The Trilliant Surgical Sniper Staple System is indicated for fixation of fractures and osteotomies of the hand, foot, and bones appropriate for the size of the device.

Device Description

The Sniper Staple is a mechanical osteosynthesis device allowing for fixation and compression of the bone fragments in order to encourage early bone healing. The staple is fabricated from a nickel-titanium alloy (Nitinol) and possesses super-elastic properties at room temperature. The staple offering is composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shaped wire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mm sizes.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Sniper Staple System." It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, not a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and AI/MRMC studies is not applicable to this type of document.

However, I can extract the relevant information from the document in the context of a traditional medical device (a surgical staple).

Here's the information that can be extracted:

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

For a traditional medical device like a surgical staple, "acceptance criteria" are typically defined by recognized standards and mechanical testing rather than a numerical performance metric like sensitivity/specificity for an AI. The document describes several non-clinical tests performed.

Test Performed	Acceptance Criteria (Implied by standard)	Reported Device Performance
Four-point Bending (ASTM F564)	Meets performance requirements of ASTM F564 for fixation devices	Results indicate equivalence to predicate devices (Implied satisfactory performance)
Pull-out Testing (ASTM F564)	Meets performance requirements of ASTM F564 for fixation devices	Results indicate equivalence to predicate devices (Implied satisfactory performance)
Bend and Free Recovery (ASTM F2082)	Meets performance requirements of ASTM F2082 for Nitinol	Results indicate equivalence to predicate devices (Implied satisfactory performance)
Corrosion testing (ASTM F2129)	Meets performance requirements of ASTM F2129 for surgical implants	Results indicate equivalence to predicate devices (Implied satisfactory performance)
Pyrogenicity (LAL assay)	Recommended maximum endotoxin level of 20 EU per device	Demonstrated that the subject device meets the recommended maximum endotoxin level.

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

Sample Size: Not specified in the document. For mechanical testing, sample sizes are typically determined by the specific ASTM standards referenced (e.g., F564, F2082, F2129).
Data Provenance: Not applicable. These are laboratory-based mechanical and biological (pyrogenicity) tests performed on the device itself, not data from human subjects or clinical records.

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 as typically understood for AI/diagnostic algorithms is not relevant here. The "truth" is established by the physical properties and performance of the device as measured by standardized engineering and biological tests.

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

Not applicable. This concept pertains to human review of medical data for ground truth establishment, which is not relevant for this device's testing.

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

No. This is a traditional surgical staple, not an AI or diagnostic imaging device.

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

No. This is a physical medical device, not an algorithm.

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

For mechanical tests: Engineering standards (ASTM F564, F2082, F2129) define acceptable performance.
For biocompatibility/safety test: Biological standards (e.g., maximum endotoxin level for pyrogenicity).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary from the document for the Sniper Staple System:
The device's substantial equivalence to predicate devices is based on non-clinical testing, including:

Four-point Bending (ASTM F564)
Pull-out Testing (ASTM F564)
Bend and Free Recovery Testing (ASTM F2082)
Corrosion testing (ASTM F2129)
Pyrogenicity testing (Limulus amebocyte lysate (LAL) assay)

The document states, "The results of these evaluations indicate that the Sniper Staple is equivalent to predicate devices," and for pyrogenicity, "The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device." No clinical studies were performed. The conclusion for equivalence is based on similarities in principles of operation, technology, materials, and indications for use.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

April 20, 2017

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

Trilliant Surgical LTD % J.D. Webb Authorized Contact Person The Orthomedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681

Re: K162354 Trade/Device Name: Sniper Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: March 6, 2017 Received: March 8, 2017

Dear J.D. 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. 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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" (21 CFR 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,

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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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K162354

Device Name Sniper Staple System

Indications for Use (Describe)

The Trilliant Surgical Sniper Staple System is indicated for fixation of the hand, foot, and bones appropriate for the size of the device.

Type of Use (Select one or both, as applicable)

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

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary: Sniper Staple System

Date Prepared	April 7, 2017
Submitted By	Trilliant Surgical, LTD6721 Portwest Dr.Suite 160Houston, TX 77024Tele: 713-388-6055Contact: Jon Olsonemail: jolson@trilliantsurgical.com
RegulatoryContact	J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net
Trade Name	Sniper Staple System
Common Name	bone staple
Classification Name	Staple, Fixation, Bone
Class	II
Product Code	JDR
CFR Section	21 CFR section 888.3030
Device Panel	Orthopedic
Primary PredicateDevice	MemoFix Super Elastic Nitinol Staple System (Metasurg (Integra), K123926)
Secondary PredicateDevices	Super Staple Classic (Metric Medical Devices, K123363)Smith and Nephew Richards Staple, (pre-amendment device)
Device Description	The Sniper Staple is a mechanical osteosynthesis device allowing for fixationand compression of the bone fragments in order to encourage early bonehealing. The staple is fabricated from a nickel-titanium alloy (Nitinol) andpossesses super-elastic properties at room temperature. The staple offeringis composed of staples consisting of a 1.5 mm x 1.2 mm diameter "U" shapedwire. The "U" shaped staple is available in 8 mm x 8 mm and 10 mm x 10 mmsizes.
Materials	Nickel-titanium alloy (Nitinol) per ASTM F2063
Summary ofTechnologicalCharacteristics	The rationale for substantial equivalence is based on consideration of thefollowing characteristics:Intended Use: The subject device and the predicate devices are intended forbone fixation.Indications for Use: The subject device and the predicates have equivalentindications for use.Materials: The subject device and predicate devices are manufactured fromNitinolDesign Features: The subject device has similar design features to that of thepredicates.Dimensions: The dimensions of the subject device and the predicates areequivalent.
	Sterilization: The subject device and one of the predicate devices areprovided sterile by gamma irradiation.
Indications for Use	The Trilliant Surgical Sniper Staple System is indicated for fixation of fracturesand osteotomies of the hand, foot, and bones appropriate for the size of thedevice.
Non-clinical TestSummary	The following analyses were conducted:• Four-point Bending (ASTM F564)• Pull-out Testing (ASTM F564)• Bend and Free Recovery Testing per ASTM F2082• Corrosion testing per ASTM F2129• Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL)assay. The testing demonstrated that the subject device meets therecommended maximum endotoxin level of 20 EU per device.The results of these evaluations indicate that the Sniper Staple is equivalentto predicate devices.
Clinical TestSummary	No clinical studies were performed
Conclusions:Non-clinical andClinical	Trilliant Surgical considers the Sniper Staple System to be equivalent to thepredicate device listed above. This conclusion is based upon the devices'similarities in principles of operation, technology, materials and indications foruse.

In accordance with 21 CFR 807.92 of the Federal Code of Regulations

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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.