The DYNAMIC COMPRESSION SMA Staple System is indicated for use in: (1) Hand and foot bone fragment and osteotomy fixation and joint arthrodesis, (2) Fixation of proximal tibial metaphysis osteotomy, and (3) Fixation of soft tissue to bone such as in anterior cruciate ligament reconstruction.

Device Description

The DYNAMIC COMPRESSION SMA Staple is fabricated from Nitinol Shape Memory Alloy. This bone fixation device consists of both two and four prong staples and is intended to achieve compression in fixation of bones in the hand, foot, tibia and ankle. Nitinol can change its configuration (shape) based on temperature. At room temperature, the material is pliant and the staple prongs can be straightened. This allows for easy insertion into the bone. After the staple has reached body temperature, the staple prongs deflect inward to their original shape. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site. This inward bending creates a claw effect, and helps prevent the staple from backing out of the bone.

AI/ML Overview

The provided text is a 510(k) summary for the DYNAMIC COMPRESSION Shape Memory Alloy (SMA) Staple System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than a study with acceptance criteria for a new device's performance.

Therefore, the specific information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because the 510(k) pathway for this device relies on equivalence, not a direct performance study with defined criteria against a new benchmark.

Specifically:

A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence, not performance against specific criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or specific performance data from a study is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No test set or ground truth establishment process is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication process is described.
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 device is a surgical staple, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical staple, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth is established in the context of a performance study.
The sample size for the training set: Not applicable. No training set is mentioned as this is not a machine learning device.
How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment process is described.

Summary from the provided text:

Mechanism of Equivalence: The submission primarily relies on demonstrating substantial equivalence to other previously cleared shape memory alloy staples.
Device Description: The DYNAMIC COMPRESSION SMA Staple is made from Nitinol, which changes shape with temperature (pliant at room temperature for insertion, deflects inward at body temperature for compression).
Indications for Use: Hand and foot bone fragment and osteotomy fixation, joint arthrodesis, fixation of proximal tibial metaphysis osteotomy, and fixation of soft tissue to bone (e.g., ACL reconstruction).

Since this 510(k) is based on substantial equivalence, it does not describe a study involving detailed acceptance criteria and performance metrics for the device itself, but rather references its similarity to already approved devices.

Summary

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K012081

OCT - 1 2001

DYNAMIC COMPRESSION Shape Memory Alloy (SMA) Staple System 510(k) Summary of Safety and Effectiveness June 2001

Medtronic Sofamor Danek, Inc. USA I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: DYNAMIC COMPRESSION Shape Memory II. Alloy (SMA) Staple System

III. Product Description

IV. Indications

V. Substantial Equivalence

Documentation was provided which demonstrated the DYNAMIC COMPRESSION SMA Staple System to be substantially equivalent to other previously cleared shape memory alloy staples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features a stylized image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle. The text is in a sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 1 2001

Dr. Richard W. Treharne Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K012081

Trade Name: Dynamic Compression Shape Memory Alloy (SMA) Staple System Regulation Number: 888.3030 Regulatory Class: II Product Code: JDR Dated: June 29, 2001 Received: July 3, 2001

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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Page 2 - Dr. Richard W. Treharne

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark McMillan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K012081

DYNAMIC COMPRESSION Shape Memory Alloy Staple System Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use y 2 (Per 21 CFR 801.109)

Over-the-counter Use No

(Optional 1-2-96)

Mark N. Mulkerin

Division Sion-C Division of General, Restorative and Neurological Devices

510(k) Number _

KO12081

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.