The indications for the Corin Metalix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis
· Correction of functional deformity
· Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
· Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)
The Corin Metafix Hip Stem is intended for cementless, single use only.

Device Description

The Metafix Hip is a tapered stem manufactured from titanium (Ti6Al4V) with a layer of hydroxyapatite (HA) Coating applied. The Metafix™ Hip is available in a 135° standard offset (collared and collarless), 135° lateralized high offset (collarless), a 125° standard offset (collared and collarless), a 125° short neck (collared) and a 135° short neck (collared). The device is intended to be used with 12/14 modular taper heads.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Corin Metafix Hip Stem. It's an FDA submission, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

The document discusses the device's intended use, indications, and claims of substantial equivalence to previously marketed predicate devices. It mentions that non-clinical mechanical fatigue testing and range of motion analysis were performed, but no clinical testing was deemed necessary to establish substantial equivalence.

Here's a breakdown of why this document cannot provide the requested information:

Acceptance Criteria & Reported Performance: These are typically quantitative metrics set for a medical device's performance, often established in clinical trials or specific engineering tests. This document doesn't provide such a table.
Sample Size (Test Set) & Data Provenance: This refers to the number of patients or samples used in a study to evaluate the device's performance. Since no clinical study was conducted for this submission, this information is not present.
Number of Experts & Qualifications: This is relevant for studies where expert opinion is used to establish ground truth or evaluate outcomes. Not applicable here.
Adjudication Method: Also relevant for studies involving human interpretation of data. Not applicable here.
MRMC Comparative Effectiveness Study: This is a specific type of clinical study comparing human reader performance with and without AI. The device described, a hip stem, is a physical implant, not an AI or imaging device, so this type of study is irrelevant.
Standalone Performance (Algorithm only): This refers to the performance of an AI algorithm without human involvement. Not applicable to a physical hip stem.
Type of Ground Truth: This refers to the definitive determination of a condition or outcome in a study. Since no clinical study is presented, no ground truth is established in this document.
Sample Size (Training Set) & Ground Truth for Training Set: This is relevant for AI/machine learning models where data is used to 'train' the algorithm. Not applicable to a physical hip stem.

In summary, this document is a regulatory submission for a hip implant, not a clinical or AI performance study. It does not contain the detailed information you requested about acceptance criteria and study data.

Summary

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

January 21, 2016

Corin USA Limited Ms. Rachel King Regulatory Affairs Associate 5670 West Cypress Street, Suite C Tampa, Florida 33607

Re: K153381 Trade/Device Name: Corin Metafix Hip Stem 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, OQI, MEH, KWL, KWY, JDI Dated: November 20, 2015 Received: November 23, 2015

Dear Ms. King:

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/Resourcesfor You/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,

Lori A. Wiggins -S

for

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) K153381

Device Name Corin Metafix Hip Stem Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Indications for Use (Describe)

The indications for the Corin Metalix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis
· Correction of functional deformity
· Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
· Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)

The Corin Metafix Hip Stem is intended for cementless, 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

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1. Applicant/Sponsor:	Corin USA Limited 5670 W. Cypress Street Suite C Tampa Florida 33607 Registration No.: 1056629
2. Contact Person:	Rachel King, BSc (Hons) Regulatory Affairs Associate Corin Ltd +44 1285 884733 rachel.king@coringroup.com Kathy Trier Global VP Regulatory and Clinical Affairs Corin Ltd 813-977-4469 kathy.trier@coringroup.com
3. Date:	November 19, 2015
4. Proprietary Name:	Corin Metafix Hip Stem
5. Common Name:	Hip Prosthesis
6. Product Codes:	LZO, KWL, KWY, JDI, OQI, MEH
7. Classification Name:	Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis (21CFR 888.3390) Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis (21CFR 888.3360) Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21CFR 888.3353) Hip joint metal/polymer semi-constrained cemented prosthesis. (21CFR 888.3350)

510(K) SUMMARY 3.

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

Corin Metafix Hip Stem (K082525, K121439 & K120362) ●
Depuy Orthopaedics Corail AMT Hip System (K042992) .
Corin TriFit TS Hip Stem (K121563)

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9. Device Description:

10. Intended Use / Indications:

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty and, when used in combination with Corin hemi-arthroplasty femoral heads, as a hemi-arthroplasty, include:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
. Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
. Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH)

The Corin Metafix Hip Stem is indicated for cementless use only.

11. Summary of Technologies/Substantial Equivalence:

The Corin Metafix Collared Hip Stem has the same intended use and indications and is manufactured from the same materials as the predicates (K082525, K120362 & K121439). The Corin Metafix Collared Hip Stem has a tapered metaphyseal flare with proximal horizontal grooves, distal vertical grooves and medial calcar grooves similar to the predicate Corin Metafix Hip Stems.

The Corin Metafix Collared Hip Stem is similar to the DePuy Corail AMT Hip System (K042992) in that it has proximal horizontal grooves, a proximal collar, distal vertical grooves and medial calcar grooves.

The Corin Metafix Collared Hip Stem short neck variants are similar in design and measurements to the neck design of the Corin TriFit TS Hip Stem. Based on these similarities, Corin believes that the Metafix Collared Hip Stem is substantially equivalent to the predicate device.

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12. Non-Clinical Testing:

Non-clinical testing and analysis included mechanical fatigue testing of the neck and stem and range of motion analysis. The results of this testing show that the Corin Metafix Collared Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device.

13. Clinical Testing:

Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Collared Hip Stem 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.