(131 days)
The Arthrex Compression FT Screws is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- Osteochondral fragments (talar vault, femoral condyle)
- apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal)
- cancellous fragments (talus)
- Carpal, metacarpal, and small hand bone
- tarsal and metatarsals
- phalanges
- Intra-articular fractures
- ankle
- proximal and distal humerus
- proximal and distal radius
- proximal and distal ulna
- osteochondral fixation and fractures
- Osteochondritis Dissecans
- Fixation of fractures and osteotomies about the knee
- Oblique fractures of the fibula
- Reconstructive surgeries of the foot
- malleolar fixation
The Arthrex Compression FT Screws are a family of screws designed to provide fixation of fractures, osteotomies and arthrodesis. These titanium screws are cannulated with a tapering head. The screws will be offered in three diameters, 2.8mm, 3.7mm and 4.1mm, and will range in length from 8mm to 50mm.
The provided document is a 510(k) summary for a medical device, the Arthrex Compression FT Screws. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of a diagnostic AI/machine learning device.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a physical medical screw used for bone fixation. The "study" mentioned is mechanical testing (insertion, pull-out, and compression) to show that the physical properties of the proposed screws are comparable to predicate devices. This is a common requirement for Class II medical devices seeking 510(k) clearance, where safety and effectiveness are established by showing similarity to currently marketed devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they would apply to an AI/machine learning diagnostic device (e.g., performance metrics like sensitivity, specificity, AUC, human reader improvement, ground truth establishment) because this document is about a different type of medical device entirely, a bone fixation screw, and its clearance process does not involve AI performance evaluation.
The categories you requested are relevant for AI/ML device evaluations. The information present in the document is about mechanical testing and regulatory classification of a physical orthopedic implant.
If you have a document detailing a study for an AI/machine learning diagnostic device, please provide that, and I would be happy to describe its acceptance criteria and study details.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS . 2.1
| Date Summary Prepared | August 26, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Courtney Smith |
| Regulatory Affairs Manager | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1720 | |
| Fax: 239/598.5508 | |
| Email: csmith@arthrex.com | |
| Trade Name | Arthrex Compression FT Screws |
| Common Name | Screw, fixation, bone |
| Product Code -Classification Name | HWC |
| CFR | Smooth or threaded metallic bone fixation fastener |
| 21 CFR 888.3040 | |
| Predicate Device | K060478: Arthrex Bio-Compression Screw |
| K103705: Arthrex Low Profile Screws | |
| Purpose of Submission | This traditional 510(k) premarket notification is submittedto obtain clearance for the Arthrex Compression FTScrews. |
| Device Description | The Arthrex Compression FT Screws are a family ofscrews designed to provide fixation of fractures,osteotomies and arthrodesis. These titanium screws arecannulated with a tapering head. The screws will beoffered in three diameters, 2.8mm, 3.7mm and 4.1mm,and will range in length from 8mm to 50mm. |
| Intended Use | The Arthrex Compression FT Screws is intended forfixation of small bone fragments, such as apicalfragments, osteochondral fragments and cancellous |
| fragments. Specific applications include the following: | |
| • | Osteochondral fragments (talar vault, femoral condyle) |
| • | apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal) |
| • | cancellous fragments (talus) |
| • | Carpal, metacarpal, and small hand bone |
| • | tarsal and metatarsals |
| • | phalanges |
| • | Intra-articular fractures |
| • | ankle |
| • | proximal and distal humerus |
| • | proximal and distal radius |
| • | proximal and distal ulna |
| • | osteochondral fixation and fractures |
| • | Osteochondritis Dissecans |
| • | Fixation of fractures and osteotomies about the knee |
| • | Oblique fractures of the fibula |
| • | Reconstructive surgeries of the foot |
| • | malleolar fixation |
| Substantial Equivalence Summary | The Arthrex Compression FT Screws is substantially equivalent to the predicate devices, in which the basic design features and intended uses are the same. Any differences between the Arthrex Compression FT Screws and the predicates are considered minor and do not raise questions concerning safety and effectiveness. |
| The proposed devices are comprised of titanium. This material is substantially equivalent to the materials found in the predicate devices. | |
| The submitted mechanical testing (insertion, pull-out and compression) data demonstrates that the proposed devices are substantially equivalent to that of the predicate device. | |
| Based on the indication for use, technological characteristics, and the summary of data submitted, Arthrex, Inc. has determined that the Compression FT |
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and the same of the same of the same of the same of
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| Screws is substantially equivalent to currently marketed | |
|---|---|
| predicate devices. |
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Image /page/3/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 symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the symbol. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
November 25, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, M1) 20093-0002
Arthrex, Incorporated Ms. Courtney Smith Regulatory Affairs Manager 1370 Creekside Boulevard Naples, Florida 34108
Re: K132217
Trade/Device Name: Arthrex Compression FT Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 28, 2013 Received: October 30, 2013
Dear Ms. Smith:
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 interstalc commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments. or 10 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.
11 your device is classified (see above) into cither 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 cvents) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Courtney Smith
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.
Sincerely yours,
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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K132271, Arthrex Compression Screws - Response to Deficiency, August 6, 2013
2.1 INDICATIONS FOR USE
Indications for Use
510(k) Number (if known): K l 32217
Arthrex Compression FT Screws Device Name:
Indications For Use:
The Arthrex Compression Screw is intended for fixation of small bone fragments, such as apical fragments, osteochondral fragments and cancellous fragments. Specific applications include the following:
- Osteochondral fragments (talar vault, femoral condyle) .
- apical fragments (radial head, patellar rim, navicular, metacarpal/metatarsal) �
- cancellous fragments (talus) �
- Carpal, metacarpal, and small hand bone .
- tarsal and metatarsals .
- phalanges �
- Intra-articular fractures .
- . ankle
- o proximal and distal humerus
- proximal and distal radius .
- proximal and distal ulna .
- osteochondral fixation and fractures .
- Osteochondritis Dissecans .
- Fixation of fractures and osteotomies about the knee .
- Oblique fractures of the fibula ●
- Reconstructive surgeries of the foot o
- malleolar fixation .
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use _ V_
(21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
§ 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.