The SIGN Fin Nail system includes intramedullary nails, Interlocking Screws and Instruments. All components are manufactured from stainless steel. The SIGN Fin Nail is available with diameters of 7mm, 8mm, 9mm, 11mm, 11mm, and 12mm in the following lengths: 160mm, 190mm, 240mm and 280mm. Each nail is made from a solid type 316, ASTM F138, solid stainless steel bar with distal and proximal bends. Each nail has a hole and a slot at the proximal end to accept solid 4.5mm diameter cortical bone screws for fixation and uses rigid distal fins for rotational stability. The SIGN Fin Nail may be removed upon fracture healing.

AI/ML Overview

This looks like a 510(k) summary for a medical device called the "SIGN Fin Nail." This type of document is for regulatory clearance and focuses on substantial equivalence to already approved devices, rather than a clinical study proving performance against acceptance criteria in the way a novel technology might.

Therefore, the requested information elements related to a human subject study or detailed performance criteria are largely not applicable in this document. The document primarily focuses on establishing that the SIGN Fin Nail is similar in design, materials, and intended use to existing, legally marketed devices.

Here's the breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and corresponding reported performance from a clinical study. The clearance is based on substantial equivalence, implying that since predicate devices are safe and effective, and the new device is substantially equivalent, it too is safe and effective.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. There is no mention of a "test set" in the context of a clinical performance study. The evaluation is based on design, material, and indications for use comparison to predicate devices.

3. 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. Ground truth in the context of a clinical study is not established or discussed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method is mentioned as there's no clinical test set being adjudicated.

5. 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 an intramedullary nail, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a medical implant, not an algorithm, so standalone performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. Ground truth for clinical performance is not established or discussed. The "ground truth" for regulatory clearance is that predicate devices are legally marketed and considered safe and effective.

8. The sample size for the training set

Not Applicable. No training set is mentioned as this device is not an AI/ML algorithm requiring one.

9. How the ground truth for the training set was established

Not Applicable. No training set, no ground truth establishment for it.

Summary based on the provided document:

The regulatory clearance for the SIGN Fin Nail is based on its substantial equivalence to already legally marketed predicate devices. The document explicitly states:

Predicate Devices: SIGN IM Nail System, Howmedica Alta IM Rod System, Biomet Brooker Femoral nail, Encore True/Flex Upper Extremity Nail.
Basis for Safety and Effectiveness: "The safety and effectiveness of the SIGN Fin Nail is also based on a long history of use of this type of device in the market place."
Device Description: The document provides a detailed description of the device materials (stainless steel, type 316, ASTM F138), dimensions (diameters, lengths), design features (hole, slot, rigid distal fins), and mechanism of action (internal fixation, rotational stability). These details are implicitly compared to the known characteristics of the predicate devices to establish equivalence.
Indications for Use: "The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus." This indication is also compared to the predicate devices.

In essence, the "study" demonstrating the device meets "acceptance criteria" for a 510(k) is a comparison to predicate devices to show substantial equivalence. The acceptance criteria are implicitly that the new device does not raise new questions of safety or effectiveness compared to the similar, already-approved devices, given its design, materials, and intended use.

Summary

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

Image /page/0/Picture/0 description: The image is a logo for SIGN Fracture Care International. The logo features the word "SIGN" in bold, black letters, with the tagline "Creating Equality of Fracture Care Throughout the World" underneath. To the left of the word "SIGN" is an image of a medical device, possibly an intramedullary nail, with a globe at the top. The globe has some text on it, but it is too small to read.

510(k) Summary of Safety and Effectiveness

SIGN Fin Nail

Contact Information

Doug Donnelly 2950 George Washington Way Richland WA 99352 Phone: (509) 371-1107 Fax: (509) 371-1316 signcom@sign-post.org

Classification Name:	Rod, Fixation, Intramedullary and Accessories
Common Name:	Intramedullary Rod
Proprietary Name:	SIGN Fin Nail
Proposed Regulatory Class:	Class II, Intramedullary Fixation Rod,
	21 CFR §888.3020, OR
Device Product Code:	HSB

Substantial Equivalence Information

The SIGN Fin Nail is similar to the following Devices: SIGN IM Nail System Howmedica Alta IM Rod System Biomet Brooker Femoral nail Encore True/Flex Upper Extremity Nail

All of the devices listed above are similar in design to the SIGN Fin Nail system. The safety and effectiveness of the SIGN Fin Nail is also based on a long history of use of this type of device in the market place.

Device Description

Indications for use

The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB = 3 2005

Mr. Douglas J. Donnelly Manager, Regulatory Affairs SIGN, Inc. 2950 George Washington Way Richland, Washington 99352

Re: K043200

Trade/Device Name: SIGN Fin Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: November 15, 2004 Received: November 18, 2004

Dear Mr. Donnelly:

We have reviewed your Section 510(k) premarket notification of intent to market the are died we nave reviewed your becaon - 10(t) personalially equivalent (for the indications felerenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regars actment date of the Medical Device Amendments, or 10 commence provide to thay 20, 1978, the encordance with the provisions of the Federal Food. Drug. devices mat have been receissmed in assee approval of a premarket approval application (PMA). and Cosmetic Act (1101) that do not require to the general controls provisions of the Act. The I ou may, dicrerore, market the act include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classined (over as controls. Existing major regulations affecting your device can thay be subject to sach additions, 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 i lease oc actived that I Driver and in that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I oderal banks and seeg.
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 CI IT rate 677, adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis) by our provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. Douglas J. Donnelly

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) 276-0115. 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,
Mark A. Mikkelson

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

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

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SIGN Fin Nail Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use: The SIGN Fin nail is indicated for internal fixation of stable fractures in the femur and humerus.

Prescription Use X (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 CI Device Evaluation (ODE) ign=4 i (Division of General, Restorative, and Neurological Devices K04 3200 510(k) Number-

Page 1_of_l_

Section VI

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.