The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

Device Description

The Orthofix Contours Proximal Humeral Plate (PHP) is a modified version of the Orthofix Titanium Humeral Plating System "LSP", cleared under 510(k) K062920. Like the predicate device, the Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium plate intended for the treatment of fractures. osteotomies and non-unions of the proximal humerus. The Orthofix Contours Proximal Humeral Plate (PHP) consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve further stabilization of the bone fragments. Instrumentation is available for the insertion of the plates and screws. The modifications introduced with the Orthofix Contours Proximal Humeral Plate (PHP) are summarized below: - Dimensional changes, concerning width and central part height of the plate, diameter of some fixation points and lengths of the revision screws. - Sterilization configuration: Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration while the predicate device, Orthofix Titanium Humeral Plating System "LSP" is sold in a non-sterile configuration. - Packaging configuration: as the Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration, the packaging will be modified with respect to the predicate device.

AI/ML Overview

This document describes a 510(k) premarket notification for the Orthofix Contours Proximal Humeral Plate (PHP). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, specific device performance metrics, sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context.

Here's an explanation based on the provided document:

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

Not Applicable. This document does not describe acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI-driven device. It's for a medical implant and focuses on mechanical equivalence.

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

Not Applicable. No test set for clinical performance is mentioned. The study referenced (mechanical testing) would involve physical samples of the device, not patient data.

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. Ground truth for clinical interpretation by experts is not relevant to this submission for a bone plate.

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

Not Applicable. Clinical adjudication methods are not relevant to this submission.

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 an AI-driven device and no MRMC study was performed or is relevant.

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

Not Applicable. This is not an algorithm or AI device.

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

Not Applicable. The "ground truth" in this context is the mechanical performance standards set by ASTM (American Society for Testing and Materials) for bone plates.

8. The sample size for the training set:

Not Applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not Applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per the 510(k) document):

The "study" in this context is mechanical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical trial.

Acceptance Criteria (Implicit): The implicit acceptance criteria are that the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) must be equivalent or better than the predicate device, Orthofix Titanium Humeral Plating System "LSP". This is based on specific ASTM standards.
Study Description:
- Type of Study: Non-clinical (mechanical) testing.
- Standards Used: The testing was conducted in accordance with ASTM F384-06 (Standard Specification for Metallic Bone Plates) and ASTM F382-99 (Standard Specification for Metallic Bone Plates). These standards specify methods for evaluating the mechanical properties of bone plates.
- Reported Device Performance: "Testing in accordance with ASTM F384-06 and ASTM F382-99 shows the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) to be equivalent or better than the predicate devices." (Page 2, Section 6 and Page 3, Section 7)
- Comparison: The results were compared directly against the mechanical performance of the predicate device, the Orthofix Titanium Humeral Plating System "LSP" (K062920).
- Conclusion: Based on these mechanical test results, alongside similarities in design, materials, and intended uses, Orthofix concluded that the Contours Proximal Humeral Plate (PHP) is substantially equivalent to the predicate device.

Key takeaway for this document: The focus of a 510(k) for a medical implant like a bone plate is primarily on demonstrating substantial equivalence to a previously cleared device through comparisons in design, materials, intended use, and non-clinical performance (like mechanical strength) rather than extensive clinical efficacy or diagnostic performance studies.

Summary

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Premarket Notification Orthofix Srl Contours Proximal Humeral Plate (PHP)

Image /page/0/Picture/2 description: The image shows the logo for Orthofix. The logo consists of a stylized circular shape above the word "ORTHOFIX". The circular shape is black and white and appears to be an abstract design. The word "ORTHOFIX" is in a bold, sans-serif font.

[as required by 21 CFR 807.92(c)]

Orthofix Contours Proximal Humeral Plate (PHP)

510(k) K122541

9680825

Submitted by:

Orthofix Srl Via delle Nazioni 9 37012 Bussolengo (VR) ltaly

Registration number

Contact Person

Elena Varini International Orthopedics Regulatory Manager Telephone: +39 (045) 671 9000 Facsimile: +39 (045) 671 9380

Date Prepared

September 17, 2012

2. Device Name:

Trade/Proprietary Name

Common Name Device Classification Orthofix Contours Proximal Humeral Plate (PHP) Bone plate 87 KTW (21 CFR 888.3030) Single/multiple component metallic bone fixation appliances and accessories.

3. Predicate Device:

The Orthofix Contours Proximal Humeral Plate (PHP) is substantially equivalent to the Orthofix Titanium Humeral Plating System, "LSP", K062920

Intended Use: 4.

The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

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K1225411

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Premarket Notification Orthofix Srl Contours Proximal Humeral Plate (PHP)

5. Description:

This Special 510(k) is being supplied to the U.S. FDA to provide authorization to market the device Orthofix Contours Proximal Humeral Plate (PHP) for interstate commerce. The Orthofix Contours Proximal Humeral Plate (PHP) is a modified version of the Orthofix Titanium Humeral Plating System "LSP", cleared under 510(k) K062920.

Like the predicate device, the Orthofix Contours Proximal Humeral Plate (PHP) is a locking titanium plate intended for the treatment of fractures. osteotomies and non-unions of the proximal humerus.

The Orthofix Contours Proximal Humeral Plate (PHP) consists of a left and a right plate that has to be used in combination with at least two Diaphyseal Screws, a main locking screw and at least two titanium hexagonal Fine Threaded Screws. In addition titanium/polymeric cerclage wires can be used to achieve further stabilization of the bone fragments.

Instrumentation is available for the insertion of the plates and screws.

The modifications introduced with the Orthofix Contours Proximal Humeral Plate (PHP) are summarized below:

Dimensional changes, concerning width and central part height of the plate, diameter of some fixation points and lengths of the revision screws.
Sterilization configuration: Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration while the predicate device, Orthofix Titanium Humeral Plating System "LSP" is sold in a non-sterile configuration.
Packaging configuration: as the Orthofix Contours Proximal Humeral Plate (PHP) will be sold in a sterile configuration, the packaging will be modified with respect to the predicate device.

6. Substantial equivalence:

Documentation is provided which demonstrates the Orthofix Contours Proximal Humeral Plate (PHP) to be substantially equivalent to other legally marketed devices. The Orthofix Contours Proximal Humeral Plate (PHP) and the predicate device Orthofix Titanium Humeral Plating System "LSP" are bone plates as defined in 21 CFR 888.3030, furthermore, the size, shape and materials for the subject devices are comparable to the predicate devices.

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K122541

Page 3/3.

Premarket Notification Orthofix Srl Contours Proximal Humeral Plate (PHP)

Testing in accordance with ASTM F384-06 and ASTM F382-99 shows the mechanical strength of the Orthofix Contours Proximal Humeral Plate (PHP) to be equivalent or better than the predicate devices.

7. Conclusion:

Based upon the similarities in design, materials and intended uses, it is concluded that the Orthofix Contours Proximal Humeral Plate (PHP) is substantially equivalent to the predicate devices.

Orthofix Srl

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

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

Orthofix SRL % Ms. Candace Cederman Consultant 22423 Skyview Drive West Linn. Oregon 97068

Re: K122541

Trade/Device Name: Orthofix Contours Proximal Humeral Plate (PHP) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTW Dated: August 20, 2012 Received: August 21, 2012

Dear Ms. Cederman:

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

SEP 20 2012

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Page 2 - Ms. Candace Cederman

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 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/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 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 yours,

Erich Keith

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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Indications for Use

510(k) Number (if known):

Device Name:

Orthofix Contours Proximal Humeral Plate (PHP)

Indications for Use:

The Orthofix Contours Proximal Humeral Plate (PHP) is intended for fractures, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone.

Over-The-Counter Use Prescription 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ASL

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

510(k) Number K122541

Page 1 of 1

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.