The DynaNail Mini Tapered Hybrid is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

Device Description

The proposed DynaNail Mini Tapered Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively.

The proposed DynaNail Mini Tapered Hybrid™ is available in identical diameters and lengths to the predicate device, and to accommodate variations in patient anatomy. The proposed device differs from the predicate device only in the threaded component major diameter, which is tapered. The DynaNail Mini Tapered Hybrid™ is implanted with the same driver/ deployment frame and fixation screws as the predicate. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation identical to the predicate.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "DynaNail Mini Tapered Hybrid." It details the manufacturer's claim that this new device is substantially equivalent to a previously cleared predicate device.

Based on the provided document, there is NO study information available that proves the device meets acceptance criteria related to AI/software performance or human reader improvement.

The document discusses the substantial equivalence of a physical medical device (an orthopedic nail) to a predicate device. The acceptance criteria and "study" information provided refer to mechanical and material testing of the physical implant, not to the performance of a software or AI algorithm.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria, data provenance, expert ground truth adjudication, MRMC studies, standalone AI performance, or training set details because this document does not contain information about an AI/software device.

The "studies" conducted and described are non-clinical (mechanical) tests to demonstrate that the physical device performs equivalently to its predicate.

Here's what I can extract related to the physical device's "acceptance criteria" and "performance," as inferred from the mechanical testing, but please note this is not for an AI device:

Acceptance Criteria and Device Performance (for the physical medical device - Orthopedic Nail)

This section outlines the non-clinical (mechanical) testing performed to demonstrate the substantial equivalence of the DynaNail Mini Tapered Hybrid to its predicate device. The "acceptance criteria" are implicitly met if the proposed device's performance is "substantially equivalent" or "superior" to the predicate or relevant standards.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Test Method (Criteria)	Acceptance Criteria (Inferred)	Reported Device Performance (Results)
Mechanical Performance Tests
ASTM F1264-16e, Standard Specification for Intramedullary Fixation Devices - Static Four-Point Bend	Performance must be substantially equivalent to the predicate device (DynaNail Mini Hybrid K203381)	"The four-point bending strength of the proposed device was substantially equivalent to the predicate device"
ASTM F1264-16e - Static Torsion Test	Performance must be substantially equivalent to the predicate device	"The static torsion strength of the proposed device was substantially equivalent to the predicate device"
ASTM F1264-16e - Bending Fatigue Test	Performance must be substantially equivalent to the predicate device	"The bending fatigue strength of the proposed device was substantially equivalent to the predicate device"
US FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway", issued December 2020 (Axial Pullout)	Performance must be substantially equivalent to the predicate device AND/OR superior to the reference value recommended per the US FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway", issued December 2020.	"The axial pull-out strength of the proposed device was substantially equivalent to the predicate device"
ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Bone Screws, Annex A3 - Fixation Strength (Axial Pullout)	Performance must be substantially equivalent to the predicate device AND/OR superior to the reference value recommended per the US FDA Guidance Document "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway", issued December 2020.	"The distal and proximal fixation strength of the proposed device was substantially equivalent to the predicate device and / or superior to the reference value recommended per the US FDA Guidance Document 'Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway', issued December 2020."
Sterilization Validation
ISO/AAMI/ANSI 11137-1:2006, Sterilization of health care products - Radiation - Requirements for development, validation, and routine control of a sterilization process for medical devices	Must meet the VDmax25 requirements for radiation sterilization.	"Pass"
Biocompatibility
(Implicit by material and process equivalence)	Biocompatibility must be acceptable for patient contact.	"Biocompatibility of the predicate device was deemed unnecessary since the material, processes, assembly, packaging, and sterilization of the proposed device are identical to the predicate."
Pyrogenicity / Bacterial Endotoxin Testing (BET)	Must meet the limit of 20 EU/device.	"Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20 EU/device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011 (R2016)."

Regarding the other points of your request as they apply to an AI device (since this document is not about AI):

2. Sample sized used for the test set and the data provenance: Not applicable. The "test set" consists of physical devices subjected to mechanical testing. No patient data or clinical imagery is involved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is established by published test standards and engineering measurements, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. No human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical measurements obtained according to validated standard test methods (e.g., ASTM standards).
8. The sample size for the training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical orthopedic implant, demonstrating its substantial equivalence through mechanical and material testing, not through AI performance studies.

Summary

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March 21, 2024

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MedShape, Inc. Amberlee Soto Regulatory Affairs Specialist 1575 Northside Drive Suite 440 Atlanta, Georgia 30318

Re: K240530

Trade/Device Name: DynaNail Mini Tapered Hybrid Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, JDS Dated: February 23, 2024 Received: February 23, 2024

Dear Amberlee Soto:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240530

Device Name

DynaNail Mini Tapered Hybrid

Indications for Use (Describe)

The DynaNail Mini Tapered Hybrid is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

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

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

February 23rd, 2024. Date Submitted:

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter: MedShape, Inc. (a.k.a., MedShape, a division of ENOVIS) 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
B. Company Contact: Amberlee Soto Regulatory Affairs Specialist (469) 585-6710 (direct) amberlee.soto@enovis.com
C. Device Information: Trade Name:

Trade Name:	DynaNail Mini Tapered Hybrid™™
Common Name:	Smooth or threaded metallic bone fixation fastener
	Orthopedic Nail

Classification: D. Smooth or threaded metallic bone fixation fastener Single/multiple component metallic bone fixation appliances, accessories Class II, Panel Code: 87 HWC, Screw, Fixation Bone, 888.3040 JDS, Nail, Fixation, Bone, 888.3030
E. Predicate Device:

DynaNail Mini Hybrid™ (K203381)

F. Physical Description:

G. Indications for Use:

The DynaNail Mini Tapered Hybrid™ is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

This intended use is identical to that of the predicate device cleared under K203381.

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H. Comparison to Predicate Device:

The DynaNail Mini Tapered Hybrid™ is substantially equivalent in Intended Use, design, function, material, diameters, and lengths to the following predicate device:

DynaNail Mini Hybrid™, Orthopedic Nail, K203381

The proposed and predicate devices are comprised of implant grade Titanium alloy and Nickel Titanium Alloy and differ only in the threaded segment, which incorporates a taper of the major diameter for the proposed device. All implants are sold sterile. Engineering analyses and mechanical performance testing (per ASTM F1264 and ASTM F543) were performed. The test results and analyses demonstrate substantial equivalent performance to the predicate device. The manufacture and processing of all patient contacting materials are identical to the predicate DynaNail Mini Hybrid™ K203381.

Pyrogenicity testing was conducted per ANSI/AAMI ST72 for the worst case largest DynaNail™ system, confirming the most loaded device scenario meets the limit of 20 EU/device. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011 (R2016).

Analysis substantiates the statement that the proposed device performs equivalently to the predicate device. Refer to Table 1 below for summary of substantial equivalence.

Parameter	DynaNail Mini Tapered Hybrid(ENOVIS Proposed)	DynaNail Mini Hybrid(Predicate)
Manufacturer	ENOVIS	MedShape, Incorporated (now part of ENOVIS)
510(k) Number	Unassigned	K203381
Product Code	HWC, JDS (NO CHANGE)
Material (nail body)	Ti-6AL-4V Titanium (NO CHANGE)
Material (dynamic element)	NITINOL (NO CHANGE)
Lengths	60 - 140mm (NO CHANGE)
Proximal End Fixation	Threaded, 0.5MM TAPERED MAJOR DIAMETER	Threaded, NO TAPER TO MAJOR DIAMETER
Distal End Fixation	1 Fixation Screw (NO CHANGE)
Outside Diameter, mm	7mm - 8mm (NO CHANGE)
Cross Sectional Shape	Round (NO CHANGE)
Potential Critical Stress Concentrators	None (NO CHANGE)
Insertion Mechanism	Driver / External Frame (NO CHANGE)
Compression Method	External Frame and NITINOL Element (NO CHANGE)
NITINOL Sustained Compression	8% (NO CHANGE)
Intended use	Fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle(NO CHANGE)

Table 1. Table of Substantial Equivalence

l. Summary of Non-Clinical Tests:

Product characterization using known standards and / or clinically relevant acceptance criteria was performed on the proposed device. A summary of this testing is provided in Table 2.

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Table 2. Non-Clinical Testing Information

Test	Test Summary	Results
ASTM F1264-16e, Standard Specification for IntramedullaryFixation Devices	Static Four-PointBend	The four-point bending strength of the proposed device wassubstantially equivalent to the predicate device
	Static Torsion Test	The static torsion strength of the proposed device wassubstantially equivalent to the predicate device
	Bending Fatigue Test	The bending fatigue strength of the proposed device wassubstantially equivalent to the predicate device
US FDA Guidance Document "Orthopedic Non-Spinal MetallicBone Screws and Washers - Performance Criteria for Safetyand Performance Based Pathway", issued December 2020		The axial pull-out strength of the proposed device wassubstantially equivalent to the predicate device
ASTM F543-17, Standard Specification and Test Methods forMetallic Medical Bone Screws, Annex A3	Fixation Strength(Axial Pullout)Analysis	The distal and proximal fixation strength of the proposed devicewas substantially equivalent to the predicate device and / orsuperior to the reference value recommended per the US FDAGuidance Document "Orthopedic Non-Spinal Metallic Bone Screwsand Washers – Performance Criteria for Safety and PerformanceBased Pathway", issued December 2020.

J. Biocompatibility Testing:

Biocompatibility of the predicate device was deemed unnecessary since the material, processes, assembly, packaging, and sterilization of the proposed device are identical to the predicate.

K. Sterilization:

The method employed to ensure sterility of the proposed device is provided in Table 4. The sterilization process is identical for the subject and predicate device.

Table 4. Sterilization Information

Test	Test Method Summary	Results
SterilizationValidation	VDmax25 per ISO/AAMI/ANSI 11137-1:2006, Sterilization of health care products- Radiation- Requirements fordevelopment, validation, and routine control of a sterilization process for medical devices	Pass

L. Animal Studies:

There were no animal studies necessary to establish safety of the proposed device against the predicate device.

M. Clinical Studies:

No human studies were necessary to prove the safety and efficacy of the device.

N. Conclusion:

No new questions of safety or effectiveness were identified during device testing; therefore, the proposed device is considered substantially equivalent to the predicate device and that the proposed changes meet the requirements for Special 510(k) submission as outlined in the US FDA Guidance Document "The Special 510(k) Program" issued September 13th, 2019.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.