The OrthoHelix Clavicle Plating System Plates are indicated for fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Device Description

The OrthoHelix Clavicle Plating System is a set of metallic, implantable, bone fixation plates. The CPS includes universal plates and indication specific plates of different sizes. All plates are made from implant grade titanium alloy.

AI/ML Overview

The provided text is for a 510(k) premarket notification for a Clavicle Plating System. This type of document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the rigorous study results one would expect for a new AI/software device.

Therefore, many of the requested elements (like sample sizes, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this document. The submission aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device through mechanical testing and Finite Element Analysis, not through clinical performance metrics against a defined ground truth.

Here's an interpretation based on the provided text, highlighting what is (and isn't) present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (from "Substantial Equivalence" Section)
Mechanical Equivalence: The implants must perform mechanically similar to predicate devices.	Finite Element Analysis and mechanical testing confirm that the implants within the Clavicle Plating System are substantially equivalent to its predicate devices.
Functional Equivalence: The device must meet specified requirements for its intended use.	It meets the specified requirements for its intended use.
Safety and Efficacy Equivalence: No new issues of safety or efficacy are identified compared to predicate devices.	No new issues of safety or efficacy have been raised.
Indications for Use Equivalence: The device's indications align with those of predicate devices.	The indications for use are specified: fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission relies on mechanical testing and Finite Element Analysis (FEA), not a "test set" of clinical data or images. The "samples" would be the physical implants and associated materials used for mechanical testing and the computational models for FEA. The document does not specify the number of implants tested or the specifics of the FEA models.
Data Provenance: Not applicable in the context of clinical data. The "provenance" of the engineering data would stem from internal testing and simulations conducted by OrthoHelix Surgical Designs, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No "ground truth" in the clinical AI sense is established. The "ground truth" here is adherence to mechanical and material standards, and equivalence to predicate devices, verified through engineering analyses.

4. Adjudication method for the test set:

Not Applicable. No human-based adjudication of clinical performance against a "test set" occurred. The assessment is based on engineering principles and regulatory review.

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 a hardware medical device (bone plating system), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study involving human readers or AI assistance 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 a hardware device; there is no an algorithm or software to evaluate in a standalone manner.

7. The type of ground truth used:

Engineering Standards and Predicate Device Performance: The "ground truth" for this submission refers to the established mechanical properties, material specifications, and performance characteristics of legally marketed predicate devices, as well as relevant engineering standards for bone fixation implants. The new device is considered "substantially equivalent" if it meets or exceeds these characteristics.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. There is no "training set" or corresponding ground truth establishment process in the context of this traditional medical device submission.

Summary

{0}------------------------------------------------

KU40285

510(k) SUMMARY

JUN 1 5 2009

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.

OrthoHelix Surgical Designs, Inc. 1815 W. Market Akron, Ohio 44313 Phone: (330) 869-9582 Fax: (330) 869-9583

Contact Person: Derek Lewis Vice President of Research and Development

Date Prepared: January 21, 2009

Name of Device

Clavicle Plating System

Common or Usual Name

Fixation Plates

Classification Name

Plate, Fixation, Bone

Predicate Devices

The Clavicle Plating System is substantially equivalent to currently marketed devices.

Intended Use

The Clavicle Plating System is indicated for fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Device Description

{1}------------------------------------------------

Substantial Equivalence

Finite Element Analysis and mechanical testing confirm that the implants within the Clavicle Plating System are substantially equivalent to its predicate devices, and that it meets the specified requirements for its intended use. No new issues of safety or efficacy have been raised.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

ﺎ ﻳﻜﻠ

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and formal nature.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 5 2009

OrthoHelix Surgical Designs, Incorporated % Mr. Derek Lewis Vice President of Research and Development . 1815 W. Market St., Suite 205 Akron, Ohio 44313

Re: K090289

Trade/Device Name: Clavicle Plating System

Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: HRS Dated: May 29, 2009 Received: June 10, 2009

Dear Mr. Lewis:

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.

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

{3}------------------------------------------------

Page 2-Mr. Lewis

(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/cdrh/comp/ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Bruckner

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K090289

Indications for Use

510(k) Number (if known): TBD

Device Name: Clavicle Plating System

Indications for Use:

The OrthoHelix Clavicle Plating System Plates are indicated for fixation of fractures, fusions and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page __ of

Sonata 3

(Division Sign-G Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090289

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.