The Union Surqical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

Device Description

The Union Surgical. LLC T-Pin® is a threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures. The device incorporates a break-off shank. The device is ontionally supplied with removal tools that permit pin extraction and a sterilization tray.

AI/ML Overview

The Union Surgical, LLC T-Pin® is a cannulated fixation screw intended for the repair of specific wrist fractures. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as might be found for a novel diagnostic or AI-driven device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The T-Pin®'s acceptance criteria are framed around its substantial equivalence to a legally marketed predicate device and compliance with relevant ASTM standards. These are not performance metrics in the sense of accuracy, sensitivity, or specificity often associated with diagnostic or AI devices, but rather design, material, and mechanical property standards for surgical implants.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Demonstrates substantial equivalence to the Taras Threaded Fixation Pin (K032532). This involves a comparison of technological characteristics and mechanical performance.	"The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pins that are legally marketed and distributed by Union Surgical, LLC. This has been demonstrated through a 13-point technological comparison of features and a 3-parameter comparison of mechanical performance."
Material Standards	Compliance with ASTM F138 - 97: Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). Compliance with ASTM F899 - 95: Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical.	The device "complies with the following standards... ASTM F138 - 97" and "ASTM F899 - 95". The materials "have a long history of safe usage in medical devices."
Device Design/Function Standards	Compliance with ASTM F366 - 82 (Reapproved 2000): Standard Specification for Fixation Pins and Wires.	The device "complies with the following standards... ASTM F366 - 82 (Reapproved 2000)". The device is a "threaded and cannulated stainless steel Steinmann pin used for the repair of wrist fractures," similar to the predicate.
Safety and Effectiveness	The device is safe and effective and performs as well as, or better than, the predicate device.	"Since the Union Surgical, LLC T-Pin® meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as, or better than, the predicate device." "The T-Pin® will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use." The FDA's 510(k) clearance confirms this determination.

Detailed Study Information (Based on the Provided Text):

The provided document describes a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full-scale clinical or performance study with the types of metrics requested for AI or diagnostic devices. Therefore, many of the requested details for a "study" are not applicable or explicitly stated in this context.

A table of acceptance criteria and the reported device performance: (See table above)
Sample size used for the test set and the data provenance:
- Not Applicable in this context. For a 510(k) for a fixation pin, a "test set" in the sense of patient data is not used for proving substantial equivalence in the way it would be for an AI algorithm. The "testing" refers to mechanical and material characterization against established standards and comparison to the predicate device's specifications. The document does not specify details of any in vitro mechanical testing beyond stating that a "3-parameter comparison of mechanical performance" was done, and it doesn't mention the specifics of that comparison or sample sizes for such tests.
- Data Provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth in the context of expert review of patient cases is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and comparison to a predicate device, which is evaluated by regulatory bodies and engineers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to establish consensus among experts for ground truth in clinical data; this is not relevant for a device cleared through substantial equivalence based on technical specifications and material standards.
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:
- No. An MRMC comparative effectiveness study is not mentioned and would not be relevant for a bone fixation pin. This device is not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical medical device (a surgical pin), not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission revolves around compliance with established engineering and material standards (e.g., ASTM F366, F138, F899) and demonstrated equivalence in technological characteristics and mechanical performance to a legally marketed predicate device (Taras Threaded Fixation Pin K032532). Physical and material properties are the "truth" being assessed.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/machine learning device.

Summary

{0}------------------------------------------------

JAN 1 3 2006

K0535/3 p1/2

Page 17 of 18

Summary of Safety and Effectiveness for the T-Pin®

submitted by Union Surgical, LLC 834 Chestnut Street Philadelphia, PA 19107 Phone: (215)-521-3009

Contact Person:	Al Weisenborn
Device Trade Name:	T-Pin®
Common Name:	Cannulated Fixation Screw
Classification Name:	Smooth or threaded metallic bone fixation fastener per 21 CFR § 888.3040

Identification of a Legally Marketed Predicate Device

The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pin that is legally marketed and distributed by Union Surgical, LLC pursuant to K032532.

Device Description

Intended Use

The Union Surgical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

Summary of Technological Characteristics

A 13-point comparison of technological characteristics of the Union Surgical, LLC T-Pin® and the Taras Threaded Fixation Pin was performed. The devices were found to be substantially equivalent.

Summary of Performance Data

The Union Surgical. LLC T-Pin® complies with the following standards, practices, and guidances:

. ASTM F366 82 (Reapproved 2000), Standard Specification for Fixation Pins and Wires

{1}------------------------------------------------

. ASTM F138 - 97, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
. ASTM F899 - 95, Standard Specification for Stainless Steel Billet, Bar and Wire for Surgical

The Union Surgical, LLC T-Pin® is substantially equivalent to Taras Threaded Fixation Pins that are legally marketed and distributed by Union Surgical, LLC. This has been demonstrated through a 13-point technological comparison of features and a 3-parameter comparison of mechanical performance.

The Implantable and tissue contact materials used to fabricate the T-Pin® and Instruments have a long history of safe usage in medical devices. Since the Union Surgical, LLC T-Pin® meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as, or better than, the predicate device. The T-Pin® will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a stylized human figure.

દ્રિક

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2006

John Taras, M.D. President Union Surgical, LLC 834 Chestnut Street, Suite G- 114 Philadelphia, PA 19107

Re: K053513

Trade/Device Name: T-Pin® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: December 12, 2005 Received: December 16, 2005

Dear Dr. Taras:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve reviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for assured in 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - John Taras, M.D.

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

Mark N. Melkerson for Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use - Indications for Users

K053513 510(k) Number (if known): _

Device Name: T-Pin®

Indications for Use:

The Union Surqical, LLC implantable T-Pin® is intended for the repair of distal radius fractures, proximal ulna fractures, and comminuted wrist fractures without intraarticular fracture gapping.

Prescription Use_ X (Per 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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number_ Los 353

Union Surgical, LLC

834 Chestnut Street, Philadelphia, PA 19107

Revised: January 5, 2006

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.