The Corin Optimized Positioning System (OPS) is intended to be used as patient-specific surgical instrument to assist in the alignment of components during total hip arthroplasty. The Corin OPS is intended to assist in the orientation of the acetabular cup intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative X- rays and CT imaging scans.

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single use only.

Device Description

The Corin Optimized Positioning System (OPS) consists of software and hardware components to assist the surgeon in the alignment of components during Total Hip Arthroplasty.

The software component assists the surgeon in determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report.

The hardware components assist the surgeon in delivering the target orientation through the use of a Patient Specific Guide and bone model (replica of the patient's acetabulum, into which the guide fits), and associated reusable instrumentation.

The Corin OPS can be used with the Trinity Acetabular System and the respective compatible components.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Corin Optimized Positioning System (OPS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Study Type
Biocompatibility	Raw material biocompatibility performed according to ISO 10993.	Non-clinical testing
Mechanical Performance (Patient Specific Guides)	Able to withstand conditions during storage, shipping, distribution, and normal use. No damage or fracture in drop testing. Satisfactory flexural creep. (Specific quantitative metrics not provided)	Non-clinical testing
Cleaning and Sterilization (Patient Specific Guides & Reusable Instruments)	Validated.	Non-clinical testing
Packaging and Shelf Life (Patient Specific Guides)	Validated.	Non-clinical testing
Software Verification and Validation	Completed in accordance with FDA guidance ("General Principles of Software Validation; Final Guidance for Industry and FDA Staff" and "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices").	Non-clinical testing
Repeatability (Intra-observer variability) of System Performance	Verified adequate to perform as intended.	Cadaver study
Reproducibility (Inter-observer variability) of System Performance	Verified adequate to perform as intended.	Cadaver study
System Accuracy of Implanted Cup Orientation Relative to Pre-operative Plan	Verified adequate to perform as intended.	Cadaver study
Reproducibility and Repeatability of FHA software module and acetabular guide design (processed by multiple operators)	Verified.	Non-clinical testing (specific details of this test, if separate from the cadaver study, are not given)

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

The text explicitly mentions a cadaver study for device performance verification. However, it does not specify the sample size (i.e., number of cadavers) used. The data provenance is implied to be a laboratory setting (cadaver study). No information is given about the country of origin. The study was conducted retrospectively or prospectively on cadavers for device verification.

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

The text does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver study. It states that the study measured "repeatability (intra-observer variability) and reproducibility (inter-observer variability) of the system," which suggests that multiple individuals (likely experts like surgeons or trained technicians) performed measurements to assess variability, but their specific roles in establishing a definitive "ground truth" for the test set are not detailed in the provided summary.

4. Adjudication Method for the Test Set

The text does not explicitly state an adjudication method (e.g., 2+1, 3+1, none). The mention of "repeatability (intra-observer variability) and reproducibility (inter-observer variability)" suggests a comparison among observers' measurements, but how discrepancies or a final "ground truth" were resolved is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not necessary for this Traditional 510(k)." The described studies focus on the device's technical performance and accuracy, not its comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the algorithm (software component) was done. The text says:

"Software verification and validation was completed in accordance with FDA guidance..."
"Testing was also performed to verify that the FHA software module and acetabular quide design is reproducible and repeatable when processed by multiple operators."
The system itself is described as assisting in "determining a patient specific target orientation for the acetabular cup through a pre-operative patient specific analysis and two patient specific reports: Functional Hip Analysis (FHA) report and Patient Specific Visualisation (PSV) report." This implies the software's ability to generate these outputs on its own.

7. The Type of Ground Truth Used

For the cadaver study, the ground truth was based on the accuracy of the implanted cup orientation relative to the pre-operative plan. This implies that a pre-operative plan (generated by the device's software) served as the target, and the actual physical implantation in the cadaver was measured against this plan. The details of how this "actual" implantation was precisely measured and considered the "ground truth" are not expanded upon (e.g., whether it was through high-precision imaging, direct measurement, etc.).

For the software validation, the ground truth would typically be established through predefined specifications, expected outputs, and comparison against known correct computations or reference data.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific "training set" or its size. This device's purpose (patient-specific surgical instrument based on pre-operative scans) suggests it might not rely on a conventional machine learning model that requires a distinct training/validation/test split of patient data in the typical sense. Instead, its software likely employs computational geometry and image processing algorithms.

If there was an underlying machine learning component used to develop parts of the software (e.g., for automated anatomical landmark identification), this information is not disclosed in the summary.

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

Since no training set information is provided, the method for establishing its ground truth is also not available in this document.

Summary

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

June 3, 2016

CORIN USA Kathy Trier, Ph.D. Global VP Regulatory and Clinical Affairs 5670 West Cypress Street, Suite C Tampa, Florida 33607

Re: K152893 Trade/Device Name: Corin Optimized Positioning System (OPS) 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, LWJ Dated: April 26, 2016 Received: April 27, 2016

Dear Dr. Trier:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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" (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 Industry and Consumer Education 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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic 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): _K152893

Device Name: Corin Optimized Positioning System (OPS)

Indications for Use:

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single 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)

Page 1 of 1

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2. 510(K) SUMMARY

1. Applicant/Sponsor:Distributor	Corin USA5670 W. CypressStreet Suite CTampa, Florida 33607Establishment Registration No.: 1056629
2. Manufacturer:	Optimized Ortho Pty Ltd17 Bridge StreetPymble NSW 2073AustraliaEstablishment Registration No: None
3. Contact Person:	Kathy TrierGlobal VP Regulatory and Clinical AffairsCorin USA(813) 302-9604Kathy.Trier@coringroup.comDiana Nader-MartoneRegulatory Affairs AssociateCorin USA813-977-4469Diana.nader-martone@coringroup.com
4. Date:	April 21st 2016
5. Proprietary Name:	Corin Optimized Positioning System (OPS)
6. Common Name:	Hip Prosthesis
7. Product Code(s):	LZO, MEH, LWJ

8. Classification Name:

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

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

· Materialise N.V. Signature™ Personalized Patient Care System (K111863)
Corin Trinity Acetabular System (K093472, K110087, K111481, K122305, K123705, K130128, K130343, K131647)
· Corin Instrument 510(k) Exempt (Product Code KIL)
Reference Predicate Device Medacta Pedicle Screw Placement Guides (K132788)

10. Device Description:

The Corin Optimized Positioning System (OPS) consists of software and hardware components to assist the surgeon in the alignment of components during Total Hip Arthroplasty.

The Corin OPS can be used with the Trinity Acetabular System and the respective compatible components.

11. Intended Use / Indications:

The Optimized Positioning System including the Patient Specific Guides is intended for use with the Corin Trinity Acetabular System (K093472, K111481, K122305, K123705, K130128, K130343 and K131647) for total hip arthroplasty.

The Corin Optimized Positioning System is intended for use with the Direct Anterior or Posterolateral surgical approaches.

The Patient Specific Guides are intended for single use only.

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12. Non-Clinical Testing:

Non-clinical testing was performed to assess the safety and effectiveness of the device. Testing included biocompatibility testing of the raw material performed by the raw material supplier according to ISO 10993. Mechanical and performance testing was also performed on the Patient Specific Guides to ensure that the devices are able to withstand the conditions that may be encountered during storage, shipping, distribution and normal use including drop testing for damage or fracture, flexural creep, cleaning and sterilization, packaging and shelf life validation. A cadaver study was performed to measure the repeatability (intra-observer variability) and reproducibility (inter-observer variability) of the system to verify the performance of the system was adequate to perform as intended and to assure the system accuracy of implanted cup orientation relative to the pre-operative plan. Software verification and validation was completed in accordance with FDA guidance including General Principles of Software Validation; Final Guidance for Industry and FDA Staff and Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices. Testing was also performed to verify that the FHA software module and acetabular quide design is reproducible and repeatable when processed by multiple operators. Cleaning and sterilization validation of the re-usable instruments was completed. Testing verified that the accuracy and performance of the device is adequate to perform as intended.

13. Clinical Testing:

Clinical testing was not necessary for this Traditional 510(k).

14. Summary of Technologies/Substantial Equivalence:

Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to 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.