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 Device Reconstruction 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. This line extension adds new components to the Hedrocel Trabecular Metal Reconstruction System.

AI/ML Overview

The provided text describes a 510(k) submission for "The Hedrocel Trabecular Metal Reconstructive System" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance criteria against predefined acceptance thresholds for a diagnostic AI device.

Therefore, many of the requested items related to acceptance criteria, ground truth establishment, expert review, and AI performance studies (MRMC, standalone) are not applicable or cannot be extracted from this document.

Here's an analysis based on the information available:

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

Not applicable in the context of this 510(k) summary. This document is for a reconstructive surgical system, not a diagnostic AI device. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of material properties and mechanical performance to existing predicate devices, not diagnostic accuracy metrics.
Reported Device Performance: The summary states: "The Hedrocel Trabecular Metal Reconstructive System was tested per FDA guidance documents and applicable standards for K010378, as referenced in the predicate K023882, K032282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and calculations found herein indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use."
- This indicates the device's performance was evaluated based on mechanical strength to ensure it can support weakened/deficient bony structures as intended. Specific quantitative results (e.g., tensile strength, fatigue life) are referenced in MAF #920 and K962468 but are not detailed in this summary.

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/Not specified. This pertains to clinical or diagnostic study data. The testing mentioned in the document refers to mechanical testing of the material and device components. Sample sizes for these types of engineering tests are typically determined by standards and are not described here in terms of "test sets" or data provenance.

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. There is no "ground truth" in the diagnostic sense for this type of surgical implant. The closest equivalent would be the engineering expertise used to design the tests and interpret the mechanical data, but this is not detailed.

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

Not applicable. No adjudication method is mentioned as there's no diagnostic test set or expert disagreement to resolve.

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 a surgical reconstructive system, not an AI diagnostic tool. Therefore, MRMC studies are irrelevant.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. As mentioned, there is no diagnostic "ground truth." The performance is measured against established engineering standards and material properties deemed suitable for the indicated orthopedic uses.

8. The sample size for the training set

Not applicable. No machine learning or AI model is involved, so there's no training set.

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

Not applicable. No machine learning or AI model is involved.

Summary of Relevant Information from the Document:

Device Type: Surgical Mesh / Reconstructive System (Hedrocel Trabecular Metal Reconstructive System)
Purpose: Reinforcing weak and/or deficient bony tissues in orthopedic surgical procedures.
Performance Evaluation Method: "Mechanical test data... and calculations... indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use." This was done "per FDA guidance documents and applicable standards" and referenced previous 510(k) submissions (K010378, K023882, K032282, K032344) and specific mechanical test data (MAF #920 and K962468).
Conclusion: The device is "substantially equivalent" to predicate devices, based on technological characteristics and performance data.

Summary

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NOV 1 9 2003

1 . 42 510(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:	Marci Halevi
Phone Number:	(201) 818 - 1800, ext. 507
Fax Number:	(973) 829 - 0825
Date Prepared:	October 21, 2003
Device Trade Name:	The Hedrocel Trabecular Metal Reconstructive System
Device Common Name:	Surgical Mesh
Classification Numberand Name:	21 CFR § 878.3300Surgical Mesh

Substantial The term "substantial equivalence" as used in this 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 Device Hedrocel Trabecular Reconstruction Svstem The ાંટ Description: manufactured wholly of Hedrocel porous tantalum. Hedrocel porous tantalum is 80% porous with fully interconnecting pores that are about 0.5mm in diameter. This line extension adds new components to the Hedrocel Trabecular Metal Reconstruction System.

MATERIALS: Tantalum (Hedrocel porous tantalum)

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10333359

510(k) Summary Continued ...

Indications for The Hedrocel Trabecular Metal Reconstruction System is indicated for use in reinforcing weak and/or deficient bony tissues in orthopaedic Use: 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 Mefal Reconstructive System was tested per FDA quidance documents and applicable standards for K010378, as Data: referenced in the predicate K023882, K032282 and K032344. In addition, mechanical test data found in MAF #920 and K962468, and calculations found herein indicate the subject Hedrocel porous tantalum devices possess sufficient strength for the indicated use. These results indicate that the subject device will perform as indicated for use in support of weakened and/or deficient bony structures.

Conclusion: The Hedrocel Trabecular Metal Reconstructive System is substantially equivalent to the cited predicate devices identified in this premarket notification.

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2003

Ms. Marci Halevi Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401-1600

K033384 Device Name: Hedrocel Trabecular Metal Reconstruction System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: October 21, 2003 Received: October 23, 2003

Dear Ms. Halevi:

Re:

We have reviewed your Section 510(k) pre-market 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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING:

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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 vour 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.

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Page 2 - Ms. Marci Halevi

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.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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,

Daniel Schultz, M.D.

Daniel Schultz, N M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Implex Corp.

1033384

Hedrocel Trabecular Metal Reconstruction System Special 510(k) Premarket Notification

510(k) Number (if known) :

K03384

Device Name:

The Hedrocel Trabecular Metal Reconstruction System

Indications For Use :

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescripti
on Use
(Per 21 CFR 801.109)

OR . . .

Over - The -Counter Use

(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.