POROUS TITANIUM ACETABULAR AUGMENTS by BIOMET MANUFACTURING CORP.

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 using other techniques.
Revision of previously failed total hip arthroplasty.

The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

The porous titanium acetabular augment is affixed to the mating acetabular cup using bone cement. The assembled porous titanium augment/acetabular construct is intended for cemented or uncemented use.

The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.

Device Description

The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments range in outer diameter size from 48 mm to 58 mm in 2 mm increments. Each outer diameter will have three subsizes; small, medium, and large. The Porous Titanium Acetabular Augments incorporate screw holes that allow for the use of 6.5 mm bone screws, for adjunct fixation of the acetabular component and the native bone.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Porous Titanium Acetabular Augments. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as seen with novel devices. Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/diagnostic devices, is largely not applicable in this context.

Here's why and what information can be extracted based on your request:

Key Takeaway: No clinical studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies were performed or reported in this 510(k) submission. The device received clearance based on non-clinical testing demonstrating functional equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) summarized here does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for its performance. Substantial equivalence is determined by comparing the new device's technological characteristics and intended use to a legally marketed predicate device.

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

Not Applicable. No clinical "test set" and associated size or provenance information are mentioned. The clearance was based on non-clinical laboratory testing.

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

Not Applicable. No clinical "test set" requiring expert ground truth was used for this 510(k) submission.

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

Not Applicable. No clinical "test set" requiring adjudication was used.

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 device is a passive implant for hip arthroplasty, not an AI or diagnostic device that would involve human readers or AI assistance. Therefore, an MRMC study is not relevant.

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

Not Applicable. This is a physical orthopedic implant, not an algorithm or AI device.

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

Not Applicable. For this 510(k) submission, "ground truth" in the diagnostic sense is not relevant. The equivalence was established through non-clinical testing. The "truth" here relates to the mechanical and material properties meeting established standards (e.g., ASTM F 1580-95 for the material) and performing functionally as intended.

8. The sample size for the training set

Not Applicable. This refers to a medical implant, not a machine learning model. There is no "training set" in this context.

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

Not Applicable. As there is no training set for a machine learning model, this question is irrelevant to the provided document.

Summary of Relevant Information from the Provided Text about Device Performance and Testing:

Acceptance Criteria (Implied): The implied acceptance criteria for a 510(k) submission are that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and performance.
Study Proving Equivalence: The study performed was "Non-Clinical Testing".
Reported Device Performance: "The results indicated that the device was functional within its intended use."
Predicate Device: Hedrocel® Acetabular Augment (K001471).
Basis for Equivalence: The submission states, "The technological characteristics (material modification, design, sizing, indications) of the Porous Titanium Acetabular Augments are similar to or identical to the predicate device."
Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical trials were conducted or reported for this submission to establish safety and effectiveness for a new device, which reinforces why the detailed clinical study data you asked for is absent.

In essence, the device was cleared because it was shown to be very similar to an already approved device through benchtop (non-clinical) testing, without requiring new clinical outcome studies.

Summary

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K05>888 pgx '14

DEC 6 2005

510(k) Summary

Applicant/Sponsor: Biomet Manufacturing Corp.

Allison Koskey Contact Person:

Proprietary Name: Porous Titanium Acetabular Augments

Common Name: Acetabular augments

Classification Name: Prosthesis, Hip, Semi-constrained, Metal/Polymer, Porous Uncemented (888.3358); Prosthesis, Hip, Semi-constrained, Metal/Polymer, Cemented (888.3350); Hip joint metal/polymer constrained cemented or uncemented prosthesis (888.3310); Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (888.3320); Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (888.3330); Hip joint metal/ceramic/polymer semi-constrained cemented or non porous uncemented prosthesis (888.3353)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Hedrocel® Acetabular Augment (K001471)

Device Description: The acetabular augments are constructed of porous titanium alloy conforming to ASTM F 1580-95. The augments range in outer diameter size from 48 mm to 58 mm in 2 mm increments. Each outer diameter will have three subsizes; small, medium, and large. The Porous Titanium Acetabular Augments incorporate screw holes that allow for the use of 6.5 mm bone screws, for adjunct fixation of the acetabular component and the native bone.

Intended Use: The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:

1. 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 using other techniques.
1. Revision of previously failed total hip arthroplasty.

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The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.

Summary of Technologies: The technological characteristics (material modification, design, sizing, indications) of the Porous Titanium Acetabular Augments are similar to or identical to the predicate device.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc. except for Hedrocel®, which is property of Zimmer Holdings

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with outstretched arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 6 2005

Allison Koskey Regulatory Specialist Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K052888

K052860
Trade/Device Name: Porous Titanium Acetabular Augments Regulation Number: 21 CFR 888.3320 Regulation Name: Hip joint metal/metal semi-constrained, with a cemented acetabular component, prostheses Regulatory Class: III Regulatory Class: In
Product Codes: KWA, JDI, JDL, KWZ, LPH, LZO, MAY, MEH Dated: October 10, 2005 Received: October 13, 2005

Dear Ms. Koskey:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section > IQ(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave delemined the active are devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate device Amendments for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug commerce prior to May 28, 1970, the chaculence with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance whiles approval application (IPMA).
and Cosmetic Act (Act) that do not require approval as provisions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to tire genirements for annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the receiners required required in the branding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it can If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Time A. B.A. In oddition FTA m may be subject to such additional controlist Existing major osyon to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, our device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuales of a substition on the requirements of the Act
that FDA has made a determination that your device coderal groppies. You must that FDA has made a determination inal your areas by other Federal agencies. You must or any Federal statutes and regilantons annimaling, but limited to: registration and listing (21
comply with all the Act's requirements, including, but him and isats as set comply with all the Act S requirements, merasms, manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if emplicable, the electronic CFR Part 807); labeling (21 CFR Fall on (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 820); and if applicable, forth in the quanty systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1

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Page 2- Allison Koskey

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, per premarket notification. The PDA intuing of substanted by and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the recultive and the same of the said to the regulation entitled If you desire specific advice for your ac 110 concerner and and the regulation entitled. contact the Office of Compliance at (301) 99 - 100.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Partha Division of Small "Misbranding by reference to premants noufficalson of Sct from the Division of Small other general information on your responsion.com its toll-free number (800) 638-2041 or 2010)
Manufacturers, International and Consumer Assistance of Virginator viruspotvinde Manufacturers, International and Consumer > Ibolicanoo a rovedrh/industry/suppoty/index.html.

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Porous Titanium Acetabular Augments

Indications For Use:

The Porous Titanium Acetabular Augments are indicated for cemented or non-cemented use in cases of:

1 . 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 using other techniques.
1. Revision of previously failed total hip arthroplasty.

The porous titanium augments are intended to provide the orthopedic surgeon with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

The porous titanium acetabular augments are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

AND/OR (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)

Q.83

(Division Sign-Off) Division of Ceneral, Rostorative,

Page 1 of 1

and Neurological Devices

510(k) Number K052889

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.