The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

Device Description

The Tiger Cannulated Screw System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy. The system features 2.0mm diameter, 2.4mm diameter, 3.0mm diameter and 4.0mm diameter cannulated screws. System instruments include 2.0mm/2.4mm drill bit, countersink, driver, 3.0mm/4.0mm drill bit, countersink, driver, screw driver handle, depth gauge, screw remover and K-wires to facilitate the placement of screws.

AI/ML Overview

This 510(k) summary for the Tiger Cannulated Screw System does not contain the information you requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is provided:

What the document does say:

Device Description: The Tiger Cannulated Screw System is comprised of screws (2.0mm, 2.4mm, 3.0mm, and 4.0mm diameter) and instruments for bone fixation in the hand and foot following trauma or osteotomy.
Materials: Screws are manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.
Intended Use/Indications for Use: Fixation of fractures, non-unions, arthrodeses, and osteotomies of the small bones in the hand and foot.
Predicate Device: The Tiger Cannulated Screw System is substantially equivalent to similar previously cleared cannulated screws.
No Testing: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, Trilliant Surgical believes that the Tiger Cannulated Screw Fixation System does not raise any new safety or effectiveness issues and does not require any nonclinical testing."

Regarding your specific questions:

A table of acceptance criteria and the reported device performance: Not provided. The document explicitly states no nonclinical testing was required or performed because of substantial equivalence to predicate devices.
Sample sized used for the test set and the data provenance: Not applicable. No test set was used as no testing was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established as no testing was performed.
Adjudication method for the test set: Not applicable. No test set was used.
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 a medical device (screw system), not an AI-assisted diagnostic tool. No such study was conducted or would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
The type of ground truth used: Not applicable. No ground truth was used as no testing was performed.
The sample size for the training set: Not applicable. No training set was used as no AI model was developed or tested.
How the ground truth for the training set was established: Not applicable. No training set was used.

In essence, for this 510(k) submission, the manufacturer leveraged the "substantial equivalence" pathway, arguing that the device is so similar to already-approved devices that no new performance testing or clinical studies were necessary to demonstrate its safety and effectiveness. Therefore, the document does not contain any of the detailed performance study information you've requested.

Summary

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510(k) Summary for the Tiger Cannulated Screw System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Tiger Cannulated Screw System.

Date Prepared: May 27, 2008

AUG - 4 2008

1. Submitter:	Contact Person:	A
Trilliant Surgical Ltd1630 W.13th StHouston, TX 77008	J.D. WebbThe OrthoMedix Group, Inc.1001 Oakwood BlvdRound Rock, TX 78681Telephone: 512-388-0199

2. Trade name:	Tiger Cannulated Screw System
Common Name:	Bone screw
Classification Name:	Screw, Fixation, BoneClass II per 21 CFR section 888.3040
	HWC

3. Predicate or legally marketed devices which are substantially equivalent:

The Tiger Cannulated Screw System is substantially equivalent to similar previously cleared cannulated screws.

4. Description of the device:

Materials:

The screws will be manufactured from titanium alloy (Ti-6Al-4V) per ASTM F136.

Function:

The Tiger Cannulated Screw Fixation System is comprised of screws used for bone fixation of the hand and foot following trauma or osteotomy.

5. Intended Use:

The Tiger Cannulated Screw Fixati on System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

Comparison of the technological characteristics of the device to predicate and legally marketed 6. devices:

Due to the similarity of materials and design to both pre-enactment and post-enactment devices, Trilliant Surgical believes that the Tiger Cannulated Screw Fixation System does not raise any new safety or effectiveness issues and does not require any nonclinical testing.

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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 stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trillian Surgical Ltd. % The OrthoMedix Group, Inc. Mr. J.D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

AUG - 4 2008

Re: K081510

Trade/Device Name: Tiger Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 27, 2008 Received: May 29, 2008

Dear Mr. Webb:

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.

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 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.

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Page 2 - Mr. J.D. Webb

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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

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Indications for Use

510(k) Number (if known): _K0815 | را | ر

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Tiger Cannulated Screw Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones In the hand and foot.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Wilkerson

Division of General, Restorative, and Neurological Devices

0815 510(k) Number

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.