The subject devices are single use components, intended for use in conjunction with associated acetabular shells, femoral bearings, and femoral hip stems as part of a cemented or cementless total hip replacement procedure. Indications for use, in keeping with those of other commercially available Class II total hip devices, are as follows:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
. rheumatoid arthritis,
. correction of functional deformity,
revision procedures where other treatments or devices have failed, and .
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

Device Description

The subject Crossfire™System 12® Acetabular Inserts are the same as the predicate non-Crossfire™System 12® Acetabular Inserts, except that the subject devices are fabricated from polyethylene that has been crosslinked via the procedure described in, and found Substantially Equivalent in, 510(k) #K974685.

AI/ML Overview

This document describes a 510(k) submission for "Additional Crossfire™ Acetabular Components," specifically Crossfire™ System 12® Acetabular Inserts. It focuses on demonstrating substantial equivalence to previously marketed devices and does not present a typical "study" in the sense of a clinical trial or algorithm performance evaluation. Instead, it relies on materials comparison, design equivalence, and mechanical testing to show the new components are safe and effective.

Here's a breakdown based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by the performance of the predicate devices and the focus of the additional testing. The primary "performance" assessed here is the structural integrity and locking strength of the acetabular inserts, particularly after the Crossfire™ crosslinking process.

Acceptance Criterion (Implied)	Reported Device Performance
Structural integrity (no gross evidence of impending catastrophic failure) after fatigue testing	"All inserts were inspected for signs of structural compromise with no gross evidence of impending catastrophic failure."
Sufficient locking strength pre- and post-fatigue testing	"Axial distraction test results demonstrated sufficient locking strength pre-and post- fatigue testing."
Not adversely affected by Crossfire™ process (locking/fatigue strength)	"Additional testing has been performed on Crossfire™ versions of the System 12® Acetabular Inserts to validate that these inserts are not adversely affected, with regard to locking strength or fatigue strength, as a result of the Crossfire™ process."
Wear Rate (in specific configurations, compared to standard polyethylene)	90% reduction in gravimetric wear rate (unaged) 88% reduction in gravimetric wear rate (aged) 78% reduction in gravimetric wear rate (abrasive wear)

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

Sample Size for Structural/Locking Test: "After 107 cycles, three inserts were axially distracted (pushed-out) and two were carefully removed by sectioning their metal shells." For the wear claims, specific insert models (e.g., 2041C-2850) were used, but the exact number of samples for each wear test condition isn't explicitly stated beyond implying "inserts."
Data Provenance: The tests are described as in vitro mechanical and wear simulator tests. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities (Howmedica Osteonics Corp.). These are prospective tests performed for regulatory submission.

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

This type of information is not applicable to this submission. The "ground truth" here is objective mechanical performance data, not expert subjective interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical tests follow defined protocols and yield objective measurements, not subjective evaluations requiring adjudication.

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 applicable. This submission is for a medical device (acetabular components), not an AI algorithm or an imaging study.

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

This is not applicable. This is not an algorithm, and there is no human-in-the-loop component relevant to its mechanical function.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the acetabular components is based on:

Objective Mechanical Measurements: Axial distraction force measurements for locking strength, and gravimetric wear measurements from hip wear simulation.
Visual Inspection: Gross inspection for signs of structural compromise.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense.

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

This is not applicable for the same reason as point 8.

Summary

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(993352

NOV 1 9 1999

Additional Crossfire™Acetabular Components

510(k) Summary

Additional Crossfire™ Acetabular Components

Submission Information

Name and Address of the Sponsor:	Howmedica Osteonics Corp.
	59 Route 17
	Allendale, NJ 07401-1677
Contact Person:	Terry Sheridan Powell
Date of Summary Preparation:	November 19, 1999

Device Identification

Proprietary Name:	Crossfire™ System 12® Acetabular Inserts
Common Name:	Artificial Total Hip Replacement Component
	(Acetabular Inserts)

Classification Name and Reference:	888.3358: Prosthesis, hip, semi-constrained, metal-
	polymer, porous, uncemented

Predicate Device Identification

Osteonics Polyethylene Acetabular Inserts, fabricated from crosslinked polyethylene . called "Crossfire", were determined Substantially Equivalent via 510(k) #K974685 on 12/16/97 (sponsor: Osteonics Corp.).

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Howmedica System 120 Acetabular Inserts (non-Crossfire) were determined
Substantially Equivalent as follows:
via 510(k) #K903362. These were room air irradiated versions, previously called -Osteolock inserts (sponsor: Howmedica Inc..).
via 510(k) #K951114. These were room air irradiated versions, specifically for the . additional P1 26mm size.
via 510(k) #K951115. These were room air irradiated versions, specifically for the additional 22mm sizes.
via 510(k) #K934060. These were Duration® Stabilized versions. -
via 510(k) #K963612. This submission allowed additional wear claims for the -Duration® Stabilized versions.

Device Description

Intended Use:

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noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis,
Necrosis,
rheumatoid arthritis, .
correction of functional deformity, .
. revision procedures where other treatments or devices have failed, and
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur . with head involvement that are unmanageable using other techniques.

Statement of Technological Comparison:

Materials

The subject and predicate Crossfire™ System 120 Acctabular Inserts are manufactured from UHMWPE per ASTM-F648. The UNMWPE material to be used for the subject System 120 Acetabular Inserts will be crosslinked in exactly the same manner used for the acetabular inserts determined Substantially Equivalent via K974685.

Indications for Use

The indications for use of the subject and predicate System 12@ Acetabular Inserts are identical.

Design

The subject (Crossfire) and predicate (non-Crossfire) System 12@ Acetabular Inserts are identical in design. Additional testing has been performed on Crossfire™ versions of the System 12@ Acetabular Inserts to validate that these inserts are not adversely affected, with regard to locking strength or fatigue strength, as a result of the Crossfire™ process.

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510(k) Summary

Additional Crossfire™Acetabular Components Performance Data:

Crossfire polyethylene has been well characterized previously under 510(k) #K974685. Testing of the subject acetabular inserts, therefore, focused on the structural aspects of System 12 inserts assembled within Howmedica-design (e.g., Osteolock) acetabular shells.

The smallest insert size (P1) was assembled within metal backings and fatigue loaded. After 107 cycles, three inserts were axially distracted (pushed-out) and two were carefully removed by sectioning their metal shells. All inserts were inspected for signs of structural compromise with no gross evidence of impending catastrophic failure. Other surface features, e.g. screw hole impressions, were consistent with those observed in an earlier study used to originally qualify Osteonics-design Crossfire inserts. Axial distraction test results demonstrated sufficient locking strength pre-and post- fatigue testing.

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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 image of a bird with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1999

Ms. Elizabeth Staub ris. Birzabeen boaan
Vice President, Quality Assurance/Regulatory Affairs/Clinical Research Howmedica Osteonics Corporation 59 Route 17 07401-1677 Allendale, New Jersey

K993352 Re: Additional Crossfire™ Acetabular Components Trade Name: Regulatory Class: II Product Codes: LPH and JDI Dated: November 4, 1999 Received: November 8, 1999

Dear Ms. Staub:

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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 In addition, FDA may publish further announcements action. 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.

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Page 2 - Ms. Elizabeth Staub

This letter will allow you to beqin 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.

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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell J. Tayer

for James E. Dillard III Acting 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): K 993352

Device Name: Additional Crossfire™ Acetabular Components

Indications For Use:

noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, .
. rheumatoid arthritis,
. correction of functional deformity,
revision procedures where other treatments or devices have failed, and .
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with . head involvement that are unmanageable using other techniques.

The additional Crossfire™ Acetabular Inserts include the following devices:

System 12® Acetabular Inserts .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Russell Lozano SUTTO

Division Sign-Off Restorative Devices Division of Gene 79587 510(k) Number.

Prescription Use a (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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Wear Claims:

The Howmedica Osteonics Crossfire Polyethylene Acetabular Inserts, 2041C-2850, show a 90% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, and a 9,4mm bearing thickness. Testing was performed under multiaxial hip ioint simulation for 5 million cycles, using a 28mm CoCr articulating counterface and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

The Howmedica Osteonics Crossfire Polyethylene Acetabular Inserts, 2041C-2850, show an 88% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850, when evaluated following an accelerated aging cycle. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, a 9.4mm bearing thickness, and were aged under 80°C in air for 14 days. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface and a bovine calf serum lubricant. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

The Howmedica Osteonics Crossfire Polyethylene Acetabular Inserts, 2041C-2850, show a 78% reduction in gravimetric wear rate versus the same acetabular inserts fabricated from standard polyethylene, 2041-2850, when evaluated under abrasive wear conditions. These inserts mate with a 50mm acetabular shell, have a 10° elevated rim, a 28mm inner diameter, and a 9.4mm bearing thickness. Testing was performed under multiaxial hip joint simulation for 5 million cycles, using a 28mm CoCr articulating counterface, a bovine calf serum lubricant, and an abrasive media of bone cement particulate. The results of in vitro hip wear simulator tests have not been shown to quantitatively predict clinical wear performance.

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.