The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures and osteotomies. The Sonoma Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.

AI/ML Overview

Here's an analysis of the provided text regarding the Sonoma Fibula Repair System, outlining the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or provide detailed performance data from a study. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, indications for use, and material composition.

However, based on the context of a 510(k) submission, the implicit "acceptance criteria" revolve around demonstrating comparable safety and effectiveness to legally marketed predicate devices. The "reported device performance" in this context refers to the similarities identified.

Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use Equivalence: The new device's intended use is substantially the same as predicate devices.	The intended use of the subject device (Sonoma Fibula Repair System) is stated to be the same as the Acumed predicate devices (Acumed Small Bone Locking Rod System II). Both are for the fixation of fibula fractures and osteotomies.
Indications for Use Equivalence: The new device's indications for use are substantially similar, or a subset of, predicate devices.	The indications for use for the subject device are "the fixation of fibula fractures and osteotomies." This is described as limited to the fibula compared to additional anatomical locations for the Acumed predicate devices, indicating it is a subset. There were "no changes to the subject components or accessories compared to the predicate Sonoma Fibula Repair System (K142945)." This implies that the previous K142945 submission already established equivalence for the fibula.
Technological Characteristics Equivalence: The new device's technological characteristics do not raise new questions of safety or effectiveness.	The implants are composed of "316 stainless steel per ASTM F138," a common and well-understood material in medical devices. The system utilizes "Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws," which is a design feature of the device. The assertion of "no changes to the subject components or accessories compared to the predicate Sonoma Fibula Repair System (K142945)" further supports technological equivalence for this specific system.
Performance Testing (if required): Device meets relevant performance standards or demonstrates comparable performance to predicate(s).	The document explicitly states: "No performance testing was performed associated with the additional indication of osteotomies for the Sonoma Fibular Rod System." This suggests that previous performance testing (for K142945) was deemed sufficient for "fractures," and the "osteotomies" indication was considered equivalent without new testing based on design similarity.
Material Equivalence: The materials used are equivalent to predicate devices or well-established for medical use.	Implants are made of "316 stainless steel per ASTM F138." This is a standard medical grade material for orthopedic implants.

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

The document does not describe an independent test set with efficacy data. The submission is a 510(k) for "substantial equivalence" to existing predicate devices, rather than a de novo submission requiring extensive clinical trial data.

The "data provenance" primarily consists of referencing existing FDA clearances (K142945, K071944, K031438) for the predicate devices. This indicates a reliance on the previously established safety and effectiveness of those devices, rather than new, primary data from a study for this submission.

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

Not applicable. As no independent test set with efficacy data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No independent 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 an AI-based device. It is a physical orthopedic implant system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI-based device.

7. The Type of Ground Truth Used

Not applicable. For a substantial equivalence claim for a physical implant, "ground truth" in the clinical efficacy sense (e.g., pathology, outcomes data) is typically established through a combination of:

Engineering and Biomechanical Testing: (Though not explicitly detailed in this summary, would have been part of previous submissions for K142945).
Clinical Experience with Predicate Devices: The long history of successful use of the predicate devices.
Material Standards Compliance: Adherence to established ASTM standards for medical-grade materials.

8. The Sample Size for the Training Set

Not applicable. This is not an AI-based device that would require a training set.

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

Not applicable. This is not an AI-based device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.

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

Sonoma Orthopedics Products, Incorporated % Ms. Dawn Norman Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, Tennessee 38133

March 10, 2016

Re: K160069

Trade/Device Name: Sonoma Fibula Repair System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 12, 2016 Received: January 13, 2016

Dear Ms. Norman:

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/ResourcesforYou/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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K160069

Device Name

Sonoma Fibula Repair System

Indications for Use (Describe)

The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

Sonoma Fibula Repair System January 12, 2016

Company:	Sonoma Orthopedics Products, Inc1388 Busch ParkwayBuffalo Grove, IL 60089Phone: 847-807-4378Fax: 847-947-8082
EstablishmentRegistration:	3007038372
Primary Contact:	Dawn Norman, MSManaging PartnerMemphis Regulatory Consulting, LLC3416 Roxee Run CoveBartlett, TN 38133, USAPhone: 618-604-3064Fax: 707-526-2022
Company/Secondary Contact:	Kyle LappinSonoma Orthopedics Products, Inc1388 Busch ParkwayBuffalo Grove, IL 60089Phone: 707-526-1335Fax: 707-526-2022
Trade Name:	Sonoma Fibula Repair System
Common Name:	Rod, Fixation, Intramedullary and Accessories
Classification:	Class II
Regulation Number:	888.3020
Panel:	87- Orthopedic
Product Code:	HSB

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Predicate Devices:	K142945	Sonoma Fibula Repair System
	K071944	Acumed Small Bone Locking Rod System II
	K031438	Acumed Small Bone Locking Rod System II

Device Description: The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures and osteotomies. The Sonoma Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.

Indications for Use: The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures and osteotomies.

Substantial Equivalence: The intended use of the subject device is the same as the Acumed predicate devices. The indications for use for the subject device is limited to the fibula as opposed to additional anatomical locations for the Acumed predicate devices. There are no changes to the subject components or accessories compared to the predicate Sonoma Fibula Repair System (K142945). Thus, the subject device is substantially equivalent to the predicate devices.
Performance Testing: No performance testing was performed associated with the additional indication of osteotomies for the Sonoma Fibular Rod System.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.