TRINITY ACETABULAR SYSTEM by CORIN U.S.A.

o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis o
o Correction of functional deformity
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o

The Trinity Acetabular System is intended for cementless use only.

Device Description

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset, EPW and 10° hooded designs) and a dedicated range of 28mm and 32mm modular 12/14 taper femoral heads providing ceramic (i.e., zirconia and Biolox delta in the USA) or metal on UHMWPE articulation for use in total hip replacement procedures using Corin titanium femoral stems with a 12/14 taper connection. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole.

The purpose of this submission is to modify the labeling for the Trinity Acetabular System to include additional Corin titanium femoral stems with a 12/14 taper connection as compatible components, intended for use with the Trinity Acetabular Cup and Liner and the Trinity CoCr Femoral Heads.

The Trinity Acetabular System is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

AI/ML Overview

The provided text describes a 510(k) submission for the Trinity Acetabular System, which proposes to modify the labeling to include additional Corin titanium femoral stems as compatible components. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically required for AI/ML device evaluations. This submission is for a medical device (hip prosthesis) and its expanded compatibility, not a diagnostic or prognostic AI system.

However, based on the provided text, I can infer the acceptance criteria and the study in the context of demonstrating substantial equivalence for this device modification.

Acceptance Criteria and Study for K103518: Trinity Acetabular System

Given that this is a 510(k) submission primarily focused on modifying the labeling of an existing device to include additional compatible components, the "acceptance criteria" revolve around demonstrating that the modified device (Trinity Acetabular System with new femoral stems) is substantially equivalent to the previously cleared Trinity Acetabular System.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (as demonstrated by comparison)
Intended Use	The device with the additional femoral stems maintains the same intended use as the predicate device.	The additional, compatible Corin titanium femoral stems have the same intended use as the previously cleared Tri-Fit femoral stems for the Trinity Acetabular System.
Materials	The materials of the additional femoral stems are comparable to the predicate device's compatible stems.	A comparison of materials was conducted between the additional, compatible Corin titanium femoral stems and the Corin Tri-Fit femoral stems, demonstrating substantial equivalence. (Specific details of material comparison are not provided beyond this statement).
Design	The design of the additional femoral stems is comparable to the predicate device's compatible stems.	A comparison of designs was conducted between the additional, compatible Corin titanium femoral stems and the Corin Tri-Fit femoral stems, demonstrating substantial equivalence. (Specific details of design comparison are not provided beyond this statement).
Taper Characteristics	The taper characteristics of the additional femoral stems are comparable to the predicate device's compatible stems.	A comparison of taper characteristics was conducted between the additional, compatible Corin titanium femoral stems and the Corin Tri-Fit femoral stems, demonstrating substantial equivalence.
Indications for Use	The device with the additional femoral stems maintains similar indications for use as the predicate device.	The additional, compatible Corin titanium femoral stems have similar indications as the previously cleared Tri-Fit femoral stems.
Range of Motion	The range of motion achieved with the additional femoral stems is equivalent to or greater than that of the predicate.	A range of motion study was conducted, showing that the ranges of motion achieved with the additional femoral stems are equivalent to or greater than those achieved with the Tri-Fit femoral stems.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not applicable in the context of a traditional "test set" for AI. The "test" for this device was a combination of direct comparisons of specifications and specific non-clinical evaluations. The document does not specify a "sample size" for the range of motion study, but it would involve a limited number of test configurations or specimens rather than a large patient dataset.
Data Provenance: The studies mentioned ("comparison of materials, designs and taper characteristics" and "range of motion study") are non-clinical tests. This means they were likely conducted in a laboratory setting (e.g., in vitro, cadaveric, or simulation) rather than using patient data. The country of origin for the data is not explicitly stated but would presumably be associated with the manufacturer's R&D facilities.

3. Number of Experts and Qualifications for Ground Truth

Experts: Not applicable. The "ground truth" for this submission is established through engineering specifications, material science principles, and biomechanical testing standards, rather than expert clinical consensus on patient data.
Qualifications: N/A

4. Adjudication Method for Test Set

Adjudication Method: Not applicable in the traditional sense for AI/ML performance. The "adjudication" for substantial equivalence would be performed by the FDA based on the submitted non-clinical test reports and comparisons.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. This is not an AI/ML diagnostic or image analysis device, so a MRMC study is irrelevant to this submission.

6. Standalone (Algorithm Only) Performance

Standalone Performance: No. This is a physical medical device (hip prosthesis components), not a software algorithm.

7. Type of Ground Truth Used

Ground Truth: The "ground truth" for this submission is based on:
- Engineering specifications and material properties for component comparisons (materials, design, taper characteristics).
- Biomechanical performance standards and measurements from the range of motion study.
- The predicate device's established safety and effectiveness as the benchmark for substantial equivalence.

8. Sample Size for Training Set

Sample Size: Not applicable. There is no "training set" as this is not an AI/ML device. The development of the components would involve engineering design and iterative testing, but not machine learning training.

9. How Ground Truth for Training Set Was Established

Ground Truth Establishment: Not applicable. There is no "training set" for ground truth establishment.

Summary

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K103518 (pg 1/3)

	3. 510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA10500 University Center DriveSuite 190Tampa, Florida 33612Establishment Registration No.:	MAR - 9
2. Contact Person:	Lucinda Gerber, BA (Hons)Regulatory Affairs AssociateCorin USA813-977-4469lucinda.gerber@coringroup.com
3. Proprietary Name:	Trinity Acetabular System
4. Common Name:	Hip Prosthesis
5. Classification Name:	Hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (21CFR 888.3353)
6. Legally Marketed Devices to which Substantial Equivalence is claimed:	- Corin Trinity Acetabular System (K093472)
	- Corin Metafix Femoral Stem (K082525)

■ Corin MiniHip Femoral Stem (K083312)

7. Device Description:

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1. Intended Use / Indications:
  The indications for the Trinity Acetabular System as a total hip arthroplasty include:
Non-inflammatory degenerative joint disease including osteoarthritis and . avascular necrosis
트 Rheumatoid arthritis
Correction of functional deformity 트
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip 메 (CDH)

The Trinity Acetabular System is intended for cementless use only.

1. Summary of Technologies/Substantial Equivalence:
  The additional, compatible Corin titanium femoral stems with a 12/14 taper connection have the same intended use and material and similar indications and designs as the Tri-Fit femoral stems that were previously cleared for use with the Trinity Acetabular System. Based on these similarities, the Trinity Acetabular System with modified labeling is believed to be substantially equivalent to the previously cleared Trinity Acetabular System.
1. Non-Clinical Testing:
  A comparison of materials, designs and taper characteristics between the additional, compatible Corin titanium femoral stems with a 12/14 taper connection and the Corin Tri-Fit femoral stems was conducted to demonstrate substantial equivalence of the Trinity Acetabular System, labeled for use with the additional femoral stems, to the previously cleared Trinity Acetabular System. In addition, a range of motion study was conducted to show that the ranges of motion achieved with the additional femoral stems are equivalent to or greater than those achieved with the Tri-Fit femoral stems.

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11. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Trinity Acetabular System with modified labeling to the originally cleared Trinity Acetabular System.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Corin U.S.A. % Lucinda Gerber, BA (Hons) Regulatory Affairs Associate 10500 University Center Dr., Suite 190 Tampa, Florida 33612

MAR - 9 2011

Re: K103518

Trade/Device Name: Trinity Acetabular System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: MEH, LZO, LWJ Dated: February 2, 2011 Received: February 3, 2011

Dear Ms. Gerber:

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. Please note: CDRH 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 (sce 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.

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Page - 2 - Ms. Lucinda Gerber

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Mark N. Melkerson

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

Enclosure

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2. INDICATIONS FOR USE

510(k) Number (if known): K103518Lpg|/1)

Device Name: Trinity Acetabular System

Indications for Use:

The indications for the Trinity Acetabular System as a total hip arthroplasty include:

o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis o
o Correction of functional deformity
Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o

The Trinity Acetabular System is intended for cementless use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Ar. m. Melkerson

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

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K103518

510(k) Number

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.