(204 days)
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.
The Arthrex Low Profile Screws are headed and self-tapping screws manufactured from Titanium. They are available as fully and solid. The screw family ranges from 4.5 mm to 5.5 mm in diameter and from 80 mm to 120 mm in length (in 5 mm increments). The Arthrex Low Profile Screws are sold as sterile, single-use and non-sterile single-use.
This document is a 510(k) premarket notification for the "Arthrex Low Profile Screws," a medical device intended for internal bone fixation. It does not describe a study involving an AI/algorithmic device or a comparative effectiveness study with human readers.
Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics for an AI/algorithmic device is not present in the provided text. The document focuses on the substantial equivalence of a physical medical device (screws) to a predicate device based on design, materials, and mechanical/safety testing.
Here's an attempt to answer the relevant questions based on the provided text, and highlighting what's not present:
1. A table of acceptance criteria and the reported device performance
Based on the "Performance Testing" section, the acceptance criteria relate to mechanical strength (driving torque, failure torque/insertion), MRI safety (force, torque, image artifact), and pyrogenicity. The exact numerical acceptance criteria are not specified in this summary, only that testing was "conducted in accordance with FDA guidance" and "demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Strength | "Arthrex performed driving torque and failure torque/insertion testing to evaluate the potential risk of decrease in mechanical strength." (Specific values and acceptance thresholds not provided) |
| MRI Safety | "MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." (Specific test results and acceptance outcomes not provided beyond adherence to guidance) |
| Pyrogenicity (Bacterial Endotoxins) | "The testing conducted demonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications." (Specific limit and actual test result not provided) |
2. Sample size used for the test set and the data provenance
For the physical device testing (mechanical, MRI, biological), the sample sizes are not explicitly stated.
The data provenance is from Arthrex Inc. as part of this 510(k) submission. It's a pre-market submission, implying the data was generated to support the clearance, not necessarily from a large-scale clinical trial. The testing appears to be primarily lab-based and engineering verification rather than human clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a physical medical device, not an AI/algorithmic device requiring expert ground truth in the context of diagnostic/image interpretation. The "ground truth" here would be the physical properties and safety profiles verified through engineering and biocompatibility testing.
4. Adjudication method for the test set
This is not applicable for the type of testing described (mechanical, MRI safety, pyrogenicity for a physical orthopedic screw).
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 is not applicable. This document is for a physical orthopedic screw, not an AI/algorithmic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical orthopedic screw, not an AI/algorithmic device.
7. The type of ground truth used
For the described device, the "ground truth" is established through:
- Engineering specifications and standards: For mechanical properties (torque, strength).
- FDA Guidance Documents: For MRI safety testing protocols and acceptable limits.
- Pharmacopoeia/Standards (ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14): For bacterial endotoxin levels.
8. The sample size for the training set
This is not applicable. There is no machine learning "training set" described for this physical device. The device itself is manufactured; it does not learn from data.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model for this device.
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October 30, 2019
Arthrex Inc. Heli Chambi Infantas Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190921
Trade/Device Name: Arthrex Low Profile Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HRS Dated: September 27, 2019 Received: September 30, 2019
Dear Heli Chambi Infantas:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K190921
Device Name Arthrex Low Profile Screws
Indications for Use (Describe)
The Arthrex Low Profile Screws are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | October 30, 2019 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Heli F Chambi InfantasSenior Regulatory Affairs Associate1-239-643-5553, ext. 71263Heli.chambiinfantas@arthrex.com |
| Name of Device | Arthrex Low Profile Screws |
| Common Name | Screw, Fixation, BonePlate, Fixation, Bone |
| Product Code | HWC, HRS |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener21 CFR 888.3030: Single/multiple component metallic bone fixation appliances andaccessories |
| Regulatory Class | II |
| Predicate Device | K141735 – Arthrex Ankle Fusion Plating System |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for theArthrex Low Profile screws as a line extension to the Arthrex Ankle Fusion platingSystem cleared under K141735. |
| Device Description | The Arthrex Low Profile Screws are headed and self-tapping screws manufacturedfrom Titanium. They are available as fully and solid. The screw family ranges from 4.5mm to 5.5 mm in diameter and from 80 mm to 120 mm in length (in 5 mmincrements). The Arthrex Low Profile Screws are sold as sterile, single-use and non-sterile single-use. |
| Indications for Use | The Arthrex Low Profile Screws are intended to be used in a plate-screw system forinternal bone fixation for bone fractures, fusions, osteotomies and non-unions in thefoot and ankle. The screws may be used with the Arthrex Ankle Fusion Plates. |
| Performance Testing | Arthrex performed driving torque and failure torque/insertion testing to evaluate thepotential risk of decrease in mechanical strength.MRI force, torque, and image artifact testing were conducted in accordance with FDAguidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance(MR) Environment.Bacterial Endotoxins Test (BET) was performed on the Arthrex Low Profile Screwsutilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. The testing conducteddemonstrates that the Arthrex Low Profile Screws meets pyrogen limit specifications. |
| Conclusion | The Arthrex Low Profile screws are substantially equivalent to the predicate device inwhich the basic design features and intended use are the same. Any differencesbetween the Arthrex Low Profile screws and the predicates are considered minor anddo not raised different questions concerning safety and effectiveness. Based on theindications for use, technological characteristics, and the summary of data submitted,Arthrex Inc. has determined that the proposed device is substantially equivalent tothe currently marketed predicate device |
§ 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.