Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
Rheumatoid arthritis,
Revision where other devices or treatments have failed.
Correction of functional deformity.
Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

Device Description

The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.

AI/ML Overview

The provided text is a 510(k) summary for the Discovery™ Elbow - X-Small, an elbow prosthesis. It is a submission to the FDA for market clearance and discusses the device description, intended use, and comparison to a predicate device.

Based on the information provided, no acceptance criteria or a study that proves the device meets specific acceptance criteria are described in the typical format of a clinical trial or performance study for a medical device with measurable outcomes (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Discovery™ Elbow, K013042 and K051975). This is a regulatory pathway that primarily relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is substantially equivalent to the predicate device. This means it must:
- Have the same intended use.
- Have the same technological characteristics, or have different technological characteristics that do not raise different questions of safety and effectiveness.
- If there are different technological characteristics, data must demonstrate that the device is as safe and effective as the predicate device.
Reported Device Performance:
- 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." This is a very general statement and does not provide specific performance metrics, methodology, or results in a table format. It implies mechanical and material testing, but no details are given.
- Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical performance data was used to demonstrate substantial equivalence for this particular submission.

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

Not applicable. There is no "test set" in the context of clinical or device performance data described in this 510(k) summary because no clinical testing was performed for this submission. Non-clinical (laboratory) testing was mentioned but no sample sizes or data provenance for that testing are provided.

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)

Not applicable. As no clinical testing was performed and no "ground truth" for a test set was established in this submission.

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

Not applicable. No test set or associated adjudication method is mentioned.

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 an elbow prosthesis (a physical implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Not applicable. As above, this is a physical medical device, not an algorithm.

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

Not applicable. No clinical ground truth data was used for this submission. The "ground truth" for substantial equivalence is effectively the performance (safety and effectiveness) of the predicate device, which is assumed to be established.

8. The sample size for the training set

Not applicable. There is no "training set" mentioned or relevant for this type of 510(k) submission for an elbow prosthesis.

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

Not applicable. As above, no training set is mentioned.

In summary, the provided 510(k) summary details a regulatory submission based on substantial equivalence to a predicate device, supported by non-clinical laboratory testing. It does not contain information about specific acceptance criteria for performance metrics, clinical studies, or expert-adjudicated ground truth data, as these are typically not required for this type of submission when demonstrating substantial equivalence without clinical data.

Summary

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MAR 2 5 2009

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 geometric design. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font. The text is black and the background is white.

510(k) Summary

510(k) Number:	K090473
Preparation Date:	March 24, 2009
Applicant/Sponsor:	Biomet Manufacturing Corp.
Contact Person:	Patricia Sandborn BeresSenior Regulatory SpecialistBiomet Manufacturing Corp.P.O. Box 587Warsaw, Indiana 46581-0578
Proprietary Name:	Discovery™ Elbow - X-Small
Common Name:	Elbow Prosthesis
Classification Name:	Elbow joint metal/polymer constrained cemented prosthesis(21 CFR 888.3150)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The predicate device is the Discovery™ Elbow, originally cleared through 510(k) K013042, on October 10, 2001 and modified on through 510(k) K051975 cleared on September 6, 2005.

Device Description: The Discovery™ Elbow is a total elbow prosthesis comprised of an ulnar and humeral component. Placing the humeral articulation through the ulnar articulation links the ulnar and humeral component. The humeral components are available with or without a flange. The numeral and ulnar components are avialalbe with either a smooth or roughened surface. The components contained in this submission are X-Small in size.

Intended Use: The indications for use for the Discovery™ Elbow - X-Small include:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
1. Rheumatoid arthritis,
1. Revision where other devices or treatments have failed,
1. Correction of functional deformity,

Mailing Address PO Rox 587 Warsaw, IN 46581 0587 Toll Free: 800,348,9600 Ollice: 574 757 6639 Hain Fax: 574 287 2137 1979 1100000 11001

Skinning Address Frast 36-1 300 F Warsay IN 46597

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510(k) Summary K090473 - Discovery Elbow - X-Small Page 2

1. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods.
  The device is intended for use with bone cement.

Summary of Technologies: The Discovery™ Elbow X-Small has similar or identical technologies to the predicate devices.

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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2009

Biomet Manufacturing Corp. % Ms. Patricia Sandborn Beres P.O. Box 587 Warsaw, Indiana 46581-0578

Re: K090473

Trade/Device Name: Discovery Elbow - X-Small Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow joint metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: JDC Dated: February 20, 2009 Received: February 24, 2009

Dear Ms. Beres:

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. Patricia Sandborn Beres

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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

જિલ્લાઓ પૈકીના એક એવા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય

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):

Device Name: Discovery Elbow - X-Small

Indications For Use: The Discovery Elbow - X-Small is intended for cemented use in patients with the following conditions:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis,
1. Rheumatoid arthritis,
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
1. Treatment of acute or chronic fractures with humeral epicondyle involvement, which are unmanageable using other treatment methods

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)

O. O. Rumm

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

510(k) Number K09047

Page 1 of 1

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”