The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for pre-operative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.

The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.

Device Description

The Corin Optimized Positioning System™ Plan (OPS™ Plan) is a pre-operative templating tool to assist the Surgeon in the planning of primary total hip arthroplasty using any Corin femoral stem. The Corin OPS™ Plan assists in selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray. The OPS™ Plan report is a static report which displays the selection (for example, lateralised or standard stem), sizing and placement of implant components.

The Corin OPS™ Plan process begins with booking the OPS case to final release of the OPS Plan Report. OPS™ case booking details and required CT and X-ray imaging in DICOM format are electronically transferred to the manufacturer via the online end-user interface, the OPS™ Portal. Image processing is completed by an OPS™ Simulation Engineer with results of the OPS™ analysis provided in the OPS™ Plan Report. The Surgeon does not actively interact with the image processing, implant positioning and/or report generation. Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results.

AI/ML Overview

The provided text describes the Corin Optimized Positioning System (OPS™) Plan, which is a pre-operative templating tool for primary total hip arthroplasty. Here's a breakdown of the acceptance criteria and the study information based on the provided document:

Acceptance Criteria and Device Performance for Corin Optimized Positioning System (OPS™) Plan

The document does not explicitly state numerical acceptance criteria in a table format. However, it outlines the general performance aspects that were tested.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly Derived)	Reported Device Performance/Conclusion
Accuracy	Ability to produce accurate implant selection, sizing, and placement of components.	"Testing verified that the accuracy and performance of the system is adequate to perform as intended." The system uses CT scans for 3D patient-specific bone models and X-ray imaging for bony landmarks to achieve this.
Repeatability	Consistency of results when the same inputs are processed multiple times.	"Testing verified that the accuracy and performance of the system is adequate to perform as intended."
Reproducibility	Consistency of results when different operators or conditions produce the outputs.	"Testing verified that the accuracy and performance of the system is adequate to perform as intended."
Usability	Ease of use and effectiveness of the OPS™ Plan provided to the Surgeon.	"Testing...demonstrate...the usability of the OPS™ Plan that is provided to the Surgeon." No specific metrics are given, but implies it was found acceptable.
Safety & Effectiveness	No new issues in terms of safety or effectiveness compared to the predicate device.	"The differences between the device and its predicate device raise no new issues in terms of safety or effectiveness."

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

Sample Size: The document does not specify the sample size (number of cases or patients) used for the non-clinical testing.
Data Provenance: Not explicitly stated. The manufacturer, Optimized Ortho Pty Ltd, is located in Pymble NSW, Australia, suggesting the data may originate from Australia or other regions where Corin operates. The document only mentions "patient imaging in DICOM format are electronically transferred to the manufacturer." It does not specify if these were retrospective or prospective studies.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the non-clinical testing. The process described for generating the OPS™ Plan states that "Image processing is completed by an OPS™ Simulation Engineer," and "Final acceptance of the OPS™ Plan by the Surgeon is confirmed following any modifications or clarifications of the reported results." This implies a Surgeon's clinical judgment is the ultimate arbiter, but detailed information about their role in establishing ground truth for testing is missing.

4. Adjudication Method for the Test Set

The document does not mention a formal adjudication method (e.g., 2+1, 3+1). The process involves an "OPS™ Simulation Engineer" generating the plan and the "Surgeon" confirming final acceptance. For testing purposes, the method by which ground truth was definitively established from multiple expert opinions is not detailed.

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

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not necessary for this Traditional 510(k)." The testing described is "Non-Clinical testing."

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

The device is described as a "pre-operative templating tool" where "Image processing is completed by an OPS™ Simulation Engineer," and the "Surgeon does not actively interact with the image processing, implant positioning and/or report generation." This indicates a human (the OPS™ Simulation Engineer) is in the loop during the generation of the plan. Therefore, a purely standalone algorithm evaluation without human interaction is not explicitly described or implied for the final output generation. However, the "accuracy, repeatability and reproducibility" testing could have involved testing specific algorithmic components in a standalone manner, but the overall system performance evaluated includes human involvement.

7. The Type of Ground Truth Used

The type of ground truth used for non-clinical testing is implied to be based on established anatomical landmarks and surgical planning principles, likely validated by expert surgical opinion or established surgical methodology. The document mentions "selection (for example, lateralised or standard stem), sizing and placement of implant components (stem, head, cup) using anatomical landmarks of the femur and pelvis obtained from pre-operative CT scan and AP X-ray." However, it does not explicitly state whether this involved pathology, outcomes data, or a formal expert consensus process as the ground truth standard for the testing.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how ground truth was established for a training set. Given that it's a 510(k) submission not requiring clinical trials, and the process involves human engineers and surgeon confirmation, it's possible that a formal machine learning training set with expert-labeled ground truth in the typical sense was not explicitly detailed or a primary focus of the submission documentation provided.

Summary

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April 5, 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Corin USA Limited % Ms. Martina Cecconi Regulatory and Clinical Affairs Team Leader 12750 Citrus Park Lane, Suite 120 TAMPA FL 33625

Re: K171847

Trade/Device Name: Corin Optimized Positioning System (OPSTM) Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, LZO, MEH Dated: March 20, 2018 Received: March 22, 2018

Dear Ms. Cecconi:

We have reviewed vour 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.

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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.

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,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171847

Device Name Corin Optimized Positioning System (OPS™) Plan

Indications for Use (Describe)

The Corin OPS™ Plan is intended to be used with the Corin TriFit TS (K121563, K153772), MetaFix (K082525, K121439, K131952, K153381), TaperFit (K142761, K153725), MiniHip (K083312, K11046, K131986) Femoral Hip Stems.

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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3.2 510(K) SUMMARY

1. Applicant/Sponsor:	Corin USA Limited
Distributor	12750 Citrus Park Lane
	Suite 120
	Tampa, Florida 33625
	Establishment Registration No.: 1056629
2. Manufacturer:	Optimized Ortho Pty Ltd
	17 Bridge Street
	Pymble NSW
	2073 Australia
	Establishment Registration No: 3012916784
3. Contact Person:	Martina Cecconi
	Regulatory and Clinical Affairs Team Leader
	Corin Australia
	011 61 2 94977400
	Martina.Cecconi@coringroup.com
	Lucinda Gerber
	Global Regulatory Affairs Manager
	Corin USA Limited
	1 (772) 321-2478
	Lucinda.Gerber@coringroup.com
4. Date:	March 20, 2018
5. Trade Name:	Corin Optimized Positioning System (OPSTM) Plan
6. Common Name:	Image Processing Software
7. Classification Product Code(s):	LLZ

Additional Product Code(s): LZO, MEH

1. Classification Name: 21 CFR 892.2050 Picture archiving and communications

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Additional Classification Names:

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

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

. ZedView (K133022)

10. Device Description:

11. Indications for Use / Intended Purpose:

The Corin Optimized Positioning System Plan (OPS™ Plan) is indicated for preoperative planning for primary total hip arthroplasty. OPS™ Plan is intended to be used as a pre-operative tool to assist the Surgeon in the selection (for example, lateralised or standard stem), sizing and positioning of components of primary total hip arthroplasty.

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Summary of Technologies/Substantial Equivalence: 12.

The device comparison showed that the subject device is substantially equivalent to the predicate in that both have similar indications for use as a pre-operative surgical planning tool for total hip replacement. The subject device and predicate device have similar technological characteristics and principles of operation with both utilizing CT scans to generate 3D patient specific bone models which enables 3D implant templating for surgical planning and X-ray imaging to identify boney landmarks. The subject device differs from the predicate in that the Surgeon cannot actively generate, alter or change the surgical pre-plan and must communicate any desired changes to the manufacturer so that the OPS™ Simulation Engineer and make the requested changes to the pre-operative plan. The final end user in both the subject and predicate devices is the Surgeon. The subject device is used for total hip replacement while the predicate can be used for pre-operative planning for both total hip and total knee replacement.

13. Non-Clinical Testing:

Non-clinical testing was performed to assess the safety and effectiveness of the device, to demonstrate the processing of patient imaging to produce accurate, repeatable and reproducible implant selection, sizing and placement of components, and the usability of the OPS™ Plan that is provided to the Surgeon. Testing verified that the accuracy and performance of the system 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 principles of operation as its predicate device. The differences between the device and its predicate device raise no new issues in terms of safety or effectiveness.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).