1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
1. Rheumatoid Arthritis
1. Correction of functional deformity
1. Revision of previously failed total hip arthroplasty,
1. Patients at increased risk of dislocation
1. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

Device Description

The Trinity™ Dual Mobility System is a modular system consisting of two articulating surfaces in the same joint space. The system includes a highly polished Cobalt Chromium Alloy (CoCr) liner that articulates with an ECiMa™ (Vitamin E Ultra-High-Molecular-Weight Polyethylene) mobile insert. A Trinity™ femoral head, 22mm or 28mm CoCr or 28mm BIOLOX® delta heads, articulates within the ECiMa™ mobile insert to allow for a second articulation. The Trinity™ Dual Mobility System is intended to be used only with compatible Trinity™ acetabular Shells. The Trinity™ Dual Mobility System is designed for use with any Corin femoral stem with a 12/14 taper connection. The Trinity™ Dual Mobility System is intended for use in primary and revision total hip arthroplasty (THA) to provide increased stability and reduce pain by replacing the hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
28mm CoCr heads (K110087, K131647) .
. 28mm BIOLOX® delta Ceramic Heads (K103120)

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Trinity Dual Mobility System," which is a hip prosthesis. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy in a de novo manner. Therefore, the information provided does not detail an acceptance criteria table or a study proving the device meets an algorithm's acceptance criteria in the way one might expect for a digital health or AI-driven device.

Based on the provided text, here's an analysis of the "acceptance criteria" and "study" that relate to this medical device:

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

The document does not present a formal table of acceptance criteria with specific numerical targets for performance in the context of an algorithm or diagnostic accuracy. Instead, the "acceptance criteria" for this device's FDA clearance revolved around demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

The acceptance criteria are implied by the types of non-clinical tests performed and their successful outcomes, which showed the device is "expected to be safe and effective."

Acceptance Criteria Category (Implied)	Reported Device Performance / Evaluation Method
Material Biocompatibility	Pyrogenicity Assessment: Bacterial endotoxin testing was conducted and met expected endotoxin limits.
Mechanical Strength & Stability	Non-Clinical Testing: This included static tests (Push-out, lever-out, torque-off) and dynamic tests (Impingement, corrosion, range of motion, and wear). The results demonstrated that the Trinity™ Dual Mobility System is "expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Specific numerical results of these tests are not provided in this summary but would have been part of the full 510(k) submission.
Substantial Equivalence	Comparison to Predicate Devices: The Trinity™ Dual Mobility System was found to be "similar to the predicate devices (K110087, K111481, K150522 and K103233) in terms of intended use and indications, materials, sizes, design and testing."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

For this type of device (hip prosthesis), the "test set" refers to the physical prototypes and materials subjected to non-clinical mechanical and biological testing.

Sample Size: The document does not specify the exact sample size for each non-clinical test (e.g., how many liners were subjected to wear testing or how many components to push-out tests). This level of detail is typically found in the full test reports, not the 510(k) summary.
Data Provenance: The tests were conducted to evaluate the device itself. There's no "country of origin for data" in the sense of patient data. The tests would have been performed in a laboratory setting, likely in the country of manufacture or a certified testing facility.

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):

This question is not applicable to a physical medical device like a hip prosthesis in the context of its 510(k) submission for substantial equivalence. "Ground truth" and "experts" in this sense typically refer to the validation of diagnostic accuracy for software or imaging devices. For this device, standard engineering and materials science testing methods are used, and the "ground truth" is established by adherence to recognized ASTM or ISO testing standards. The experts involved would be qualified engineers and scientists in fields such as mechanical engineering, materials science, and biocompatibility testing. Their qualifications are not specified in this summary.

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

Not applicable. Adjudication methods like "2+1" are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies. The non-clinical tests for this device involve objective measurements against predetermined acceptance limits based on engineering standards.

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 associated with the evaluation of diagnostic performance for imaging systems or AI algorithms where human interpretation plays a role. This document concerns a physical implant.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the non-clinical testing of this device is established by:

Engineering Standards: Compliance with industry-recognized ASTM, ISO, or other relevant standards for mechanical strength, wear, corrosion, and material properties.
Predicate Device Performance: The performance characteristics of the legally marketed predicate devices serve as an established baseline that the new device must meet or exceed to demonstrate substantial equivalence.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical hip prosthesis device or its 510(k) clearance process. This terminology applies to machine learning algorithms.

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

Not applicable. As there is no training set, there is no ground truth for it.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the U.S. Department of Health & Human Services, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to it.

October 31, 2017

Corin USA Limited Lucinda Gerber Global Regulatory Affairs Manager 5670 W Cypress Street, Suite C Tampa, Florida 33607

Re: K170359

Trade/Device Name: Trinity Dual Mobility 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: LZO, MEH Dated: September 28, 2017 Received: September 29, 2017

Dear Lucinda 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 (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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free 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" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K170359

Device Name Trinity™ Dual Mobility System

Indications for Use (Describe) The Trinity™ Dual Mobility System is intended for use in the following indications:

1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis
1. Rheumatoid Arthritis
1. Correction of functional deformity
1. Revision of previously failed total hip arthroplasty,
1. Patients at increased risk of dislocation
1. Developmental dysplasia of the hip (DDH)

The TrinityTM Dual Mobility System is indicated for cementless use only.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

3. 510(k) SUMMARY

1. Applicant/Sponsor:	Corin USA12750 Citrus Park LaneSuite 120Tampa, Florida 33625Establishment Registration No.: 1056629
2. Contact Person:	Lucinda Gerber, BA (Hons)Global Regulatory Affairs ManagerCorin Ltd / Corin USA1 (772) 321-2478lucinda.gerber@coringroup.com
3. Date:	February 2, 2017
4. Proprietary Name:	Trinity™ Dual Mobility System
5. Common Name:	Hip Prosthesis
6. Product Code(s):	LZO, MEH
7. Classification Name:	888.3353 - Hip joint metal/ceramic/ polymer semi-constrained cemented orNonporous uncemented prosthesis

8. Legally Marketed Devices to which Substantial Equivalence is claimed:

Stryker MDM™ (K103233) .
Zimmer Biomet G7 Dual Mobility System (K150522) ●
Corin Trinity Acetabular System (K110087, K111481, K131647) .

9. Device Description:

The Trinity™ Dual Mobility System is intended to be used with the following approved devices:

Trinity™ Acetabular Shells (Sizes 2- 5) (K093472, K123705, K122305, K130128) .
28mm CoCr heads (K110087, K131647) .
. 28mm BIOLOX® delta Ceramic Heads (K103120)

{4}------------------------------------------------

10. Intended Use / Indications:

The Trinity™ Dual Mobility system is intended for use in the following indications:

1. Non-inflammatory degenerative joint disease, including osteoarthritis & avascular necrosis,
Rheumatoid Arthritis, 2.
1. Correction of functional deformity,
1. Revision of previously failed total hip arthroplasty,
Patients at increased risk of dislocation, 5.
1. Developmental dysplasia of the hip (DDH),

The TrinityTM Dual Mobility System is indicated for cementless use only.

11. Summary of Technologies/Substantial Equivalence:

The Trinity™ Dual Mobility System is similar to the predicate devices (K110087, K111481, K150522 and K103233) in terms of intended use and indications, materials, sizes, design and testing. Based on these similarities, the Trinity™ Dual Mobility System is believed to be substantially equivalent to the predicate devices.

12. Pyrogenicity Assessment:

Bacterial endotoxin testing was conducted and was found to meet the expected endotoxin limits.

13. Non-Clinical Testing:

Non-clinical testing conducted to demonstrate substantial equivalence includes static tests (Push-out, lever-out, torque-off) and Dynamic Tests (Impingement, corrosion, range of motion, and wear). The results of this testing show that the Trinity™ Dual Mobility System is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.

14. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Trinity™ Dual Mobility System and the predicate devices.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.