Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed.

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented or uncemented use.

Indications for Biomet G7 Freedom Constrained Liners:

The Biomet G7 Freedom Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Device Description

The G7™ Finned Acetabular Shell is a medical device intended to be used as part of a hip joint replacement in Total Hip Arthroplasty procedure by qualified surgeons in the field of orthopaedics. The G7™ Finned Acetabular Shell is utilized to replace the acetabulum, and will be used in conjunction with the existing G7 Acetabular Cup bearing system (K121874), instruments and modular femoral system. The G7™ Finned Acetabular Shell will have the same internal geometry, liner locking system and PPS coating as the G7 Acetabular Cup System Shells (K121874) but will feature fins to provide improved primary fixation and anti-rotational stability.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the G7™ Finned Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics typically associated with AI/software devices.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes, experts, ground truth, MRMC studies, standalone performance), and training set ground truth are not applicable in this context. The document does not describe an acceptance criteria table, device performance against such criteria, or a study designed to meet specific performance targets.

Instead, the document focuses on demonstrating that the G7™ Finned Acetabular Shell is substantially equivalent to existing predicate devices based on:

Indications for Use: The G7™ Finned Acetabular Shell has the same intended use and indications for use as the predicate devices.
Technological Characteristics: The device shares similar materials (Ti4Al6V alloy), design features (with the addition of fins for improved primary fixation and anti-rotational stability), and sterilization methods (Gamma irradiated) as the predicate devices.
Non-Clinical Testing: The submission includes non-clinical tests to support substantial equivalence.

Here's the information that can be extracted or inferred from the provided text, related to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This document is a 510(k) submission for a physical medical device (acetabular shell) based on substantial equivalence to predicate devices, not a study evaluating performance of an AI/software device against predefined acceptance criteria. There is no such table in the document.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No "test set" in the context of an AI/software device performance study is mentioned. The non-clinical tests conducted (Push-In, Torque-out, Deformation, Comparison fatigue via FEA, Tolerance Analysis) are laboratory-based mechanical tests, not based on patient data sets. The document does not specify sample sizes for these tests, nor data provenance in the sense of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. "Ground truth" in the context of an AI/software device is not relevant here. The substantial equivalence claim is based on engineering analyses and mechanical testing, not expert-adjudicated clinical data.

4. Adjudication Method for the Test Set:

Not applicable. As there is no clinical "test set" or ground truth adjudication in the AI/software sense, no adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. The document explicitly states: "Clinical Tests: None provided as a basis for substantial equivalence." Therefore, no MRMC study, which is a type of clinical comparative effectiveness study, was performed or presented for this 510(k). The concept of human readers improving with AI assistance is not relevant to this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This is a physical hip implant component, not an algorithm or software device. The concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used:

Not applicable (in the AI sense). For the engineering tests, the "ground truth" would be the physical properties and performance characteristics measured in the lab environment or predicted by validated models (e.g., Finite Element Analysis). These are engineering specifications and measurements rather than clinical "ground truth" like pathology or outcomes data.

8. The Sample Size for the Training Set:

Not applicable. No training set for an AI/software device is mentioned or used for this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As no training set is relevant, this question is not re-applicable.

Summary of Non-Clinical Performance Data Provided:

The document lists the following non-clinical tests performed to support substantial equivalence:

Push-In testing of Acetabular Shell
Torque-out testing of Acetabular Shell
Deformation testing of Acetabular Shell
Comparison fatigue testing with Predicate device (Finite Element Analysis)
Comparison with Predicate device (Tolerance Analysis)

The conclusion states that these tests demonstrate:

Any differences (e.g., the addition of fins) do not raise new questions of safety and effectiveness.
The proposed device is at least as safe and effective as the legally marketed predicate device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.

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

Biomet Manufacturing Corporation Mr. Dean Heit Senior Regulatory Affairs Specialist Biomet UK Ltd. Waterton Industrial Estate Bridgend, Mid Glam, CF31 3XA UK

December 29, 2014

Re: K142746

Trade/Device Name: G7TM Finned 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, LZO, OQG, KWZ, JDI, OQH, OQI, PBI Dated: December 2, 2014 Received: December 4, 2014

Dear Mr. Heit:

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

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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 (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/Resourcesfor You/Industry/default.htm. 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 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 yours,

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)

K142746

Device Name G7TM Finned Acetabular Shell

Indications for Use (Describe)

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
Revision procedures where other treatment or devices have failed.

Indications for Biomet G7 Freedom Constrained Liners:

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the G7™ Finned Acetabular Shell 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Manufacturing Corp.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Dean HeitSenior Regulatory Affairs SpecialistDDI +44 (0)1656 678359Fax +44 (0)1656 645454
Date:	December 2, 2014
Subject Device:	Trade Name: G7™ Finned Acetabular ShellCommon Name: Acetabular Shells
Classification Name:	LPH – Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3358)
Other Applicable Product Codes:
	LZO - Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis. (21 CFR 888.3353)
	OQG - Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. (21 CFR 888.3358)
	KWZ – Hip joint metal/polymer constrained cemented or uncementedprosthesis (21 CFR 888.3310)
	JDI - Hip joint metal/polymer semi-constrained cemented prosthesis(21 CFR 888.3350)
	OQH – Hip joint metal/polymer semi-constrained cementedprosthesis. (21 CFR 888.3350)
	OQI – Hip joint metal/ceramic/polymer semi-constrained cementedor nonporous uncemented prosthesis (21 CFR 888.3353)
	PBI – Hip joint metal/polymer constrained cemented or uncementedprosthesis. (21 CFR 888.3310)

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Legally marketed devices to which substantial equivalence is claimed:

G7™ PPS Acetabular Shell – Part of G7™ Acetabular System K121874 (Biomet)
Mallory-Head Acetabular Shell part of Mallory-Head Hip System K921181 (Biomet) ●

Device Description

Intended Use and Indications for Use

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.

1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
1. Revision procedures where other treatment or devices have failed.

Indications for Biomet G7 Freedom Constrained Liners:

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

The G7™ Finned Acetabular Shell for Primary and Revision Total Intended Use: Hip Arthroplasty. ●
- Indications for Use: Indications for use are given above and the same indication for use as the predicate devices.

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BIOMET	510(k) SummaryG7TM Finned Acetabular Shell Traditional 510(k)
Materials:	Ti4Al6V alloy compliant to ISO 5832-3:2012 & ASTM F136 and

Materials: are the same material as the predicate devices. ● Design Features: The design features are the same as the predicate devices but will feature fins to provide improved primary fixation and anti-rotational stability ● Sterilization: The sterilization is identical to the predicate devices and are

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
- o Push-In testing of Acetabular Shell.
- Torque-out testing of Acetabular Shell. O
- Deformation testing of Acetabular Shell O
- Comparison fatigue testing with Predicate device (Finite Element Analysis) O

Gamma irradiated. 25-40kGy Sterility Assurance Level: 10°

Comparison with Predicate device (Tolerance Analysis) O
. Clinical Tests
- None provided as a basis for substantial equivalence o

Substantial Equivalence Conclusion

The proposed G7™ Finned Acetabular Shell has the same intended use and indications for use as the predicate devices. The proposed device has similar technological characteristics to the predicates, and the information provided herein demonstrates that:

. any differences do not raise new questions of safety and effectiveness; and
. the proposed device is at least as safe and effective as the legally marketed predicate device.

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.