The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force. This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called HammerLock. This is a regulatory submission for a medical device seeking clearance to market, demonstrating substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving device performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel AI software would.

Instead, the "study" mentioned here is primarily bench testing to demonstrate that the upgraded device maintains the same mechanical and material properties as its predicate.

Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, or ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI performance evaluations, which are not detailed here.

Here's a breakdown based on the information provided:

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Bend Test	Substantially equivalent to predicate K091951 Hammerlock for stiffness and strength (as per ASTM F382-99).	All new Hammerlock designs were found to be substantially equivalent to the stiffness and strength of the predicate.
Corrosion Resistance	Adequate according to technical literature and substantially equivalent to predicate SmartToes devices (K070598), as per ASTM F2129-08.	The Hammerlock corrosion resistance was found to be adequate according to technical literature and substantially equivalent to that of the SmartToe (K070598).
Material Composition	Nitinol, per ASTM F2063-05.	Nitinol, per ASTM F2063-05. (Matches predicate)
Heat Source	Fully transformed at body temperature.	Fully transformed at body temperature. (Matches predicate)

Study Details

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

Sample Size: Not specified for the bench tests. Typically, these involve a small number of representative samples for mechanical and material testing.
Data Provenance: Not applicable. The "data" here refers to physical properties measured in a laboratory setting, not patient data.

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. Bench testing does not involve human experts establishing ground truth in the clinical sense. The "ground truth" is defined by the objective physical properties and standards (ASTM F382-99, ASTM F2129-08).

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

Not Applicable. Adjudication methods are relevant for subjective human assessments, not direct physical measurements in bench 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 physical medical implant, not an AI or imaging device involving human readers or AI assistance.

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

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

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

For mechanical and corrosion resistance: Objective physical measurements against established ASTM standards and comparison to predicate devices' measured properties.

8. The sample size for the training set:

Not Applicable. This device did not involve a "training set" in the context of machine learning or clinical trials. Bench testing does not have a training phase; it's a direct evaluation of manufactured samples.

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

Not Applicable. As there is no training set mentioned, this question is not relevant.

Summary

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(510(k) Summary)

K131640

Product: HammerLock

Submitter Information

BioMedical Enterprises, Inc. 14785 Omicron Drive, Ste. 205 San Antonio, Texas 78245

OCT 1 6 2013

Telephone:	(210) 677-0354
Fax:	(210) 677-0355
Contact:	Joe W. Soward
Date Prepared:	September 12, 2013

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

Classification:	Class II
Product Code:	HTY
Common/Usual Name:Intramedullary Bone Fastener:
Proprietary Name:	Hammerlock

Intended Use:

The Hammerlock is indicated for: Small bone reconstruction and fusion such as interdigital fusion of fingers and toes.

Substantial Equivalence:

The upgraded Hammerlock is substantially equivalent to the predicate BME Hammerlock cleared in K091951.

Device Description

The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock

device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force.

This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.

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K131640

Technological Characteristics Comparison to the Predicates:

Product Name:	Upgraded Hammerlock	Predicate Hammerlock(K091951)
Raw Material:	Nitinol, per ASTM F2063-05	Nitinol, per ASTM F2063-05
Sizes:	12,14,16,19,22 mm	16,19,22 mm
Styles:	Straight and 10 degreeAngled	Straight
Pre-Operative Storage:	Must be frozen prior to use	Must be frozen prior to use
Heat Source:	Fully transformed at bodytemperature	Fully transformed at bodytemperature

Performance Bench Testing:

Standard ASTM F382-99 was used to compare the mechanical bend test parameters of the new Hammerlock to the predicate K091951 Hammerlock. The results showed that all of the new Hammerlock designs were substantially equivalent to the stiffness and strength of the predicate.

Standard ASTM F2129-08 was used to compare the corrosion resistance of representative samples of the new Hammerlock to technical literature and to predicate SmartToes devices (K070598). The test results demonstrate that the Hammerlock corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe.

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Public Health Service

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

October 16, 2013

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

Re: K131640

Trade/Device Name: HammerLock® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: September 19, 2013 Received: September 20, 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

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Page 2 - Mr. Joe W. 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/Resourcesfor You/Industry/default.htm.

WARNING: THIS PRODUCT CONTAINS A CHEMICAL KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER AND BIRTH DEFECTS OR OTHER REPRODUCTIVE HARM.

Sincerely yours,

Erini Joeith

for

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

Enclosure

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Indications for Use

510(k) Number (if known):	K131640
Device Name:	HammerLock®
Indications For Use:	The HammerLock® is indicated for:Small bone reconstruction and fusion such as inter-digital fusion offingers and toes.

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 1

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.