The HammerLock® 2 is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force. The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called HammerLock® 2. This document focuses on demonstrating substantial equivalence to a predicate device through material and mechanical testing, rather than clinical study data involving AI or human interpretation. Therefore, many of the requested elements for AI/imaging studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Material Composition	Nitinol, per ASTM F2063-05	Conforms to "Nitinol, per ASTM F2063-05"
Mechanical Bending	Meet or exceed stiffness and strength of predicate (K131640 HammerLock®)	"The results showed that all of the new HammerLock® 2 designs exceed the stiffness and strength of the predicate." (Tested using ASTM F382-99)
Corrosion Resistance	Adequate according to technical literature and substantially equivalent to predicate SmartToe devices (K070598).	"Test results demonstrate that the HammerLock® corrosion resistance is adequate according to technical literature and substantially equivalent to that of the SmartToe." (Tested using ASTM F2129-08)
Intended Use	Small bone reconstruction and fusion	No direct test result provided for this in the context of acceptance criteria, but substantial equivalence to the predicate (which has the same intended use) implies this criterion is met. The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
Design Characteristics	Maintain similar design principles (intramedullary fixation, shape-memory)	"The HammerLock® 2 device is situated in the intramedullary space and the legs extend into the cancellous bone. After reaching body temperature, the legs fully deflect outward to create an anchoring force." (This confirms similar mechanism to nitinol shape-memory implants). The primary change is an extended proximal length for "better fixation."
Dimensions (Ranges)	New sizes introduced (17, 20, 22, 25 mm)	The device comes in sizes 17, 20, 22, and 25 mm, which are a different set of sizes compared to the predicate (12, 14, 16, 19, 22 mm). The design justification is that the new HammerLock® 2 is longer than the predicate, specifically on the proximal side, to allow for better fixation. The mechanical testing implicitly covers the performance of these new dimensions. This isn't an acceptance criterion in the sense of a pass/fail range, but rather a design specification that was tested.

For the remaining points, please note that this is a 510(k) summary for a mechanical medical device (implant) and not an AI or imaging diagnostic device. Therefore, many of the questions are not applicable to this document.

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 explicitly stated as a numerical sample size of "devices" in the same way a clinical trial would report patients. For mechanical testing, samples of the device (HammerLock® 2) and the predicate (K131640 HammerLock®) were used for each test. The ASTM standards (F382-99 for bending, F2129-08 for corrosion) would specify the minimum number of samples required for robust testing, but these numbers are not detailed in the summary.
- Data Provenance: The data is generated from laboratory bench testing conducted in accordance with ASTM standards. The summary does not specify the country of origin of the lab or if it was prospective/retrospective; however, bench testing is inherently prospective in its execution (i.e., new tests are run for the new device).
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. This document describes mechanical testing of an orthopedic implant, not an diagnostic imaging device that requires interpretation by medical experts to establish ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As above, this pertains to expert review of diagnostic results, which is not relevant to this device's testing. Mechanical testing results are objective measurements (e.g., stiffness values, corrosion rates), not subject to expert adjudication in this context.
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. No MRMC study was performed as this is a device for surgical implantation, not an AI or imaging diagnostic tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Mechanical Testing: The "ground truth" is defined by the objective performance parameters (stiffness, strength, corrosion resistance) as measured against established ASTM standards and compared to a legally marketed predicate device. The "ground truth" for the predicate's performance is its previously characterized mechanical properties.
- For Substantial Equivalence: The ultimate "ground truth" being demonstrated is that the HammerLock® 2 is as safe and effective as its predicate.
The sample size for the training set
- Not Applicable. There is no "training set" as this is a physical medical device undergoing mechanical validation, not a machine learning model.
How the ground truth for the training set was established
- Not Applicable. See point 8.

Summary

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(510(k) Summary)

JAN - 9 2014

Product: HammerLock® 2

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: October 31, 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® 2

Intended Use:

The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

Substantial Equivalence:

The HammerLock® 2 is substantially equivalent to the predicate BME HammerLock® cleared in K131640.

Device Description

The changes for the HammerLock® 2 system involve design changes to the implant and new disposable instrumentation.

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Product Name:	HammerLock® 2New device	PredicateHammerLock® (K131640)
Raw Material:	Nitinol, per ASTMF2063-05	Nitinol, per ASTMF2063-05
Sizes:	17, 20, 22, and 25 mm	12, 14, 16, 19, 22 mm
Styles:	Straight and 10 degree Angled	Straight and 10 degree angled
Pre-OperativeStorage:	Room temperature	Must be frozen prior to use
Heat Source:	Fully transformedat body temperature	Fully transformed at bodytemperature

Technological Characteristics Comparison to the Predicates

Implant Dimensions:

The new HammerLock® 2 device is longer than the predicate K131640 HammerLock®. The length is added to the proximal side of the implant (the portion designed to be inserted into the proximal phalanx). The extended proximal length of the HammerLock® 2 allows for better fixation.

Performance Bench Testing:

Standard ASTM F382-99 was used to compare the mechanical bending parameters of the new HammerLock® 2 to the predicate K131640 HammerLock®. The results showed that all of the new HammerLock® 2 designs exceed 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® 2 to technical literature and to predicate SmartToe devices (K070598). 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

January 9, 2014

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

Re: K133520

Trade/Device Name: HammerLock® 2 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: November 7, 2013 Received: November 15, 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" (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 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.

Ronaldingean -S 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): K133520

Device Name: HammerLock® 2

Indications For Use:

The HammerLock® 2 is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers 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)

Page 1. of

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

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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.