Shoulder: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions). Acromnioclavicular separation repairs, Rotator cuff repairs, Bicep tenodesis;

Elbow, Wrist, and Hand: Biceps tendon reattachmnent, Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair;

Knee: Extra-capsular repairs (Medial collateral ligament, Lateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medials obliquous advancement), Illiotibial band tenodesis;

Foot and Ankle: Hallux valgus repairs. Medial or Lateral instability repairs/reconstructions. Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

Device Description

The Tigon Medical Tissue Anchor System consists of multiple-sized medial, lateral tissue anchors, and a single sized labral anchor. The medial anchors are threaded and are offered in 5.5 and 6.5 mm outer diameter sizes. The lateral anchors are conically barbed and are offered in 4.8 and 6 mm outer diameter sizes. The lateral anchors also offer unique angled locking slits to eliminate the need for knotting to secure the suture. The labral anchors are also barbed, and are offered in a 2.9 mm outer diameter, and are available with grooves, and two groove-less, knotless varieties (with and without locking slit). Tigon Tissue Anchors can be used with Tigon 2mm CuffTape and Tigon #2CuffCable (sold separately). Each tissue anchor will have a similar inserter.

AI/ML Overview

The provided text describes the 510(k) summary for the Tigon Medical Tissue Anchors, specifically addressing its substantial equivalence to predicate devices. It outlines the device's indications for use, description, and technological characteristics. Crucially, it details the non-clinical and clinical performance data, but does not describe a study that uses AI/algorithm-based outcomes or human-in-the-loop performance.

The document discusses acceptance criteria and device performance in the context of mechanical, material, and sterilization testing for a medical device (tissue anchors), not a software or AI-based diagnostic/assessment tool. Therefore, many of the specific questions related to AI/algorithm performance (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth for training set) are not applicable to this submission.

However, based on the provided text, I can infer the following about the acceptance criteria and proof of substantial equivalence for this mechanical device:

Acceptance Criteria and Device Performance (for Tigon Medical Tissue Anchors - a physical medical device)

This submission focuses on demonstrating substantial equivalence to predicate devices through physical and material testing, rather than an AI/algorithm-based performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that tests were completed and results concluded that the device "passed all pre-determined acceptance criteria." It implies that the acceptance criteria were defined by relevant ASTM and ISO standards for medical devices.

Acceptance Criteria Category	Specific Tests/Standards Mentioned	Reported Device Performance
Mechanical Performance	ASTM F-543 Testing (Standard Specification for Metallic Bone Plates) - Likely used for pull-out strength, insertion torque, etc., given the device type (tissue anchors).	"The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria." (Implies meeting or exceeding predicate device performance and relevant standard requirements for mechanical integrity).
Material Biocompatibility	Material: PEEK per ASTM F-2026 or equivalent. Mention of biocompatible material identical to predicate device in formulation, processing, sterilization, and geometry.	"No Biocompatibility testing was necessary" because the material is identical to the cleared predicate and is well-known biocompatible. This implies acceptable biocompatibility by proxy.
Sterility/Pyrogenicity	Limulus Amebocyte Lysate (LAL) Testing (for endotoxin/pyrogenicity)Material-Mediated Pyrogen (MMP) TestingPre-vac steam sterilization validation per ANSI/AAMI ST79:2017Pre-vac drying time validation per ANSI/AAMI ST79:2017	"Endotoxin, Pyrogenicity, Sterility... testing has been completed." "The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria." (Implies meeting sterility assurance levels and freedom from pyrogens).
Packaging & Shelf-life	Pre-validated Medical Packaging: Sealing and five-year real-time aging of QSEAL® pouch packaging systems per ASTM F1886/F1886M, ASTM F88/F88M, ASTM F1929, and ISO 11137-1.	"Shelf life, Packaging... testing has been completed.""The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria." (Implies maintaining integrity and sterility over stated shelf life).
Instrument Cleaning	Instrument Cleaning validation as outlined by AAMI TIR12-2010	"The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria." (Implies the instruments can be effectively cleaned for reuse if applicable).
Overall Equivalence	Comparison against Predicate Devices: Smith and Nephew BIORAPTOR Knotless Suture Anchors (K121018) and Cayenne Medical Quattro Link Knotless Anchor (K122314) in material, construction, and performance characteristics for the same intended use.	"Considered substantially equivalent" to predicate devices based on testing results and comparisons.

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

The document does not specify a "test set" in the context of an AI/algorithm.
For the non-clinical performance data (mechanical, material, packaging, sterilization), typical sample sizes are used as defined by the respective ASTM/ISO standards. This is not explicitly stated but is an industry standard.
The data provenance is from in-vitro laboratory testing conducted by the manufacturer (Tigon Medical and/or its testing partners) to meet regulatory requirements for a physical medical device. This is prospective testing of the manufactured device.

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

This is not applicable. Ground truth, in the context of AI/algorithm performance, refers to expertly labeled data. For a physical medical device, "ground truth" is established by the physical and chemical properties of the device and its performance against established engineering and safety standards. The "experts" would be the engineers, material scientists, and quality assurance personnel conducting and verifying the tests according to the standards.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication is relevant for resolving discrepancies in expert labeling of data for AI. For physical device testing, results are quantitative and compared directly to predetermined acceptance criteria defined by standards.

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:

This is not applicable. This submission is for a physical tissue anchor, not an AI-assisted diagnostic or treatment planning system. There are no "human readers" to assist or improve.

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

This is not applicable. The device is a physical tissue anchor, 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 based on established engineering standards, material science principles, and regulatory requirements for the physical properties, mechanical strength, biocompatibility, and sterility of medical implants. Performance is validated against these objective standards.

8. The Sample Size for the Training Set:

This is not applicable. There is no AI/algorithm training set for this physical device.

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

This is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

January 21, 2019

Tigon Medical % Lee Strnad President Intrepid Orthopedics, LLC 3953 Humphrey Road Richfield, Ohio 44286

Re: K182507

Trade/Device Name: Tigon Medical Tissue Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 21, 2018 Received: November 23, 2018

Dear Mr. Strnad:

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, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/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,

Laurence D. Coyne -S

For 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) K182507

Device Name Tigon Medical Tissue Anchors

Indications for Use (Describe)

The Tigon Medical Tissue Anchor System is intended for use for the reattachment of soft tissue to bone for the following indications:

Elbow, Wrist, and Hand: Biceps tendon reattachmnent, 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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510(k) number : K182507 Date submitted: September 12th, 2018

Image /page/3/Picture/1 description: The image is a logo for Tigon Medical. The word "Tigon" is written in bold, black letters. The "T" in Tigon is stylized to look like a screw. The "O" in Tigon is stylized to look like a tiger's eye. Underneath the word "Tigon" is the word "Medical" written in smaller, gray letters.

05. 510(k) Summary

Submitter Information

Applicant:	Tigon Medical
Contact Person:	Lee A. StrnadManagement RepresentativeIntrepid Orthopedics3953 Humphrey RdRichfield, OH 44286(440) 465-4321
Date Prepared:	8/7/18
Name of Device:	Tigon Medical Tissue Anchor
Common Name:	Tissue/Suture Anchor
Classification Name	Smooth or threaded metallic bone fixation fastener (per 21CFR 888.3040)
Product Code/Panel:	MBI
Predicate Devices:	Smith and Nephew BIORAPTOR Knotless Suture Anchors(K121018)
Intended Use:	Cayenne Medical Quattro Link Knotless Anchor (K122314)

The Tigon Medical Tissue Anchor System is intended for use for the reattachment of soft tissue to bone for the following indications:

Shoulder Capsular stabilization Bankart repair Anterior shoulder instability SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromnioclavicular separation repairs Deltoid repairs Rotator cuff repairs Bicep tenodesis Elbow, Wrist, and Hand Biceps tendon reattachmnent Ulnar or radial collateral ligament reconstruction

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Image /page/4/Picture/0 description: The image shows the logo for Tigon Medical. The word "Tigon" is written in bold, black letters, with the "I" resembling a screw and the "O" replaced by a stylized tiger eye. Below the word "Tigon" is the word "Medical" in smaller, thinner, black letters.

05. 510(k) Summary

Lateral epicondylitis repair

Knee Extra-capsular repairs Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs Vastus medials obliquous advancement Illiotibial band tenodesis Foot and Ankle Hallux valgus repairs Medial or Lateral instability repairs/reconstructions Achilles tendon repairs/reconstructions Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Bunionectomy

Device Description

Technological Characteristics

The Tigon Medical Tissue Anchors have the same intended use as the predicate devices. The Tigon Medical Tissue Anchors have similar indications for use as the predicate devices. The Tigon Medical Tissue Anchors are manufactured from the same material as the predicate devices. Tigon Medical Tissue Anchor implants are manufactured from PEEK per ASTM F-2026 or equivalent. The range of sizes of the Tigon Medical Tissue Anchors are similar to the predicate devices.

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Image /page/5/Picture/0 description: The image shows the logo for Tigon Medical. The word "Tigon" is written in bold, black letters, with the "T" stylized to look like a screw. The "O" is replaced with a stylized tiger eye. Below the word "Tigon" is the word "Medical" in smaller, sans-serif font.

05. 510(k) Summary

Non-Clinical Performance Data Summary

1. ASTM F-543 Testing
1. Limulus Amebocyte Lysate (LAL) Testing
1. Material-Mediated Pyrogen (MMP) Testing
1. Pre-validated Medical Packaging: Sealing and five year real time aging of QSEAL® pouch packaging systems per ASTM F1886/F1886M, ASTM F88/F88M, ASTM F1929, and ISO 11137-1.
1. Instrument Cleaning validation as outlined by AAMI TIR12-2010
1. Pre-vac steam sterilization validation per ANSI/AAMI ST79:2017
1. Pre-vac drying time validation per ANSI/AAMI ST79:2017

Clinical Performance Data Summary

No clinical testing was required.

Non-Clinical and Clinical Performance Data Conclusions

The Tigon Medical Tissue Anchors implants are manufactured from well-known biocompatible material PEEK (ASTM F2026). The Tigon Medical Tissue Anchors material, PEEK, of the final device is identical to the predicate device in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents). No Biocompatibility testing was necessary.

Endotoxin, Pyrogenicity, Sterility, Shelf life, Packaging, and Mechanical testing has been completed. The test results concluded that the Tigon Medical PEEK Anchors Package System passed all pre-determined acceptance criteria and is substantially equivalent to current predicate systems.

Based on testing results and the comparisons provided, the Tigon Medical Tissue Anchors are considered substantially equivalent to the Knotless Suture Anchors (K121018) and the Cayenne Medical Quattro Link Knotless Anchor (K122314) in material, construction, and performance characteristics.

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.