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 OPS™ Plan and compatible components. The dislocating Femoral Guide is intended for use with the posterolateral surgical approach and the in-site Ferrorel. 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 a preoperative plan (either OPS™ Plan (K171847, K183038) or OPS™ Insight (K192656)). OPS™ Plan and OPS™ Insight are pre-operative tools 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.

Corin OPS™ Femoral was originally cleared under K181061. The purpose of this submission is to include OPS™ Insight (K192656) to the Indications for Use as an alternative compatible component. The design and manufacturing process of the device subject of this submission is identical to that of the predicate device K181061.

OPS™ Plan was previously cleared under K171847 and K183038; OPS™ Insight (K192656) is currently under review with FDA. OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656) are not submitted for review in this 510k submission.

AI/ML Overview

The provided text describes a 510(k) summary for the Corin Optimized Positioning System (OPS) Femoral. A 510(k) submission is typically for demonstrating substantial equivalence to a predicate device, and it often does not require new clinical studies for acceptance criteria in the same way a Premarket Approval (PMA) would.

Based on the provided document, here's an analysis of the acceptance criteria and the study (or lack thereof) that supports the device meeting those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a tabled format, nor does it present specific performance metrics from a study that would directly map to such criteria for the current 510(k) submission. Instead, it refers to "non-clinical testing" for safety and effectiveness.

The closest we get to performance assessment is the statement in Section 13: "Testing verified that the accuracy and performance of the device is adequate to perform as intended."

Given the nature of this 510(k):

Acceptance Criteria (Implied): The device, Corin OPS™ Femoral, should exhibit sufficient "accuracy and performance" to assist in delivering a target femoral neck osteotomy, consistent with its intended use and equivalent to the predicate device (K181061). This implicitly means it should be able to guide the surgeon accurately and reliably for the pre-planned osteotomy. The non-clinical tests would have aimed to confirm this.
Reported Device Performance: The document only provides a qualitative summary: "Testing verified that the accuracy and performance of the device is adequate to perform as intended." No specific accuracy values (e.g., in mm or degrees) are reported in this summary. The testing included "quantitative assessments of clinical accuracy," but the results of these quantitative assessments are not provided here.

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

The document states in Section 14: "Clinical testing was not necessary for this Traditional 510(k)." This means there was no new clinical test set (i.e., patient data) generated for this specific submission with human subjects to evaluate the device's performance in a clinical setting.

The "non-clinical testing" mentioned in Section 13 would typically involve bench testing, mechanical tests, and potentially simulations, not patient data. Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size for a test set based on human data are not applicable to the studies supporting this 510(k). The validation of the device relies on its substantial equivalence to a previously cleared device for which clinical or performance data might have been presented in its original 510(k).

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

Since no new clinical test set with human patients was acquired for this 510(k) submission (as stated in Section 14), there is no information provided about experts establishing ground truth for such a test set.

For the non-clinical tests (e.g., accuracy of the guide), the "ground truth" would likely be established by engineering measurements against known specifications or designs, rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical test set with human data was used for direct evaluation in this 510(k) submission.

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

No. The document explicitly states that "Clinical testing was not necessary for this Traditional 510(k)." An MRMC study would be a type of clinical study involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

The device is described as a "patient-specific surgical instrument to assist the surgeon". It is a physical guide, not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance is not applicable. The core function relates to its physical accuracy and fit for guiding the osteotomy, which was assessed through "non-clinical testing."

7. The Type of Ground Truth Used

For the "quantitative assessments of clinical accuracy" during non-clinical testing (Section 13), the ground truth would likely refer to:

Design Specifications: The accuracy of the guide compared to the pre-operative plan's target osteotomy.
Physical Measurements: Using metrology tools to verify the dimensions and functional features of the manufactured surgical guides against the design.

It is not based on expert consensus, pathology, or outcomes data from human patients for this submission.

8. The Sample Size for the Training Set

The Corin OPS™ Femoral is a physical patient-specific instrument. It is not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning. The design and manufacturing process are validated, and the device's effectiveness is based on its physical accuracy and design principles, not on being trained on a dataset.

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

As explained in point 8, there is no "training set" for this device in the context of an AI/ML algorithm. The "ground truth" during its development would refer to engineering specifications, anatomical references from medical imaging (CT scans), and surgical principles validated through design controls and manufacturing processes.

Summary

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August 4, 2020

Corin USA % Martina Cecconi Regulatory and Clinical Affairs Team Leader Corin (Australia) 17 Bridge Street Sydney, 2073 Australia

Re: K193545

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: May 14, 2020 Received: May 15, 2020

Dear Martina Cecconi:

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K193545

Device Name

Corin Optimized Positioning System Femoral (Corin 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. 510(K) SUMMARY

	1. Applicant/Sponsor	Corin USA Limited
	Distributor:	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:	Crissy Tomarelli
		Regulatory and Quality Director - Australia
		Corin Australia
		0011 61 2 94977400
		crissy.tomarelli@coringroup.com
		Lucinda Gerber
		Global Regulatory Affairs Manager
		Corin USA Limited
		1 (772) 321-2478
		Lucinda.Gerber@coringroup.com

1. Date: July 14, 2020
1. Trade Name: Corin Optimized Positioning System (OPS™) Femoral
1. Common Name: OPS™ Femoral
1. Classification Product Code(s): LZO, LWJ, MEH, PBF

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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):

Primary predicate:

Corin Optimized Positioning System (OPS™) Femoral (K181061) .
Other predicates:
OPS™ Plan (K171847, K183038) and, ●
. OPS™ Insight (K192656)

10. Device Description:

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manufacturing process of the device subject of this submission is identical to that of the predicate device K181061.

11. Indications for Use / Intended Purpose:

The Corin OPS™ Femoral is intended to be used with OPS™ Insight, Corin OPS™ Plan and 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 OPS™ Femoral PSI is intended for single use only.

12. Summary of Technologies/Substantial Equivalence:

The Corin OPS™ Femoral is identical to the primary predicate device Corin OPS™ Femoral (K181061).

The subject device has similar intended uses and indications, 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.

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

The subject device works with predicate preoperative plans, OPS™ Plan (K171847, K183038) and OPS™ Insight (K192656)

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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 device. The differences between the device and its predicate device 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.