HEDROCEL ACETABULAR CAGE SYSTEM by IMPLEX CORP.

The indications for use of the Implex Hedrocel® Acetabular Cage are as follows:
• For cemented or cementless use.
• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

Device Description

The Hedrocel® Acetabular Cage System consists of the Hedrocel® Acetabular Cage configured with an Implex All-Poly Cup. The Hedrocel® Acetabular Cage System, cemented and cementless, is available in OD sizes from 52 mm to 70 mm in 2 mm increments. The Hedrocel Acetabular Cage (Shell) is compatible with All-Poly Cups in OD sizes from 40 mm to 58 mm. The All-Poly Cups, cemented, are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0° and 10° face angles. The All-Poly Cup is affixed to the Hedrocel® Acetabular Cage using acrylic bone cement.

AI/ML Overview

The provided document is a 510(k) summary for the Implex Hedrocel® Acetabular Cage System. It is a premarket notification for a medical device aiming to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study demonstrating the device meets specific acceptance criteria through clinical performance metrics like sensitivity or specificity.

Therefore, many of the requested categories related to clinical study design (sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission. The document focuses on demonstrating that the device has comparable technological characteristics and intended use to existing devices.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for 510(k) Equivalence)	Reported Device Performance
Substantial equivalence to predicate devices in terms of technological characteristics.	"A comparison of technical characteristics [demonstrates] that the Hedrocel® Acetabular Cage System is substantially equivalent to commercially available reconstructive devices."
Device functions as intended.	"Testing conducted on the commercially available devices comprised wholly or in part of Hedrocel® and the Hedrocel Acetabular Cage System indicate that the device will function as intended."

Note: For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating substantial equivalence to a legally marketed predicate device, rather than achieving specific performance metrics like those for a diagnostic algorithm. The "reported device performance" refers to the manufacturer's claim that testing supports the device's intended function and its equivalence.

Study Information

The document does not describe a clinical study of the type that would typically establish performance metrics for a diagnostic or AI device. Instead, it refers to "testing" to demonstrate substantial equivalence and intended function, common for orthopedic implants.

Here's a breakdown of the requested information, noting when it is not applicable:

Sample size used for the test set and the data provenance: Not applicable. This document refers to technical characteristics and unspecified "testing" for substantial equivalence of an orthopedic implant, not a clinical trial with a test set of human subjects or data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic or AI studies is not relevant here. The "ground truth" for a 510(k) mechanical device is typically established through engineering and biomechanical testing demonstrating material properties, strength, and fit, compared against established standards or predicate devices. There's no mention of expert consensus on clinical cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to clinical studies involving subjective interpretation, which is not the focus of this 510(k) for an orthopedic implant.
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 an acetabular cage system (an orthopedic implant), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an orthopedic implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a mechanical orthopedic device seeking 510(k) clearance, the "ground truth" is generally established through:
- Engineering specifications and material science: Ensuring the device meets design and material standards for strength, biocompatibility, and durability.
- Biomechanical testing: Demonstrating that the device can withstand expected physiological loads and perform its mechanical function comparably to predicate devices.
- Clinical experience with predicate devices: The "ground truth" for safety and effectiveness is largely drawn from the established performance and safety record of the legally marketed predicate devices to which this new device claims substantial equivalence.
  The document mentions "Testing conducted on the commercially available devices" which would likely encompass these types of evaluations.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The Implex Hedrocel® Acetabular Cage System

Submitter Name:	Implex Corp.	K983831
Submitter Address:	80 Commerce DriveAllendale, New Jersey 07401-1600
Contact Person:	John Schalago or Robert Poggie
Phone Number:	(201) 818-1800
Fax Number:	(201) 818-0567
Date Prepared:	June 17, 1999
Device Trade Name:	The Implex Hedrocel® Acetabular Cage System
Device Common Name:	Acetabular Reconstructive Cage
Classification Number :	21 CFR § 888.3350

Substantial Equivalence: The term "substantial equivalence" as used in this 510(k) 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 device can be marketed without which a or reclassification. premarket approval (1) 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 Hedrocel® Acetabular Cage System consists of the Hedrocel® Acetabular Cage configured with an Implex All-Poly Cup. The Hedrocel® Acetabular Cage System, cemented and cementless, is available in OD sizes from 52 mm to 70 mm in 2 mm increments. The Hedrocel Acetabular Cage (Shell) is compatible with All-Poly Cups in OD sizes from 40 mm to 58 mm. The All-Poly Cups, cemented, are available with four ID size options (22 mm, 26 mm, 28 mm and 32 mm) and in 0° and 10° face angles. The All-Poly Cup is affixed to the Hedrocel® Acetabular Cage using acrylic bone cement.

The Hedrocel® Acetabular Cage may be used with Continuum Hip Bone Screws.

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Indications for Use:	The indications for use of the Implex Hedrocel®Acetabular Cage are as follows:• For cemented or cementless use.• Painful, disabling joint disease of the hipresulting from: degenerative arthritis,rheumatoid arthritis or late stage avascularnecrosis.• Revision of previous unsuccessful femoralhead replacement, cup arthroplasty or otherprocedure.• Clinical management problems wherearthrodesis or alternative reconstructivetechniques are less likely to achievesatisfactory results.• Where bone stock is of poor quality or isinadequate for other reconstructivetechniques as indicated by deficiencies ofthe acetabulum.
Device TechnologicalCharacteristics andComparison toPredicate Device:	A comparison of technical characteristics included inthis 510(k) Premarket notification demonstrates thatthe Hedrocel® Acetabular Cage System issubstantially equivalent to commercially availablereconstructive devices.
Performance Data:	Testing conducted on the commercially availabledevices comprised wholly or in part of Hedrocel® andthe Hedrocel Acetabular Cage System indicate thatthe device will function as intended.
Conclusion:	The Implex Hedrocel® Acetabular Cage issubstantially equivalent to the identified predicatedevices.

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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

John A. Schalago, RAC Manager of Regulatory Affairs Implex Corporation 80 Commerce Drive Allendale, New Jersey 07401

Re: K983837

Implex Hedrocel® Acetabular Cage System for Cemented or Cementless Fixation Regulatory Class: II Product Code: LPH and JDI Dated: April 21, 1999 Received: April 22, 1999

Dear Mr. Schalago:

We have reviewed your Section 510(k) 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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2- Mr. John Schalago

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

P. Cotter

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

Enclosure

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510(k) Number (if known):

K983837

Device Name:

The Hedrocel® Acetabular Cage System

Indications For Use:

The indications for use of the Implex Hedrocel® Acetabular Cage are as follows:

For cemented or cementless use. .
Painful, disabling joint disease of the hip resulting from: degenerative arthritis, . rheumatoid arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty ● or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
Where bone stock is of poor quality or is inadequate for other reconstructive . techniques as indicated by deficiencies of the acetabulum.

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Concurrence of CDRH; Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K983835

Prescription Use(Per 21 CFR 801.109)	X
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OR...

Over-The-Counter Use
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(Optional Format 1-2-96)

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.