The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

Device Description

The ICONACY I-Hip System consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross linked ultrahigh molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMVPE liner. Standard instrumentation is used to implant the device.

The current submission adds angled face, lateralized and extended wall acetabular liners and an apex hole plug to the I-Hip Total Hip System. The compatible femoral heads, acetabular cups, locking rings and bone screws were cleared in K121034. Additional compatible acctabular cups and locking rings were cleared in K131279.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the ICONACY™ I-Hip™ System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through clinical or standalone performance studies like those common for AI/ML-enabled devices.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable to this document. The device is a total hip system, which is a physical implant, not an AI/ML-enabled device or software.

Here's a breakdown of what can be extracted and what is not relevant:

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

Not Applicable. This document does not describe specific numerical acceptance criteria typical for AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The only performance data explicitly mentioned is:
- "Range of motion analyses were completed for the acetabular liners to ensure that adequate range of motion was maintained."
- "Characterization and biocompatibility data for color additives is provided in a Master File."
- No specific quantitative results from these analyses are provided 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. No test set in the context of AI/ML evaluation is mentioned or performed. The demonstration of substantial equivalence is based on design, materials, function, and indications for use compared to predicate devices.

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" establishment in the context of an AI/ML test set mentioned.

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

Not Applicable. No test set or adjudication method is described.

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. MRMC studies are relevant for evaluating AI-assisted diagnostic tools. This device is a physical orthopedic implant.

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. Ground truth in the context of AI/ML validation is not applicable here.

8. The sample size for the training set

Not Applicable. There is no AI/ML model, hence no training set.

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

Not Applicable. No training set or ground truth for it exists in this submission.

Summary of Device Acceptance and Study:

The ICONACY™ I-Hip™ System met the criteria for substantial equivalence to its predicate device (ICONACY I-Hip Total Hip System, K121034) by demonstrating similarities in design, materials, function, and indications for use.

Acceptance Criteria (for regulatory clearance): Substantial Equivalence to a legally marketed predicate device.
Study Proving Acceptance: The regulatory submission (510(k)) itself, which included comparisons of the device's characteristics to the predicate.
Performance Data Mentioned:
- Range of motion analyses for acetabular liners to ensure adequate range of motion.
- Characterization and biocompatibility data for color additives (referenced in a Master File).
Clinical Testing: Explicitly stated as "Clinical testing was not required for determining substantial equivalence with the predicate devices."

In essence, the "study" for this type of device clearance is a comparative analysis against a predicate device based on technical specifications and existing regulatory precedents, not a performance study in the same vein as those for AI/ML-enabled devices.

Summary

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K132572 page 1 of 2

510(k) Summary
PREPARED:	September 10, 2013
510(k) SPONSOR:	ICONACY Orthopedic Implants, LLC4130 Corridor DriveWarsaw, IN 46582
CONTACT PERSON:	Marc E. RuhlingDirector of Development, Hips & Shoulders(574) 269-4266 or (574) 549-7710FAX: (866) 685-8226MRuhling@iconacy.com
TRADE NAME:	ICONACY™ I-Hip™ System
COMMON NAMES:	Total Hip System
CLASSIFICATIONand CLASS:	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesis ( 21 CFR Section 888.3358, Class II)
PRODUCT CODES:	LPH
PREDICATE DEVICE:	ICONACY I-Hip Total Hip System, K121034

DEVICE DESCRIPTION: The ICONACY I-Hip System consists of a collarless, tapered, forged titanium alloy femoral stem mated to a cobalt chrome alloy modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispherical titanium alloy cup (i.e., shell) coupled with a highly cross linked ultrahigh molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press-fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press-fit fixation. A titanium locking ring is fixed into grooves on the cup to engage grooves on the HXL-UHMVPE liner. Standard instrumentation is used to implant the device.

The current submission adds angled face, lateralized and extended wall acetabular liners and an apex hole plug to the I-Hip Total Hip System. The compatible femoral heads, acetabular

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cups, locking rings and bone screws were cleared in K121034. Additional compatible acctabular cups and locking rings were cleared in K131279.

INDICATIONS FOR USE: The ICONACY I-Hip System is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip System consists of femoral stem and acerabular cup (i.e. shill) porous coated components intended for cementless, press-fit fixation.

BASIS FOR SUBSTANTIAL EQUIVALENCE: The additional components of the ICONACY I-Hip Total Hip System are substantially equivalent to the components cleared in K121034 based on similarities in design, materials, function and indications for use.

PERFORMANCE DATA: Range of motion analyses were completed for the acetabular liners to ensure that adequate range of motion was maintained. Characterization and biocompatibility data for color additives is provided in a Master File, which is referenced in the submission.

CLINICAL TESTING: Clinical testing was not required for determining substantial equivalence with the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2014

Iconacy Orthopedic Implants, LLC Mr. Marc E. Ruhling Director of Development. Hips & Shoulders 4130 Corridor Drive Warsaw, Indiana 46582

Re: K132572

Trade/Device Name: Iconacy I-Hip Total Hip System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/mctal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: February 14. 2014 Received: February 18, 2014

Dear Mr. Ruhling:

We have reviewed your Scction 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 10 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 adultcration. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse cvents) (21 CFR 803); good manufacturing practice requirements as sct

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Page 2 - Mr. Marc E. Ruhling

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiqqins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K132572 page 1 of 1

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Iconacy I-Hip Total Hip System

Indications for Use:

The ICONACY I-Hip System consists of femoral stem and acetabular cup (i.e. shell) porous coated components intended for cementless, press-fit fixation.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabet顾莎rank -S

Page 1 of 1

Division of Orthopedic Devices

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.