The Corin OPS™ Femoral is intended to be used as a patient-specific surgical instrument to assist the surgeon in delivering a target femoral neck osteotomy, based on a pre-operative plan with implant sizing, type and placement.

The Corin OPS™ Femoral is intended to be used with the Corin OPS™ Plan (K171847) and the compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-situ Femoral Guide is intended for use with the direct anterior surgical approach.

The Corin OPSTM Femoral PSI is intended for single use only.

Device Description

The Corin Optimized Positioning System (OPS™) Femoral consists of Femoral Patient Specific Instruments (PSI) and reusable instrumentation. The Femoral Patient Specific Instruments include a Femoral Guide and an optional Trial Femoral Head (Bone Model).

The Femoral Guide is shape-matched to the patient's femoral anatomy and provides a guide for the femoral neck osteotomy during total hip arthroplasty. The planned femoral resection, or target osteotomy, is defined by the previously cleared OPS™ Plan (K171847). The OPS™ Plan is a pre-operative tool used by the Surgeon for the selection, sizing and placement of implant components using anatomical landmarks of the femur and pelvis identified from pre-operative CT scan and AP X-ray. The OPS™ Plan was previously cleared under K171847 and is not submitted for review in this 510k submission.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and a study proving the device meets them in the format requested. The document is an FDA 510(k) clearance letter for the Corin Optimized Positioning System (OPS) Femoral. While it mentions non-clinical testing for accuracy and performance, it does not provide the specific metrics or the details of the study.

However, I can extract the information that is present and indicate where details are missing based on your request.

Missing Information:
The document does not provide:

A table of actual acceptance criteria values.
Specific reported device performance values against detailed criteria.
Sample size used for the test set.
Data provenance (country of origin, retrospective/prospective).
Number of experts, their qualifications, or adjudication method for ground truth establishment.
Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
Details on standalone algorithm performance.
Specific type of ground truth used (beyond "clinical accuracy").
Sample size for the training set.
Specifics on how ground truth for the training set was established.

Information Extracted from the Document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Quantitative Assessments of Clinical Accuracy:	"Testing verified that the accuracy and performance of the device is adequate to perform as intended." (Specific metrics and values are not provided in this document.)
Biocompatibility:	"Testing completed." (Specific metrics and values are not provided in this document.)
Dimensional Stability:	"Testing completed." (Specific metrics and values are not provided in this document.)
Packaging, Distribution, Cleaning, Sterilization Validation:	"Testing completed." (Specific metrics and values are not provided in this document.)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified.
Data Provenance: Not specified. The manufacturer (Optimized Ortho Pty Ltd) is based in Pymble NSW, Australia, which might suggest data could originate from Australia, but this is not confirmed. The document only mentions "Non-clinical testing was performed..." without detailing data sources.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document refers to "quantitative assessments of clinical accuracy" but does not detail the method of ground truth establishment or the involvement of experts.

4. Adjudication method for the test set:

Not specified.

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 specified. This document is for the "Corin Optimized Positioning System (OPS) Femoral", which is described as a patient-specific surgical instrument and planning system (OPS™ Plan). It does not explicitly involve an "AI" component in the context of diagnostic image analysis or human reader improvement, but rather an instrument to deliver a target osteotomy based on a pre-operative plan.

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

The device (OPS™ Femoral) is described as a "patient-specific surgical instrument" that assists a surgeon in delivering a target osteotomy based on a pre-operative plan generated by the "OPS™ Plan". This implies a "human-in-the-loop" system where the instrument guides the surgeon. A "standalone" performance for the instrument itself (without human interaction) would not be directly applicable in the same way as a diagnostic AI algorithm. The accuracy of the instrument in performing its guiding function was tested, but details are not provided.

7. The type of ground truth used:

The document mentions "quantitative assessments of clinical accuracy." This suggests a comparison against a reference standard or ideal measurement, but the specific nature of this ground truth (e.g., direct measurement, expert opinion, high-resolution imaging) is not detailed. It's implied to be related to the accuracy of the femoral neck osteotomy.

8. The sample size for the training set:

Not specified. The document does not mention a "training set" in the context of an algorithm that learns from data. The system uses pre-operative CT scans and AP X-rays to plan.

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

Not applicable as a "training set" for an algorithm, as traditionally understood, is not explicitly mentioned. The "OPS™ Plan" (K171847) is a pre-operative tool for implant selection, sizing, and placement based on anatomical landmarks. The details of its development and validation are outside the scope of this particular 510(k) summary (K181061).

Summary

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September 7, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Corin USA % Crissy Tomarelli Clinical, Regulatory and Quality Affairs Manager Corin (Australia) 17 Bridge Street Sydney, 2073 Australia

Re: K181061

Trade/Device Name: Corin Optimized Positioning System (OPS) Femoral 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, LWJ, MEH, PBF Dated: August 6, 2018 Received: August 8, 2018

Dear Ms. Tomarelli:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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Indications for Use

510(k) Number (if known) K181061

Device Name

Corin Optimized Positioning System (OPSTM) Femoral

Indications for Use (Describe)

The Corin OPSTM Femoral PSI is intended for single use only.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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1.	Applicant/SponsorDistributor:	Corin USA LimitedDistributor12750 Citrus Park LaneSuite 120Tampa, Florida 33625Establishment Registration No.: 1056629
2.	Manufacturer:	Optimized Ortho Pty Ltd17 Bridge StreetPymble NSW2073 AustraliaEstablishment Registration No: 3012916784
3.	Contact Person:	Crissy TomarelliClinical, Regulatory and Quality AffairsManagerCorin (Australia) Pty LimitedCrissy.Tomarelli@coringroup.comLucinda GerberGlobal Regulatory Affairs ManagerCorin USA Limited1 (772) 321-2478Lucinda.Gerber@coringroup.com

1. Date: April 20, 2018
1. Trade Name: Corin Optimized Positioning System (OPS™) Femoral
1. Common Name: OPS™ Femoral
1. Classification Product Code(s): LZO, LWJ, MEH

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8. Classification Name:

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

21 CFR 888.3030 - Orthopaedic Surgical Planning And Instrument Guides.

9. Substantially Equivalent (predicate) device(s):

. Corin Optimized Positioning System (OPS) (K152893)
. Stryker Triathlon Knee System (K141056)

10. Device Description:

11. Indications for Use / Intended Purpose:

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The Corin OPS™ Femoral PSI is intended for single use only.

12. Summary of Technologies/Substantial Equivalence:

Device comparison showed that the proposed device is substantially equivalent in intended use, technology, material and performance characteristics to the predicate devices.

13. Non-Clinical Testing:

Non-clinical testing was performed to assess the safety and effectiveness of the device.

Testing included quantitative assessments of clinical accuracy, biocompatibility and dimensional stability. Packaging, distribution, cleaning and sterilization validation of the OPS™ Femoral PSI was completed.

Testing verified that the accuracy and performance of the device is adequate to perform as intended.

14. Clinical Testing:

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

15. Conclusion:

The subject device has similar intended uses and indications, and technological characteristics, and material as its predicate devices. The differences between the device and its predicate devices raise no new issues in terms of safety or effectiveness.

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.