The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Responsive Arthroscopy Large Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

The Responsive Arthroscopy Small Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair.

The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures.
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, Acetabular Labral Repair,

Device Description

The Responsive Arthroscopy (RA) Suture Anchor System is a family of suture anchors for the fixation of soft tissue to bone. The system includes a variety of suture anchors made of polyether ether ketone per ASTM F2026 (PEEK) along with repair sutures, inserters, taps, punches, drills, and quide tubes.
The suture anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Suture Anchors range in diameter from 2.5mm to 5.5mm and are either pre-loaded with or accept #2 suture.
The RA Suture Anchor System implants are pre-loaded on inserters and provided sterile, RA Suture Anchor System single-use instruments are provided sterile, and the RA Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Suture Anchor System implants and single-use instruments are sterilized with ethylene oxide (EO).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Responsive Arthroscopy Suture Anchor System. This document outlines the device's indications for use, technological characteristics, and performance testing to demonstrate substantial equivalence to legally marketed predicate devices.

However, the provided text DOES NOT contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device. Specifically, it lacks:

A table of acceptance criteria and reported device performance (for an AI model).
Sample sizes, data provenance, expert numbers, adjudication methods, MRMC studies, or standalone algorithm performance, as these are related to the evaluation of AI/ML models.
Details on ground truth establishment for AI training or test sets.

The document focuses on the substantial equivalence of a physical medical device (suture anchors) based on its mechanical performance and material properties. The performance testing mentioned ("Suture Characterization," "Insertion Torque Testing," "Static & Fatigue Pullout Force Testing," "Suture Locking Force Testing," "Bacterial endotoxin testing") are engineering and biocompatibility tests typical for a physical orthopedic implant, not studies for an AI/ML algorithm.

Therefore, I cannot fulfill the request as it is predicated on the assumption that the provided text describes an AI/ML device and its validation. The content of the document is solely for a physical medical device.

Summary

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Image /page/0/Picture/0 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 a blue box with the letters "FDA" in white. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 3, 2019

Responsive Arthroscopy LLC % Benjamin Arnold Managing Member Cor Medical Ventures LLC 215 S. Highway 101, Suite 200 Solana Beach, California 92075

Re: K180951

Trade/Device Name: Responsive Arthroscopy Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 8, 2018 Received: November 9, 2018

Dear Mr. Arnold:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (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 (OS) 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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510(k) Number (if known) K180951

Device Name

Responsive Arthroscopy Large Screw-In Suture Anchors

Indications for Use (Describe)

The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures.

Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K180951

Device Name

Responsive Arthroscopy Large Push-In Suture Anchors

Indications for Use (Describe)

The Responsive Arthroscopy Large Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K180951

Device Name

Responsive Arthroscopy Small Push-In Suture Anchors

Indications for Use (Describe)

Shoulder: Rotator Cuff Repair, Bankart 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP Joints for all Digits, Digital Tendon Transfers.

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

Hip: Capsular Repair, Acetabular Labral 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)
--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Number (if known) K180951

Device Name

Responsive Arthroscopy Knotless Push-In Suture Anchors

Indications for Use (Describe)

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair,

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(K) SUMMARY

SUBMITTER:

Submitted By:

Company Name:Address:	Responsive Arthroscopy LLC701 N. 3rd Street, Suite 202Minneapolis, MN 55401
Telephone:	858-720-1847
CONTACT PERSON:	Benjamin Arnold
DATE PREPARED:	April 09, 2018
TRADE NAME:	Responsive Arthroscopy Suture Anchor System
COMMON NAME:	Suture Anchor System
CLASSIFICATION NAME:	Smooth or threaded metallic bone fixation fastener.(21 CFR 888.3040)
PRODUCT CODE:	MBI

PREDICATE DEVICES:

The Responsive Arthroscopy (RA) Suture Anchor System is substantially equivalent to the predicate devices in all facets including: function, design, performance, material, and intended use.

Primary Predicate Device: Arthrex PushLock Anchors: K101679

Additional Predicate Devices: Arthrex Corkscrew Suture Anchors: K143745 Smith & Nephew TWINFIX Ultra PK Suture Anchors: K112526 Smith & Nephew FOOTPRINT Ultra PK Suture Anchors: K113274 ArthroCare MultiFIX S Ultra Knotless Fixation System: K131182 Arthrex SutureTak Suture Anchors: K140855 Arthrex Knotless SutureTak Suture Anchor: K171020 ConMed Linvatec NANO Suture Anchor: K112965 Smith & Nephew BIORAPTOR Knotless Suture Anchor: K121018 Arthrex Micro Corkscrew FT: K112237

DEVICE DESCRIPTION:

The suture anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Suture Anchors range in diameter from 2.5mm to 5.5mm and are either pre-loaded with or accept #2 suture.

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The RA Suture Anchor System implants are pre-loaded on inserters and provided sterile, RA Suture Anchor System single-use instruments are provided sterile, and the RA Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user. All RA Suture Anchor System implants and single-use instruments are sterilized with ethylene oxide (EO).

MATERIALS:

The RA Suture Anchor System anchors are machined from extruded PEEK per ASTM F2026. Implantable repair sutures are Riverpoint Medical #2 HS Fiber ultra high molecular weight polyethylene suture, previously cleared under K100006.

INDICATIONS FOR USE:

The Responsive Arthroscopy Large Screw-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:

Shoulder: Rotator Cuff Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

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

The Responsive Arthroscopy Large Push-In Suture Anchors are intended to be used for fixation of soft tissue to bone in the shoulder, foot/ankle, hand/wrist, and elbow in the following procedures:

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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

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

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Vastus Medialis Obliquus Advancement, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure.

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Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondvlitis Repair,

Hip: Capsular Repair, Acetabular Labral Repair.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction.

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

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

Hip: Capsular Repair, Acetabular Labral Repair.

TECHNOLOGICAL CHARACTERISTICS:

The Responsive Arthroscopy Suture Anchor System devices are made from similar anchor and suture materials and have identical diameters, similar fixation grooves and/or threads, identical numbers of sutures, and similar insertion method to the predicate devices. Any differences between the Responsive Arthroscopy Suture Anchor System devices and the predicates are considered minor and do not raise questions concerning safety or effectiveness.

PERFORMANCE TESTING:

The following bench testing was performed on the Responsive Arthroscopy Suture Anchor System and predicate devices:

Suture Characterization (previously cleared device reference) Insertion Torque Testing Insertion Force Testing Static & Fatique Pullout Force Testing Suture Locking Force Testing

Bacterial endotoxin testing was completed and met acceptable endotoxin limits per ANSI/AAMI ST72:2011(R2016). Mechanical testing of the Responsive Arthroscopy Suture Anchor System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.

CONCLUSIONS:

The Responsive Arthroscopy Suture Anchor System has shown to be substantially equivalent to legally marketed predicates based on indications for use, technological characteristics, performance testing, and comparison to predicate devices.

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.