Tensyn ™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.

Device Description

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder. The Tensyn™ Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.

AI/ML Overview

This document is a 510(k) premarket notification for the Tensyn™ Band, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in an AI/ML device submission.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for Class II devices like the Tensyn™ Band. The "Performance Data" section briefly describes the types of tests performed but does not provide specific acceptance criteria or detailed results.

Therefore, I cannot provide the requested information from the provided text. The document states:

Performance Data: "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices."

This indicates that mechanical and physical performance tests were conducted to show the new device performs similarly to existing, legally marketed predicate devices, rather than meeting specific pre-defined quantitative acceptance criteria in the context of an AI/ML study.

To directly answer your numbered points based only on the provided text, I must state that the relevant information is not present or applicable in the context of an AI/ML device study:

A table of acceptance criteria and the reported device performance: Not provided. The document states testing was performed to assure substantial equivalence, but no specific performance metrics or acceptance criteria are listed.
Sample sized used for the test set and the data provenance: Not provided. The performance data refers to mechanical testing, not a clinical test set with human data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a mechanical fixation device, not an AI/ML diagnostic tool requiring expert ground truth.
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. This is not an AI/ML device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. For a mechanical device, "ground truth" would be engineering specifications and validated test methods.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

August 21, 2014

Dallen Medical, Inc. Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo Suite G San Clemente, California 92673

Re: K141264

Trade/Device Name: Tensyn™ Band Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: June 27, 2014 Received: June 30, 2014

Dear Mr. Memmolo:

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

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Page 2 - Mr. Al Memmolo

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 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/Resourcesfor You/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,

Image /page/1/Picture/8 description: The image shows the name "Lori A. Wiggins -S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.

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 Statement

Page 1 of 1

K141264 510(k) Number (if known):

Device Name: Tensyn™ Band

Indications for Use:

Tensyn 110 Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter-Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

GENERAL INFORMATION

APPLICANT:	Dallen Medical, Inc.1046 Calle Recodo, Suite GSan Clemente, CA 92673(949) 218-0030 Phone(949) 218-0040 Fax
CONTACT PERSON:	Al MemmoloChief Operating Officer
DATE PREPARED:	August 15, 2014
DEVICE DESCRIPTION:
TRADE NAME:	Tensyn™ Band
GENERIC/COMMONNAME	Button / Lock / Suture
CLASSIFICATION NAME:	Washer, Bolt Nut, CFR 888.3030 (code HTN)
DEVICE CLASSIFICATION:	Class II
PREDICATE DEVICES:	Tensyn™ Band (K133858)OrthoHelix Syndesmosis Fixation Devices (K132733)

Product Description:

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Indications for Use:

Tensyn " Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn 100 Band is used in conjunction with, but not connected to, supplemental fixation.

Technical Characteristics:

The Tensyn™ Band has similar physical and technical characteristics to the predicate devices since all devices achieve fixation through a suture between two metal fasteners.

Performance Data:

All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices.

Basis for Determination of Substantial Equivalence:

Upon reviewing the technical information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Tensyn™ Band is determined to be substantially equivalent to existing legally marketed 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.