Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

Device Description

The cement restrictor is a single, molded component intended to be used for blocking the diaphysis of the femoral canal. It is positioned a few centimeters distal to the distal tip of the prosthesis stem or the stem's centralizer to prevent migration of bone cement beyond the proximal zone of the femoral medullary canal. The cement restrictor is positioned with the aid of an insertion instrument. The restrictors are manufactured of radiolucent medical grade Ultra-High Molecular-Weight Polyethylene (UHMWPE) per ASTM standard F648-00, and ISO standards ISO 5834-1:1998 and ISO 5834-2:1998. They are manufactured in two sizes: "Small" and "Large." The small restrictors are to be used for femoral medullary canals ranging from 12 to 18 mm. The large restrictors are to be used for femoral medullary canals ranging from 18 to 24 mm.

AI/ML Overview

The provided document does not contain information about a study proving the device meets acceptance criteria in the way typically structured for a medical device that uses an algorithm or AI.

This document is a 510(k) summary for a physical medical device, the Tecres Cement Restrictor. The 510(k) process for such devices primarily focuses on demonstrating substantial equivalence to a previously legally marketed device, not on meeting specific quantitative performance metrics through a clinical or algorithmic performance study with acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of submission as presented in the provided text.

Here's a breakdown of what can be gleaned from the document based on the request:

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

Not Applicable. This document is a 510(k) summary for a physical medical device, the Tecres Cement Restrictor, demonstrating substantial equivalence to predicate devices. It does not contain performance acceptance criteria in the context of an algorithm or AI, nor does it report specific numerical performance metrics from a study to meet such criteria. The "performance" is implicitly deemed equivalent to the predicate devices.

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

Not Applicable. No test set or data provenance is mentioned as this is not an AI/algorithm-based device and no such study is detailed.

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. Ground truth definition by experts is not relevant to this submission for a physical device.

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

Not Applicable. No test set or 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 is not an AI-assisted device, so no MRMC study improving human readers with AI assistance would be conducted.

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

Not Applicable. This is a physical device, not an algorithm.

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

Not Applicable. Ground truth, in the context of an AI/algorithm performance study, is not relevant to this submission for a physical device.

8. The sample size for the training set

Not Applicable. No training set is mentioned as this concerns a physical medical device, not an algorithm.

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

Not Applicable. As there is no training set, there is no ground truth establishment for it.

Summary of what the document does provide regarding "acceptance" or clearance:

The document describes the device description, intended use, indications, and contraindications. The "acceptance" in this context refers to clearance via the 510(k) pathway by demonstrating substantial equivalence to legally marketed predicate devices.

The FDA reviewed the submission and determined the device is "substantially equivalent" to predicate devices, allowing it to be marketed. This is the primary "acceptance criterion" for a 510(k) submission for a non-novel physical device.

The study that "proves" the device meets acceptance criteria in this specific context is the 510(k) submission itself, which articulates how the device is equivalent to existing cleared devices through:

Similar intended use: Blockage of the femoral medullary canal (Page 2).
Similar technological characteristics: Manufactured from UHMWPE, similar sizes (Small for 12-18mm canals, Large for 18-24mm canals) (Page 2).
Performance: While not explicitly detailed with quantitative data in this summary, the implication is that its mechanical and biological performance is comparable to the predicate devices made of similar materials and functions structurally the same way. The sterilisation method (gamma ray irradiation) is also specified to a SAL of 10-6 (Page 3).

The FDA's letter (Page 4-5) confirms the finding of substantial equivalence based on the provided information in the 510(k) premarket notification.

Summary

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510(k) Summary of Safety and Effectiveness

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Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653

Phone:	(352) - 377 - 1140
Fax:	(352) - 378 - 2617

FDA Establishment Numbers:

Applicant/Sponsor – Exactech # 1038671 Manufacturer – Tecres #1526534

Gary J. Miller, PH.D. Contact: Executive Vice President of Research & Development Exactech, Inc.
Date: May 24, 2002

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510(k) Summary of Safety and Effectiveness

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Classifications / Proprietary Names

Classification Name:	Prosthesis, Hip, Cement Restrictor
Product Code:	JDK
C.F.R. Section:	878.3300
Device Class:	II
Classification Panel:	General and Plastic Surgery
Common Name(s):	Cement Restrictor, Cement Plug
Trade / Proprietary Model Names:	Cement Restrictor - SmallCement Restrictor - Large

Legally Marketed Devices for Substantial Equivalence Comparison

The Tecres Cement Restrictor is substantially equivalent to the following legally marketed devices that were cleared for marketing via the premarket approval (510(k)) numbers listed below.

Manufacturer	Model	Product Code	510(k) Number
Tornier	Tornier Cement Restrictor	JDI	K001932
Sunmed, Inc.	Orthoplug Hard Bone Plug	LZN	K955631
Sunmed, Inc.	Orthoplug Soft Bone Plug	LZN	K955632
Zimmer, Inc.	Allen Medullary CementPlugs, Zimmer Poly PlugMedullary Plugs	JDI	K001733
Osteonics Corp.	Omniflex-C UHMPE Mid-Shaft Restrictor	JDK	K923616

Device Description

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510(k) Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The restrictors are manufactured of radiolucent medical grade Ultra-High Molecular-Weight Polyethylene (UHMWPE) per ASTM standard F648-00, and ISO standards ISO 5834-1:1998 and ISO 5834-2:1998. They are manufactured in two sizes: "Small" and "Large." The small restrictors are to be used for femoral medullary canals ranging from 12 to 18 mm. The large restrictors are to be used for femoral medullary canals ranging from 18 to 24 mm.

One of each size restrictor is packaged in a bone cement preparation kit with other bone cement accessories, including:

The cement restrictor inserter .
A femoral canal brush .
A femoral canal sponge ●
A cement pressurizer, and ●
Two curettes to aid in removal of excess bone cement. .

The kit's packaging consists of a two-tray system with Copolyester (PETG) blister packs and Tyvek lids.

An alternative packaging is available in which a single restrictor is loaded onto its disposable, medical-grade Acrylonitrile Butadiene Styrene (ABS) insertion instrument. This assembly is packaged in double pouch system consisting of a laminate of polyethylene and polyamide. The final packaging for this version consists of a cardboard box.

Intended Use

The Tecres Cement Restrictor is inserted into the femoral medullary canal to limit the flow of bone cement and to aid in cement pressurization during primary or revision hip arthroplasty surgery.

Indications

Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

Contraindications

Tecres Cement Restrictors are contraindicated for non-cemented total hip procedures and for applications other than those which are indicated.

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510(k) Summary of Safety and Effectiveness

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Tecres Cement Restrictors are contraindicated in infectious arthritis and in active infection of the joint(s) to be replaced. Use of the cement restrictors is also contraindicated where the loss of musculature or neuromuscular compromise in the affected limb would render the surgical procedure unjustifiable.

The Tecres Cement Restrictors are NOT indicated for any spinal applications.

The Tecres Cement Restrictors are contraindicated for any patients exhibiting allergies to UHMWPE implant materials.

Sterilization

Tecres Cement Restrictors, whether in the kit or pouch packaging, are sterilized by gamma ray irradiation to a Sterility Assurance Level (SAL) of 10 6.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 6 2002

Gary J. Miller, Ph.D. Executive Vice President of Research and Deveopment Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K021765

Trade/Device Name: Tecres Cement Restrictors -- Small and Large Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: May 24, 2002 Received: May 29, 2002

Dear Dr. Miller:

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 - Gary J. Miller, Ph.D.

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

b. Mark A. Mclennan

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

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K021765 510(k) Number:

Cement Restrictors Device Name:

Indications:

Tecres Cement Restrictors are indicated for the blockage of the femoral medullary canal prior to cement insertion and as an aid to cemented hip arthroplasty procedures.

Contraindications:

Tecres Cement Restrictors are contraindicated for non-cemented total hip procedures and for applications other than those which are indicated.

The Tecres Cement Restrictors are NOT indicated for any spinal applications.

The Tecres Cement Restrictors are contraindicated for any patients exhibiting allergies to UHMWPE implant materials.

Please do not witte below this line - use another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use

Mark M. Melvern

General, Restorative Section 3 Page 1 of 1

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.