The Speed Triad is a nitinol implant that comes in a range of sizes for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis of the hand and foot. The implant is delivered to the operating room in an "open" state in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient temperature and body heat after insertion, and contracts to a "closed" and compressive state. The implants do not require any external heating; they are completely transformed at room temperature. The Speed Triad incorporates design changes from the Speed Shift. The design is changed to include a third leg to provide additional fixation. Importantly, the Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).

AI/ML Overview

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Speed Triad™ bone staple.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (Speed Triad)
Pull-out Strength	Goal: Substantially equivalent pull-out resistance compared to the predicate OSSplate. Method: Performed according to ASTM F564-10 (2010), comparing all three sizes of Speed Triad to a comparably sized predicate OSSplate.	Result: The Speed Triad demonstrated substantially equivalent pull-out resistance when compared to the predicate OSSplate implant.
Mechanical Strength	Goal: Substantially equivalent bending stiffness compared to the predicate OSSplate. Method: Performed according to ASTM F564-10 (2010), comparing all three sizes of Speed Triad to a similar-sized predicate OSSplate.	Result: The Speed Triad implants achieved substantially equivalent bending stiffness when compared to the predicate OSSplate.
Corrosion Resistance	Goal: Substantially equivalent corrosion resistance compared to the predicate OSSplate and SmartToe. Method: Performed according to ASTM F2129-08, comparing representative samples of the Speed Triad to the predicate OSSplate and the secondary predicate SmartToe (K070598).	Result: Test results demonstrate the substantially equivalent corrosion resistance of the Speed Triad compared to the predicate OSSplate and SmartToe.
Material Composition	Goal: Use of a material that meets established standards and is the same as predicate devices. Method: Not explicitly described as a specific test, but material specification is provided for comparison.	Result: Nitinol, per ASTM F2063-12 (same as predicate Speed Shift and OSSplate). Grey PC #5816, SS 17-4, SS-303 (same patient-contacting materials as predicate Speed Shift and OSSplate, with the exception of OSSplate not listing Grey PC #5816).
Manufacturing Process	Goal: Use of the same raw material, manufacturing process (heat treatment, surface treatment, and passivation) as the predicate Speed Shift. Method: Not explicitly described as a specific test, but process equivalence is stated.	Result: The Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation). Surface Finish: Mechanical tumbling, acid cleaning, and chemical passivation (same as Speed Shift, but different from OSSplate which is mechanical tumbling only).
Functional State	Goal: Fully transformed at room temperature. Method: Not explicitly described as a specific test, but functional characteristic is stated.	Result: Fully transformed at room temperature (same as Speed Shift, different from OSSplate which uses an electrical heating unit).
Sterilization & Storage	Goal: Sterile packaged and stored at room temperature until used. Method: Not explicitly described as a specific test, but storage conditions are provided.	Result: Sterile packaged stored at room temp until used (same as both Speed Shift and OSSplate predicates).

2. Sample Sizes Used for the Test Set and the Data Provenance

The provided text details performance bench testing. For all three types of tests (pull-out strength, mechanical strength, and corrosion resistance), the sample size is described as "Specimens of all three sizes of the Speed Triad were used" and "representative samples of the new Speed Triad." The exact number of specimens per size or per test is not specified.

The data provenance is from bench testing conducted by the manufacturer, BioMedical Enterprises, Inc., in San Antonio, Texas, USA. This is an in vitro study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The "ground truth" in this context refers to the absolute physical properties (e.g., pull-out strength, bending stiffness, corrosion resistance) measured through standardized ASTM methods, not through expert human interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or clinical endpoints where there's a need to resolve discrepancies among observers. This study involves standardized mechanical and material property testing, where the results are quantitative and directly measured.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study solely focuses on the mechanical and material characteristics of the device through bench testing, comparing it to predicate devices. It does not involve human readers, case interpretations, or an assessment of human performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable as the device (Speed Triad™) is a physical bone staple, not an algorithm or AI software. Therefore, there is no "algorithm only" performance to evaluate. The study assesses the standalone physical characteristics of the device.

7. Type of Ground Truth Used

The "ground truth" used for this study is based on objective, quantitative measurements of physical properties, specifically defined and validated by industry standards:

ASTM F564-10 (2010) for pull-out strength and mechanical strength (bending stiffness).
ASTM F2129-08 for corrosion resistance.

These standards provide the methodology for determining the "true" physical performance of the device under specific test conditions.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical bone staple, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical bone staple, not an AI or machine learning model.

Summary

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Section 5: 510(k) Summary

APR 0 7 2014

Speed Triad™ Product:

Submitter Information

BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245 Telephone: (210) 677-0354 (210) 677-0355 Fax: Joe W. Soward Contact:

Date Prepared: April 3, 2014

Classification name: Single/multiple component metallic bone fixation appliances and accessories (21 CFR 888.3030)

Classification:	Class II ·
Product Code:	JDR
Common/Usual Name:	Bone Staple
Proprietary Name:	Speed Triad

Intended Use:

The Speed Triad is indicated for:

Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Substantial Equivalence:

The Speed Triad is substantially equivalent to the predicate BME Speed Shift™ cleared in K124022, predicate OSSplate™ cleared in K993714, labeled as the Memograph® Staple, and predicate K070598 (SmartToe). The K993714 predicate also includes an intended use of fixation of proximal tibial metaphysis osteotomy and fixation of soft tissue to bone (anterior cruciate reconstruction) which is not included in this submission.

Device Description:

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The Speed Triad incorporates design changes from the Speed Shift. The design is changed to include a third leg to provide additional fixation. Importantly, the Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).

A second predicate is used for comparison of mechanical and corrosion properties of the Speed Triad. Because the Speed Triad implants are more similar shaped to the predicate OSSplate implants than the Speed Shift implants, BME has used the OSSplate to show substantial mechanical and corrosion resistance equivalence to a similar-sized implant.

The table below summarizes the technological characteristics of the Speed Triad and the predicate devices.

ProductName:	Speed Triad	PredicateSpeed Shift(K124022)	PredicateOSSplate (K993714)
RawMaterial:	Nitinol, per ASTMF2063-12	Nitinol, per ASTMF2063-12	Nitinol, per ASTMF2063-12
BridgeLengths(mm):	18, 20, and 25	15 and 20	15
Leg Lengths(mm):	10, 12, and 15	20	6, 8, and 10
Cross-sectionDimensions(mm):	1.25 x 1.50 (DoubleLeg)/1.25 x 1.80 (Single Leg)	1.8 x 2.0 (Leg)	1.20 x 1.50 (Leg)
Barbs:	Barbs on the legs	Barbs on the legs	Smooth legs
Heat Source:	Fully transformedat room temperature	Fully transformedat room temperature	OSSforce electricalheating unit
SurfaceFinish:	Mechanical tumbling,acid cleaning, andchemical passivation.	Mechanical tumbling,acid cleaning, andchemical passivation.	Mechanicaltumbling only.
PatientContactingMaterials:	NitinolGrey PC #5816SS 17-4SS-303	NitinolGrey PC #5816SS 17-4SS-303	NitinolSS 17-4SS-303
Storage:	Sterile packaged storedat room temp until used.	Sterile packaged,stored at room tempuntil used.	Sterile packaged,stored at room tempuntil used.

Technological Characteristics Comparison to the Predicate Devices

1 - Predicate SmartToe not shown, but it is a nitinol extremity fixation device used for comparison of corrosion resistance only.

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Performance Bench Testing:

Standard ASTM F564-10 (2010) was used to compare the pull-out strength of the Speed Triad to the predicate OSSplate. Specimens of all three sizes of the Speed Triad were used and compared to a comparably sized predicate OSSplate. The results showed that the Speed Triad has substantially equivalent pull-out resistance than the predicate OSSplate implant.

Standard ASTM F564-10 (2010) was used to compare the mechanical strength of the new Speed Triad to the predicate OSSplate. Specimens of all three sizes of the Speed Triad were used and compared to a similar sized predicate OSSplate. The results showed that the Speed Triad implants achieved substantially equivalent bending stiffness when compared to the predicate OSSplate.

Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Speed Triad to the predicate OSSplate. We also have used a secondary predicate for corrosion resistance, the SmartToe (K070598). Test results demonstrate the substantially equivalent corrosion resistance of the Speed Triad compared to the predicate OSSplate and SmartToe.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 7, 2014

BioMedical Enterprises, Incorporated Mr. Joe Soward Director, Quality Assurance and Regulatory Affairs 14785 Omicron Drive, Suite 205 San Antonio, Texas 78245

Re: K133844

Trade/Device Name: Specd TriadTM 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 11, 2014 Received: March 14, 2014

Dear Mr. Soward:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Joe Soward

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Lori A. Wiggins

for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Device Name: Speed Triad™

Indications for Use

The Speed Triad™ is indicated for:

Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

4-1

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.