The proposed DynaNail™ is a sterile, single use titanium Intramedullary Fixation Rod for use in tibiotalocalcaneal fusions. The DynaNail is implanted with a proprietary deployment frame and various lengths of fixation screws. Similar to existing IMFR's, the DynaNail™ provides rigid fixation across the arthrodesis site, and also provides a method of in-line compression through the nail. The nail incorporates a method of compression that is applied during implantation in the same manner as existing nails. The construction of the DynaNail™ body is equivalent to that of the VersaNail™ device. Both devices are made from Ti-6AL-4V Titanium, have a hollow body with flutes and distal and proximal screw attachment points. The DynaNail™ is offered in a 12 mm diameter, as is the VersaNail™. The DynaNail™ is offered in lengths comparable to those of the VersaNail™. The DynaNail™ device has an external frame that aligns the IMFR with the tibia and calcaneous and compresses the fusion site before insertion of the distal fixation screws. The DynaNail™ fusion site compression is a function of the compression applied by the external frame and the DynaNail™ Nitinol element.

AI/ML Overview

Here's an analysis of the provided text regarding the MedShape Solutions DynaNail Ankle Nail, focusing on the acceptance criteria and study information:

The provided text is a 510(k) summary for the DynaNail Ankle Nail, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to a predicate device, rather than proving efficacy and safety through extensive clinical trials as an FDA PMA submission would.

Therefore, the "acceptance criteria" and "study" described are primarily focused on demonstrating substantial equivalence to the predicate device, not necessarily on meeting independent performance benchmarks in a clinical setting in the way an imaging AI algorithm might.

Here's the breakdown based on your request, filling in "N/A" where the information is not provided or applicable to this type of device submission:

Acceptance Criteria and Device Performance Study for DynaNail Ankle Nail (K101934)

The primary acceptance criterion for the DynaNail Ankle Nail, as demonstrated in this 510(k) submission, is substantial equivalence to its predicate device, the DePuy Ace VersaNail™ Intramedullary Fixation Rod (K023115), in terms of design, function, intended use, and functional performance.

The study performed was a functional performance comparison with the predicate device, conducted per ASTM F 1264-03, "Standard Specification and Test Methods for Intramedullary Fixation Devices."

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Demonstrating Substantial Equivalence)	Reported Device Performance (DynaNail Ankle Nail)
Material Composition: Ti-6AL-4V Titanium	Made from Ti-6AL-4V Titanium
Device Body Design: Hollow body with flutes	Hollow body with flutes
Attachment Points: Distal and proximal screw attachment points	Distal and proximal screw attachment points
Diameter: 12 mm	Offered in a 12 mm diameter
Lengths: Comparable to predicate device	Offered in lengths comparable to predicate device
Functional Performance (ASTM F 1264-03):
- Four-point bend testing (nail and screws)	Performed; results demonstrate substantial equivalence to predicate.
- Fatigue testing (fixation screws)	Performed; results demonstrate substantial equivalence to predicate.
- Nickel Release Testing	Performed; results demonstrate substantial equivalence.
- Corrosion Testing	Performed; results demonstrate substantial equivalence.

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

Sample Size: The document does not specify the exact number of DynaNail and VersaNail™ devices or components tested for the functional performance studies (four-point bend, fatigue, nickel release, corrosion). Typically, these types of tests involve a statistically significant sample size based on engineering standards and regulatory guidance for device testing, but the specific number is not disclosed in this summary.
Data Provenance: The data is based on prospective laboratory testing conducted by MedShape Solutions, Inc. on their DynaNail device and the predicate device. The country of origin of the data is implied to be within the USA, where MedShape Solutions is located.

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

N/A. This type of device submission does not involve clinical testing with "ground truth" established by medical experts for a "test set" in the way an AI diagnostic device would. The "ground truth" for mechanical testing is defined by the ASTM standard's methodology and acceptance limits, and the comparison to the predicate device's performance.

4. Adjudication Method for the Test Set:

N/A. Adjudication methods like 2+1 or 3+1 are relevant for clinical studies involving human interpretation or pathology, not for mechanical device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No. An MRMC study is not applicable to an intramedullary fixation rod. This type of study is typically used for diagnostic imaging devices to assess human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

N/A. The DynaNail Ankle Nail is a physical implantable medical device, not an algorithm, so "standalone performance" in this context is not applicable. The functional performance tests described are essentially "standalone" device performance evaluations in a laboratory setting.

7. The Type of Ground Truth Used:

For the functional performance testing, the "ground truth" or reference for evaluating performance was defined by:
- ASTM F 1264-03 Standard Specification and Test Methods: This standard outlines the methodology and expected performance characteristics for intramedullary fixation devices.
- Performance of the Predicate Device (DePuy Ace VersaNail™): The DynaNail was tested against the predicate, with the acceptance being that its performance is "substantially equivalent" to (i.e., not worse than) the predicate under the defined test conditions.

8. The Sample Size for the Training Set:

N/A. The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.

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

N/A. (See point 8).

Summary

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MFDSHAP SOLUTIONS

AUG - 3 2011

510(k) Summary

510(k) Number: K101934

Date Prepared: July 9, 2010

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

A. Submitter: MedShape Solutions, Inc. 1575 Northside Drive, Suite 440 Atlanta, Georgia 30318
B. Company Contact: Don Griffin Director of Operations (678) 235-3317(direct) (404) 249-9158 (fax) Don.Griffin@MedShapeSolutions.com
். Device Information: Trade Name: DynaNail Ankle Nail Common Name: Ankle Nail
D. Classification Name: Intramedullary Fixation Rod HSB 21 CFR 888.3020
E. Predicate Device(s): DePuy Ace VersaNail™ Intramedullary Fixation Rod, K023115
F. Physical Description:

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G. Indications for Use:

The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:

Post-traumatic and degenerative arthritis. Post-traumatic or primary arthrosis involving both ankle and subtalar joints. Revision after failed ankle arthrodesis with subtalar involvement. Failed total ankle arthroplasty. Non-union ankle arthrodesis. Rheumatoid hindfoot. Absent Talus (requiring tibiocalcaneal arthrodesis). Avascular necrosis of the talus. Neuroarthropathy or neuropathic ankle deformity. Neuromuscular disease and severe deformity. Osteoarthritis. Charcot Foot. Previously infected arthrosis, second degree

H. Comparison of Technological Characteristics:

The DynaNail is substantially equivalent in design, function and intended use to the following predicate devices:

DePuy Ace VersaNail™Intramedullary Fixation Rod, K023115

The construction of the DynaNail™ body is equivalent to that of the VersaNail™ device. Both devices are made from Ti-6AL-4V Titanium, have a hollow body with flutes and distal and proximal screw attachment points. The DynaNail™ is offered in a 12 mm diameter, as is the VersaNail™. The DynaNail™ is offered in lengths comparable to those of the VersaNail™

The DynaNail™ device has an external frame that aligns the IMFR with the tibia and calcaneous and compresses the fusion site before insertion of the distal fixation screws. The DynaNail™ fusion site compression is a function of the compression applied by the external frame and the DynaNail™ Nitinol element.

Image /page/1/Picture/10 description: The image shows the words "MEDSHAPE" on the top line and "SOLUTIONS" on the bottom line. There is a line separating the two words. The words are in a bold, sans-serif font. The image is in black and white.

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Image /page/2/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The string reads 'KIO1934'. The characters are written in black ink on a white background.

Functional performance testing and analysis of the DynaNail™ and VersaNail™ were conducted per ASTM F 1264-03, Standard Specification and Test Methods for Intramedullary Fixation Devices. Four point bend testing was performed on the DynaNail™ and VersaNail™ devices and fixation screws. Fatigue testing was performed on the DynaNail™ and VersaNail™ fixation screws. Nickel release testing and corrosion testing were also performed on the DynaNail™. Analysis of the results demonstrates that the proposed device performs in a substantially equivalent manner to the predicate device.

Don Griffly Director of Operations

Image /page/2/Picture/4 description: The image shows the words "MEDSHAPE SOLUTIONS" in bold, black letters. The word "MEDSHAPE" is on the top line, and the word "SOLUTIONS" is on the bottom line. There is a line separating the two words. The words are centered and the font is sans-serif.

1575 Northside Drive, Suite 440 Allanta, GA 30318 404-249-9156 phone 404-249-9158 fax

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

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

MedShape Solutions % Mr. Don Griffin 1575 Northside Drive, Suite 440 Atlanta. Georgia 30318

Re: K101934

Trade/Device Name: DynaNail Ankle Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: July 11, 2011 Received: July 15, 2011

AUG - 3 2011

Dear Mr. Griffin:

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. Don Griffin

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.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark A. Millhusan

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

Enclosure

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Indications for Use

510(k) Number: K101934

Device Name: DynaNai/™ Ankle Nail

Indications for Use:

The DynaNail™ Ankle Nail is intended for tibio-talo-calcaneal fusions:

Post-traumatic and degenerative arthritis. .
Post-traumatic or primary arthrosis involving both ankle and subtalar joints. ●
Revision after failed ankle arthrodesis with subtalar involvement. ●
Failed total ankle arthroplasty. .
Non-union ankle arthrodesis. ●
Rheumatoid hindfoot. .
Absent Talus (requiring tibiocalcaneal arthrodesis). �
Avascular necrosis of the talus. .
Neuroarthropathy or neuropathic ankle deformity. ●
Neuromuscular disease and severe deformity. ●
Osteoarthritis. .
Charcot Foot. .
Previously infected arthrosis, second degree .

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)

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for M. melkeron

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101934

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.