Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, 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.
Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.

Device Description

The Vanguard™ CR Stem Housings are comprised of Co-Cr-Mo and enhance fixation of prosthesis to bone. The device is to be used with the appropriate Vanguard™ knee components and is available in 10 sizes.

AI/ML Overview

This submission {0} does not contain information about acceptance criteria or a study proving that a device meets such criteria to the extent requested. The document is a 510(k) Summary for the Vanguard™ CR Stem Housings, focusing on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance criteria or clinical trial results.

Here's why the requested information cannot be fully provided based on the given text:

No specific acceptance criteria are listed: The document states "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device is functional within its intended use," but it does not specify what those acceptance criteria were (e.g., specific thresholds for fatigue strength, wear rates, etc.).
No detailed study report is provided: While non-clinical testing was performed, the document does not detail the methodology, results, or how these results specifically "proved" the device met unstated acceptance criteria.
No clinical testing was performed as a basis for substantial equivalence: The document explicitly states, "Clinical Testing: None provided as a basis for substantial equivalence." This means there would be no data related to human readers, ground truth established by experts, or multi-reader multi-case studies.

Therefore, many of the specific points requested (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or extractable from this document.

Based on the available text, here's what can be inferred or directly stated regarding testing:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion Reported Device Performance
Not specified "functional within its intended use" (based on non-clinical laboratory testing)
Sample size used for the test set and the data provenance:
- Sample Size: Not specified for non-clinical testing.
- Data Provenance: Non-clinical laboratory testing. No geographical origin or retrospective/prospective status is mentioned, as it's not clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No human expert review for establishing ground truth is mentioned in relation to the non-clinical tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human review or adjudication process is mentioned for the non-clinical tests.
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. No clinical or MRMC study was performed; the device is a knee implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm. The non-clinical testing likely involved mechanical testing of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for non-clinical lab testing of a mechanical implant, "ground truth" would likely refer to engineering specifications, material properties, and mechanical performance standards, rather than clinical outcomes or expert consensus.
The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable. No training set mentioned.

Acceptance Criterion	Reported Device Performance
Not specified	"functional within its intended use" (based on non-clinical laboratory testing)

Summary

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K082826

OCT 2 4 2008

Image /page/0/Picture/2 description: The image shows the logo for Biomet Manufacturing Corp. The word "BIOMET" is in a bold, sans-serif font, with a registered trademark symbol in the upper right corner. Below the logo, the words "MANUFACTURING CORP." are printed in a smaller, sans-serif font.

510(k) Summary

September 24, 2008 Preparation Date:
Biomet Manufacturing Corp. Applicant/Sponsor:

Contact Person: Susan Alexander

Vanquard™ CR Stem Housings Proprietary Name:

Knee prosthesis Common Name:

Classification Name/Product Code:

21 CER 6888.3560, Knee Joint Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed:

Maxim® CR Revision Stems (Cement-On Femoral Stems), K963709, Biomet, Inc.

Device Description:

Device Description:
The Vanguard™ CR Stem Housings are comprised of Co-Cr-Mo and enhance fixation of prosthesis to bone. The device is to be used with the appropriate Vanguard™ knee components and is available in 10 sizes.

Indications for Use:

Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis 1. where one or more compartments are involved.
Correction of varus, valgus, or posttraumatic deformity. 2.
Correction or railab, raigessful osteotomy, arthrodesis, or failure of previous joint replacement 3. procedure.

Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.

Summary of Technologies:

Stimmal your real characteristics (material, design and sizing) of the Vanguard™ CR Stem Housings are similar 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 is functional within its intended use.

Clinical Testing:

None provided as a basis for substantial equivalence.

All trademarks are property of Biomet

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

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wing-like shapes, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Manufacturing Corporation % Ms. Susan Alexander Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

Re: K082826

Trade/Device Name: Vanguard™ CR Stem Housings Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Codes: JWH Dated: September 24, 2008 Received: September 25, 2008

OCT 2 4 2008

Dear Ms. Alexander:

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.

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 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Ms. Susan Alexander

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulkerson

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): _ KO82826

Device Name: Vanquard™ CR Stem Housings

Indications for Use:

1. Painful and disabled knee joint resulting from osteoarthritis, traumatoid arthritis, 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.

Vanguard™ CR Stem Housings are indicated for use with Vanguard™ CR Femorals. The devices are single-use implants intended for cemented applications.

Prescription Use _ YES (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)

Mark A. Mellman

Page 1 of 1

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number

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.