(119 days)
The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.
The In2Bones CoLink™ View Plating System is a system of plates and screws and surgical instruments used to treat fracture and reconstruction of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 4Vanadium Alloy (Ti6A14V) materials.
This document describes a 510(k) premarket notification for a medical device, the In2Bones USA LLC, CoLink™ View Plating System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's safety and effectiveness through extensive clinical trials for de novo devices. Therefore, the information provided in the document is primarily related to mechanical testing and material compatibility, not the clinical performance or diagnostic capabilities of an AI-powered device.
Based on the provided text, it is not possible to provide the requested information about acceptance criteria and a study proving a device meets them, specifically regarding AI performance metrics. The document describes a traditional orthopedic implant (plating system) and the performance testing mentioned is mechanical and material-based, not related to AI or diagnostic accuracy.
Here's why the requested information cannot be extracted from this document, along with an explanation of what is present:
What the document is about:
- Device Type: The CoLink™ View Plating System is a system of plates and screws used for orthopedic fixation (e.g., treating fractures, fusions) in small bones of the hand, wrist, foot, and ankle.
- Regulatory Pathway: This is a 510(k) submission, meaning the manufacturer is demonstrating that its new device is "substantially equivalent" to an existing, legally marketed device (the predicate device). This pathway is for devices that are not significantly different from devices already on the market.
- Performance Testing Mentioned:
- Mechanical Testing: Four-point bend testing per ASTM F382-14 was performed to show the subject plates are mechanically equivalent to predicate plates.
- Biocompatibility Testing: Material Mediated Pyrogen Testing and bacterial endotoxin testing were conducted to establish non-pyrogenicity (i.e., that the materials are not harmful to the body).
- Conclusion: The device was determined to be substantially equivalent to the predicate devices based on indications, materials, geometry, and the mentioned performance testing.
Why the requested AI-related information is NOT in this document:
The provided text discusses the regulatory approval for a physical medical device (orthopedic plates and screws), not an AI/ML-driven diagnostic or assistive software. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI performance (like sensitivity, specificity, human reader improvement, ground truth establishment) are entirely irrelevant to this document.
To directly address your prompts:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for this device): Implied criteria are substantial equivalence to predicate devices in terms of indications, materials, geometry, and mechanical performance (e.g., meeting or exceeding certain bend strength thresholds per ASTM F382-14).
- Reported Device Performance: "the results show the subject plates to be substantially equivalent to the predicate plates." Specific numerical performance data from the mechanical tests (e.g., actual bend strength values) are not provided in this summary.
- No AI-related metrics as this is not an AI device.
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Sample size used for the test set and the data provenance:
- For mechanical testing, the "sample size" would refer to the number of physical plates tested. This information is not detailed in the summary.
- Data provenance is not applicable as this is not a study involving patient data for AI development or validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no diagnostic "ground truth" to establish for an orthopedic implant.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no human reading or diagnostic assessment described for this device.
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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 device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is its mechanical integrity and biocompatibility, typically established through standardized physical tests and material science, not clinical outcomes in the way an AI diagnostic would be.
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The sample size for the training set:
- Not applicable. There is no AI training set.
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How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document is a regulatory filing for a traditional medical device (orthopedic hardware), not an AI-powered one. Therefore, the questions related to AI-specific performance criteria and study methodologies cannot be answered from this text.
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November 27, 2017
In2Bones USA, LLC % Christine Scifert Exec VP MRC-X, LLC 6060 Poplar Ave, Suite 380 Memphis, Tennessee 38119
Re: K172300
Trade/Device Name: CoLink™ View Plating 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: October 19, 2017 Received: October 20, 2017
Dear Christine Scifert:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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Indications for Use
510(k) Number (if known)
Device Name CoLink™ Plating System
Indications for Use (Describe)
The In2Bones USA LLC, CoLink™ Plating System is indication and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediativ and adult patients.
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)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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510(k) Summary
CoLink™ Plating System November 22, 2017
| Company: | In2Bones USA, LLC6060 Poplar Ave, Suite 380Memphis, TN 38119901-260-7931 |
|---|---|
| Primary Contact: | Christine Scifert |
| Company Contact: | Rebecca Wahl |
| Trade Name: | CoLinkTM View Plating System |
| Common Name: | Plate, Fixation, BoneScrew, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3030 - Single/multiple component metallic bone fixation appliancesand accessories888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HRS, HWC |
The In2Bones CoLink™ View Plating System is a system of plates and screws and Device Description: surgical instruments used to treat fracture and reconstruction of the extremities. The current plate offering cleared under K163293 are made of ASTM F 136 Titanium 6Aluminum 4Vanadium Alloy (Ti6Al4V) material. The scope of this submission is to add plates that include inserts made of ASTM F 2026 Poly Ether Ether Ketone (PEEK) or ASTM F 136 Titanium 4Vanadium Alloy (Ti6A14V) materials.
The In2Bones USA LLC, CoLink™ Plating System is indicated for stabilization Indications for Use: and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
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Primary Predicate
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K163293 In2Bones CoLink™ Plating System .
Additional Predicates -
K120157 Wright Medical Mini MaxLock Extreme® Plating System ●
The subject CoLink™ Plating System made of Titanium Alloy and PEEK have demonstrated to be substantially equivalent to the previously cleared devices cleared under K163293 and K120157 as the products are similar in indications, materials and geometry.
Performance Testing: Mechanical testing four-point bend testing was performed per ASTM F382-14 on the subject CoLink™ View Plates and the results show the subject plates to be substantially equivalent to the predicate plates. Material Mediated Pyrogen Testing and bacterial endotoxin testing were conducted to establish non-pyrogenicity.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the 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.