WOLF LONG BONE PLATE SYSTEM by TOBY ORTHOPAEDICS

The TOBY® WOLF® Long Bone Plate system consists of implantable titanium alloy bone plates and fasteners used for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses. The system includes specialized stainless steel instrumentation that is provided to assist with the installation of the bone plates and fasteners.

AI/ML Overview

The provided text describes the 510(k) summary for the TOBY® WOLF® Long Bone Plate System. This is a medical device and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against defined acceptance criteria using a study in the way an AI/ML device would.

Therefore, many of the requested categories are not directly applicable or cannot be extracted from this specific document. However, I will do my best to map the available information to your request.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported Device Performance (from document)
Material Compliance	ASTM F136-12a, Standards Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)	The TOBY® WOLF® Long Bone Plate system complies with the requirements of listed FDA Recognized Consensus Standards, including ASTM F136-12a and ASTM F899-12b. The implantable and tissue contact materials used...have a long history of safe usage in medical devices. The materials of construction are safe and effective, and similar to those used in the predicate device system.
	ASTM F899-12b, Standard Specification for Wrought Stainless Steels for Surgical Instruments
Mechanical Performance	Demonstrated through a multi-parameter comparison with predicate devices. Specific tests mentioned: Stiffness, Strength, and Fatigue testing per ASTM F382-99, and Screw Pullout testing.	Substantial equivalence is demonstrated… through a 20-point comparison of technological features and a multiparameter comparison of mechanical performance. The design features are similar in the device systems, as are the indications for use. Results from stiffness, strength and fatigue testing per ASTM F382-99, and screw pullout testing, demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.
Technological Features	Comparison performed to demonstrate substantial equivalence to predicate devices.	A comparison of the technological characteristics and performance characteristics of the WOLF® Long Bone Plate system and the predicate devices was performed. The devices were found to be substantially equivalent. The design features are similar in the device systems.
Intended Use	The WOLF® Long Bone Plate system is intended for fractures, osteotomies, and non-unions of upper extremity diaphyses (must be substantially equivalent to predicates).	The WOLF® Long Bone Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses. The indications for use are similar to those of the predicate devices.
Safety and Effectiveness	Demonstrated through compliance with material standards and mechanical testing, and similarity to predicate devices.	The implantable and tissue contact materials… are safe and effective. Results from [mechanical testing] demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.

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 / Not Provided: This document describes a traditional medical device (implantable plate system) and its mechanical testing, not a diagnostic or AI/ML device that would have "test sets" of data provenance. The testing would involve physical samples of the device components.

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 / Not Provided: Ground truth in the context of expert review for medical images or diagnoses is not relevant to this type of device submission. The "ground truth" for material and mechanical properties would be established by standardized testing methods and specifications (e.g., ASTM standards).

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

Not Applicable / Not Provided: Adjudication methods are typically for subjective assessments (like image interpretation) in clinical studies or AI/ML ground truth establishment, which is not relevant here.

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 / Not Provided: This is not an AI/ML device, so no MRMC study would be performed.

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

Not Applicable / Not Provided: This is not an AI/ML device.

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

Material and Mechanical Standards: The "ground truth" for the device's properties relies on established engineering standards (e.g., ASTM F136, F899, F382) for material composition, strength, stiffness, fatigue, and screw pullout. The performance is compared against the requirements of these standards and against the performance of legally marketed predicate devices.

8. The sample size for the training set

Not Applicable / Not Provided: This is not an AI/ML device.

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

Not Applicable / Not Provided: This is not an AI/ML device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" outlined in the document to prove the device meets acceptance criteria is primarily an engineering and materials compliance assessment, rather than a clinical trial or AI performance study.

The primary method used to demonstrate substantial equivalence and confirm safety and effectiveness is:

Bench Testing / Mechanical Performance Testing: The device underwent several standardized tests to evaluate its mechanical properties:
- Stiffness testing
- Strength testing
- Fatigue testing (per ASTM F382-99)
- Screw pullout testing
  These tests are designed to evaluate how the device performs under various forces and stresses it would experience in the human body. The results from these tests were then compared to the performance of predicate devices and against the requirements of the ASTM F382-99 standard.
Materials Compliance: The materials used for the plate (Wrought Titanium-6Aluminum-4Vanadium ELI Alloy) and instruments (Wrought Stainless Steels) were evaluated against recognized FDA consensus standards (ASTM F136-12a and ASTM F899-12b, respectively) to ensure they meet established biocompatibility and material strength specifications. The document states these materials have a "long history of safe usage in medical devices" and are "safe and effective, and similar to those used in the predicate device system."
Technological Features Comparison: A "20-point comparison" of technological features was performed between the WOLF® system and its predicate devices. This likely involves comparing design elements, dimensions, locking mechanisms, plate profiles, etc., to ensure no significant differences exist that would raise new questions of safety or effectiveness.
Indications for Use Comparison: The intended use statement of the WOLF® system was compared to that of the predicate devices to establish substantial equivalence.

Conclusion: The document asserts that through this comprehensive comparison of technological features and mechanical performance testing, the TOBY® WOLF® Long Bone Plate system is "substantially equivalent" to its predicate devices, thereby demonstrating its safety and effectiveness for its intended use. This is the common regulatory pathway for many traditional medical devices.

Summary

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K131834 page 1 of 2

510(k) Summary

Submitted By:	Toby Orthopaedics401 SW 42nd Ave, Suite 200Miami, FL 33134 USAPhone: (866) 979-8629Fax: (305) 768-0269
Contact Name:	Eric Neyhard
Date Prepared:	June 18th, 2013
Trade Name:	WOLF® Long Bone Plate System
Common Name:	Bone Plate
Classification:	21 CFR 888.3030 - Single / multiple componentmetallic bone fixation appliances and accessories
Predicate Devices:	Synthes LCP System - K082807Synthes 1/3 Tubular DCL Plate - K011335Acumed Congruent Bone Plate System - K012655,K102998
Device Description:	The TOBY® WOLF® Long Bone Plate system consistsof implantable titanium alloy bone plates and fastenersused for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses. The systemincludes specialized stainless steel instrumentation thatis provided to assist with the installation of the boneplates and fasteners.
Intended Use:	The WOLF® Long Bone Plate system is indicated forfractures, osteotomies, and non-unions of upperextremity diaphyses.
TechnologicalCharacteristics:	A comparison of the technological characteristics andperformance characteristics of the WOLF® Long BonePlate system and the predicate devices was performed.The devices were found to be substantially equivalent.NOV 04 2013

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Performance Data:

The TOBY @ WOLF & Long Bone Plate system complies with the requirements of listed FDA Recognized Consensus Standards.

· ASTM F136-12a, Standards Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
· ASTM F899-12b, Standard Specification for Wrought Stainless Steels for Surgical Instruments

The implantable and tissue contact materials used to fabricate the WOLF® Long Bone Plate system components have a long history of safe usage in medical devices. The materials of construction are safe and effective, and similar to those used in the predicate device system.

Substantial equivalence is demonstrated between the TOBY @ WOLF® Long Bone Plate system and the predicate device systems listed above through the review of various performance data. Substantial equivalence has been determined through a 20-point comparison of technological features and a multiparameter comparison of mechanical performance. The design features are similar in the device systems, as are the indications for use. Results from stiffness. strength and fatigue testing per ASTM F382-99, and screw pullout testing, demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.

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

November 4. 2013

TOBY ORTHOPAEDICS Mr. Eric Neyhard Chief Operating Officer 1805 Ponce de Leon Boulevard, Suite 501 Coral Gables, Florida 33134

Re: K131834

Trade/Device Name: WOLF® Long Bone Plate 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 Date: October 3, 2013 Received: October 4, 2013

Dear Mr. Neyhard:

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 - Mr. Eric Neyhard

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Erin DKeith

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): __K131834

Device Name: WOLF® Long Bone Plate System

Indications For Use: The WOLF® Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses.

× Prescription Use (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)

Elizabeth L. Frank -S

Page 1 of 1

Division of Orthopedic Devices

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.