MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ by IMPLEX CORP.

The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocel® Vertebral Body Replacement is intended for use with supplemental internal spinal fixation systems. The Hedrocel® Vertebral Body Replacement may be used with bone graft.

Device Description

The Hedrocel® Vertebral Body Replacement System is designed to be used as a replacement for a single diseased or damaged vertebral body and the adjacent disc when spinal surgery through an anterior approach is indicated.

The Hedrocel® Vertebral Body Replacement (VBR) System is comprised wholly of Hedrocel® Porous Tantalum (tantalum deposited on a vitreous carbon skeleton). The VBR is available to accommodate replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to properly tension the spine.

The superior and inferior surfaces of the device have a pattern of ripples to provide increased stability. The Hedrocel® Vertebral Body Replacement implants have an included angle to maintain the natural contour of the lumbar spine.

The use of titanium or titanium alloy instrumentation is recommended.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Hedrocel Vertebral Body Replacement System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study to prove efficacy and safety with specific acceptance criteria related to a new device performance.

Therefore, much of the information requested in your prompt (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) is not applicable to this type of regulatory submission and is not present in the provided document.

Here's a breakdown of what can be extracted from the text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" and "reported device performance" are primarily focused on demonstrating mechanical equivalence to predicate devices. The acceptance criteria are implicit in the "applicable standards" referenced, and the "reported device performance" refers to the device meeting the mechanical safety and performance benchmarks set by those standards and the predicate devices.

Acceptance Criteria (Implicit)	Reported Device Performance Statement
Compliance with applicable standards for vertebral body replacement devices, demonstrating equivalent mechanical behavior to predicate devices.	"The Hedrocel Vertebral Body Replacement System was tested per applicable standards. Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicates. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding: Static compression, Dynamic compression, Static torsion, Dynamic torsion, and Abrasion."

Acceptance Criteria (Implicit)

Reported Device Performance Statement

Compliance with applicable standards for vertebral body replacement devices, demonstrating equivalent mechanical behavior to predicate devices.

"The Hedrocel Vertebral Body Replacement System was tested per applicable standards. Biocompatibility data was provided to support the material's use. Performance testing was provided to support equivalent mechanical behavior to the predicates. The results demonstrated that the device will perform as intended and is equivalent to the cited predicate devices. Test data was provided regarding: Static compression, Dynamic compression, Static torsion, Dynamic torsion, and Abrasion."

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

Sample Size for Test Set: Not specified. The document states "test data was provided regarding" various mechanical tests, but doesn't detail the number of units tested.
Data Provenance: Not specified. These are likely in vitro mechanical tests conducted in a laboratory setting, not clinical data from patients in a specific country.

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

Number of Experts: Not applicable. For mechanical performance testing, "ground truth" is established through engineering and biomechanical testing against defined standards, not expert clinical consensus on images or outcomes.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This concept is relevant for clinical studies involving expert review, not for mechanical bench testing.

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

MRMC Study: No, an MRMC study was not done. This type of study is for evaluating the impact of AI on human reader performance, typically in diagnostic imaging, and is not relevant to the mechanical performance of a vertebral implant.
Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Performance: Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's performance is based on biomechanical and material science standards and benchmarks established by the predicate devices. These standards define acceptable levels of static compression, dynamic compression, static torsion, dynamic torsion, and abrasion.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This refers to training an AI model, which is not relevant to this device submission.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable.

Summary of Inapplicability:

The requested information (points 2-6, 8-9) largely pertains to the validation of AI/software devices or clinical efficacy studies. The K021025 submission for the Hedrocel Vertebral Body Replacement System is a 510(k) for a physical implant, demonstrating substantial equivalence through mechanical and biocompatibility testing against predicate devices and applicable standards. This process does not involve clinical "test sets" or "training sets" in the traditional sense of AI/diagnostic imaging validation.

Summary

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K021025

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Hedrocel Vertebral Body Replacement System

Submitter NameAnd Address:	Implex Corp.80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	Robert A Poggie, PhD
Phone Number:	(201) 818-1800
Fax Number:	(201) 995-9722
Date Prepared:	March 7, 2002
Device Trade Name:	Hedrocel Vertebral Body Replacement System
Device Common Name:	Vertebral Body Replacement Device
Classification Numberand Name:	21 CFR § 888.3060Spinal Vertebral Body Replacement Device

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.

Device Description:

The use of titanium or titanium alloy instrumentation is recommended.

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Implex Corp

Kozio25

510(k) Summary (Continued)

Indications for Use:	The Hedrocel® Vertebral Body Replacement System is avertebral body replacement device intended for use in thethoracolumbar spine (T1 - L5) to replace a collapsed, damagedor unstable vertebral body due to tumor or trauma (i.e.,fracture). The Hedrocel® Vertebral Body Replacement isintended for use with supplemental internal spinal fixationsystems. The Hedrocel® Vertebral Body Replacement may beused with bone graft.
Device TechnologicalCharacteristics andComparison toPredicate Device:	The device is unique in comparison to predicates for thisindication with regard to porous tantalum material and itsstructure. The material has been used in cited predicates forother applications.
Performance Data:	The Hedrocel Vertebral Body Replacement System was testedper applicable standards. Biocompatibility data was provided tosupport the material's use. Performance testing was providedto support equivalent mechanical behavior to the predicates.The results demonstrated that the device will perform asintended and is equivalent to the cited predicate devices. Testdata was provided regarding:Static compression,Dynamic compression,Static torsion,Dynamic torsion, andAbrasion.
Conclusion:	The Implex Hedrocel Vertebral Body Replacement System issubstantially equivalent to the following predicate devicesidentified in this premarket notification:

510(k) #	Product Name	Company
K010378	Hedrocel Vertebral Body Replacement	Implex
K003709	Surgical Dynamics (SDI) Mesh CageSystem	United States Surgical

P2/2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2002

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

Re: K021025

Trade/Device Name: Hedrocel Vertebral Body Replacement Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: April 22, 2002 Received: April 23, 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 (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 - Robert A. Poggie, PhD.

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.

Sincerely yours,

Mark A. Mellman

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

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Implex Corp

Hedrocel® Vertebral Body Replacement Special 510(k) Premarket Notification

510(k) Number (if . known) :

K021025

ge 1 of 1.

Device Name:

The Implex Hedrocel Vertebral Body Replacement System

Indications For Use:

The Hedrocel® Vertebral Body Replacement System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Hedrocer® Vertebral Body Replacement is intended for use with The Hedrocel® Vertebral Body supplemental internal spinal fixation systems. Replacement may be used with bone graft.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

Prescriptio n Use (Per 21 CFR 801.109) OR. .

Over-The-Counter Use

(Optional Format 1-2-96)

Mark A. Milleson

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

510(k) Number _$K0_{2}1025$

March 20, 2002

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.