The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

. Femoral neck and trochanteric fractures of the proximal femur;
Osteonecrosis of the femoral head;
Revision procedures where other devices or treatments for these indications have failed.

Device Description

The Apex Hip System Bipolar Head consists of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have an inner diameter that mates with a 28 mm diameter femoral head. The Apex Hip System Bipolar Head may be used in conjunction with an Apex Hip System femoral stem (K060072) for hemiarthroplasty.

AI/ML Overview

The provided document does not describe a study involving an AI or algorithmic device, nor does it include acceptance criteria and performance data in the typical sense of a software-based medical device.

Instead, the document is a 510(k) Premarket Notification for a medical implant: the OMNI life science Apex Hip System Bipolar Head. This submission demonstrates substantial equivalence to a predicate device, as required by the FDA for certain medical devices.

Therefore, many of the requested categories are not applicable to the information contained in this document.

Here's an analysis based on the document:

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

Acceptance Criteria (Bench Test Type)	Reported Device Performance
Push-out and lever-out testing	Conducted (details not provided on specific criteria or results, only that the test was done). The conclusion implies satisfactory performance for substantial equivalence.
Locking ring spring storage heat tolerance test (150°F)	Conducted (details not provided on specific criteria or results, only that the test was done). The conclusion implies satisfactory performance for substantial equivalence.
ETO sterilization validation, SAL 106	Conducted (details not provided on specific criteria or results, only that the test was done). The conclusion implies satisfactory performance for substantial equivalence.

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

Test Set Sample Size: Not specified in the document for the non-clinical tests. These would typically be a small number of physical samples for mechanical testing.
Data Provenance: Not explicitly stated, but assumed to be from OMNI life science, Inc.'s internal testing labs or contracted labs. The document indicates the submitter's location as E. Taunton, MA, USA, and the contact's location as Raynham, MA, USA, suggesting testing was conducted in the US.
Retrospective or Prospective: Not applicable as these are bench tests on physical devices, not data analysis.

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. This document describes non-clinical bench testing of a physical implant, not a study requiring expert-established ground truth for data. The "ground truth" here is the physical performance of the device against engineering specifications.

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

Not applicable. No adjudication method is relevant for the described non-clinical bench tests. The results of these tests are objective measurements.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This is a device for physical implantation, not an AI or imaging diagnostic device that would involve human readers.

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

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

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

For the non-clinical tests, the "ground truth" is defined by engineering specifications and established test methods (e.g., ASTM standards for UHMWPE, internal specifications for push-out/lever-out forces, and sterilization standards).

8. The sample size for the training set

Not applicable. This is a physical medical implant, not an AI device that requires a training set.

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

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

Summary

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Image /page/0/Picture/1 description: The image shows the text 'K100151' in a handwritten style. The characters are clearly visible and legible. The text appears to be a code or identifier.

OMNI life science Apex Hip System Bipolar Head

Submitter	OMNI life science, Inc.50 O'Connell WayE. Taunton MA 02718
Contact	Robert ZolettiVP Regulatory Affairs774-226-1845
Preparation Date	April 8, 2010

MAY 2 8 2010

Device Name
Common Name	Hemi-hip prosthesis, uncemented
Trade Name	Apex Hip System Bipolar Head
Classification Name	Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesisOrthopedic (OR)
Regulatory Class	Class II per 21 CFR §888.3390
Product Code	KWY
Legally MarketedPredicate Device(s)	Apex Hip System Bipolar HeadK 082468, K945793, K931655
Device Description	The Apex Hip System Bipolar Head consists of a factory assembled Ultra HighMolecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell andUHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outerdiameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patientanatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mateswith a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm)have an inner diameter that mates with a 28 mm diameter femoral head. The ApexHip System Bipolar Head may be used in conjunction with an Apex Hip Systemfemoral stem (K060072) for hemiarthroplasty.
Indications for Use	The indications have not changed from the predicate. The Apex Hip System BipolarHead is intended for use in combination with an Apex Hip System femoral stem foruncemented primary or revision hemiarthroplasty of the hip. This prosthesis may beused for the following conditions, as appropriate:Femoral neck and trochanteric fractures of the proximal femur;Osteonecrosis of the femoral head;Revision procedures where other devices or treatments for these indications have failed.
Predicate DeviceComparison	The Apex Hip System Bipolar Head is identical to the Apex Hip System Bipolar Headcleared in K082468 with the following exceptions:The UHMWPE (ASTM F-648) retaining ring in the Acetabular component was modified to increase the amount of interference/overlap between the retaining ring and the head.A Retaining Spring (Ti-6Al-4V Eli) was added to the UHMWPE Retaining Ring.
Non-Clinical TestSummary	The following tests were conducted:Push-out and lever-out testing.Locking ring spring storage heat tolerance test (150°F).ETO sterilization validation, SAL 106
Clinical TestSummary	No clinical studies were performed.
Conclusions	The Apex Hip System Bipolar head is substantially equivalent to the predicate device.

rage

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is oriented to follow the curve 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. % Mr. Robert Zoletti VP Regulatory Affairs 175 Paramount Drive Raynham, MA 02767

MAY 2 8 2010

Re: K100151

Trade/Device Name: Apex Hip System Bipolar Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented Regulatory Class: Class II Product Code: KWY Dated: May 21, 2010 Received: May 26, 2010

Dear Mr. Robert 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 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 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 -Mr. Robert Zoletti

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 CER.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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Wilkerson

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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K100151

Indications for Use

510(k) Number (if known): K100151

Device Name: Apex Hip System Bipolar Head

Indications For Use:

. Femoral neck and trochanteric fractures of the proximal femur;
Osteonecrosis of the femoral head;
Revision procedures where other devices or treatments for these indications have failed.

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)

	for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1510(k) Number K|0015/

OMNI BiPolar

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.