metal/ Acetabular cup Liner, uncementedHip joint metal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis
Apex Modular Head	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis

Device Class

Acetabular Liners and Femoral Heads have been classified as Class II 21 CFR §888.3353, Product Code LZO, MEH 21 CFR §888.3358, Product Code LPH These products are reviewed by the Orthopedic Devices panel

3. Intended use

The Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup Liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total hip arthroplasty to treat the following conditions, as apropriate:

· 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.

4. Device Description

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Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.

5. Predicate Device Comparison

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. .

Description	Predicate Device Comparison
	ApeX-LNK(subject device)	ApeX-LNK(K073150)
INTENDED USE
Modular liner in metal shell, primary and revision THA	Yes, cementless	Yes, cementless
DESIGN
Liner engagement	19° taper and PE locking ring	19° taper and PE locking ring
Liner options	Neutral and 10° hooded	Neutral and 10° hooded
Head diameters	40 mm	28, 32, and 36 mm
MATERIALS
Cross-linked UHMWPE	Yes	Yes
Standards	ASTM F648	ASTM F648
PACKAGING & STERILIZATION
Sterilization	Ethylene oxide	Ethylene oxide
SAL	10-6	10-6
Packaging	Paper board box, Foil outer pouch, Double Tyvek inner pouch	Paper board box, Foil outer pouch, Double Tyvek inner pouch
	Apex Modular Femoral HeadsApex Modular Femoral Heads (subject device)	Apex Modular Femoral Heads(K000788)
Intended Use
Primary and revision total hip replacement	Yes	Yes
Design
Taper Design	Identical (size "N" bore in ASTM F1636-95)	Identical (size "N" bore in ASTM F1636-95)
Head Diameters	40 mm	22.225, 28, and 32 mm
Offsets	-3.5, +0, +3.5, +7	-3.5, +0, +3.5, +7
Materials
Femoral Heads	Wrought cobalt chromium(ASTM F1537)	Wrought cobalt chromium(ASTM F1537)
Standards	ASTM F1537	ASTM F1537
PACKAGING ANDSTERILIZATION
Sterilization	Ethylene oxide	Ethylene oxide
Sal	10-6	10-6
Packaging	Paper Board Box, Double	Paper Board Box, Double Tyvek

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6. Basis of Substantial Equivalence

The ApeX-LNK Poly Acetabular Cup Liners and Apex Modular Heads described in this submission are substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices.

The modified ApeX-LNK Acetabular Cup Liners and Apex Modular Heads have the following similarities to their respective predicate devices:

· Same indicated use: (see indications statement)

Same operating principle: "ball-in-socket" cobalt chromium-UHMWPE articular bearing components
Same materials as predicates: the ApeX -- NK Acetabular Cup Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648) with identical specifications and processing parameters as the predicate ApeX-LNK Acetabular liners; the Apex Modular Heads are manufactured from the same material as the predicate Apex Modular Heads (wrought cobalt chromium per ASTM F1537)

· Same basic design: UHMWPE liners, cobalt chromium heads; identical modular interface dimensions and specifications as the predicates, including surface finish, taper dimensions, and locking features

· Same shelf life: 5 years from date of manufacture.

· Packaged and sterilized using the same materials and processes: ETO, SAL 10 *.

The only modifications made are:

1. The addition of a 40 mm size head to the Apex Modular System.
1. The addition of a 40 mm ID liner to the Apex Modular System.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

OMNI Life Science, Inc. % Ms. Radhika Pondicherry Regulatory Affairs Specialist 50 O'Connell Way, Suite 10 E. Taunton, Massachusetts 02718

MAR 2 9 2010

Re: K100555

Trade/Device Name: ApeX-LNK Poly Acetabular Cup Liners and Apex Modular Head Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, MEH Dated: March 23, 2010 Received: March 24, 2010

Dear Ms. Pondicherry:

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.

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Page 2 - Ms. Radhika Pondicherry

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 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 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/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 Small Manufacturers, International and Consumer Assistance 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,

Barbara Buehum

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

Enclosure

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Indications for Use

510(k) Number: K100555

Device Name: ApeX-LNK Poly™ Acetabular Cup Liners,

Apex Modular Head

Indications for Use

· 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

AND/OR

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qutu for mkm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100555

Page 1 of 1

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.