The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug 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
-Acromioclavicular separations due to coracoclavicular ligament disruptions
Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions;
-Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue to- bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Device Description

The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromioclavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel and titanium.

AI/ML Overview

This document is a 510(k) premarket notification for the Tensyn™ Plug, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria metrics, detailed study design, and performance outcomes for a device that "meets acceptance criteria" in terms of clinical accuracy or diagnostic performance is not present in this regulatory filing.

However, I can extract information related to the device's performance testing which serves to establish substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" in a table format that would typically be seen for diagnostic or AI-based devices. Instead, it refers to performance testing conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the Tensyn™ Plug performs similarly or equivalently to the predicate devices in the described tests.

Acceptance Criterion (Implicit)	Reported Device Performance
Rotational Loading	Demonstrated substantial equivalence to predicate devices.
Cyclic Loading	Demonstrated substantial equivalence to predicate devices.
Ultimate Load	Demonstrated substantial equivalence to predicate devices.
Load at 3mm	Demonstrated substantial equivalence to predicate devices.
Shear Test	Demonstrated substantial equivalence to predicate devices.

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

The document refers to "testing" performed but does not specify the sample size for the test set (e.g., number of devices tested, number of simulated applications). It also does not mention data provenance (e.g., country of origin, retrospective/prospective) as the testing appears to be primarily mechanical performance testing on the device itself, rather than clinical data from human subjects.

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

Not applicable. This type of information is relevant for studies involving human interpretation or diagnostic accuracy. The testing described (rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test) is mechanical and likely involves engineering analysis and measurements, not human expert consensus for "ground truth."

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like "2+1" or "3+1" are used when multiple readers/experts are involved in establishing ground truth, which is not the case for the mechanical performance testing described.

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

No. An MRMC comparative effectiveness study is typically performed for diagnostic devices to assess how much human readers improve with AI assistance. This document describes a mechanical fixation device, and an MRMC study is not relevant to its regulatory submission for substantial equivalence.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. The Tensyn™ Plug is a mechanical implant, not an algorithm. The "standalone performance" refers to the device's mechanical integrity and strength under various loads.

7. The Type of Ground Truth Used:

For the mechanical performance tests, the "ground truth" would be established by physical measurements and engineering standards for mechanical properties (e.g., specific load at which failure occurs, displacement at a certain load). This is not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this mechanical device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and appear to be a single, continuous line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

May 7, 2015

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

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

Re: K150359 Trade/Device Name: Tensyn™ Plug 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: February 11, 2015 Received: February 12, 2015

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 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/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 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,

Mark N. Melkerson -S

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

Enclosure

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K150359

Dallen Medical, Inc. 510(k) K150359 – Amendment 1 April 10, 2015 - Tensyn™ Plug

Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K150359

Device Name: Tensyn™ Plug

Indications for Use:

A syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures
-Acromioclavicular separations due to coracoclavicular ligament disruptions
Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions;
-Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
-Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

Prescription Use	X
(Per 21 CFR 801.109)

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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Dallen Medical, Inc. 510(k) K150359 – Amendment 1 April 10, 2015 – Tensyn™ Plug

Image /page/3/Picture/1 description: The image shows the logo for Dallen Medical. The word "dallen" is written in a simple, sans-serif font in gray. Below it, the word "MEDICAL" is written in a bold, sans-serif font in yellow. The logo is clean and modern.

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 G
	San Clemente, CA 92673
	(949) 218-0030 Phone
	(949) 218-0040 Fax
CONTACT PERSON:	Al Memmolo
	Chief Operating Officer
DATE PREPARED:	April 10, 2015
DEVICE DESCRIPTION:
TRADE NAME:	Tensyn™ Plug
GENERIC/COMMONNAME	Button / Lock / Suture
CLASSIFICATION NAME:	Washer, Bolt Nut, CFR 888.3030 (code HTN)
DEVICE CLASSIFICATION:	Class II
PREDICATE DEVICES:	Tensyn Plug (K143092)
	TightRope Syndesmosis Device (K043248)

Product Description:

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Dallen Medical, Inc. 510(k) K150359 – Amendment 1 April 10, 2015 - Tensyn™ Plug

Image /page/4/Picture/1 description: The image shows the logo for Dallen Medical. The word "dallen" is written in a simple, sans-serif font in a light gray color. Below "dallen" is the word "MEDICAL" in a bold, sans-serif font in a golden yellow color. The logo is clean and modern.

Indications for Use:

A syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures
-Acromioclavicular separations due to coracoclavicular ligament disruptions
Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions:
Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

Technical Characteristics:

The Tensyn Plug 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 Plug 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 Plug 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 Plug 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.