(122 days)
The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies of the distal tibia, talus, and calcaneus.
ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
The subject Universal Anterior Plate is designed to facilitate arthrodesis of the ankle and is composed of titanium alloy. The plate features poly-axial locking screw holes and one compression slot. It accepts screws of multiple diameters and lengths.
The provided text is a U.S. FDA 510(k) premarket notification document for a medical device. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.
The document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device or a diagnostic device. It is for a mechanical orthopedic implant (an ankle fusion plating system).
The "study" referenced in this document is a "non-clinical" engineering analysis (Finite Element Analysis and cross-sectional analysis) rather than a clinical trial or performance study against specific acceptance criteria for diagnostic output.
Therefore, most of the information requested in your prompt (e.g., sample size for test/training sets, data provenance, number/qualifications of experts, ground truth, MRMC study, standalone performance) is not applicable or not present in this document because it pertains to a different type of medical device evaluation.
However, I can extract the relevant information from the document as best as possible, focusing on how substantial equivalence was demonstrated:
1. Table of Acceptance Criteria and Reported Device Performance
For this orthopedic implant, the "acceptance criteria" are implied by the demonstration of "substantial equivalence" to a predicate device in terms of mechanical performance. The study aimed to show that the new device's bending strength was comparable to the predicate and did not introduce a new worst-case scenario.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bending strength comparable to predicate device | Demonstrated substantial equivalence in bending strength to the predicate. |
| No new worst-case scenario introduced compared to the predicate. | Did not introduce a new worst case into the system. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The "test" here refers to non-clinical engineering analysis (Finite Element Analysis and cross-sectional analysis), not a traditional clinical sample size or dataset for diagnostic performance.
- Data Provenance: Not applicable. As an engineering analysis, it relies on material properties, design specifications, and computational models, not patient data from a specific country or retrospective/prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of diagnostic performance, is not relevant for this mechanical engineering analysis.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a mechanical implant, not a diagnostic tool evaluated by human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
Not applicable. For a mechanical device evaluated through engineering analysis, "ground truth" as typically understood in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not applied. The "truth" is established by the laws of physics and engineering principles applied in the analysis.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a mechanical device evaluated through engineering analysis, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" or "ground truth" in the context of an engineering analysis for a mechanical device.
Summary of the Study for Substantial Equivalence:
The study performed was a non-clinical evaluation consisting of:
- Finite Element Analysis (FEA)
- Cross-sectional analysis
These analyses were conducted to compare the bending strength of the new ORTHOLOC® 3Di Universal Anterior Plate to its predicate device (K121425: ORTHOLOC® 3Di Ankle Fusion Plating System). The conclusion was that the new plate demonstrated substantial equivalence in bending strength and did not introduce a new worst-case scenario into the system. This type of evaluation is standard for demonstrating the safety and effectiveness of mechanical orthopedic implants for 510(k) clearance, rather than the clinical performance studies typically required for AI/ML or diagnostic devices.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2017
Wright Medical Technology, Inc. Ms. Rachel Roberts Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117
Re: K163650
Trade/Device Name: ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension 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: March 16, 2017 Received: March 20, 2017
Dear Ms. Roberts:
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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension
Indications for Use (Describe)
The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies of the distal tibia, talus, and calcaneus.
ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 wmt.com
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K163650 510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the ORTHOLOC® 3Di Ankle Fusion Plating System - Line Extension.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|
| Date: | March 17, 2017 |
| Contact Person: | Rachel RobertsRegulatory Affairs SpecialistOffice - (901) 867-9708Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | ORTHOLOC® 3Di Ankle Fusion Plating System –Line Extension |
| Common Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Classification Name and Reference: | 21 CFR 888.3030 - Class II21 CFR 888.3040 - Class II |
| Device Product Code, Device Panel: | HRS - OrthopedicHWC - Orthopedic |
| (a)(3). Predicate Device: | K121425: ORTHOLOC® 3Di Ankle Fusion PlatingSystem |
(a)(4). Device Description
The subject Universal Anterior Plate is designed to facilitate arthrodesis of the ankle and is composed of titanium alloy. The plate features poly-axial locking screw holes and one compression slot. It accepts screws of multiple diameters and lengths.
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K163650
(a)(5). INTENDED USE
The ORTHOLOC® 3Di Ankle Fusion Plating System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints and tibiocalcaneal arthrodessis, in conjuction with osteotomies and fractures of the distal tibia, talus, and calcaneus.
ORTHOLOC® Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
(a)(6). Technological Characteristics Comparison
The subject ORTHOLOC 3Di Universal Anterior Plate is substantially equivalent to the predicate devices in materials and design. The plate incorporated the predicate 3Di locking technology with an additional size of screws which allow for low profile fixation in the talus.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Finite element analysis and cross-sectional analysis demonstrated substantial equivalence. Through this testing it was determined that the addition of the Universal Anterior Plate is substantially equivalent in bending strength to the predicate and does not introduce a new worse case into the system.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject plate do not raise any new types of questions of safety of effectiveness. From the evidence submitted in this 510(k), the subject device can be expected to perform at least as well as the predicate.
§ 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.