The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications:

Hip Indications: Capsule Repair, Acetabular Labrum Reattachment

Shoulder Indications: Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Rotator Cuff Repair, Biceps Tenodesis.

Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy.

Elbow. Wrist, and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Knee: Extra Capsular Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus Medialis Obliquous Advancement, Iliotibial Band Tenodesis.

Device Description

The ICONN Square 2.5MM Suture Anchors (P/N 125000) are sterile (gamma irradiation), single use implantable devices made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The anchors are available in one size (Width x Length): 2.5mm x 7.95mm and can be used as a knotted or knotless anchor.

AI/ML Overview

This document is related to a 510(k) premarket notification for a medical device, specifically the ICONN Square 2.5MM Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm or diagnostic device. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study proving its performance (like sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

The "acceptance criteria" for this device are based on its mechanical performance relative to predicate devices, ensuring it is at least as safe and effective.

Here's the information extracted from the provided text as it relates to the mechanical device, with an explanation of why certain AI-specific questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are embodied by demonstrating performance that is "similarly or better than the predicates or within acceptable ranges for the intended use."

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Anchor displacement after cyclic loading "acceptable ranges"	Performed similarly or better than the predicates.
Ultimate anchor pull-out within "acceptable ranges"	Performed similarly or better than the predicates.
Insertion of the device is safe.	Insertion testing demonstrated the device can be safely implanted.
Biocompatibility:
Biocompatibility equivalent to predicate devices.	Demonstrated substantial equivalence in biocompatibility to a predicate.
Sterility:
Sterile (gamma irradiation).	Device is sterile via gamma irradiation.
Material:
Material (PEEK) is suitable for intended use.	Made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact number of units tested for "anchor displacement after cyclic loading," "ultimate anchor pull-out," or "insertion testing." It refers to "side by side mechanical testing."
Data Provenance: The testing was conducted in a laboratory setting as part of the premarket notification process for the manufacturer (ICONN Orthopedics, LLC). It is not clinical data from patients or a specific country of origin in the way an AI study would entail. It's not retrospective or prospective clinical data but rather engineering test data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This is a mechanical device, not an AI algorithm requiring expert interpretation to establish a "ground truth" for diagnostic purposes. The "ground truth" here is objective mechanical measurements (e.g., force, displacement).

4. Adjudication Method for the Test Set

Not Applicable. This concept applies to human interpretation of data where disagreements need resolution. Mechanical testing results are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not Applicable. An MRMC study is for evaluating the impact of a new diagnostic technology (often AI) on human reader performance. This device is a surgical implant.

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

In a sense, yes, for mechanical performance. The "standalone" performance here refers to the device's intrinsic mechanical properties (pull-out strength, displacement) in a test environment, independent of a surgical outcome. However, this is not an "algorithm" and does not relate to human-computer interaction.

7. The Type of Ground Truth Used

Mechanical Measurement and Engineering Standards: The ground truth for this device's performance is derived from established mechanical testing standards and comparison to the performance characteristics of predicate devices. The FDA's "Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996)" was used for guidance.
Biocompatibility: Demonstrated through equivalence to a predicate device (ICONN Answer Suture Anchor, K132724) which presumably had its biocompatibility established.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As above, no training set was used.

Summary

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November 29, 2017

ICONN Orthopedics, LLC Whitt Israel CEO 400 Union Hill Drive, Suite 150 Birmingham, Alabama 35209

Re: K172491

Trade/Device Name: ICONN Square 2.5MM Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 31, 2017 Received: November 1, 2017

Dear Whitt Israel:

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K172491

Device Name ICONN Square 2.5MM Suture Anchor

Indications for Use (Describe)

Hip Indications: Capsule Repair, Acetabular Labrum Reattachment

Foot/Ankle Indications: Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy.

Elbow. Wrist, and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for "ICONN ORTHOPEDICS". The word "ICONN" is written in a sans-serif font, with the "O" being a blue circle. Below the word "ICONN" is the word "ORTHOPEDICS" with two lines on either side of the word.

400 Union Hill Drive, Suite 150 Birmingham, AL 35209

510(k) SUMMARY

Submitter's Name:	ICONN Orthopedics, LLC
Submitter's Address:	400 Union Hill DriveSuite 150Birmingham, AL 35209
Submitter Contact Person:	Whitt IsraelCEO(205) 913-2068
Date Summary was Prepared:	November 27, 2017
Trade Name or Proprietary Name:	ICONN Square 2.5MM Suture Anchor
Common or Usual Name:	Suture Anchor
Classification:	Class II per 21 CFR §888.3040
Product Code:	MBI - Fastener, Fixation, Nondegradable, Soft Tissue
Classification Panel:	Division of Orthopedic Devices

Device Description:	The ICONN Square 2.5MM Suture Anchors (P/N 125000) are sterile (gamma irradiation), single use implantable devices made from Solvay's Zeniva® ZA-500 polyetheretherketone (PEEK) material intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The anchors are available in one size (Width x Length): 2.5mm x 7.95mm and can be used as a knotted or knotless anchor.
Intended Use:	The ICONN Square Suture Anchor System is intended to provide secure fixation of soft tissue to bone in orthopedic procedures where fixation is needed as a result of injury or degenerative disease. The system is designed for use in the hip, shoulder, foot, ankle, elbow, wrist, hand, and knee for the following indications:
	Hip Indications : Capsule Repair, Acetabular Labrum Reattachment.
	Shoulder Indications : Capsular Stabilization, Bankart Repair, Anterior Shoulder Instability, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Acromioclavicular Separation Repair, Deltoid Repair, Rotator Cuff Repair, Biceps Tenodesis.
	Foot/Ankle Indications : Hallux Valgus Repair, Medial or Lateral Instability Repair/Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair/Reconstruction, Bunionectomy.

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	Elbow, Wrist, and Hand: Biceps Tendon Reattachment, Ulnar orRadial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.Knee: Extra Capsular Repair, Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Patellar Realignment and Tendon Repair, Vastus MedialisObliquous Advancement, Iliotibial Band Tenodesis.
Predicate Devices:	Two predicate devices from two manufacturers were used to help demonstrate substantial equivalence of several characteristics to include intended use, design, sizes, PEEK material, supplying the device in the sterile state, and provision of sutures. The predicate devices are:Smith & Nephew, Inc. BIORAPTOR 2.3PK Suture Anchor, Model 72201542 (K121018) Arthrex 2.9mm Short PEEK Pushlock Suture Anchor, Model Number AR-2923PS (K063479) Both predicates are intended for soft tissue fixation to bone for the same indications listed for the ICONN Square 2.5MM Suture Anchor. The ICONN 2.5MM Square Suture Anchor knot configuration was compared to the predicate of the same category (BIORAPTOR 2.3PK for knotted configuration and 2.9mm Short PEEK Pushlock for the knotless configuration).As well, the ICONN Answer Suture Anchor (K132724) was used as a predicate device to demonstrate substantial equivalence as it relates to biocompatibility of the subject device.
TechnologicalCharacteristics:	The ICONN Square 2.5MM Suture Anchor System suture anchors are of similar design to the predicates and are manufactured with the same basic material in similar size. The differences are in the manner in which the suture is secured to the anchor. The Smith and Nephew BIORAPTOR 2.3PK includes a single, integral eyelet that is used to secure the suture and the Arthrex 2.9mm Short PEEK Pushlock uses a separate eyelet with a cannulated anchor design to secure the suture. The ICONN Square 2.5MM Suture Anchor is designed to have the suture wrap through one of two integral eyelets to secure the suture. Due to the design differences, performance testing was conducted to characterize the performance of the ICONN Square 2.5MM Suture Anchor in comparison to the predicate devices.
Performance Data:	The FDA's Draft Guidance Document for Testing Bone Anchor Devices (April 20, 1996) was used for guidance in side by side mechanical testing performed on the subject device and predicates for the following test modes:

Anchor displacement after cyclic loading .

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Ultimate anchor pull-out
Testing showed that the ICONN Square 2.5mm Suture Anchor performed similarly or better than the predicates or within acceptable ranges for the intended use.

Insertion testing was also conducted on the subject device to demonstrate that the device can be safely implanted.

Conclusion: The ICONN Square 2.5MM Suture Anchor is substantially equivalent to the predicates and does not raise different questions of safety and effectiveness.

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.