The In2Bones USA, CoLink® Plating System/CoLink® View Plating System/CoLink ® Mini Plating System is indicated for stabilization 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.

CoLink® Afx Plating System -

The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.

Device Description

The In2Bones CoLink® 2 Plating System is a system of plates and screws and surgical instruments used to treat fractures and reconstruction of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® 2 Plating System. In addition, a washer is being added to the CoLink® Afx Plating System.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device, specifically the CoLink Plating System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting the results of clinical performance studies of an AI/ML device.

Therefore, many of the requested categories for a study proving device performance (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of submission. This submission primarily relies on mechanical performance testing and a comparison of materials, geometry, and indications for use to predicate devices.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations for an AI/ML context:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for a bone fixation system and not an AI/ML device, the "acceptance criteria" are not related to diagnostic performance metrics but rather to mechanical properties and substantial equivalence to predicate devices. The document refers to existing ASTM standards for testing.

Acceptance Criteria (Implicit for mechanical devices based on predicate equivalence)	Reported Device Performance
Mechanical performance for plates (e.g., bending strength) per ASTM F382 (consistent with predicate devices).	A rationale was conducted related to the CoLink® Plating four-point bend testing per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. (Implies performance is comparable and acceptable).
Mechanical performance for screws (e.g., axial pullout, torque capacity, insertion torque) per ASTM F543 (consistent with predicate devices).	A rationale was conducted related to the plate screws of the predicate CoLink® system for axial pullout, torque capacity and insertion torque characteristics per ASTM F543. (Implies performance is comparable and acceptable).
Sterilization, biocompatibility, shelf life, and pyrogenicity (consistent with predicate devices).	The CoLink® 2 Plating System components and CoLink® Afx washers are not considered a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and were adopted into the previous validations for the CoLink® Afx System (K181113). Bacterial endotoxin testing (LAL) is performed on each lot. (Implies compliance with established validations and testing).
MR environment compatibility, including RF induced heating (consistent with predicate devices).	An assessment was conducted regarding MR environment and labeling, including RF induced heating simulation, and it was determined that the CoLink® 2 components are not considered a worst case compared to K163293. (Implies acceptable MR compatibility).
Overall substantial equivalence in indications, materials, and geometry to predicate devices.	The subject CoLink® Plating System is made of Titanium Alloy and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry. (This is the overarching conclusion of the submission, demonstrating all criteria for substantial equivalence were met).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a premarket notification (510(k)) where substantial equivalence is demonstrated primarily through mechanical testing and comparison to predicate devices, not through a clinical "test set" of patient data as would be used for an AI/ML device.

Sample Size: Not applicable in the context of this 510(k). The "samples" would be physical devices subjected to mechanical stress tests. The document doesn't specify the number of devices tested for each mechanical property, but rather refers to rationales and existing validations.
Data Provenance: Not applicable. The data is from mechanical testing of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" establishment by medical experts in this type of submission. The ground truth for mechanical performance is established by adherence to engineering standards (ASTM).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a diagnostic device involving expert interpretation.

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 bone fixation system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by:

Adherence to recognized mechanical testing standards (e.g., ASTM F382 for bending, ASTM F543 for screws).
Demonstration of substantial equivalence in materials, design, and intended use to predicate devices that have already been cleared by the FDA and are presumed safe and effective.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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July 15, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

In2Bones USA, LLC Christine Scifert VP of Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119

Re: K201149

Trade/Device Name: CoLink 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. HTN Dated: July 2, 2020 Received: July 6, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K201149

Device Name CoLink® Plating System

Indications for Use (Describe)

CoLink® 2 Plating System -

CoLink® Afx Plating System -

The In2Bones USA, CoLink® Afx Plating System is indicated for stabilization of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

CoLink® Plating System July 2, 2020

Company:	In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931
Primary Contact:	Christine Scifert
Company Contact:	Rebecca Wahl
Trade Name:	CoLink® Plating System
Common Name:	Plate, Fixation, BoneScrew, Fixation, BoneWasher, Bolt Nut
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, HTN

Device Description: The In2Bones CoLink® 2 Plating System is a system of plates and screws and surgical instruments used to treat fractures and reconstruction of the extremities. These subject devices are part of the overarching CoLink® Plating System and will be commonly referred to as the CoLink® 2 Plating System. In addition, a washer is being added to the CoLink® Afx Plating System.

Indications for Use:

CoLink® 2 Plating System

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CoLink® Afx Plating System

The In2Bones USA, CoLink® Afx Plating System is indication and fixation of fractures and osteotomies in the ankle, including tibia and fibula, in both pediatric and adult patients.

The In2Bones USA CoLink® Afx Plating System screws are intended to be used as stand-alone bone screws, or in a plate-screw system for fracture fixation.

Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:

Primary Predicate

K163293 In2Bones CoLink® Plating System .
Additional Predicates
K172300 In2Bones CoLink® View Plating System .
K181113 In2Bones CoLink® Afx Plating System ●
K170518 In2Bones Fracture and Correction System ●
K200762 - In2Bones CoLink® Cfx Plating System

The subject CoLink® Plating System is made of Titanium Alloy and has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.

Performance Testing: No additional mechanical testing was required for the CoLink® 2 Plating System. The 3.0mm screws are nearly identical to previously cleared screws and no new worst-case plates or screws were added. A rationale was conducted related to the CoLink® Plating four-point bend testing per ASTM F382 to show the subject plates are substantially equivalent to the predicate plates. A rationale was conducted related to the plate screws of the predicate CoLink® system for axial pullout, torque capacity and insertion torque characteristics per ASTM F543. The CoLink® 2 Plating System components and CoLink® Afx washers are not considered a worst case for sterilization, biocompatibility, shelf life and pyrogenicity and were adopted into the previous validations for the CoLink® Afx System (K181113). An assessment was conducted regarding MR environment and labeling, including RF induced heating simulation, and it was determined that the CoLink® 2 components are not considered a worst case compared to K163293. Bacterial endotoxin testing (LAL) is performed on each lot.

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.

Regulation Number and Section

§ 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.