(23 days)
The Arthrex RetroFusion Screw is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
The Arthrex RetroFusion Screw is an implant with a dual threaded design and ranges in size from 20 to 32mm in length. The RetroFusion screw is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint.
This document is a 510(k) premarket notification for a medical device called the "Arthrex RetroFusion Screw." It is a regulatory submission to the FDA (Food and Drug Administration) and contains information about the device's intended use, design, and a summary of performance testing to demonstrate substantial equivalence to a predicate device.
Here's an analysis to extract the requested information, while noting that this document does not describe an AI/ML device, but rather a physical surgical screw. Therefore, many of the requested fields related to AI/ML device studies (like sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, etc.) will not be applicable or present in this type of submission.
The document primarily focuses on demonstrating that the new device (Arthrex RetroFusion Screw) is substantially equivalent to a previously cleared predicate device (K050259: Arthrex Bio-Pin). This is typically done through non-clinical performance testing (e.g., mechanical testing, biomaterial testing) and comparison of design and intended use, rather than clinical studies with human readers or AI algorithms.
Acceptance Criteria and Study for Arthrex RetroFusion Screw (as derived from a 510(k) submission for a non-AI/ML device)
(Note: This device is a physical surgical screw, not an AI/ML device. Therefore, many of the requested fields related to AI/ML performance testing, such as expert ground truth, MRMC studies, and separate training/test sets for AI, are not applicable to this document. The information provided below is extracted from the 510(k) summary and reflects the type of testing performed for a physical implant.)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from predicate comparison) | Reported Device Performance (Arthrex RetroFusion Screw) |
|---|---|
| Substantial equivalence to predicate device (K050259: Arthrex Bio-Pin) in basic design features, intended uses, and safety/effectiveness. | "The Arthrex RetroFusion Screw is substantially equivalent to the predicate devices in which the basic design features and intended uses are the same. Any differences between the Arthrex RetroFusion Screw and the predicate are considered minor and do not raise questions concerning safety and effectiveness." |
| Adequate mechanical strength for intended use, at least comparable to or better than predicate. (Specifically, pull-out strength for bone fixation). | "Pull-out testing demonstrates that the pull-out strength of the Arthrex RetroFusion Screw is significantly greater than the predicate." |
| Appropriate biomaterial (stainless steel, as per common metallic bone fixation fasteners, though specific material isn't detailed in the provided excerpt). | The device is classified under "Smooth or Threaded Metallic Bone Fixation Fastener" (21 CFR 888.3040), implying metallic construction. The 510(k) process ensures material compatibility. (Specific material details are not in this summary, but would be in the full submission). |
| Compliance with general controls provisions (e.g., annual registration, good manufacturing practice, labeling, prohibitions against misbranding and adulteration). | FDA's letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the manufacturer committed to meeting these, but performance data is not typically included in the 510(k) summary for these aspects. |
| Intended Use matches or is a subset of the predicate device's intended use, and is supported by design/performance. | The stated "Indications for Use" for the Arthrex RetroFusion Screw are provided and compared to the predicate's (implicitly found to be equivalent or non-inferior based on the substantial equivalence determination). The description of the device's function (fixation of small bony or apical chondral fragments, etc.) supports this use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided 510(k) summary. For mechanical testing like pull-out strength, typically several samples of the device and predicate would be tested according to a validated test method. These are physical samples of the screw, not patient data or images.
- Data Provenance: The document describes non-clinical laboratory testing performed by the manufacturer, Arthrex, Inc., located in Naples, FL, USA. This is an in-vitro (benchtop) study comparing mechanical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable (N/A). This is a mechanical device, not an AI/ML diagnostic or image analysis device. "Ground truth" in this context would be objective physical measurements from laboratory equipment, not expert human interpretation.
4. Adjudication Method for the Test Set
- N/A. As this is mechanical testing of a physical device, there is no expert adjudication process. The results are quantitative measurements interpreted against engineering specifications and predicate data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an AI/ML device, and therefore, an MRMC study is not relevant or performed for this type of submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This applies to AI/ML algorithms. The device is a physical screw. Its "standalone" performance is assessed through its mechanical properties.
7. The Type of Ground Truth Used
- Objective Mechanical Measurements. For "pull-out testing," the ground truth is the measured force required to extract the screw, obtained using materials testing equipment (e.g., a universal testing machine). This is a direct physical measurement.
8. The Sample Size for the Training Set
- N/A. This concept is for AI/ML models. For a physical device, there isn't a "training set" in the AI sense. Design iterations and prototyping would involve testing many physical samples, but this is part of the product development and verification process, not an AI training phase.
9. How the Ground Truth for the Training Set was Established
- N/A. Not applicable, as there is no "training set" for an AI algorithm.
Summary of what the document does indicate about performance:
The core of the performance evaluation for this physical device is the demonstration of substantial equivalence to an existing legally marketed predicate device (Arthrex Bio-Pin, K050259).
The key performance data explicitly mentioned is:
- "Pull-out testing demonstrates that the pull-out strength of the Arthrex RetroFusion Screw is significantly greater than the predicate."
This statement highlights that at least one critical mechanical property (pull-out strength, important for bone fixation) was tested, and the new device performed better than the predicate, thus supporting its safety and effectiveness for its intended use. The 510(k) process relies on demonstrating that the new device is as safe and effective as a predicate device, and often, this involves showing comparable or superior performance in relevant non-clinical tests.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 15, 2015
Arthrex, Inc. Mr. David Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K151078
Trade/Device Name: Arthrex RetroFusion Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 20, 2015 Received: April 22, 2015
Dear Mr. Rogers:
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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Arthrex RetroFusion Screw
Indications for Use (Describe)
The Arthrex RetroFusion Screw is intended to fix small bony or apical chondral fragments in the foot, ankle, upper extremities, hand, and wrist, where such fragments are not under tension or load-bearing. These devices are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The devices can be used for inherently stablization of ioint arthroplasty (resection) or fusion for the treatment of divital deformities of the foot or hand. This device is also used in inherently stable long bone fractures such as the femur, fibula, tibia, radius and ulna, including the diaphyseal, epiphyseal, and metaphyseal areas.
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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| Date Summary Prepared | April 20, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | David L RogersRegulatory Affairs AssociateArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@Arthrex.com |
| Trade Name | Arthrex RetroFusion Screw |
| Common Name | Screw |
| Product Code -Classification Name | HWC - Screw, Fixation, Bone |
| CFR | 21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener |
| Predicate Device | K050259: Arthrex Bio-Pin |
| Purpose of Submission | This special 510(k) premarket notification is submitted toobtain FDA clearance for the Arthrex RetroFusion Screw. |
| Device Description | The Arthrex RetroFusion Screw is an implant with a dualthreaded design and ranges in size from 20 to 32mm inlength. The RetroFusion screw is inserted between theproximal and middle phalanges, so the opposing threadsfixate on the phalangeal canal of the toe and compressthe joint. |
| Intended Use | The Arthrex RetroFusion Screw is intended to fix smallbony or apical chondral fragments in the foot, ankle,upper extremities, hand, and wrist, where suchfragments are not under tension or load-bearing. Thesedevices are used in cases of osteochondritis dissecansand osteochondral fragments, fixation of fractures, 1stmetatarsal (bunionectomy osteotomies), cuneiformbones, inherently stable osteotomies, and fusions of thephalanges, metatarsals, metacarpals, carpal bones, tarsalbones, ankle, and wrist. The devices can be used forinherently stable intramedullary stabilization of joint |
| arthroplasty (resection) or fusion for the treatment ofdigital deformities of the foot or hand. This device is alsoused in inherently stable long bone fractures such as thefemur, fibula, tibia, radius and ulna, including thediaphyseal, epiphyseal, and metaphyseal areas. | |
| Substantial Equivalence Summary | The Arthrex RetroFusion Screw is substantially equivalentto the predicate devices in which the basic designfeatures and intended uses are the same.Anydifferences between the Arthrex RetroFusion Screw andthe predicate are considered minor and do not raisequestions concerning safety and effectiveness. |
| Pull-out testing demonstrates that the pull-out strengthof the Arthrex RetroFusion Screw is significantly greaterthan the predicate. | |
| Based on the indications for use, technologicalcharacteristics, and the summary of data submitted,Arthrex, Inc. has determined that the ArthrexRetroFusion Screw is substantially equivalent to thepredicates. |
2.6 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
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§ 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.