Non-inflammatory 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.

Acetabular shells and femoral stems with porous coatings 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™ Acetabular System is a modular system, designed to provide numerous options for surgeons and patients in one compatible system. The titanium alloy (ASTM F136) shell is available in both a solid shell and limited hole design, with an apical hole and plug. The outer diameter of the shells is coated with Biomet's Porous Plasma Spray (ASTM F1580). The acetabular liners are manufactured from UHMWPE (ASTM F648) as ArComXL® or E1® (UHMWPE infused with vitamin E) and available in a Neutral, High Wall, or Ten Degree Face Changing design. Additionally, the system has provided for a constrained liner and head when such an option is required. The Biomet Freedom" product line has added a 32mm Freedom" head (cobalt chrome, ASTM F1537) to its offerings, as well as a new series of constrained liners (E1®, ASTM F648) designed for compatibility with the G7™ shells. A new line of cobalt chrome (ASTM F1537) femoral heads in varying sizes and neck lengths, with either a Type 1 or 12/14 taper, has been added to the system. The system is compatible with Biomet® ceramic heads and femoral stems.

AI/ML Overview

The provided FDA 510(k) summary for the Biomet G7™ Acetabular System (K121874) describes a medical device, specifically a hip prosthesis system. This document is a premarket notification for a medical device and, as such, focuses on demonstrating "substantial equivalence" to previously cleared devices rather than presenting novel clinical study designs with acceptance criteria and device performance metrics in the way a diagnostic AI/ML device submission would.

Therefore, the information required to populate the requested table (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC, standalone studies, etc.) is not typically included or relevant in a 510(k) submission for a hip prosthesis system.

Here's why and what information is available in the document:

Why the requested information is not present:

Device Type: The G7™ Acetabular System is a physical orthopedic implant (hip prosthesis), not an AI/ML diagnostic or predictive software device.
Regulatory Pathway (510(k)): The 510(k) pathway demonstrates substantial equivalence to a legally marketed predicate device. This typically involves non-clinical (bench) testing to show that the new device performs similarly and does not raise new questions of safety or effectiveness compared to the predicate. It does not generally require extensive clinical trials with acceptance criteria, human reader studies, or detailed ground truth studies as would be expected for a diagnostic device.
Focus of the Document: The document focuses on:
- Descriptions of the device components and materials.
- Identification of predicate devices for comparison.
- Indications for Use.
- A list of non-clinical (bench) tests performed.
- A statement regarding the lack of clinical testing.

Information that is available or can be inferred from the document:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided because the testing for an orthopedic implant focuses on mechanical properties, material properties, and compatibility, rather than diagnostic accuracy or sensitivity/specificity metrics. The document states:
- "Testing demonstrates that the modifications made to the G7™ Acetabular System do not introduce any new risks of safety or efficacy, and that the G7™ Acetabular System is substantially equivalent to the predicates." This is the overarching "acceptance" or conclusion. Specific numerical acceptance criteria for each bench test are not detailed in this summary.
Sample Size used for the test set and the data provenance: Not applicable in the context of clinical data for a diagnostic device. The "test set" here refers to the physical components of the implant undergoing bench testing. The sample sizes for these tests (e.g., number of implants tested for fatigue, push-out, etc.) are not specified in this summary. Data provenance would be from laboratory bench testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on medical images) is not relevant for this type of device. Performance is assessed through engineering and material science standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the diagnostic sense. For mechanical testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM standards listed for materials), and the performance characteristics of the predicate devices.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the AI/ML sense.
How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Testing (as listed in the document):

The document lists various non-clinical (bench) tests performed to support substantial equivalence. These tests evaluate mechanical aspects of the device components. While specific acceptance criteria for each of these tests are not provided in this summary, the overall conclusion is that the device passes these tests and is substantially equivalent.

Poly Push Out
Poly Lever Out
Poly Torque Out
Poly Rim Impingement
Poly Deformed Cup Push Out
Poly Deformed Cup Lever Out
Poly Fatigue, Lever Out
Poly Constrained Liner Rim Impingement and Lever Out Testing
Range-of-Motion Study (Poly)
Poly Deformed Cup Push In
Freedom Head Pull Out of Constrained Liner
Screw Pull Through
Screw Torsional Properties
Torque Curve for MIM Screw Hole Plugs
Verification of Insertion Torque and Measurement of Torque Out
Poly Wear Simulator
Metal Head Justification
MRI Justification
Metal Head Axial Head Pull Off
Metal Head Fretting/Corrosion

Conclusion:

The K121874 submission is for a traditional medical device (hip prosthesis) seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical bench testing. It does not involve AI/ML components or clinical studies with the type of acceptance criteria, reader studies, and ground truth establishment typically requested for diagnostic software devices. Therefore, most of the specific categories in your request are not applicable to this document.

Summary

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K121874

Image /page/0/Picture/1 description: The image shows the logo for Biomet Inc. The logo is in black and white and features a stylized font. The letters are bold and outlined, giving them a three-dimensional appearance.

510(k) Summary

NOV 2 3-2012

Preparation Date:

Contact Person:

Proprietary Name:

Classification Name:

Common Name:

Applicant/Sponsor:

August 23, 2012

Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment Registration Number: 1825034

Becky Earl Regulatory Specialist

G7™ Acetabular System

Acetabular System

LPH- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented (21 CFR 888.3358)

LZO-Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented (21 CFR 888.3353)

OQG-Prosthesis, hip, semi-constrained, metal/polymer + additive, porous uncemented (21 CFR 888.3358)

KWZ-Prosthesis, hip, constrained, cemented or uncemented, metal/polymer (21 CFR 888.3310) 0

jDI- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented (21 CFR 888.3350)

OQH-Hip, semi-constrained, cemented, metal/polymer + additive, cemented (21 CFR 888.3350)

OQI-Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented (21 CFR 888.3353)

PBI-Prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive (21 CFR 888.3310)

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 ww.biomet.com

Shipping Address: 56 East Bell Drive Warsaw, IN 46582

p. 1 of 3

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K121874

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Acetabular Shells:

Porous Plasma Spray (PPS®) RingLoc®+ Acetabular System, K093235 (Biomet) Reflection Acetabular Cup System, K033442 (Smith and Nephew) Continuum Acetabular System, K103662 (Zimmer)

Acetabular Liners:

Ringloc® E1® Acetabular Liners, K093549 (Biomet) Reflection Acetabular Cup System, K033442 (Smith and Nephew) Continuum Acetabular System, K103662 (Zimmer)

Constrained Heads and Liners: Freedom Constrained Liners, K043537 (Biomet) Cobalt Chrome Femoral Heads: Cobalt Chrome Femoral Components, K911684 (Biomet)

Device Description:

Indications for Use:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 1.

1. Rheumatoid arthritis.
1. Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with 4. head involvement, unmanageable by other techniques.
ഗ് Revision procedures where other treatment or devices have failed.

Indications for Biomet G7™ Freedom™ Constrained Liners:

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Klzs74

Summary of Technologies:

The technological characteristics of the proposed device are the same as or similar to the predicates. The G7™ acetabular shells are similar in design, dimensions, and intended use to their Biomet predicate, K093235, but have incorporated a different locking mechanism, which is also similar to legally marketed predicates, K091508 and K103662. The acetabular liners are made of the same material as their predicates, and use previously cleared liner types, sizes and designs. The additional constrained head is a line extension to the Biomet Freedom™ constrained heads, and the constrained liners use the same design principles as the Freedom liner predicate, K030047. The cobalt chrome femoral heads are very similar to the Biomet predicate, K911684.

Non-Clinical Testing:

The following testing has been completed to support substantial equivalence: v

Poly Push Out .
Poly Lever Out .
Poly Torque Out .
Poly Rim Impingement .
Poly Deformed Cup Push Out .
Poly Deformed Cup Lever Out
Poly Fatigue, Lever Out �
Poly Constrained Liner Rim Impingement and Lever Out Testing .
Range-of-Motion Study (Poly) .
Poly Deformed Cup Push In .
. Freedom Head Pull Out of Constrained Liner
Screw Pull Through �
Screw Torsional Properties .
Torque Curve for MIM Screw Hole Plugs .
Verification of Insertion Torque and Measurement of Torque Out .

Justifications:

Poly Wear Simulator .
Metal Head Justification .
. MRI Justification
Metal Head Axial Head Pull Off .
Metal Head Fretting/Corrosion ●

Clinical Testing:

None provided as a basis for substantial equivalence.

Testing demonstrates that the modifications made to the G7™ Acetabular System do not introduce any new risks of safety or efficacy, and that the G7™ Acetabular System is substantially equivalent to the predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The bird is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 23, 2012

Biomet Manufacturing Corporation % Ms. Becky Earl 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 US

Re: K121874

Trade/Device Name: G7™ acetabular system Regulation Number: 21 CFR 888.3310 Regulation Name: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis Regulatory Class: Class II . Product Code: PBI, LPH, LZO, OQG, KWZ, JDI, OQH, OQI

Dated: October 19, 2012
Received: October 22, 2012

Dear Ms. Earl:

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

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Page 2 - Ms. Becky Earl

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 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 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,

Erin I. Keith

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):_K121894

Device Name: G7™ Acetabular System

Indications For Use:

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 procedures where other treatment or devices have failed.

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Asindi

Jor (Division Sign-Off) . Division of Orthopedic Devices 510(k) Number K121874

Page 1 of 1

Regulation Number and Section

§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”