The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Device Description

The Hedrocel Trabecular Metal Reconstructive System is manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The Hedrocel Trabecular Metal Reconstructive System has oval cross-sectional geometries of 11mm by 14mm and 21mm by 32mm and is available in height options ranging from 8mm to 62mm. The superior and inferior faces of the implant are canted (included angle of 7 degrees) to provide for initial stability and to facilitate implantation.

AI/ML Overview

The provided text describes a 510(k) summary for "The Hedrocel Trabecular Metal Reconstructive System," a surgical mesh device. Based on the document, here's an analysis of the acceptance criteria and study information:

This document does not provide specific acceptance criteria in terms of numerical thresholds for device performance. Instead, it relies on substantial equivalence to predicate devices and general performance testing. Therefore, I cannot generate a table comparing acceptance criteria to reported device performance as that detailed information is not present.

However, I can extract information related to the device performance study as described:

Study Information for The Hedrocel Trabecular Metal Reconstructive System:

1. A table of acceptance criteria and the reported device performance:
As stated above, no explicit numerical or quantitative acceptance criteria are provided in the document. The general acceptance is implied through the "substantially equivalent" determination to predicate devices and performance testing indicating the device "will perform as indicated."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a distinct "test set" sample size or data provenance. It mentions "Performance Data: The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement." This suggests performance testing was conducted, but details on sample size, origin, or study design (retrospective/prospective) are absent.
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):
This information is not applicable and not provided in the document. This device is a physical implant, not an AI or diagnostic device that requires expert ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided.
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:
This is not an AI-assisted device. Therefore, no MRMC comparative effectiveness study involving AI or human readers was conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not an AI algorithm. Therefore, no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this physical medical device, "ground truth" would typically refer to the successful mechanical or biological performance of the implant in its intended use, usually assessed through in-vitro mechanical testing, pre-clinical animal studies, or clinical outcomes (though no clinical trials are explicitly mentioned for this 510(k) submission beyond "performance testing"). The document indicates that testing was done "per FDA guidance documents and applicable standards." However, the specific type of ground truth (e.g., specific pathology results, long-term outcomes) is not detailed.
8. The sample size for the training set:
This is not an AI algorithm and thus does not have a "training set."
9. How the ground truth for the training set was established:
This is not an AI algorithm and thus does not have a "training set."

Summary of Acceptance related to Substantial Equivalence:

The primary "acceptance" for this device is based on substantial equivalence to predicate devices. The document states:

"A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices."
"The Hedrocel Trabecular Metal Reconstructive System is substantially equivalent to the cited predicate devices identified in this premarket notification."

The study that "proves" the device meets acceptance criteria (i.e., is substantially equivalent and performs as indicated) is summarized as:

"The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement. These results indicate that the subject device will perform as indicated for use in support of weakened bony structures."

This indicates that mechanical and/or material performance testing was conducted according to regulatory standards to support its intended use and similarity to previously cleared devices, forming the basis for its 510(k) clearance.

Summary

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P. 12

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The Hedrocel Trabecular Metal Reconstructive System

Submitter Name	Implex Corp.
And Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Robert A. Poggie, PhD
Phone Number:	(201) 818 - 1800, X 519
Fax Number:	(973) 829 - 0825
Date Prepared:	February 14, 2002
	FEB 1 9 2003
Device Trade Name:	The Hedrocel Trabecular Metal Reconstructive System
Device Common Name:	Surgical Mesh
Classification Numberand Name:	21 CFR § 878.3300Surgical Mesh

The term "substantial equivalence" as used in this Substantial 510(k) Equivalence: notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

Metal Reconstructive System Device The Hedrocel Trabecular ોડ Description: manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. The Hedrocel Trabecular Metal Reconstructive System has oval cross-sectional geometries of 11mm by 14mm and 21mm by 32mm and is available in height options ranging from 8mm to The superior and inferior faces of the implant are canted 62mm. (included angle of 7 degrees) to provide for initial stability and to facilitate implantation.

MATERIALS: Tantalum (Hedrocel porous tantalum)

( 1 R

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K023882

p.2/2

510(k) Summary Continued ...

Indications for The Hedrocel Trabecular Metal Reconstruction System is indicated for Use: use in reinforcing weak and/or deficient bony tissues in orthopaedic surgical procedures such as pelvic reconstruction, acetabular reconstruction, cement restriction, and in long bone procedures such as femoral and humeral reconstruction. When used in long bone procedures, ancillary fixation, such as plates and screws, must be used. The Hedrocel Trabecular Metal Reconstruction System may also be used with bone graft.

Device

Technological Characteristics & Comparison to Predicate Device: A comparison of device technological characteristics and properties demonstrates that the device is substantial equivalent to the cited predicate devices.

Performance The Hedrocel Trabecular Metal Reconstructive System was tested per Data: FDA guidance documents and applicable standards for K010378 for use as a structural void filler in vertebral body replacement. These results indicate that the subject device will perform as indicated for use in support of weakened bony structures.
The Hedrocel Trabecular Metal Reconstructive System is substantially Conclusion: equivalent to the cited predicate devices identified in this premarket notification.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Robert A. Poggie, Ph.D. Director, Applied Research Implex Corp. 80 Commerce Drive Allendale, New Jersey 07401-1600

Re: K023882

Trade/Device Name: The Hedrocel Trabecular Metal Reconstruction System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: EZX Dated: November 20, 2002 Received: November 21, 2002

Dear Dr. Poggie:

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 (OS) 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 - Robert A. Poggie, 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milburn

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

Enclosure

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510 (k) Number (if known) :

23882

Device Name:

The Hedrocel Trabecular Metal Reconstruction System

Indications For Use :

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

Concurrence of CORH; Office of Device Evaluation (ODE)

for Mark n Milun
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

Prescriptio10(k) Number K023882
n Use OR...
Over-The-
Counter Use
(Per 21. CFR 801.109)

(Optional Format 1-2-96)

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.