(93 days)
The Arthrex Distal Radius System is intended for fixation of fractures, fusions, ostectomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.
The Arthrex Distal Radius System is a family of implantable titanium plates and screws intended to be used for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.
The subject plates are contoured and may be available in left and right configurations, ranging in length from 25mm to 166mm and feature both locking and non-locking holes.
The accompanying screws are solid, fully or partially threaded, and may be locking or non-locking. The proposed screw offering subject of this application are 2.4mm to 3.5mm in diameter and 8mm to 34mm in length and include the Arthrex Low Profile Screws previously cleared under the auspices of K131474.
The provided document is a 510(k) premarket notification for a medical device called the "Arthrex Distal Radius System". This type of submission focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performance through clinical studies in the same way a novel AI or diagnostic device might.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth definitions for a "study that proves the device meets the acceptance criteria" is largely not applicable in the context of this specific document.
This document describes a medical device (bone fixation system) that is evaluated primarily through mechanical testing to demonstrate its substantial equivalence to predicate devices, rather than through studies involving human readers or expert consensus on diagnostic tasks.
However, I can extract the relevant information that is present in the document.
Here's a breakdown of what can be derived from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that the device is "substantially equivalent" to predicate devices. The primary performance metric mentioned is related to mechanical strength.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical bending strength equivalent to predicate devices | "The submitted mechanical testing data demonstrates that the bending strength of the plates is substantially equivalent to that of the predicate devices." |
| Intended Use | "The Arthrex Distal Radius System is intended for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus." (Matches predicate's intended use). |
| Technological Characteristics | Similar basic design features to predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not explicitly stated in the document. The document mentions "mechanical testing data" but does not detail the sample size (e.g., number of plates/screws tested) or the provenance of this test data. It's safe to assume this is laboratory-based mechanical testing, not a clinical study on patients.
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. This document pertains to a bone fixation system and its mechanical properties, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No adjudication method is mentioned as there are no human interpretations being evaluated.
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 not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the device's mechanical performance, the "ground truth" would be established by engineering standards and testing methodologies (e.g., ASTM standards for bone fixation devices) that define parameters like yield strength, ultimate tensile strength, fatigue life, etc. The document does not specify the exact standards but refers to "mechanical testing data." For the substantial equivalence argument, the reference point is the performance of the predicate devices.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a hardware device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set" or need to establish ground truth for it for this type of device.
In summary: The provided document is a 510(k) submission for a traditional Class II medical device (bone fixation system). The "study" referenced for meeting acceptance criteria is primarily mechanical testing to demonstrate substantial equivalence to predicate devices in terms of function and safety, particularly mechanical strength. The concepts of acceptance criteria, sample sizes, expert review, and ground truth as typically understood for AI/diagnostic devices are not directly applicable in this context.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3. 2015
Arthrex Inc. Ms. Laura Medlin Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K143749 Trade/Device Name: Arthrex Distal Radius System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: February 5, 2015 Received: February 11, 2015
Dear Ms. Laura Medlin:
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 – Ms. Laura Medlin
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 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/Resourcesfor You/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 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex TRADITIONAL 510(K): ARTHREX DISTAL RADIUS SYSTEM
2.4 INDICATIONS FOR USE
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug AdministrationIndications for Use | Expiration Date: January 31, 2017See PRA Statement below. | ||
| 510(k) Number (if known) | K143749 | ||
| Device NameArthrex Distal Radius System | |||
| Indications for Use (Describe) | |||
| The Arthrex Distal Radius System is intended for fixation of fractures, fusions, ostectomies and non-unions of the radius, | |||
| ulna, olecranon, metacarpal, metatarsal, and malleolus. | |||
| 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) | ||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | |||
| The burden time for this collection of information is estimated to average 79 hours per response, including the | |||
| time to review instructions, search existing data sources, gather and maintain the data needed and complete | |||
| and review the collection of information. Send comments regarding this burden estimate or any other aspect | |||
| of this information collection, including suggestions for reducing this burden, to: | |||
| Department of Health and Human Services | |||
| Food and Drug Administration | |||
| Office of Chief Information Officer | |||
| Paperwork Reduction Act (PRA) Staff | |||
| PRAStaff@fda.hhs.gov | |||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | |||
| information unless it displays a currently valid OMB number." |
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2.5 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | February 5, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Laura MedlinRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 72005Fax: 239/598.5508Email: Laura.Medlin@Arthrex.com |
| Trade Name | Arthrex Distal Radius System |
| Common Name | Plate, fixation, boneScrew, fixation, bone |
| Product Code,Classification Name | HRS - Plate, Fixation, BoneHWC - Screw, Fixation, Bone |
| CFR | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Predicate Device | K082300: DePuy Orthopaedics Anatomic Locking Plating SystemK081546: DePuy Orthopaedics Small Bone Locking Plating SystemK131474: Arthrex Distal Radius Plate SystemK040907: Arthrex Small Fragment Plates and Screws |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Distal Radius System. |
| Device Description | The Arthrex Distal Radius System is a family of implantable titanium plates andscrews intended to be used for fixation of fractures, fusions, osteotomies and non-unions of the radius, ulna, olecranon, metacarpal, metatarsal, and malleolus.The subject plates are contoured and may be available in left and rightconfigurations, ranging in length from 25mm to 166mm and feature both lockingand non-locking holes.The accompanying screws are solid, fully or partially threaded, and may be lockingor non-locking. The proposed screw offering subject of this application are 2.4mmto 3.5mm in diameter and 8mm to 34mm in length and include the Arthrex LowProfile Screws previously cleared under the auspices of K131474. |
| Intended Use | The Arthrex Distal Radius System is intended for fixation of fractures, fusions,osteotomies and non-unions of the radius, ulna, olecranon, metacarpal,metatarsal, and malleolus. |
| SubstantialEquivalence Summary | The Arthrex Distal Radius System is substantially equivalent to the predicatedevices, in which the basic design features and intended uses are the same. Anydifferences between the Arthrex Distal Radius System and the predicates areconsidered minor and do not raise questions concerning safety and effectiveness.The submitted mechanical testing data demonstrates that the bending strength ofthe plates is substantially equivalent to that of the predicate devices.Based on the indication for use, technological characteristics, and the summary ofdata submitted, Arthrex, Inc. has determined that the Arthrex Distal RadiusSystem is substantially equivalent to currently marketed predicate devices |
§ 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.