(89 days)
The ARROW-LOK Digital Fusion System is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
The ARROW-LOK Digital Fusion device features a three dimensional arrow shape. The implants are available in multiple lengths with arrowheads of various diameters and in 2 different angles. The implant is manufactured from stainless steel and is designed for single use only.
This document describes a 510(k) submission for the ARROW-LOK Digital Fusion System, which includes additions of a 2.5mm Diameter ARROW-LOK Implant and ARROW-LOK Hybrid Implant. This is a medical device submission, and therefore the "study" referred to in the prompt is actually the performance evaluations conducted to demonstrate substantial equivalence to predicate devices. The concept of "acceptance criteria" and "device performance" in this context refers to showing that the new device performs at least as well as, or equivalently to, the predicate devices based on specific mechanical tests.
Here's a breakdown of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format with numerical targets. Instead, it describes performance evaluations that demonstrated the new device to be "at least equivalent to the predicate devices." The performance is reported in terms of achieving this equivalence.
| Performance Evaluation Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Rotational Forces Testing | Performance equivalent to or better than predicate devices (Arrowhead Fixation Device (K100926) and NEWDEAL, S.A. K-wire (K022599)). | Equivalence to predicate devices confirmed. |
| Pull-out Testing | Performance equivalent to or better than predicate devices (Arrowhead Fixation Device (K100926) and NEWDEAL, S.A. K-wire (K022599)). | Equivalence to predicate devices confirmed. |
| Four-Point Bend evaluations | Performance equivalent to or better than predicate devices (Arrowhead Fixation Device (K100926) and NEWDEAL, S.A. K-wire (K022599)). | Equivalence to predicate devices confirmed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the mechanical tests. The data provenance is not mentioned, but as this is a 510(k) submission to the FDA, it is expected that the tests were conducted under controlled conditions as part of a prospective evaluation for regulatory approval.
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)
This is a submission for a mechanical implant. The "ground truth" here is established by engineering and biomechanical testing standards and methodology, not clinical expert consensus in the same way an AI diagnostic tool would. Therefore, the concept of "experts" in the context of clinical ground truth establishment is not applicable. The evaluations were likely performed by engineers or technicians skilled in biomechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this involves objective mechanical testing, there is no "adjudication method" in the sense of reconciling divergent human assessments. The results are quantitative and directly measurable according to established test protocols.
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
Not applicable. This is a physical medical device (implant), not an AI algorithm for clinical image interpretation or diagnosis. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluations (Rotational Forces, Pull-out, Four-Point Bend) is established by engineering specifications, industry standards for mechanical testing of orthopedic implants, and direct comparative measurements against predicate devices. It is not expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no concept of a "training set" as found in machine learning or AI development.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for a physical medical device.
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Exhibit 2
510(k) Summary
DEC | 2 2011
KII2675
The 2.5mm Diameter ARROW-LOK Implant and the ARROW-LOK Hybrid Implant as Additions to the ARROW-LOK Digital Fusion System
| Submitted by: | Arrowhead Medical Device Technologies, LLC328 Poplar View Lane East, Suite 2Collierville, TN 38017 |
|---|---|
| Date: | December 12, 2011 |
| Contact Person: | Thomas J. TwardzikVice President, Sales and MarketingOffice: (901) 853-4366Fax: (206) 222-9173Email: Tom@ArrowheadDevices.com |
| Proprietary Name: | ARROW-LOK Digital Fusion System |
| Common Name | Intramedullary Bone Fastener |
| DeviceClassificationRegulation | 21 CFR 888.3040 (implants/instruments) - Class II |
| Device ProductCode and Panel | HTY: Pin, Fixation, Smooth87 Orthopedics |
| Device Description | The ARROW-LOK Digital Fusion device features a threedimensional arrow shape. The implants are available in multiplelengthswith arrowheads of various diameters and in 2 different angles.The implant is manufactured from stainless steel and is designedfor single use only. |
| Intended Use | The ARROW-LOK Digital Fusion System is indicated for fixation ofosteotomies, arthrodeses and reconstruction in the lesser toesfollowing corrective procedures. It is not intended for use in thespine. |
| Predicate Devices | Arrowhead Fixation Device (K100926)NEWDEAL, S.A. K-wire (K022599) |
| TechnologicalCharacteristics | The ARROW-LOK Digital Fusion System has similar technologicalcharacteristics when compared to the predicate devices. Inaddition, substantial equivalence was shown through RotationalForces Testing, Pull-out Testing and Four-Point Bend evaluations.The evaluations confirmed that the ARROW-LOK Digital FusionSystem is at least equivalent to the predicate devices. |
| SubstantialEquivalenceInformation | The ARROW-LOK Digital Fusion System is similar to legallymarketed devices including the Arrowhead Fixation Device,newdeal K-wire, and the Arthrex K-wire. The ARROW-LOK DigitalFusion System has similar indications for use and technologicalcharacteristics as these predicate systems. Device andperformance evaluations confirmed that the ARROW-LOK DigitalFusion System is substantially equivalent to the newdeal K-wire.Therefore, the ARROW-LOK Digital Fusion System is determined tobe substantially equivalent to the predicate devices. |
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K112675 (pg 212)
Exhibit 2
510(k) Summary
The 2.5mm Diameter ARROW-LOK Implant and the ARROW-LOK Hybrid Implant as Additions to the ARROW-LOK Digital Fusion System
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
DEC 1 2 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arrowhead Medical Device Technologies, LLC % Thomas J. Twardzik Vice President, Sales and Marketing 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017
Re: K112675
Trade/Device Name: ARROW-LOK Digital Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: September 13, 2011 Received: September 14, 2011
Dear Mr. Twardzik:
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
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Page - 2 - Mr. Thomas J. Twardzik
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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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.
Sincerely yours,
Erich Keith.
-for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit 1
Indications for Use Statement
510(k) Number: K112675
ARROW-LOK Digital Fusion System Device Name:
Indications for Use: The ARROW-LOK implant is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Prescription Use _ X _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael Owens for MXM
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112675
Page 1 of _ 1
§ 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.