DynaBridge by Fusion Orthopedics, LLC

· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
· Fixation of proximal tibial metaphysis osteotomy.
· Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

Device Description

The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis of the hand, foot, and bone appropriate for the size of the device. The implant is offered in a range of sizes to address a variety of indications and patient anatomy with bridge sizes from 9mm to 25mm. The system is offered sterile and non-sterile.

AI/ML Overview

This is a 510(k) summary for a medical device called DynaBridge, which is a bone staple. 510(k) summaries are for demonstrating substantial equivalence to a predicate device, not for providing detailed clinical efficacy data. Therefore, the information you are looking for regarding acceptance criteria and detailed study results to prove device performance for an AI/ML device is not present in this document.

Here's why and what information can be extracted:

This is not an AI/ML device: The description identifies it as a "Nickel-Titanium alloy (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, and arthrodesis." This is a physical orthopedic implant, not a software or AI/ML diagnostic/therapeutic device. Therefore, the concepts of "acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, AUC), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication methods," "MRMC studies," or "standalone performance" for an algorithm simply do not apply here.
"Acceptance Criteria" for this device type: For a bone staple, acceptance criteria would typically involve engineering performance specifications and biocompatibility, not AI performance. The document lists "Non-clinical Test Summary" which implies performance testing such as "Static Four-Point Bend Test," "Dynamic Four-Point Bend Test," "Pull-out Test," "Corrosion Test," "AI Temperature Test" (likely a typo and meant to be "Atmospheric Temperature Test" or similar), and "Pyrogenicity" testing. The acceptance criteria for these tests would be defined in standards (e.g., ASTM standards referenced for materials) or internal specifications, and the reported performance would be that the device "meets the recommended maximum endotoxin level" and that "The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices."
No Clinical Studies: The document explicitly states: "No clinical studies were performed." This further confirms that this submission relies on engineering and biocompatibility testing to demonstrate substantial equivalence, rather than clinical efficacy studies.

Given the nature of the device and the content of the 510(k) summary, I cannot populate the table or answer most of your detailed questions regarding AI/ML device performance or study design.

Here is the information directly extracted or inferred from the provided text, aligning with the type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Inferrred from Non-clinical Test Summary)	Reported Device Performance
Mechanical Strength/Durability (Static Four-Point Bend)	"The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices." (Specific quantitative values not provided in this summary, but implied to meet an equivalence standard).
Mechanical Strength/Durability (Dynamic Four-Point Bend)	"The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices."
Mechanical Fixation (Pull-out Test)	"The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices."
Corrosion Resistance	"The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices."
Biocompatibility (Pyrogenicity)	"The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device."
Material Properties (Nitinol, Stainless Steel, Aluminum)	Conforms to specified ASTM standards (ASTM F-2063, ASTM F899, ASTM B209). Implicitly, this means the materials meet the chemical and mechanical properties defined by these standards.

Regarding the AI/ML specific questions:

Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "test set" would refer to physical devices or materials tested in non-clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant would relate to accurate measurements against engineering standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. No clinical studies were performed, and it's not an AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. Not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests, ground truth would be established by physical measurements and adherence to recognized engineering standards (e.g., ASTM) and biocompatibility limits.
The sample size for the training set: Not applicable. No AI/ML model.
How the ground truth for the training set was established: Not applicable. No AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Fusion Orthopedics, LLC % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K181815

Trade/Device Name: DynaBridge Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: September 14, 2018 Received: September 17, 2018

Dear Mr. Webb:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

October 15, 2018

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel S. Ramsey -S 2018.10.15 14:54:22 -04'00'

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)

K181815

Device Name

DynaBridge

Indications for Use (Describe)

DynaBridge is indicated for:

· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
· Fixation of proximal tibial metaphysis osteotomy.
· Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.

· Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.

Type of Use (Select one or both, as applicable)
For activities identified in 321 CMR 3.02(2): Shooting Preserves
For Field Carries identified in 321 CMR 3.02(3)

Y Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary: DynaBridge

Date Prepared	September 25, 2018
Submitted By:	Fusion Orthopedics, LLC4135 S. Power Rd., Suite 110Mesa, AZ 85212800-403-8876
Primary Contact:	J.D. Webb1001 Oakwood Blvd.Round Rock, TX 78681512-388-0199 Teleemail: jdwebb@orthomedix.net
Trade Name:	DynaBridge
Common Name:	Bone Staple
Classification Name:	Staple, Fixation, Bone
Class:	II
Product Code:	JDR
CFR Section:	21CFR section 888.3030
Device Panel:	Orthopedic
Primary PredicateDevices:	Speed Staple, BioMedical Enterprises, Inc. (K142292)
Secondary PredicateDevices:	Sniper Staple System, Trilliant Surgical (K1623545/ K172405)
Device Description:	The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy(Nitinol) bone implant intended primarily for fixation of fractured, osteotomy,and arthrodesis of the hand, foot, and bone appropriate for the size of thedevice. The implant is offered in a range of sizes to address a variety ofindications and patient anatomy with bridge sizes from 9mm to 25mm. Thesystem is offered sterile and non-sterile.
Indications for Use:	The DynaBridge is indicated for:· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.· Fixation of proximal tibial metaphysis osteotomy.· Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.· Fixation of small bone fragments (i.e. small fragments of bone which arenot comminuted to the extent to preclude staple placement). Thesefragments may be located in long bones such as the femur, fibula, and tibiain the lower extremities; the humerus, ulna, or radius in the upperextremities; the clavicle and ribs; and in flat bones such as the pelvis,scapula, and sternum.
		K181815PAGE2 OF 2
Materials:	Nitinol (ASTM F-2063)Stainless steel (ASTM F899)6061 Aluminum (ASTM B209)
SubstantialEquivalence Claimedto Predicate Devices:	The DynaBridge is substantially equivalent to the predicate devices in termsof intended use, design, materials used, mechanical safety and performances.
Non-clinical TestSummary:	The following analyses were conducted:• Static Four-Point Bend Test.• Dynamic Four-Point BendTest.• Pull-out Test.• Corrosion Test.• AI Temperature Test.• Pyrogenicity was evaluated using the Limulus amebocyte lysate(LAL) assay. The testing demonstrated that the subject device meetsthe recommended maximum endotoxin level of 20 EU per device.The results of these evaluations indicate that the DynaBridge Staple isequivalent to predicate devices.
Clinical TestSummary:	No clinical studies were performed.
Conclusions: Non-clinical and Clinical	Fusion Orthopedics, LLC considers the DynaBridge to be equivalent to thepredicate devices listed above. This conclusion is based upon the devices'similarities in principals of operation, technology, materials, and indicationsfor use.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.