Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

Device Description

The Elite™ Nitinol Fixation System, like primary predicate Speed Titan™ K133780, is a Nitinol implant for bone fixation and is designed to be delivered to the operating room in an "open" (legs parallel) and constrained state. The Elite™ Nitinol Fixation System was designed for surgeons who desire additional fixation points for increased rotational stability. The implant does not require any external heating. The implant is fully active at room and body temperature so that the legs compress after release from instrument (additional legs in Straight design compress in tandem). The primary differences between the Elite™ Nitinol Fixation System and the cleared Speed Titan™ K133780 are the configurations featured. The Speed Titan™ K133780 is a staple with two legs, while the Elite™ Nitinol Fixation System introduces three configurations: a Straight (with two and four legs), a Y-shape (three and four legs) and an H-shape (four legs).

AI/ML Overview

The provided text is a 510(k) summary for the Elite™ Nitinol Fixation System, which is a bone staple. Medical device submissions like this primarily focus on showing substantial equivalence to a predicate device rather than comprehensive clinical studies proving specific performance metrics against acceptance criteria like those seen for AI/ML devices. Therefore, a direct answer for all your requested points, especially related to AI/ML device testing (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies), cannot be fully provided based solely on this document.

However, I can extract the information that is present and indicate where information is not available in the given text.

Here's the breakdown based on the provided document:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a specified threshold (e.g., Sensitivity > X%, Specificity > Y%). Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "reported device performance" is framed as meeting or exceeding the performance of the predicate in these tests.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Corrosion (ASTM F2129-08)	Performance comparable to predicate device.	Results "demonstrate substantial equivalence or better."
Elastic Static Bending (ASTM F564-10, A4)	Performance comparable to predicate device.	Results "demonstrate substantial equivalence or better."
Pull-out Fixation Strength (ASTM F564-10, A2)	Performance comparable to predicate device.	Results "demonstrate substantial equivalence or better."
MR Compatibility (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182)	Performance comparable to predicate device.	Results "demonstrate substantial equivalence or better."

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the implied "acceptance criteria" (i.e., substantial equivalence) is a non-clinical performance testing study. The document states: "Performance testing includes: Corrosion (ASTM F2129-08), Elastic Static Bending (ASTM F564-10, A4) Pull-out Fixation Strength (ASTM F564-10, A2) and MR Compatibility (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) results of which demonstrate substantial equivalence or better."

Information Not Available (or Not Applicable for this type of device according to the document):

Sample sized used for the test set and the data provenance: Not applicable/provided in this document format. This is a physical bone staple, not an AI/ML device. The "test set" would refer to the samples used in the physical performance tests (e.g., number of staples tested for pull-out strength). This detail is not specified in the summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This concept is for AI/ML diagnostic devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for AI/ML diagnostic devices.
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 physical bone staple, not an AI/ML diagnostic device meant to assist human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical bone staple.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable/Provided. For non-clinical performance testing of a physical device, the "ground truth" is typically defined by the ASTM standard test methods themselves and the physical measurements obtained.
The sample size for the training set: Not applicable. This is a physical staple, not an AI/ML device that requires a "training set."
How the ground truth for the training set was established: Not applicable. This is a physical staple.

Summary of what the document focuses on:

The Elite™ Nitinol Fixation System is cleared based on substantial equivalence to existing predicate devices (Speed Titan™ K133780, Speed Triad™ K133844, OSSplate™ K993714). The rationale for substantial equivalence is based on:

Identical Indications for Use.
Same technological characteristics: both are made of nitinol, follow the same manufacturing procedures, and function similarly.
Non-clinical performance testing: demonstrating that the new device performs "substantially equivalent or better" than the predicate in terms of corrosion resistance, elastic static bending, pull-out fixation strength, and MR compatibility, according to specific ASTM standards.
No new questions of safety or effectiveness are raised by the design changes (changes in geometry, number of legs, width, and implant shapes).
No clinical evidence was deemed necessary ("N/A" for "Substantial Equivalence Clinical Evidence").

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, representing the department's focus on health and human well-being. The profiles are depicted in a simple, abstract manner.

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

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

May 11, 2015

Re: K150125 Trade/Device Name: Elite™ Nitinol Fixation 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: April 8, 2015 Received: April 13, 2015

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

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

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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" (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 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 yours,

Mark N. Melkerson -S

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

Enclosure

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

Indications for Use

510(k) Number (if known) K150125

Device Name Elite™ Nitinol Fixation System

Indications for Use (Describe)

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

• Fixation of proximal tibial metaphysis osteotomy.

· Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.

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

For activities ID at 30 CFR 900 Subchapter D

For Coal Combustion Residuals (CCR)
X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image shows the logo for BioMedical Enterprises. The logo consists of a stylized graphic of three connected shapes that resemble staples with sharp points. Below the graphic, the words "BioMedical Enterprises" are written in a sans-serif font, with "BioMedical" in a slightly larger font size and a different color than "Enterprises".

510(K) Summary

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the Elite™ Nitinol Fixation System.

	1. Submitted By:	BioMedical Enterprises, Inc.14785 Omicron Dr., Suite 205San Antonio, TX 78245
	Date:	May 4, 2015
	Contact Person:	Joe SowardDirector Quality Compliance and Regulatory AffairsOffice: 210-881-0011Fax: 210-677-0355
	2. Proprietary Name:	Elite™ Nitinol Fixation System
	Common Name:	Bone Staple
	Classification Name and Reference:	Single/multiple component metallic bone fixationappliances and accessories(21 CFR 888.3030 – Class II)
	Device Product Code, Device Panel:	JDR - Orthopedic

	3. Primary Predicate:	Speed Titan™ (formerly cleared as Speed XL K133780)
	Reference Devices:	OSSplate™ (formerly cleared as Memograph StapleSystem K993714), Speed Triad™ (K133844)

4. Device Description:

The primary differences between the Elite™ Nitinol Fixation System and the cleared Speed Titan™ K133780 are the configurations featured. The Speed Titan™ K133780 is a staple with two legs, while the Elite™ Nitinol Fixation System introduces three configurations: a Straight (with two and four legs), a Y-shape (three and four legs) and an H-shape (four legs).

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for BioMedical Enterprises. The logo consists of a stylized gray symbol that resembles a series of interconnected staples or brackets with pointed ends. Below the symbol, the words "BioMedical Enterprises" are written in an orange sans-serif font. The overall design is clean and modern.

1. Intended Use
  The Elite™ Nitinol Fixation System is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. Fixation of proximal tibial metaphysis osteotomy. Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
1. Technological Characteristics Comparison
  The Speed Titan™ K133780 was originally cleared as Speed XL in K133780. It was introduced in two sizes and featured a wide. flat bridge dimension for use in midfoot/hindfoot procedures. The Speed Titan™ K133780 was additionally cleared as part of bundle submission K142292 which expanded its indications for use and size offerings.

The Elite™ Nitinol Fixation System and primary predicate Speed Titan™ K133780 share the same technological characteristics. More specifically, they share the same indications and intended use and are both fabricated from nitinol. following same manufacturing procedures. The only modifications to the device involve changes in geometry related to number of legs, legs, width, and implant shapes (Straight, Y-shape and H-shape). The straight shape configurations are similar in shape to the Speed Titan™ K133780. The Y-shape and H-shape configurations are similar in shape to the reference Speed Triad™ K133844 and OSSplate™ K993714, respectively.

1. Substantial Equivalence Non-Clinical Evidence
  Performance testing includes: Corrosion (ASTM F2129-08), Elastic Static Bending (ASTM F564-10, A4) Pull-out Fixation Strength (ASTM F564-10, A2) and MR Compatibility (ASTM F2052, ASTM F2213, ASTM F2119, ASTM F2182) results of which demonstrate substantial equivalence or better.
1. Substantial Equivalence Clinical Evidence N/A
1. Substantial Equivalence Conclusions

The design characteristics of the subject devices do not raise any new types of questions regarding safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems and are substantially equivalent. The safety and effectiveness of the Elite™ Nitinol Fixation System is adequately supported by testing, substantial equivalence information, materials information and comparison of design characteristics provided within this premarket submission.

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.