The Apex ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis 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 Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty.

AI/ML Overview

The provided document describes the 510(k) Summary for the Apex ARC™ Hip Stem (K090845). This is a medical device submission to the FDA, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through a traditional clinical study with defined endpoints as would be expected for a novel AI/software device.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance) are not directly applicable in the context of this device's submission type and the information provided. Traditional clinical trials with acceptance criteria and statistical analysis are typically not required for Class II devices demonstrating substantial equivalence through non-clinical testing.

However, I can extract the relevant information regarding the non-clinical tests conducted which serve a similar purpose to demonstrating the device's functional integrity and safety, and compare them to the general characteristics of the predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a mechanical implant, "acceptance criteria" are not explicitly defined in terms the performance metrics commonly associated with AI/software (e.g., sensitivity, specificity, AUC). Instead, the device's "performance" is demonstrated through non-clinical mechanical and material testing based on recognized international and ASTM standards. The acceptance criterion for these tests is generally successful completion of the test without failure, meeting the requirements of the specified standard, and demonstrating equivalence to predicate devices.

Acceptance Criterion (Implicit: Compliance with Standard and Predicate)	Reported Device Performance
Mechanical Strength & Durability:
Distal fatigue strength per ISO 7206-4:1989, ISO 7206-8:1992, and ASTM 2068-09.	Tests conducted and results deemed successful.
Fretting potential per ISO 17853:2003.	Tests conducted and results deemed successful.
Disassembly strength after fatigue testing per ASTM F2009-00.	Tests conducted and results deemed successful.
Proximal fatigue strength per ISO 7206-6:1992 and ASTM 2068-09.	Tests conducted and results deemed successful.
Torsional strength of the modular neck.	Tests conducted and results deemed successful.
Burst test, fatigue test, post-fatigue burst test, pull-off, and rotational stability of the worst case modular neck-ceramic head combination per FDA Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, and ISO 7206-10:2003.	Tests conducted and results deemed successful.
Functional Compatibility:
Range of motion per ISO 21535:2007.	Tests conducted and results deemed successful.
Biocompatibility/Sterilization:
ETO Residuals per ANSI/AAMI/ISO 10993-7.	Tests conducted and results deemed successful.
Hydroxyapatite coating clearance.	Previously cleared in K043123.
Design and Material Equivalence to Predicates:
Demonstrated through detailed comparison table with Apex K2™ Hip System and Aesculap Metha® Hip System.	Features and materials largely align; differences (e.g., modular neck material and junction) addressed through specific additional testing where needed (e.g., torsional strength, burst/fatigue tests for neck combination).

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in terms of number of physical devices tested for each non-clinical test. For mechanical tests, representative samples are typically used to meet the requirements of the standards. For material properties, it refers to the composition. The document doesn't detail the number of physical units tested.
Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting, not on human subjects. No country of origin is specified for the testing, but the submitter (OMNI life science, Inc.) is based in E. Taunton, MA, USA. This is a prospective assessment for market clearance, meaning the tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this 510(k) summary. For mechanical devices, "ground truth" typically relates to objective physical measurements or material properties as defined by engineering standards, not expert consensus as in diagnostic imaging. The "experts" involved would be the engineers and technicians conducting and validating the tests, adhering to the specified ISO and ASTM standards. Their qualifications are inherent in the rigorous nature of these testing facilities.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical findings, not for objective mechanical test results. The results of the non-clinical tests are binary (pass/fail compliance with the standard).

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 is a total hip replacement device, not an AI/software diagnostic tool, and therefore no MRMC study was performed.

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

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

7. The type of ground truth used

The "ground truth" for this device's evaluation is primarily based on engineering standards (ISO, ASTM) for mechanical performance and material properties. This includes objective measurements of fatigue strength, fretting potential, disassembly strength, torsional strength, range of motion, and material composition. Biocompatibility (ETO residuals) is also assessed against established standards.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

In summary: The Apex ARC™ Hip Stem, a Class II medical device, demonstrates its safety and effectiveness for market clearance by showing substantial equivalence to existing predicate devices (Apex K2™ Hip System and Aesculap Metha® Hip System) through a detailed comparison of design, materials, and intended use, and by successfully completing a series of non-clinical mechanical and material tests according to recognized international standards (ISO, ASTM) and FDA guidance documents. No clinical studies or AI-related evaluations were performed for this submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for OMNIlife science. The logo consists of a circular graphic above the company name. The graphic appears to be a stylized representation of a cell or a similar biological structure. The text "OMNIlife science" is written in a bold, sans-serif font, with the word "OMNI" in a larger size than "life science".

510(K) Summary K090845

Apex ARC™ Hip Stem

April 7, 2010

1.Submitter	OMNI life science, Inc50 O'Connell WayE. Taunton, MA 02718
Contact:	Robert ZolettiVP Regulatory Affairs774-226-1845

2. Device Name	Apex ADCM Hip Stem
----------------	--------------------

Proprietary Name:	Apex ARC TM Hip Stem
Common Name:	Hip prosthesis, uncemented
Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class:	Class II per 21 CFR §888.3353 and §888.3358
Product Codes:	LZO, MEH, and LPH
3. Legally Marketed Predicate Device	K041950 - Apex K2, K071946, K083495 - Aesculap Metha®
4. Device Description	The Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty.
5. Intended Use	The Apex ARC™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis 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.
6. Predicate Device Comparison	Substantial equivalence is claimed to the Apex K2™ Hip System (distributed by OMNI life science, Inc.) and the Metha® Hip System (distributed by Aesculap Implant Systems, Inc.). The table below compares the features and characteristics of the Apex ARC Hip Stem to these predicate devices:

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510(K) Summary K090845

Image /page/1/Picture/1 description: The image shows the logo for Omni Life Science. The logo features a stylized eye-like symbol above the company name. The eye symbol is composed of concentric circles, with the innermost circle being white and the outer circles being black. The text "OMNI life science" is written in a bold, sans-serif font below the eye symbol.

	Apex ARC™	Apex K2™	Aesculap Metha®
FDA 510(k)'s		K041950	K071916 and K083495
INTENDED USE
Primary and revision hip replacement,non-cemented	Yes	Yes	Yes
DESIGN
Circumferential porous coating	Yes - plasmasprayed CP Ti	Yes - plasmasprayed CP Ti	Yes - plasma sprayedCP Ti
Proximal coating (only)	Yes	Yes	Yes
Modular head	Yes	Yes	Yes
Modular neck	Yes	Yes	Yes
Tapered stem	Yes	Yes	Yes
Cross-sectional shape	Rectangular	Rectangular	Rectangular/ rounded
Distal slot(s)	Yes	No	No
Distal flutes	No	No	No
MATERIALS
Titanium alloy (Ti6Al4V) stem	Yes	Yes	Yes
Cobalt chromium modular neck	Yes	No - titanium alloy	Yes
Cobalt chromium or alumina ceramicheads	Yes (both)	Yes (both)	Yes (both)
Titanium porous coating	Yes - unalloyed	Yes - unalloyed	Yes - unalloyed
Hydroxyapatite overcoat option	Yes	No	Yes - calciumphosphate

The most significant difference between these devices is that the subject Apex ARC hip stem and the predicate Aesculap Metha hip stem both employ cobalt chromium modular necks with a tapered junction between the neck and the stem, whereas the Apex K2 stem system employs titanium alloy modular necks with a cylindrical press-fit junction and alignment pin.

Non-Clinical Test Summary The following tests were conducted:

Distal fatigue strength per ISO 7206-4:1989, ISO 7206-8:1992, and ASTM 2068-. 09.
Fretting potential per ISO 17853:2003. .
Disassembly strength after fatigue testing per ASTM F2009-00. .
Proximal fatigue strength per ISO 7206-6:1992 and ASTM 2068-09. .
Torsional strength of the modular neck. .
Range of motion per ISO 21535:2007. .
Burst test, fatigue test, post-fatigue burst test, pull-off, and rotational stability of . the worst case modular neck-ceramic head combination per FDA Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems, and ISO 7206-10:2003.
ETO Residuals per ANSI/AAMI/ISO 10993-7. .
The Hydroxyapatite coating was previously cleared in K043123 .

Clinical Test No clinical studies were performed. Summary

The Apex ARC™ is substantially equivalent to the predicate devices. 9. Conclusions Nonclinical and Clinical

OMNI Apex ARC

K090845-S3-Page 1 of 2

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Image /page/2/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

OMNI life science, Inc. % Mr. Robert Zoletti · Vice President Regulatory Affairs 50 O'Connell Way E. Taunton, Massachusetts 02718

APR - 7 2010

Re: K090845 Trade/Device Name: - Apex ARCTM Hip Stem Regulation Number: 21 CFR 8888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis Regulatory Class: II Product Code: LZO, MEH, LPH Dated: March 31, 2010 Received: April 1, 2010

Dear Mr. Zoletti:

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 misJeading.

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

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Page 2 - Mr. Robert Zoletti

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, plcasc 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Millman

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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Indications for Use

510(k) Number (if known): K090845

Device Name: Apex ARC™ Hip Stem

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 X

AND/OR

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anta for mxn

(Dision Sien-Off) Division of Surgical, Orthopedic, and Resprative Devices

510(k) Number K900845

Page 1 of _ 1

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.