The Speed Shift™ is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is then transformed by ambient and body heat after insertion, and contracts to a "closed" austenitic state. The implants do not require any external heating; they are completely transformed by body heat. This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.

AI/ML Overview

The provided documentation describes the Speed Shift™ device, a nitinol implant for fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The submission focuses on demonstrating substantial equivalence to predicate devices (BME OSStaple™ and OSStaple™ Chill) through comparison of technological characteristics and performance bench testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the traditional sense of specific numerical thresholds for performance. Instead, the performance studies aim to demonstrate that the Speed Shift™ is equivalent or superior to the predicate devices in key mechanical properties. The acceptance is implicitly based on achieving this equivalence or superiority.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance (Speed Shift™)
Pull-out Strength	Higher than or equivalent to predicate OSStaple™	Higher pull-out resistance than the predicate OSStaple™
Bending Strength	Greater than or equivalent to predicate OSStaple™	Greater bending strength when compared to the predicate OSStaple™
Corrosion Resistance	Equivalent to predicate OSStaple Chill™	Equivalent corrosion resistance to the predicate OSStaple Chill™

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document states that "Specimens of the largest and smallest sizes of the Speed Shift™ were used and compared to a comparably sized predicate OSStaple™" for pull-out and bending strength tests. For corrosion resistance, "representative samples of the new Speed Shift™" were compared to the predicate. The exact number of samples (n-value) for each test is not specified.
Data Provenance: The studies are described as "Performance Bench Testing." This indicates the data was generated in a laboratory setting, likely in the US, by the manufacturer (BioMedical Enterprises, Inc.). It is retrospective in the sense that the device had already been designed and manufactured, and then tested for comparison. It is not clinical data from human subjects.

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

This question is not applicable to the provided information. The "ground truth" here refers to the actual mechanical properties, which are measured using well-established ASTM standards, not subjective expert assessment. No experts were used to establish ground truth for this type of bench testing.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image interpretation to resolve discrepancies between human readers or between human readers and an AI. In mechanical bench testing, the results are quantitative measurements, not subject to human adjudication in the same way.

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:

This question is not applicable. The Speed Shift™ is a physical medical implant (a bone staple), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is entirely irrelevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. As explained above, the Speed Shift™ is a physical surgical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

The ground truth used for these performance studies is physical measurement against established industry standards.

For pull-out strength and bending strength: ASTM F564-10 (2010)
For corrosion resistance: ASTM F2129-08

These standards define methods for objectively measuring the mechanical properties of bone fixation devices.

8. The Sample Size for the Training Set:

This question is not applicable. The Speed Shift™ is a manufactured device, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms. The device undergoes design, manufacturing, and then testing.

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

This question is not applicable, as there is no "training set" for a physical medical device.

Summary

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

(510(k) Summary)

Product: Speed Shift™

Submitter Information

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

Date Prepared: January 17, 2013

Classification name: Smooth or Threaded Metallic Bone Fastener (21 CFR 888.3040)

Classification:	Class II
Product Code:	JDR
Common/Usual Name:	Bone Staple
Proprietary Name:	Speed Shift™

Intended Use:

The Speed Shift™ is indicated for:

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

Substantial Equivalence:

The Speed Shift™ is substantially equivalent to the predicate BME OSS1aple™ cleared in K993714 and the OSStaple™ Chill cleared in K102107. The predicates also include an intended use of fixation of proximal tibial metaphysis osteotomy which is not included in this submission.

Device Description.

This configuration change for the Speed Shift™ consists of a step bend of the staple back where the bend is in line with the legs of the staple rather than perpendicular to the legs as in the predicate devices. This in line bend allows Speed Shift™ to be useful for step osteotomies such as in the calcaneal slide procedure and other various mid-foot procedures reducing the prominence of the staple back after implantation as compared to the predicate devices.

2-1

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

Product Name:	Speed Shift™	PredicateOSStaple™(K993714)	PredicateOSStaple Chill(K102107)
Raw Material:	Nitinol, per ASTMF2063-05	Nitinol, per ASTMF2063-05	Nitinol, per ASTMF2063-05
Bridge Lengths(mm):	15 and 20	9, 11, 13, 15, 18, 20,and 30	9, 11, 13, 15, 18, and20
Leg Lengths (mm):	20	7, 8, 10, 12, 15, 18,20, and 30	7, 8, 10, 12, 15, 18,and 20
Cross-sectionDimensions (mm):	1.8 x 1.8 square	Min 1.2 x 1.2Max 2.0 x 3.0	Min 1.2 x 1.2Max 2.0 x 3.0
Barbs:	Barbs on the legs	Smooth legs	Barbs on the legs
Heat Source:	Fully transformedat room temperature	OSSforce™ electricalheating unit	Body temperature
Surface Finish:	Mechanical tumbling,acid cleaning, andchemical passivation.	Mechanical tumbling,acid cleaning, andchemical passivation.	Mechanical tumbling,acid cleaning, andchemical passivation.
Storage:	Sterile packagedstored at room tempuntil used.	Sterile packaged,stored at room tempuntil used.	Sterile packaged, andrequires storage infreezer prior to use.

Technological Characteristics Comparison to the Predicates

Performance Bench Testing:

Standard ASTM F564-10 (2010) was used to compare the pull-out strength of the new Speed Shift™ to the predicatc OSStaple™. Specimens of the largest and smallest sizes of the Speed Shift"M were used and compared to a comparably sized predicate OSStaple™M. The results showed that the Specd Shift™ has higher pull-out resistance than the predicate OSStaple™

Standard ASTM F564-10 (2010) was used to compare the mechanical strength ™. The results showed that the Speed Shift™ achieve greater bending strength when compared to the predicate OSStaple™.

Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Speed Shift™ to the predicate OSStaple™. Test results demonstrate the corrosion resistance is equivalent to the predicate OSStaple Chill™

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

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

Letter dated: May 14, 2013

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

Re: K124022

Trade/Device Name: Speed Shift™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDR Dated: April 12, 2013 Received: April 16, 2013

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

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

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.

Mark N.Mielkerson -S

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

Enclosure

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

Indications for Use

510(k) Number (if known): K124022

Device Name: Speed Shift™

Indications For Use:

The Speed Shift™ Fixation system is indicated for fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

Page 1 of __

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.