(214 days)
The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metarsal, ulnar, and calcaneal bones.
The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides a stable solution for fractures, for lengthening of bones and for correcting deformities.
The Fixation Clamps are capable of controlled linear translation along the rail and of applying either compression or distraction forces. Because the Fixation Clamps can move along the rail independently of one another, a distraction force can be applied at one location along the Fixation Rail and distraction forces applied at another location along the same Fixation Rail.
The Fixation Clamps are capable of securing Fixation Screws with a diameter of 1.6mm to 3.0mm. The rail system and clamps are manufactured from aluminum and stainless steel. The fixation screws are stainless steel and available with and without hydroxyapatite coating.
The fixation screws are provided sterile while the non-implantable fixator components are provided non-sterile.
The provided text describes a 510(k) premarket notification for a medical device called the "Arrowhead Mini-Rail Fixator." This document is from the FDA and pertains to the device's substantial equivalence to legally marketed predicate devices.
Crucially, the provided document DOES NOT describe a study involving an AI/Machine Learning device or a study that uses radiological images and expert consensus. It describes a mechanical fixation device for bones and its evaluation through Finite Element Analysis (FEA) to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance (strength and stiffness).
Therefore, I cannot provide details on acceptance criteria and study proving device meets acceptance criteria regarding AI/ML performance metrics, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML.
The only "performance data" mentioned is:
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical, not AI/ML):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in strength and stiffness to predicate device (ASTM F1541-02) | "The FEA testing demonstrated that The Arrowhead Mini-Rail Fixator components met performance requirements and are equivalent in strength and stiffness to the predicate device." |
2. Sample Size for Test Set and Data Provenance:
- The study used Finite Element Analysis (FEA). This is a computational simulation, not a study on a physical "test set" of patients or images in the way an AI/ML study would. There isn't a "sample size" of patients or images in this context.
- Data provenance is not applicable as it's a computational analysis, not patient data.
3. Number of Experts and Qualifications:
- Not applicable. The evaluation was based on engineering analysis (FEA) against a standard (ASTM F1541-02). There's no mention of human experts interpreting results in the way radiologists would for an imaging AI.
4. Adjudication Method:
- Not applicable. This was an engineering analysis, not a human review process requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI/ML imaging device where human readers would be assisted by AI.
6. Standalone Performance (Algorithm Only):
- Not applicable. There is no algorithm in the sense of an AI/ML model for image interpretation. The device's "performance" is its mechanical properties as determined by FEA.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is derived from established engineering principles and standards (ASTM F1541-02) for mechanical strength and stiffness, used in a computational simulation (FEA). It's not expert consensus, pathology, or outcomes data in the medical diagnostic sense.
8. Sample Size for Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable. As there's no training set for an AI/ML model.
In summary, the provided document describes a mechanical device evaluated through engineering simulation, not an AI/Machine Learning device that processes and interprets medical images. Therefore, many of the requested details regarding AI/ML model validation are not present in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2017
Arrowhead DE, LLC Thomas Twardzik VP-Marketing and Operations 328 Poplar View Lane East, Suite 2 Collierville, Tennessee 38017
Re: K162032 Trade/Device Name: Arrowhead Mini-Rail Fixator Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTT, JDW, HTY Dated: January 18, 2017 Received: January 23, 2017
Dear Thomas 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 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" (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 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,
Vincent J. Devlin -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) K162032
Device Name Arrowhead Mini-Rail Fixator
Indications for Use (Describe)
The Arrowhead Mini-Rail Fixator is indicated for stabilizing various fractures including open and comminuted fractures, infected non-unions, fractures with length discrepancies, fusions and corrective osteotomies of the metarsal, ulnar, and calcaneal bones.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 1: 510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the Arrowhead Mini-Rail Fixator 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | Arrowhead Medical Device Technologies, LLC328 Poplar View Lane East, Suite 2Collierville, TN 38017 | |
|---|---|---|
| Contact Person: | Thomas J. TwardzikVice President, Marketing and OperationsOffice: (901) 853-4366Fax: (206) 222-9173Email: Tom@ArrowheadDevices.com | |
| Date ofSubmission: | July 20, 2016 | |
| ProprietaryName: | Arrowhead Mini-Rail Fixator | |
| Common Name | External Fixator and fixations screws | |
| Regulatory Class | Class II | |
| Regulation | 21 CFR 888.3030 | Single/multiple component metallic bone fixation appliances and accessories |
| 21 CFR 888.3040 | Smooth or threaded metallic bone fixation fastener | |
| Device ProductCode and Panel | KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Single/multiple component metallic bone fixation appliances and accessories. |
| HTY | Pin, Fixation, Smooth - Smooth or threaded metallic bone fixation fastener. | |
| JDW | Pin, Fixation, Threaded - Smooth or threaded metallic bone fixation fastener. | |
| Orthopedic |
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| PredicateDevices | SIDEKICK Rail FixatorApex Kirschner Wires and Steinmann PinsST.A.R.90 F4 External Fixation ScrewsWith Hydroxyapatite | K080071K121004K150661 |
|---|---|---|
| DeviceDescription | The Arrowhead Mini-Rail Fixator is a unilateral fixator that provides astable solution for fractures, for lengthening of bones and for correctingdeformities. | |
| The Fixation Clamps are capable of controlled linear translation along the rail and of applying either compression or distraction forces. Because the Fixation Clamps can move along the rail independently of one another, a distraction force can be applied at one location along the Fixation Rail and distraction forces applied at another location along the same Fixation Rail.The Fixation Clamps are capable of securing Fixation Screws with a diameter of 1.6mm to 3.0mm. The rail system and clamps are manufactured from aluminum and stainless steel. The fixation screws are stainless steel and available with and without hydroxyapatite coating.The fixation screws are provided sterile while the non-implantable fixator components are provided non-sterile. | ||
| Intended Use | The Arrowhead Mini-Rail Fixator is indicated for stabilizing variousfractures including open and comminuted fractures, infected non-unions,fractures with length discrepancies, fusions and corrective osteotomies ofthe metacarpal, metatarsal, ulnar, and calcaneal bones. | |
| PerformanceData | The Arrowhead Mini-Rail Fixator was evaluated using Finite ElementAnalysis (FEA) in accordance with ASTM F1541-02. The FEA testingdemonstrated that The Arrowhead Mini-Rail Fixator components metperformance requirements and are equivalent in strength and stiffness tothe predicate device. | |
| TechnologicalCharacteristicsand SubstantialEquivalence | The Arrowhead Mini-Rail Fixator is technologically substantiallyequivalent to predicate devices in terms of intended use, material, design,mechanical performance and safety. The design characteristics of thesubject system do not raise any new types of questions of safety oreffectiveness. From the evidence submitted in this 510(k), the subjectdevices can be expected to perform at least as well as the predicate device. |
§ 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.