SINGLE AXLE TOTAL ELBOW by BIOMET, INC.

The Single Axle Total Elbow is indicated for use in rheumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.

This device is a single use implant. It is intended for use with bone cement.

Device Description

The Single Axle Total Elbow Prosthesis is a constrained, "sloppyhinge" elbow device used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar component and a humeral component, which are joined by an axle (refer to Exhibit III). The Single Axle Elbow features a "sloppy-hinge" that will allow for 16 degrees of varus/valgus movement (refer to Exhibit III). A hyperextension stop (flat) is placed on the ulnar component to control the amount of hyperextension allowed by the device. The device shown in Exhibit III was designed to have 0 degrees of hyperextension, but some hyperextension may be allowed at the specific request of the surgeon. The amount of flexion of the device is approximately 137° (see Exhibit III), but this may also change somewhat due to specific patients' anatomy and surgeon requests.

The humeral component will be made of titanium alloy. Each humeral component will be custom designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the humeral component may include a replacement portion if distal humeral bone loss exists (refer to Exhibit IV). A portion of the extramedullary and intramedullary sections of the humeral component may be plasma sprayed with the remainder of the intramedullary portion having a bead blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions.

The ulnar component will be made of titanium alloy. The ulnar and humeral components will be separated by a polyethylene Saddle Bearing to prevent metal on metal contact (refer to Exhibit III). Each ulnar component will be designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the ulnar component may include a replacement portion if proximal ulnar bone loss exists (refer to Exhibit IV). The ulnar component may also contain through slots posteriorly for the attachment of soft tissues. A portion of the extramedullary and intramedullary sections of the ulnar component may be plasma sprayed to 0.030/0.040" thick or a thinner coating (Bondcoat), with the remainder of the intramedullary portion having a bead-blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions

The humeral and ulnar components are connected by an axle bearing, metal reinforcing rod or axle and a saddle bearing. The metal reinforcing rod or axle is cobalt chromium. The axle is sleeved by an axle bearing, which is manufactured from ultra high molecular weight polyethylene (UHMWPE). The axle retaining clips are manufactured from titanium alloy. The saddle bearing is also manufactured from UHMWPE. The saddle bearing. axle bearing, and retaining clips will be consistent for all Biomet Single Hinge Elbows.

AI/ML Overview

The provided text describes a medical device, the "Single Axle Total Elbow," and its FDA 510(k) clearance (K983036). However, the document is a regulatory approval letter and a summary of safety and effectiveness, not a study report detailing acceptance criteria and performance data in the way typically found for AI/ML medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance as it would be presented for an AI/ML device. The document pertains to a traditional orthopedic implant, and the approval process for such devices relies on different types of evidence, primarily substantial equivalence to predicate devices, material safety, and mechanical testing, rather than clinical performance metrics like sensitivity, specificity, or reader improvement in an MRMC study.

Here's why each point cannot be fulfilled based on the provided text:

A table of acceptance criteria and the reported device performance: This document does not contain performance metrics or acceptance criteria as would be defined for an AI/ML device (e.g., specific accuracy thresholds). The "performance" described relates to design features (e.g., 16 degrees of varus/valgus movement, 137° flexion) and material composition, not clinical outcomes from a diagnostic or prognostic study.
Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML clinical study. For this implant, evidence typically comes from bench testing, biomechanical studies, and clinical data from predicate devices, which are not detailed here in that format.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, as defined for AI/ML algorithms, would not be established by experts for the design features of an orthopedic implant.
Adjudication method 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/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used: For a device like this, "ground truth" would relate to its structural integrity, material properties, and biomechanical function as tested in a lab, or successful clinical outcomes from predicate devices. Not applicable in the AI/ML sense.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance of a traditional medical implant, not an AI/ML device. The requested information format is specific to AI/ML device evaluation, which is not present in this document.

Summary

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4/30/99

K983036

SUMMARY OF SAFETY AND EFFECTIVENESS

Sponsor:	Biomet, Inc.Airport Industrial ParkP.O. Box 587Warsaw, Indiana 46581-0587
Device:	Single Axle Total Elbow
Classification Name:	Elbow joint metal/polymer constrained cementedprosthesis(888.3150)

Intended Use: The Single Axle Total Elbow is indicated for use in rheumatoid arthritis, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structures about the elbow.

This device is a single use implant. It is intended for use with bone cement.

Device Description: The Single Axle Total Elbow Prosthesis is a constrained, "sloppyhinge" elbow device used to replace the humeral-ulnar articulation of the human elbow. The implant consists of two main components, an ulnar component and a humeral component, which are joined by an axle (refer to Exhibit III). The Single Axle Elbow features a "sloppy-hinge" that will allow for 16 degrees of varus/valgus movement (refer to Exhibit III). A hyperextension stop (flat) is placed on the ulnar component to control the amount of hyperextension allowed by the device. The device shown in Exhibit III was designed to have 0 degrees of hyperextension, but some hyperextension may be allowed at the specific request of the surgeon. The amount of flexion of the device is approximately 137° (see Exhibit III), but this may also change somewhat due to specific patients' anatomy and surgeon requests.

The ulnar component will be made of titanium alloy. The ulnar and humeral components will be separated by a polyethylene Saddle Bearing to prevent metal on metal contact

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(refer to Exhibit III). Each ulnar component will be designed for patient specific anatomy from X-rays, CT-scans, or some other media for measuring patient anatomy. In some cases the ulnar component may include a replacement portion if proximal ulnar bone loss exists (refer to Exhibit IV). The ulnar component may also contain through slots posteriorly for the attachment of soft tissues. A portion of the extramedullary and intramedullary sections of the ulnar component may be plasma sprayed to 0.030/0.040" thick or a thinner coating (Bondcoat), with the remainder of the intramedullary portion having a bead-blast finish. Please refer to Exhibit IV for the locations of the various surfaces and range of dimensions

Potential Risks: The potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to:

Reaction to bone cement Fracture of the components Cardiovascular disorders Implant loosening/migration Soft tissue imbalance Deformity of the joint Delayed wound healing Fracture of the cement Dislocation
Bone fracture Hematoma Blood vessel damage Nerve damage Excessive wear Infection Metal sensitivity Breakdown of porous surface

Substantial Equivalence: In function and overall design Biomet's Single Axle Total Elbow is equivalent to almost all elbow joint metal/polymer cemented constrained prostheses on the market. Predicate devices include:

Townley Total Elbow (Biopro, 1996, 510(k) #K955916) Osteonics Total Elbow System (Osteonics 1998, 510(k) #980502) ABC Total Elbow Prosthesis (Biomet, Inc., 1997, 510(k) #972691)

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 300 1999

Mr. Fred McClure Regulatory Specialist Biomet, Inc. P.O. Box 587 46581-0587 Warsaw, Indiana

K983036 Re: Sinqle Axle Total Elbow Trade Name: Regulatory Class: III Product Code: JDC Dated: February 19, 1999 February 22, 1999 Received:

Dear Mr. McClure:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Fred McClure

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known) : K983036

Device Name: Single Axle Total Elbow

The Single Axle Total Elbow is indicated for use in rheumatoid arthritis, non-Indications For Use: inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, and treatment of acute or chronic fractures with humeral epicondyle involvement which are unmanageable using other treatment methods. This linked constrained elbow prosthesis is indicated for joints with both intact and limited soft tissue structure about the elbow.

This device is a single use implant. It is intended for use with bone cement.

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

Prescription Use
(Per 21 CFR 801.109)

Division Sign-Off)

(Divis Division of General Res 510(k) Number

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.”