The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the following cemented systems: the Vanguard™, Ascent™, and Maxim® knee systems, as well as the Biomet® Tibial Augmentation Components, Stemmed Tibial Components, Offset Tibial Trays and Offset Tibial Tray Adaptors. The Regenerex™ Porous Titanium Sleeve Augments are indicated for use with following uncemented system: the Vanguard™ Non-Cemented Porous Coated Knee Components.

Specific indications are as follows:

Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

These are single use implants. Cemented and uncemented applications.

The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.

Specific indications are as follows:

Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
Ligament deficiencies.
Tumor resection.
Trauma.

These are single use implants. Cemented applications only.

Device Description

The Regenerex™ Porous Titanium Sleeve Augments are truncated cones with a centrally located bore that are composed of titanium alloy (Ti-6Al-4V) per ASTM F1580-95 that is approximately 67% porous. The augments are designed for attachment to selected commercially available Biomet® tibial base plates and stemmed femoral components using cement. The devices are intended for fixation into either the proximal tibia or distal femur in cases of severe bone loss.

AI/ML Overview

The provided text is a 510(k) summary for the Regenerex™ Porous Titanium Sleeve Augments, a medical device. This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a predicate device already legally marketed.

Therefore, this document does not describe the acceptance criteria and a study that proves the device meets those acceptance criteria in the way you've requested for a typical AI or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to existing, legally marketed devices.

Here's an explanation based on the provided text, addressing your points where possible, and noting where the information is not present due to the nature of a 510(k) submission for a non-diagnostic implant:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document because this is not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy.

The closest analogue is the claim of "substantial equivalence" to predicate devices. The document states:

Criterion	Reported Device Performance
Technological Characteristics	"The technological characteristics (material modification, design, sizing, indications) of the Regenerex™ Porous Titanium Sleeve Augments are similar to or identical to the predicate devices."
Intended Use	"The results indicated that the device was functional within its intended use."

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

This information is not applicable/not provided. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Non-clinical testing involved "previous non-clinical laboratory testing and engineering justification," but specific sample sizes or data provenance for these tests are not detailed in this summary.

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 information is not applicable/not provided. There was no clinical testing performed as a basis for substantial equivalence, and the device is an implant, not a diagnostic tool requiring expert ground truth for performance evaluation.

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

This information is not applicable/not provided for the reasons stated above.

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 information is not applicable/not provided. This device is a passive surgical implant, not an AI-powered diagnostic tool, and therefore no MRMC study, AI assistance, or human reader improvement is relevant.

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

This information is not applicable/not provided. This device is a passive surgical implant, not an algorithm.

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

This information is not applicable/not provided. As explained, no clinical studies were performed, and the evaluation was based on non-clinical laboratory testing and engineering justification to demonstrate similarity to predicate devices, not on ground truth for diagnostic accuracy.

8. The sample size for the training set:

This information is not applicable/not provided. This device is a passive surgical implant and does not involve AI or a "training set" in the context of machine learning.

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

This information is not applicable/not provided for the reasons stated above.

Summary regarding the device:

The Regenerex™ Porous Titanium Sleeve Augments are femoral and tibial knee augments made of titanium alloy. They are designed as single-use implants for fixation into the proximal tibia or distal femur in cases of severe bone loss, intended for use with specific cemented and uncemented knee systems.

The basis for market clearance (510(k)) is substantial equivalence to existing predicate devices (Regenerex™ Knee Augments and Trabecular Metal™ Tibial and Femoral Cone Augments). Regulatory clearance was granted based on non-clinical laboratory testing and engineering justification demonstrating that the device and its intended use are functional and similar to the predicate devices. No clinical testing was performed or submitted as a basis for substantial equivalence.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with a registered trademark symbol. Below that, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.

510(k) Summary

Preparation Date: October 19, 2007

NOV - 5 2007

Applicant/Sponsor: Biomet Manufacturing Corp.

Contact Person: Becky Earl

Proprietary Name: Regenerex™ Porous Titanium Sleeve Augments

Common Name: femoral and tibial knee augments

Classification Name(s):

Knee ioint patellofemorotibial polymer semi-constrained cemented prosthesis � (888.3560)
Knee ioint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (888.3565) ●
Knee joint femorotibial metal/polymer constrained cemented prosthesis (888.3510) .

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Regenerex™ Knee Augments (Biomet, Inc.)- K053505 and Trabecular Metal™ Tibial and Femoral Cone Augments (Zimmer, Inc.)-K053340

Device Description: The Regenerex™ Porous Titanium Sleeve Augments are truncated cones with a centrally located bore that are composed of titanium alloy (Ti-6Al-4V) per ASTM F1580-95 that is approximately 67% porous. The augments are designed for attachment to selected commercially available Biomet® tibial base plates and stemmed femoral components using cement. The devices are intended for fixation into either the proximal tibia or distal femur in cases of severe bone loss.

Indications for Use:

Specific indications are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

These are single use implants. Cemented and uncemented applications.

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800 348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com

Shipping Address: 56 East Bell Drive Warsaw. IN 46582

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510(k) Summary Regenerex™ Porous Titanium Sleeve Augments Page 2 of 2

and

The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.

Specific indications are as follows:

1. Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
1. Ligament deficiencies.
1. Tumor resection.
1. Trauma.

These are single use implants. Cemented applications only.

Summary of Technological The technological characteristics (material modification, design, sizing, indications) of the Regenerex™ Porous Titanium Sleeve Augments are similar to or identical to the predicate devices.

Non-Clinical Testing: Previous non-clinical laboratory testing and engineering justification 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 Trabecular Metal™ which is a trademark of Zimmer, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 2007

Biomet Manufacturing Corp. % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

K072336 Re:

Trade/Device Name: Regenerex™ Porous Titanium Sleeve Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH, KRO Dated: October 19, 2007 Received: October 22, 2007

Dear Ms. Earl:

We have reviewed your Section 510(k) premarket notification of intent to market the device wone roterioried your betermined 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 econment to prove 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). and Oosmetic For ( 100 ) 100 year 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can hay of birthe 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); good manufacturing practice requirements as set

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Page 2 -- Ms. Becky Earl

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. This letter will allow you to begin marketing your device as described in your Section 510(k) r mo letter notification. The FDA finding of substantial equivalence of your device to a legally premarket noticated device results in a classification for your device 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 in you atence of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mistmance and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yo

Mark N. Melkerson 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): _K072336

Device Name: Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments)

The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated rne regently - " " orders" nemented systems: the Vanguard™, Ascent™, and Maxim® knee systems, as for use with the following comments, Stemmed Tibial Components, Offset Tibial Trays well as the blometer Tibial Aganehallen Corex™ Porous Titanium Sleeve Augments are indicated for use anta Onset Tiblar Tray Hauptorer The Vanguard™ Non-Cemented Porous Coated Knee Components.

Specific indications are as follows:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatic arthritis where one or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful ostectorny, arthrodesis, or failure of previous joint replacement procedure.

These are single use implants. Cemented and uncemented applications.

Prescription Use (Part 21 CFR 801 Subpart D)	YES	AND/OR	Over-The-Counter Use (21 CFR 807 Subpart C)	NO
----------------------------------------------	-----	--------	---------------------------------------------	----

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

Concurrence of CDRH, Office of Device Evaluation (Division Sign-Off)

Division of General, Restorative, Devices

Page 1 of 2

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Indications for Use

510(k) Number (if known):_K072336

Device Name: Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments)

The Regenerex™ Porous Titanium Sleeve Augments (Femoral and Tibial Sleeve Augments) are indicated for use with the OSS™ system.

Specific indications are as follows:

1. Painful and disabled knee joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or varus, values of postfularhed. In the provious joint replacement.
1. Ligament deficiencies.
1. Tumor resection.
1. Trauma.

These are single use implants. Cemented applications only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Page 2 of 2

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.