1. Non-inflammatory 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 of previously failed total hip arthroplasty.
1. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

Device Description

The G7 Dual Mobility system consists of two articulating surfaces in the same joint space. The proposed system includes an UHMWPE Active Articulation Bearing and Cobalt-Chromium Alloy (CoCr) Liner. A femoral head articulates on the inner, concave surface of the Active Articulation Bearing. Once the femoral stem contacts the Active Articulation Bearing, a secondary motion occurs between the Active Articulation Bearing and the CoCr Liner. The G7 Dual Mobility system is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

The proposed CoCr Liners are manufactured from cast Cobalt-Chromium-Molybdenum per ASTM F75. The proposed G7 Active Articulation Bearings are manufactured from E1® (aka E-Poly) or ArComXL highly cross-linked polyethylene per ASTM F648. The proposed Active Articulation Bearings are available in sizes 32 and 36mm with a 22.2mm inner diameter. The proposed CoCr Liners are available in sizes A-J (sizes 32-60mm).

AI/ML Overview

This document, a 510(k) Premarket Notification for the Biomet G7 Dual Mobility System, describes the device and claims substantial equivalence to existing predicate devices. However, it does not include acceptance criteria or a study with performance data against those criteria in the way typically expected for an AI/CADe device.

This document is for a medical device (hip implant components), not a software algorithm or AI device. Therefore, the concept of "acceptance criteria" and "device performance" relating to metrics like sensitivity, specificity, or AUC based on a test set and ground truth is not applicable in this context. The "performance data" referred to in this document relates to mechanical and material properties of the implant.

Here's a breakdown of the requested information based on the provided document, highlighting why many aspects are not present for this type of device:

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device (hip implant components), the "acceptance criteria" and "reported device performance" are based on mechanical testing and material compatibility, not diagnostic-style metrics.

Performance Test	Acceptance Criteria (Implicit from FDA Guidance/Standards)	Reported Device Performance (Summary)
Liner axial push-out (per ASTM F1820, ASTM F2068, ISO 7206-6)	Designed to meet or exceed established standards for push-out strength.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." (Implies compliance with relevant standards/performance of predicates)
Liner lever-out (per ASTM F1820, ASTM F2068, ISO 7206-6)	Designed to meet or exceed established standards for lever-out strength.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."
Liner torque (per ASTM F1820, ASTM F2068, ISO 7206-6)	Designed to meet or exceed established standards for torque resistance.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."
Wear (per engineering analysis)	Designed to demonstrate wear characteristics comparable to or better than predicate devices.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices." (Based on engineering analysis, not direct wear data provided)
Fretting and Corrosion (per ASTM F1875)	Designed to show fretting and corrosion resistance comparable to or better than predicate devices.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."
Range of Motion (per ISO 21535)	Designed to achieve range of motion characteristics comparable to predicate devices.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."
Rim Impingement (per ASTM F2582)	Designed to prevent or minimize rim impingement under testing conditions comparable to predicate devices.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."
Femoral head lever-out (per Biomet standard)	Designed to meet Biomet's internal standards for lever-out strength.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."
Femoral head pull-out (per ASTM F1820)	Designed to meet or exceed established standards for pull-out strength.	"Results...demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices."

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

This information is not provided in the document, as it pertains to mechanical testing rather than a clinical or AI performance study. The "test set" would refer to the physical device components tested, but specific sample sizes for each test are not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for in-vitro mechanical testing.

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)

This is not applicable for a physical medical device. "Ground truth" in this context would be objective physical and chemical properties measured during mechanical and material testing, performed by laboratory technicians and engineers according to established (ASTM/ISO) standards. Expert consensus for AI model ground truth is not relevant here.

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

This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI or diagnostic performance studies. For mechanical testing, adherence to established test methods and measurement protocols are the "adjudication."

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a hip implant, which does not involve "human readers" in a diagnostic capacity or AI assistance for interpretation.

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

This is not applicable. This describes a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance is based on objective measurements from standardized mechanical and material testing (e.g., precise force measurements for push-out/lever-out, visual inspection for fretting/corrosion, precise angular measurements for range of motion). It is not based on expert consensus, pathology, or clinical outcomes data in this 510(k) submission summary. The demonstration of substantial equivalence relies on these physical measurements compared to predicate devices or established standards.

8. The sample size for the training set

This is not applicable. This document does not describe an AI/ML algorithm that requires a training set.

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

This is not applicable. This document does not describe an AI/ML algorithm that requires a training set and associated ground truth.

Summary

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May 1, 2015

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

Biomet, Incorporated Ms. Amy Walriven Manager, Regulatory Affairs 56 East Bell Drive Warsaw, Indiana 46581

Re: K150522 Trade/Device Name: G7 Dual Mobility System 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, OQG, KWY, LZO Dated: February 27, 2015 Received: March 2, 2015

Dear Ms. Walriven:

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

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Page 2 - Ms. Amy Walriven

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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)

K150522

Device Name

G7 Dual Mobility System

Indications for Use (Describe)

1. Non-inflammatory 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 of previously failed total hip arthroplasty.
1. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended applications.

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

X 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 Dual Mobility system 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 Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Amy L WalrivenManager, Regulatory AffairsPhone: (574) 372-6660Fax: (574) 372-1683
Date:	February 27, 2015
Subject Device:	Trade Name: G7 Dual Mobility SystemCommon Name: Acetabular Hip Replacement ComponentsClassification Name:• LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous,Uncemented (21 CFR 888.3358)• OQG - Hip Prosthesis, Semi-Constrained, Cemented,Metal/Polymer + Additive, Porous, Uncemented (21 CFR888.3358)• KWY - Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cementedor Uncemented (21 CFR 888.3390)• LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer,Cemented or Non-Porous, Uncemented (21 CFR 888.3353)

Legally marketed devices to which substantial equivalence is claimed:

Biomet E1 Avantage Head (K101336) ●
ArComXL Active Articulation Head (K110555)
. Stryker MDM (K103233)
Biomet Tri-Polar (K991990) - Reference

Device Description

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is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

The proposed CoCr Liners are compatible with the following devices:

G7 Acetabular Shells K121874 and K140669 ●
Biomet E1 Avantage Bearings (38-60mm) - K101336
ArComXL Active Articulation Bearings (38-60mm) K110555 ●
G7 Active Articulation Bearings (32 and 36mm) - included in this submission

The proposed Active Articulation Bearings are compatible with 22.2mm femoral heads (K974558/K030555).

Intended Use and Indications for Use

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular 1. necrosis.
Rheumatoid arthritis. 2.
1. Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 4. proximal femur with head involvement, unmanageable by other techniques.
1. Revision of previously failed total hip arthroplasty.
1. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

Summary of Technological Characteristics

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

Intended Use: The proposed G7 Dual Mobility system and predicate devices have the same intended use.
Indications for Use: The proposed G7 Dual Mobility system and predicate devices have the same indications for use.
Materials: The proposed Active Articulation Heads are composed of the same material (100 kGy E1® or ArComXL) as the predicate Biomet E1 Avantage (K101336) and ArComXL Active Articulation Heads (K110555). The proposed CoCr Liners are composed of the same material (Co-Cr-Mo) as the predicate Stryker MDM liner (K103233).
Design Features: The proposed G7 Dual Mobility system incorporate similar design features as the predicate devices.

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BIOMET

Sterilization: The proposed G7 Dual Mobility system and the predicate devices are provided sterile for single-use.

Summary of Performance Data

Results from mechanical tests and engineering analyses demonstrate the proposed G7 Dual Mobility system is substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of these tests and analyses are listed below.

Liner axial push-out per ASTM F1820, ASTM F2068 and ISO 7206-6
Liner lever-out per ASTM F1820, ASTM F2068 and ISO 7206-6
Liner torque per ASTM F1820, ASTM F2068 and ISO 7206-6 ●
Wear per engineering analysis
Fretting and Corrosion per ASTM F1875
Range of Motion per ISO 21535 ●
Rim Impingement per ASTM F2582
. Femoral head lever-out per Biomet standard
Femoral head pull-out per ASTM F1820

Substantial Equivalence Conclusion

The proposed G7 Dual Mobility system has the same intended use and indications for use as the predicate devices. Performance test data and analyses demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.

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.