The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The device is intended for prescription use only.

Device Description

The Corin Optimom Modular Head is a polished, truncated sphere with a high tolerance internal female taper. It is a device modification of the internal female taper of the Corin Unipolar Modular Heads (K063791) to provide for compatibility with an additional range of Corin femoral hip stem designs with a 12/14 male taper. The materials and dimensions of the internal female taper are substantially equivalent to the CoCr Modular Heads cleared in K003666 and K010243 and the Trinity Modular Heads cleared in K110087. The Optimom Modular Head is manufactured from Cobalt-Chrome alloy conforming to ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Corin Optimom Modular Head," a hip joint femoral prosthesis component. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study proving performance against specific acceptance criteria for a new type of device or AI algorithm.

Therefore, many of the requested categories regarding acceptance criteria, study design, and ground truth are not applicable to this type of submission.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document is a 510(k) submission for substantial equivalence. It does not present specific quantitative acceptance criteria or performance metrics for a novel technology that would typically be evaluated against such criteria. Instead, it argues that the device's design, materials, and intended use are similar enough to existing devices that no new performance testing to specific criteria is needed for market clearance beyond demonstrating equivalent physical properties.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. No clinical test set data is presented as clinical testing was not deemed necessary for this submission. The "test set" in this context would refer to physical device samples undergoing engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This submission does not involve expert review or ground truth establishment in the way an AI/CADe device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No expert adjudication of a test set is described.

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 Applicable. This is not a study involving human readers or AI assistance.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. No ground truth in the sense of a medical diagnosis or outcome is established for a study. The "ground truth" for this submission is based on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device requiring a training set.

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

Not Applicable. This is not an AI/machine learning device.

Summary of the Study/Evidence Presented in the Document:

The "study" in this context is a non-clinical engineering assessment and comparison to legally marketed predicate devices, rather than a clinical trial or performance evaluation against new, pre-defined acceptance criteria.

Key Information from the Document:

Device: Corin Optimom Modular Head
Purpose: To demonstrate substantial equivalence to predicate devices (Corin Unipolar Modular Head, Corin Taperfit Total Hip System, Corin Tri-Fit Femoral Stem, Trinity Modular Heads).
Methodology (Non-Clinical Testing):
- Comparison of designs.
- Comparison of materials.
- Comparison of intended use and indications.
- Comparison of dimensions.
- Specific engineering tests conducted: Fatigue, rotational torque, axial pull-off, and fretting corrosion. The results of these tests are not provided in the summary but were conducted to support the substantial equivalence claim.
Conclusion: Based on these comparisons and non-clinical tests, the Optimom Modular Heads are believed to be substantially equivalent to the predicate devices.
Clinical Testing: "Clinical testing was not necessary to determine substantial equivalence between the Corin Optimom Modular Heads and the predicate devices." (Page 1)

In essence, the document states that specific engineering tests were performed (fatigue, rotational torque, axial pull-off, fretting corrosion) to show that the new device performs comparably to the predicate devices in these critical aspects. The "acceptance criteria" implicitly would be that the new device meets or exceeds the performance of the predicate device for these tests, demonstrating equivalent safety and efficacy. However, the specific quantitative results or acceptance thresholds are not detailed in this 510(k) summary.

Summary

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AUG - 4 2011

3. 510(K) SUMMARY
1. Applicant/Sponsor:	Corin USA10500 University Center DriveSuite 190Tampa, Florida 33612Establishment Registration No.: 1056629
2. Contact Person:	Lucinda GerberRegulatory Affairs AssociateCorin USA813-977-4469lucinda.gerber@coringroup.com
3. Proprietary Name:	Corin Optimom Modular Head
4. Common Name:	Optimom Modular Head
5. Classification Name:	21CFR 888.3360 - Hip joint femoral (hemi-hip) metalcemented or uncemented prosthesis
6. Legally Marketed Devices to which Substantial Equivalence is claimed:
	• Corin Unipolar Modular Head (K063791)
	• Corin Taperfit Total Hip System (K003666)
	• Corin Tri-Fit Femoral Stem (K010243)

(K110087)

7. Device Description:

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ASTM F75 and is available in diameters ranging from 40-56mm with a variety of offsets.

1. Intended Use / Indications:
  The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, rheumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The device is intended for prescription use only.

1. Summary of Technologies/Substantial Equivalence:
  The Optimom Modular Heads have the same intended use and indications as the Corin Unipolar Modular Heads (K063791). The range of diameters available for the Optimom Modular Heads is within the range cleared for the predicate Unipolar Modular Heads and the device design is similar to the Unipolar Heads with the only modification of the internal female taper. The Optimom Modular Heads are manufactured from the same material as the predicates Unipolar Modular Heads, CoCr Modular Heads (K003666, K010243) and Trinity Modular Heads (K110087). The design and dimensions of the internal female taper of the Optimom Modular Heads are the same as the internal female taper of the predicates CoCr Modular Heads and Trinity CoCr Modular heads. Based upon these similarities, the Optimom Modular Heads are believed to be substantially equivalent to the predicate devices.

10. Non-Clinical Testing:

Non-clinical testing conducted to demonstrate substantial equivalence includes a comparison of the designs, materials, intended use, indications and dimensions of the Corin Optimom Modular Head to the predicate devices Fatigue, rotational torque, axial pull off, and fretting corrosion were conducted.

1. Clinical Testing:
  Clinical testing was not necessary to determine substantial equivalence between the Corin Optimom Modular Heads and the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002

Corin USA % Ms. Lucinda Gerber Regulatory Affairs Associate 10500 University Center Drive. Suite 190 Tampa. Florida 33612

AUG - 4 2011

Re: K111911 Trade/Device Name: Corin Optimom Modular Head Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL Dated: July 01, 2011 Received: July 05, 2011

Dear Ms. Gerber:

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 Part 801); medical device reporting (reporting of medical

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Page 2 - Ms. Lucinda Gerber

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vour

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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): _K1119 | |

Device Name: Corin Optimom Modular Head

Indications for Use:

The Corin Optimom Modular Head is indicated for hemi-arthroplasty in cemented and uncemented primary or revision femoral stem applications whose indications include procedures for patients suffering pain and disability due to osteoarthritis, theumatoid arthritis, avascular necrosis of the femoral head, femoral neck fracture and abnormalities where the major pathology affects the femoral head, the acetabular cavity is normal and acetabular replacement is either undesirable or not required.

The device is intended for prescription use only.

Prescription Use Over-The-Counter Use X - AND/OR (Part 21 CFR 801 Subpart D) (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)

Igor M. Melkersen

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number

Regulation Number and Section

§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.