Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction

Device Description

The Coronet Soft Tissue Fixation System consists of a single-use, sterile implant used to fixate tissue to bone and tissue to tissue. The implant consists of an anchor and soft tissue washer interconnected via a continuous loop of suture. The implant comes pre-assembled to an inserter, which facilitates concurrent placement of the anchor and soft tissue washer. A drill bit is provided to allow for the creation of a properly sized pilot hole in the bone implantation site.

AI/ML Overview

This document, a 510(k) premarket notification for the Coronet Soft Tissue Fixation System, focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing of mechanical properties and biocompatibility, rather than a clinical study evaluating diagnostic or prognostic performance with human subjects or AI-assisted interpretation.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria, particularly those related to a diagnostic or AI-driven device, are not applicable to this submission. The device described here is a medical implant (Coronet Soft Tissue Fixation System), not an AI algorithm or a diagnostic tool that provides performance metrics like sensitivity, specificity, or AUC, which would require the detailed study design (sample size, expert consensus, MRMC studies, etc.) that you inquire about.

However, I will extract the relevant information from the provided text that pertains to the "acceptance criteria" and "proof" for this specific type of device, which largely involves bench testing to demonstrate performance characteristics and safety.

Here's a breakdown based on the document:

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

The document doesn't present a formal table of acceptance criteria with quantitative thresholds alongside reported device performance results in the way one would for a diagnostic model's statistical metrics. Instead, it states that "Benchtop testing comparing Coronet to the ZipE and TwinLoop predicates demonstrates the Coronet system is substantially equivalent and introduces no new for different questions of safety or effectiveness." This implies that the acceptance criterion for these tests was equivalence (or non-inferiority) to the predicate devices regarding their performance, but specific numeric acceptance thresholds and actual measured values are not provided in this summary.

Here are the categories of performance data mentioned:

Testing Category	Specific Tests Performed	Implied Acceptance Criteria (Based on Substantial Equivalence)
Bench Testing	- Static pullout testing- Cyclic testing- Insertion testing- Fatigue limit testing	Performance (e.g., strength, durability, ease of use, resistance to forces) comparable or superior to predicate devices (ZipE, TwinLoop, Synthes Spiked Metallic Washer). The device "introduces no new or different questions of safety or effectiveness." Actual numeric values not disclosed.
Human Factors	- End-user validation	Successful and safe use by intended users. Acceptable ease of use and functionality.
Biocompatibility	- Cytotoxicity- Sensitization- Irritation- Pyrogen testing- MEM elution testing- Acute system injection- Intramuscular implantation	Biologically safe; no adverse reactions in biological systems. Compliance with ISO 10993 standards. Implants must not induce harmful reactions.
Sterilization	- Bioburden- Relative resistance- EO residual testing- Endotoxin (LAL) validation	Device is effectively sterilized and safe for human use; no harmful residues or microbial contamination.
MR Compatibility	- Induced displacement testing- Induced torque testing- Induced heating testing- Image artifact testing	Device is safe for use in an MRI environment; no significant displacement, torque, heating, or image artifacts.
Packaging	- Package integrity tests- Accelerated aging	Packaging maintains sterility and device integrity over its shelf life.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test. For mechanical bench testing, a certain number of devices would be tested, typically to statistical significance, but the exact N is not provided in this summary.
Data Provenance: This is bench testing of physical devices. It is not patient or clinical data. Therefore, concepts like "country of origin of the data" (for patients) or "retrospective/prospective" studies are not applicable. The tests were performed on the manufactured Coronet Soft Tissue Fixation System samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable for a device that relies on physical/mechanical and biocompatibility testing. "Ground truth" in this context is established by standardized testing protocols (e.g., ASTM, ISO standards) and measurable physical properties, not expert consensus on medical images or clinical outcomes.

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

Not applicable. Adjudication methods are used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus ground truth. This is not relevant for bench testing of an implant.

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. An MRMC study is designed to evaluate the performance of human readers, often with and without AI assistance, in interpreting medical images. This device is an implant, not a diagnostic imaging AI, and thus no MRMC study was performed.

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

Not applicable. This is not an algorithm or AI device. "Standalone performance" as described (algorithm only) is not relevant. The "standalone performance" of the Coronet system refers to its physical and functional integrity in bench tests.

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

For bench testing: The "ground truth" is defined by established engineering and material science principles, regulatory standards (e.g., ISO, ASTM for pullout strength, fatigue, biocompatibility), and comparison to the known effective performance of legally marketed predicate devices. There is no "pathology" or "outcomes data" in this context, as these are pre-market safety and efficacy validations, not post-market clinical trials.

8. The sample size for the training set

Not applicable. This device is not an AI model that requires a training set. Its design and manufacturing are based on established engineering principles for medical devices, not machine learning.

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

Not applicable for the same reason as #8.

Summary

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March 4, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

CoNextions Medical % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103

Re: K200028

Trade/Device Name: Coronet Soft Tissue Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 6, 2020 Received: January 6, 2020

Dear Ms. Hogan:

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 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

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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 mediation-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.

for

Laura Rose. Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200028

Device Name

Coronet Soft Tissue Fixation System

Indications for Use (Describe)

Coronet Soft Tissue Fixation System is intended for fixation of tissue to tissue to tissue.

This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular ● Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
. Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, ● Posterior Oblique Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament Reconstruction ●
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial Ligament Reconstruction ●

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K200028 510(k) SUMMARY CoNextions Medical's Coronet Soft Tissue Fixation System

Applicant Information

Manufacturer:	CoNextions Medical, Inc150 North Wright Brothers Drive, Suite 560Salt Lake City, Utah 84116Ph: 201.419.0118F: 801.436.5369
Contact Person:	Matthew Swift, Director of Marketing
Date Prepared:	March 2, 2020
Device Information
Proprietary Name:	Coronet Soft Tissue Fixation System
Common Name:	Soft Tissue Fixation Device
Classification Name:	MBI (888.3040) Fastener, fixation, nondegradable, soft tissue
Predicate Devices:	K162429 ZipE Knotless Tissue Repair and Attachment Devices,Ziptek LLC. (Primary)K070882 TwinLoopTM-PEEK Anchor, Stryker, Inc.K013806 Synthes ® Metallic Spiked Washer, Depuy Synthes, Inc.K130033 ToggleLocTM System, Zimmer Biomet, Inc.

Device Description

Intended Use/Indications for Use

Coronet Soft Tissue Fixation System is intended for fixation of tissue to bone and tissue to tissue.

This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps O Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

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Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux o Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar o Tendon Repair, Posterior Oblique Ligament Repair
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Ligament o Reconstruction
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar and Radial о Ligament Reconstruction

Technological Characteristics

Coronet Soft Tissue Fixation System is substantially equivalent to other legally marketed bone anchor devices. Specifically, use of an anchor for bone attachment with a washer for soft tissue attachment is substantially equivalent to the ZipE® Knotless Tissue Repair and Attachment Device from Ziptek LLC (K162429). Coronet and the ZipE device are similar in design, and have same intended use, same specific indications, similar technological characteristics and similar principles of operation. The anchor component of Coronet is equivalent to the TwinLoop™-PEEK Anchor from Stryker, Inc. (K070882), which has the same intended use, similar specific indications, similar technological characteristics and similar principles of operation. The soft tissue washer component of Coronet is equivalent to the Synthes® Spiked Metallic Washer from Depuy Synthes, Inc (K013806) which has a similar intended use and similar technological characteristics and principles of operation. Benchtop testing comparing Coronet to the ZipE and TwinLoop predicates demonstrates the Coronet system is substantially equivalent and introduces no new for different questions of safety or effectiveness.

Performance Data

Testing Category	Specific Tests Performed
Bench Testing	Static pullout testingCyclic testingInsertion testingFatigue limit testing
Human Factors	End-user validation
Biocompatibility Testing	CytotoxicitySensitizationIrritationPyrogen testingMEM elution testingAcute system injectionIntramuscular implantation
Sterilization validation	BioburdenRelative resistanceEO residual testingEndotoxin (LAL) validation
MR Compatibility	Induced displacement testingInduced torque testingInduced heating testing

The following non-clinical testing was conducted on Coronet Soft Tissue Fixation System.

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	Image artifact testing
Packaging	Package integrity tests
	Accelerated aging

Conclusions

The Coronet Soft Tissue Fixation System is substantially equivalent to predicate devices with respect to its indications for use, design, and function. The minor technological differences between Coronet and the predicate devices raise no new or different questions of safety or effectiveness and do not adversely impact the performance or function of the device as confirmed by performance testing. Thus, Coronet is substantially equivalent to the predicates.

Regulation Number and Section

§ 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.