(210 days)
The Arthrex Compression Plates are intended to be used for internal bone fixation for bonc fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
The Arthrex Compression Plates are a family of low profile plates available in various design configurations. The plates are made of stainless steel and are available in lengths of 20mm, 25mm and 30mm (interaxis lengths).
The prompt requests information for an AI/ML device, but the provided text describes a traditional medical device (Arthrex Compression Plates), which is a physical implant, not an AI or software device. Therefore, the questions related to AI/ML device performance metrics, such as sample size for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to this submission.
The document describes the Arthrex Compression Plates, a family of low-profile plates made of stainless steel, intended for internal bone fixation in the ankle, foot, hand, and wrist.
Here's the relevant information based on the provided text, adapted to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: The bending and compression distraction properties of the proposed devices must be substantially equivalent to predicate devices. | Mechanical testing data demonstrated that the bending and compression distraction of the proposed devices (Arthrex Compression Plates) is substantially equivalent to that of the predicate devices (Arthrex Low Profile Plates and Arthrex Compression Staple). |
| Material Equivalence: The material of the proposed device must be equivalent to predicate devices. | The Arthrex Compression Plates are made of stainless steel, similar to predicate devices. (Implied from the "material, technological characteristics and performance of the devices are similar" statement and the general nature of orthopedic implants). |
| Technological Characteristics Equivalence: The technological characteristics of the proposed device must be similar to predicate devices. | The device is a family of low-profile plates available in various design configurations and lengths (20mm, 25mm, 30mm interaxis lengths), similar to the predicate devices. |
| Intended Use Equivalence: The intended use of the proposed device must be the same as predicate devices. | The Arthrex Compression Plates are intended for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist. This is stated to be the same as the predicate devices (Arthrex Low Profile Plate and Screw System). |
| Safety and Effectiveness: Differences between the proposed device and predicates must be minor and not raise new questions concerning safety and effectiveness. | Any differences were considered minor and did not raise questions concerning safety and effectiveness, based on the mechanical testing and comparison of intended use, technological characteristics, and material. The device was deemed substantially equivalent. |
2. Sample size used for the test set and the data provenance:
Not applicable for this type of device (physical implant evaluated via mechanical testing for substantial equivalence, not a data-driven AI/ML device). The study involved mechanical testing, not a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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 orthopedic implant, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical orthopedic implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the mechanical testing, the "ground truth" is based on established engineering principles and measurements of material properties, strength, and performance under simulated loads/conditions, compared against the known performance of predicate devices.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" for this type of device as it does not involve AI/ML.
9. How the ground truth for the training set was established:
Not applicable.
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Arthrex 8 Traditional 510(K): ARTHREX COMPRESSION PLATES
510(k) Summary of Safety and Effectiveness 2
| Date Summary Prepared | February 22, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Ivette GalmezRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA.Telephone: 239/643.5333, ext. 1263Fax: 239/598.5508Email: ivette.galmez@arthrex.com |
| SEP 2 5 2013 | |
| Trade Name | Arthrex Compression Plates |
| Common Name | Plate, fixation, bone |
| Product Code -ClassificationNameCFR | HRS, HWC21 CFR 888.8030: Single/multiple component metallic bone fixationappliances and accessories |
| Predicate Device | K052614: Arthrex Low Profile Plate and Screw SystemK040907: Arthrex Small Fragment Plates and ScrewsK080111: Arthrex Compression Staple |
| Purpose of Submission | This traditional 510(k) premarket notification is submitted to obtainclearance for the Arthrex Compression Plates. |
| Device Description and IntendedUse | The Arthrex Compression Plates are a family of low profile plates availablein various design configurations. The plates are made of stainless steel andare available in lengths of 20mm, 25mm and 30mm (interaxis lengths).The Arthrex Compression Plates are intended to be used for internal bonefixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand,and wrist, such as opening wedge osteotomies of Hallux Valgus. |
| Substantial EquivalenceSummary | The Arthrex Compression Plates are substantially equivalent to thepredicates Arthrex Low Profile Plates and Screws System in which thebasic features and intended uses are the same. The Arthrex CompressionPlates are substantially equivalent to the predicates Arthrex Low ProfilePlates and Arthrex Compression Staple in which the material,technological characteristics and performance of the devices are similar. |
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Arthrex 8 TRADITIONAL 510(K): ARTHREX COMPRESSON PLATES
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| Substantial Equivalence Summary (continue) | Any differences between the Arthrex Compression Plates and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
|---|---|
| The submitted mechanical testing data demonstrated that the bending and compression distraction of the proposed devices is substantially equivalent to that of the predicate devices Arthrex Low Profile Plates and Arthrex Compression Staple. | |
| Based on the indication for use, technological characteristics, and the comparison to the predicate devices, Arthrex, Inc. has determined that the Arthrex Compression Plates is substantially equivalent to currently marketed predicate devices. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing health, services, and people. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 25, 2013
Arthrex, Incorporated Ms. Ivette Galmez Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108
Re: K130510
Trade/Device Name: Arthrex Compression Plates 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: August 6, 2013 Received: August 7, 2013
Dear Ms. Galmez:
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 Fournal 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 may or subject to additions, 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 that i Dr Had Intatutes and regulations administered by other Federal agencies. You must of any I edital stiners and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Ivette Galmez
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (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 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.
Sincercly yours,
Erin I: Keith
for
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 COMPRESSION PLATES
Indications for Use
510(k) Number (if known): K130510
Device Name: Arthrex Compression Plates
Indications For Use:
The Arthrex Compression Plates are intended to be used for internal bone fixation for bonc fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies of Hallux Valgus.
Prescription Use _ V _ AND/OR Over-The-Counter Use ____________________________________________________ (Per 21 CFR 801 Subpart D) (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 (ODF:) PAGE I of I
Elizabeth L. Frank -S
Division of Orthopedic 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.