The OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for 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.
The OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

Device Description

The OMNI Anseris Stem is a "fit and fill" femoral stem with a tapered conical design and is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "OMNI Anseris Hip Stem." It details the manufacturer's claim of substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a standalone study of its performance in a clinical setting.

Therefore, the information typically found in a study proving acceptance criteria for an AI/algorithm-based device (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment) is not present in this document because it describes a physical implantable device, not a software algorithm.

However, I can extract the information related to the device's non-clinical testing which serves as the "study" proving it meets specific engineering/physical acceptance criteria.

Here's the information parsed from the provided text, focusing on the nearest equivalent to your request:

Acceptance Criteria and Device Performance for OMNI Anseris Hip Stem (Non-Clinical Testing)

This document describes the non-clinical testing performed to demonstrate substantial equivalence of the OMNI Anseris Hip Stem to predicate devices. The "acceptance criteria" here refer to meeting specific engineering and performance standards for a hip implant, rather than clinical performance metrics of an AI algorithm.

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

Acceptance Criteria Category	Specific Test Standard / Requirement	Reported Device Performance (as stated in the document)
Fatigue Strength	ISO 7206-6 (Fatigue testing of hip joint prostheses – Part 6: Endurance performance of stemmed femoral components with application of torsion)	Met the requirements for fatigue strength per ISO 7206-6
Fatigue Strength	ISO 7206-4 (Fatigue testing of hip joint prostheses – Part 4: Endurance performance of stemmed femoral components with application of a force)	Met the requirements for fatigue strength per ISO 7206-4
Range-of-Motion (ROM)	ISO 21535 (Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacements)	Met the range-of-motion requirement per ISO 21535
Biocompatibility	Ethylene Oxide (EO) Sterilization	Devices undergo the same validated sterilization process, using EO, to a sterility assurance level (SAL) of 10-6. All ethylene oxide residuals are monitored and well below standard limits.
Biocompatibility	Endotoxin Levels	Plan to test endotoxins on all OMNIlife science device groups through Limulus amebocyte lysate (LAL) testing. Products segregated into 8 product groups (based on manufacturing process/material type) tested quarterly on a yearly rotation. Product not released if 20 EU/device limit is exceeded.
Design/Mechanical	Conical Stem FEA per ASTM F2996-13	Testing performed.
Design/Mechanical	Solidworks Simulation Verification	Verification performed.
Design/Mechanical	Conical Stem Bipolar Head Impingement Risk	Testing performed.

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

Sample Size: Not explicitly stated in terms of individual units tested, but the document refers to "the results of testing of the proposed Anseris Hip Stems." For mechanical testing, this typically refers to a specific number of samples required by the standard (e.g., n=6 or more for fatigue testing). The document does not specify the exact number of physical stems tested.
Data Provenance: The testing was carried out by the manufacturer, OMNIlife Science. The data is internal to the company's testing processes as part of their 510(k) submission. There is no mention of country of origin of data in a clinical sense, nor is it retrospective or prospective as it's mechanical testing of a physical device.

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

Not Applicable. This is a physical device being cleared through substantial equivalence to existing predicate devices based on non-clinical (mechanical and material) testing. There is no "ground truth" derived from expert consensus like in an AI/imaging study. The "ground truth" here is the pass/fail criteria of established international and industry standards (ISO, ASTM).

4. Adjudication method for the test set

Not Applicable. As there are no human readers or interpretations of data akin to an AI study, there's no adjudication method. The tests are designed to provide objective, quantifiable results against predefined engineering specifications.

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 physical hip implant, not an AI software or diagnostic imaging tool. Therefore, MRMC studies are not relevant.

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. The "standalone performance" is the performance of the hip stem in a mechanical testing environment.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" refers to compliance with established international and industry standards for hip implants, such as ISO 7206-6, ISO 7206-4, ISO 21535, and ASTM F2996-13, as well as biocompatibility standards (e.g., SAL of 10-6 for sterility, endotoxin limits).

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an algorithm undergoing machine learning.

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

Not Applicable. As there is no training set, there is no ground truth for it.

Summary

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

August 17, 2017

OMNIlife Science Christina Rovaldi Regulatory Affairs Specialist 480 Paramount Drive Raynham, Massachusetts 02767

Re: K171156

Trade/Device Name: OMNI Anseris Hip Stem 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. LWJ Dated: July 12, 2017 Received: July 13, 2017

Dear Christina Rovaldi:

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 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/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.

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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Indications for Use

510(k) Number (if known) K171156

Device Name OMNI Anseris Hip Stem

Indications for Use (Describe)

· 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.

The OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

TABLE 1: 510(k) SUMMARY
Date Summary Prepared	08/03/2017
Manufacturer/Distributor/Sponsor	OMNIlife Science480 Paramount DriveRaynham, MA 02767
510(k) Contact	Christina RovaldiRegulatory Affairs SpecialistOMNIlife Science480 Paramount DriveRaynham, MA 02767Telephone: (774)-226-1857Fax: (508)-822-6030Email: crovaldi@omnils.com
Trade Name	OMNI Anseris Hip Stem
Common Name	prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncementedprosthesis, hip, semi-constrained, metal/polymer,uncemented
Classification	Class II per 21 CFR §888.3353 Hip jointmetal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis. Product Code – LZOClass II per 21 CFR §888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.Product Code – LWJ
Primary Predicate Device	Apex Modular HA StemK043123
Additional Predicate Devices	Apex Modular Alumina Head, K012918Apex hip System Bipolar Head, K082468Apex Hip System Bipolar Head, K100151Apex Modular Head, +10.5mm offset, K101575Apex Modular Hip System Biolox delta Femoral Head
	K101451
	Interface Acetabular System, Acetabular Insert +4offset, K092443
	Omni Skirted Heads, K152919
	Apex Modular Hip Stem, K000788
	Apex Modular Acetabular Cup, K031110
	Apex Modular Acetabular Cup, K112779
	Apex HCLA Acetabular Cup Liners, K062489
	Apex HCLA Acetabular Liners, K073150
	Biopro Bipolar Head, Models 18130-18152, K082705
	OMNI Interface Acetabular System, K142201
	+4 Offset Acetabular Insert, K101976
	ARC Monoblock Hip Stem, K133381
Purpose of Submission	This traditional 510(k) premarket notification is beingsubmitted to obtain clearance for the OMNI AnserisStems to expand OMNI's product offering for total hiparthroplasty.
Intended Use	The OMNI Anseris Hip Stem is intended for use as thefemoral component of a primary or revision total hipreplacement when used with the Apex Interface™Acetabular System. The Apex Interface™ AcetabularSystem articulates with the Apex Modular FemoralHead (Cobalt Chromium or Ceramic). The femoral hipstem is intended for uncemented fixation and single useimplantation. These prostheses may be used for hiparthroplasty to treat the following conditions, asappropriate:• Non-inflammatory degenerative joint disease,including osteoarthritis and avascular necrosis;• Rheumatoid arthritis;• Correction of functional deformity;• Congenital dislocation;• Revision procedures where other treatments or deviceshave failed;• Femoral neck and trochanteric fractures of theproximal femur.The OMNI Anseris Hip Stem is also intended for use in
	hemiarthroplasty when used with the Apex BipolarHead. For further details, please refer to the Apex
	Bipolar Head Instructions for Use.
Device Description	The OMNI Anseris Stem is a "fit and fill" femoral stemwith a tapered conical design and is intended for use asthe femoral component of a primary or revision total hipreplacement when
Sterility and Biocompatibility	The proposed devices undergo the same validatedsterilization process, using ethylene oxide (EO), as thevalidated devices under the sterility assurance level(SAL) of 10-6. All ethylene oxide residuals aremonitored and well below standard limits. In addition,OMNI has developed a plan to test endotoxins on allOMNIlife science device groups through Limulusamebocyte lysate (LAL) testing. Products have beensegregated into product families based on manufacturingprocess and material type and have generated 8 productgroups that will be tested for endotoxins on a quarterlybasis on a yearly rotation. Product will not be released ifthe 20 EU/device limit is exceeded.
Substantial Equivalence Summary:Technology Comparison	The proposed Anseris Stems are substantially equivalentto the predicate Apex Modular Stem (K043123) in termsof the fundamental scientific technology and intendeduses and the reference predicate in terms of design andmaterials. Any differences between the proposed and thepredicates are considered minor and do not raise anydifferent questions of safety and effectiveness.
	The proposed devices are composed of titanium alloy,unalloyed titanium plasma spray, the identical materialused in the manufacture of the predicate device. Theproposed devices have an integral neck and trunnionrather than separate modular neck components that arepart of the predicate Apex Modular Stem system.
	The Anseris hip stem has a "fit and fill" approach, thisproposed stem will have a conical design similar toOMNIs Apex Modular Stem (K043123).
Substantial Equivalence Summary:	The results of testing of the proposed Anseris Hip Stems
K171156	Page 4 of 4
Non-Clinical Testing	met the requirements for fatigue strength per ISO 7206-6 and ISO 7206-4 and the range-of-motion requirementper ISO 21535. These test methods are the same usedfor the predicate device (K043123).- HTR-103 Conical Hip Fatigue Testing- HTR-062 Conical Tapered Stem Fatigue FEA- HTR-104 ROM Analysis- HTR-108 ROM Analysis with Bipolar Heads- HTR-106 Conical Stem FEA per ASTM F2996-13- HTR-107 Solidworks Simulation Verification-HTR-109 Conical Stem Bipolar Head ImpingementRiskBased on the indications for use, technologicalcharacteristics, and the comparison to the predicatedevices, OMNIlife Science has determined that theOMNI Anseris Hip Stem is substantially equivalent tocurrently marketed predicate device. Based on thesimilar intended use, technological characteristics,material and testing, OMNIlife science believes theproposed introduction of skirted heads to besubstantially equivalent to the legally marketedpredicate.
Conclusion Statement	The conclusions drawn from the nonclinical testsdemonstrate that the devices are safe, as effective, andperform as well as or better than the legally marketeddevice

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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.