The Coonrad/Morrey Elbow Cement Restrictor is designed to impede the flow of bone cement distal to the prosthesis in the intramedullary canal during total elbow arthroplasty. The plugs are molded from polyethylene, and they are inserted into the intramedullary canal prior to the introduction of bone cement and insertion of the appropriate prosthesis.

AI/ML Overview

The provided document describes the Coonrad/Morrey Elbow Cement Restrictor and its substantial equivalence to predicate devices, rather than a study detailing acceptance criteria and performance data for a novel device. Therefore, much of the requested information cannot be extracted directly from this submission.

However, based on the information provided, here's what can be gathered:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Performance requirements	Met performance requirements
Safety	As safe as predicate devices
Effectiveness	As effective as predicate devices

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The submission does not detail a "test set" in the context of clinical or standalone performance studies for a novel AI/device. The evaluation was based on non-clinical testing and comparison to predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. Ground truth for a test set is not relevant for this type of submission which focuses on substantial equivalence based on non-clinical performance and comparison to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. An MRMC comparative effectiveness study was not performed as this is not an AI-assisted device.

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

A standalone performance study for an algorithm was not done as this is a physical medical device, not an algorithm. However, "Non-clinical testing" was performed, indicating a form of standalone evaluation of the device's physical properties or functional performance in a simulated environment, without human interaction in a clinical setting.

7. The Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" would be established by engineering specifications, material properties, and functional benchmarks derived from standards and the performance of predicate devices. The document states the device "meets performance requirements" and is "as safe and effective as the predicate devices." This implies that the capabilities of the predicate devices and established industry standards served as the benchmark or "ground truth" for evaluating the new device.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI device that typically involves a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

Summary from the Document:

The provided document is a 510(k) Premarket Notification for the Coonrad/Morrey Elbow Cement Restrictor, indicating that it is seeking clearance based on substantial equivalence to already legally marketed devices.

The "study" referenced is the "Non-clinical testing":

Description of Study: Non-clinical testing demonstrated that the device meets performance requirements and is as safe and effective as the predicate devices. This type of testing typically involves bench testing, material characterization, and/or mechanical performance evaluations to ensure the device performs its intended function (impeding cement flow) reliably and safely.
Predicate Devices: Zimmer Allen Medullary Plugs (K001733) and Zimmer Poly-Plug™ Intramedullary System (K950312).
Conclusion: The device is equivalent to other commercially available intramedullary cement plugs by virtue of design and functionality, and has the same intended use.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a circle with a stylized "Z" inside of it. To the right of the circle is the word "zimmer" in lowercase letters.

MAY 1 7 2004

Summary of Safety and Effectiveness

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Noah J. Bartsch, MSSpecialist, Regulatory AffairsTelephone: (574) 371-8552Fax: (574) 372-4605
Date:	February 13, 2004
Trade Name:	Coonrad/Morrey Elbow Cement Restrictor
Common Name:	Cement Obturator
Classification Nameand Reference:	Orthopaedic Surgical Mesh21 CFR § 878.3300
Predicate Devices:	Zimmer Allen Medullary Plugs, K001733, clearedJune 20, 2000.Zimmer Poly-Plug™ Intramedullary System,K950312, cleared May 17, 1995
Device Description:	The Coonrad/Morrey Elbow Cement Restrictor isdesigned to impede the flow of bone cement distalto the prosthesis in the intramedullary canal duringtotal elbow arthroplasty. The plugs are moldedfrom polyethylene, and they are inserted into theintramedullary canal prior to the introduction ofbone cement and insertion of the appropriateprosthesis.
Intended Use:	Intramedullary cement plugs are indicated for use intotal joint arthroplasty to control, restrict or impedethe flow of cement.The larger intramedullary cement plugs are usefulin revision surgery where a wide, smoothintramedullary canal must be plugged.
Comparison to Predicate Device:	The Coonrad/Morrey Elbow Cement Restrictor isequivalent to other commercially availableintramedullary cement plugs currently on themarket, by virtue of design and functionality. Thedevice has the same intended use as the predicatedevices, and has demonstrated the ability tofunctionally perform the intended use.
Performance Data (Non-clinical):	Non-Clinical Performance and Conclusions:
	Non-clinical testing demonstrated that theCoonrad/Morrey Elbow Cement Restrictor meetsperformance requirements and is as safe andeffective as the predicate devices.

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Image /page/1/Picture/0 description: The image contains the word "zimmer" in a stylized font. To the left of the word is a circular logo with a bold letter "Z" inside. The letter "Z" is also stylized and fills most of the circle.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 17 2004

Noah J. Bartsch, MS Specialist, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708

Rc: K040389

Trade/Device Name: Coonrad/Morrey Elbow Cement Restrictor Regulation Number: 21 CFR 878.3150, 888.3160 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDC, JDB Dated: February 13, 2004 Received: February 17, 2004

Dear Mr. Bartsch:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your became 910(t) fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard want date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recalsmod in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciore, market the act include requirements for annual registration, listing of general controls provisions of the 120 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 If your device is classified (see aborve) into Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may be subject to such additional controllar Chile 21, Parts 800 to 898. In addition, FDA may be found in the Outs or enents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 177A s issuated of a backainments with other requirements of the Act
that FDA has made a determination that your device complies with other requirement that FDA has made a determination and Jointer Federal agencies. You must or any Federal statures and regulations damindiver, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as schoolenge CFR Part 807), fabening (21 CFRT at 001), good fif applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Noah J. Bartsch, MS

This letter will allow you to begin marketing your device as described in your Section 510(k) This icler with anow you to ogen maning of substantial equivalence of your device to a legally premailed notincation: The PDF intembly 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 If you desire spoonly at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Compliance in (bet notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N Millhussen

Celia M. Witten, Ph.D., M.D. 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:

Coonrad/Morrey Elbow Cement Restrictor

Indications for Use:

Intramedullary cement plugs are indicated for use in total joint arthroplasty to control, restrict or impede the flow of cement.

The larger intramedullary cement plugs are useful in revision surgery where a wide, smooth intramedullary canal must be plugged.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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. Milleson

Page 1 of 1

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

510(k) Number K040384

0017

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.”