The Responsive Arthroscopy Knotless Push-In Suture Anchors are intended to be used for fixation of suture (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, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy, Digital Tendon Transfers.

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.

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.

Hip: Capsular Repair, Acetabular Labral Repair.

Device Description

The Responsive Arthroscopy (RA) Knotless Push-In Suture Anchor System is an updated version of the RA Knotless Push-In Suture Anchor System previously cleared under K180951. The RA Knotless Push-In Suture Anchor is intended for fixation of suture (soft tissue) to bone. The system includes a variety of anchors made of polyetheretherketone per ASTM F2026 (PEEK) along with repair suture tape, inserters, drills, broaches, and guides.

The only differences in the subject device are regarding suture geometry, anchor body geometry, and internal screw geometry. The RA Knotless Push-In Suture Anchor System anchors are available in a variety of geometries and configurations to accommodate various procedures and patient anatomies. RA Knotless Push-In Suture Anchor System anchors range in diameter from 3.5mm to 4.75mm and are either pre-loaded with or accept #2 suture or 2.5mm suture tape.

The RA Knotless Push-In Suture Anchor System anchors are pre-loaded on inserters and provided sterilized with ethylene oxide. The RA Knotless Push-In Suture Anchor System reusable instruments are non-sterile and are to be sterilized by the end user.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "Responsive Arthroscopy Knotless Push-In Suture Anchor System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets acceptance criteria in a clinical study. Therefore, several of your requested points related to clinical study design, ground truth establishment, expert involvement, and reader studies are not applicable to this type of regulatory submission.

The FDA 510(k) process for Class II medical devices like this one typically relies on bench testing and comparison to predicate devices, not extensive clinical trials with human subjects to prove performance metrics in the way you've outlined for diagnostic AI.

Here's a breakdown of the information that is available and a note on what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission demonstrates substantial equivalence through various performance tests, but it does not specify explicit "acceptance criteria" in a numerical sense as one would expect for a diagnostic AI study (e.g., AUC > 0.9, sensitivity > 90%). Instead, the "acceptance criteria" for a 510(k) are generally that the new device performs as well as or better than the predicate device, or at least does not introduce new safety or effectiveness concerns, for its intended use. The performance reported aims to support this substantial equivalence.

Performance Characteristic	Reported Device Performance (Responsive Arthroscopy Knotless Push-In Suture Anchor System)	Acceptance Criteria (Implicit for Substantial Equivalence to Predicate K180951)
Insertion Force	Tested. (Details not provided in summary)	Comparable to or safer than predicate, demonstrating appropriate ease of use and placement.
Static & Cyclic Pullout Force	Tested. (Details not provided in summary)	Comparable to or better than predicate, demonstrating sufficient strength for soft tissue to bone fixation under various loading conditions, without introducing new risks.
Suture Locking Force	Tested. (Details not provided in summary)	Comparable to or better than predicate, ensuring secure fixation of suture.
Suture Characterization	Tested (reference to previously cleared devices K100006, K153307)	Sutures meet established standards for strength, biocompatibility, etc.
Biocompatibility	Risk Assessment performed. (Details not provided in summary)	Device components (PEEK anchors, sutures) are biocompatible per relevant standards, posing no new biological risk.
Bacterial Endotoxin	Risk Assessment performed. (Details not provided in summary)	Endotoxin levels are controlled to be safe for implantation.
Sterilization, Cleaning, and Shelf-Life	Adoptions performed. (Details not provided in summary)	Sterilization method is effective and validated, cleaning instructions are adequate for reusable components, and shelf-life is established.

Study Proving Substantial Equivalence:

The provided document describes a 510(k) Pre-Market Notification submission, which is a regulatory pathway to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The "study" in this context refers to the collection of bench testing and risk assessments performed to support this claim.

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

Sample Size for Test Set: Not explicitly stated numerically for each test. Bench testing involves a certain number of samples, but these are material/device samples, not patient data.
Data Provenance: The "data" comes from bench testing (laboratory mechanical tests) of the device components and system. It is not clinical data from patients, so concepts like "country of origin" or "retrospective/prospective" patient data do not apply.

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

Not applicable. This is not a diagnostic AI study involving expert radiologists/pathologists. The "ground truth" for bench testing is derived from established engineering and materials science principles, industry standards (e.g., ASTM F2026 for PEEK), and comparison to the predicate device's known performance.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data in the sense of a diagnostic study that would require adjudication. Bench test results are quantitative measurements.

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 not a study of AI assistance or human reader performance.

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

Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this regulatory submission is based on:

Performance standards and literature: Established engineering principles, material properties (e.g., ASTM F2026 for PEEK), and industry standards for surgical implants.
Predicate device performance: The performance of the Responsive Arthroscopy Suture Anchor System (K180951) serves as the primary benchmark.
Risk assessment: Evaluation against known biological and mechanical risks associated with similar devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device requiring a training set.

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

Not applicable.

Summary of Device and Regulatory Context:

The "Responsive Arthroscopy Knotless Push-In Suture Anchors" are intended for surgical fixation of soft tissue to bone in various joints (shoulder, foot/ankle, hip, knee, hand/wrist, elbow). Key features mentioned are:

Made of PEEK (polyetheretherketone) per ASTM F2026.
Available in 3.5mm to 4.75mm diameters.
Pre-loaded with or accept #2 suture or 2.5mm suture tape (ultra-high molecular weight polyethylene).
Introduces changes in "suture geometry, anchor body geometry, and internal screw geometry" compared to its predicate.
Sterilized with ethylene oxide (anchors). Reusable instruments are non-sterile and sterilized by the end-user.

The FDA's determination of substantial equivalence for this Class II device means that, based on the submitted information (primarily bench testing and comparison to the predicate), the new device is as safe and effective as a legally marketed predicate device. This pathway does not typically require clinical trials in the sense of demonstrating new clinical efficacy or diagnostic accuracy with human subjects.

Summary

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September 9, 2020

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Responsive Arthroscopy LLC c/o Kristen Peña Associate Manager, Product Development Operations Cor Medical Ventures LLC 215 S. Highwav 101. Suite 200 Solana Beach, California 92075

Re: K202153

Trade/Device Name: Responsive Arthroscopy Knotless 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: July 31, 2020 Received: August 3, 2020

Dear Ms. Peña:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (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 (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 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,

Laura C. Rose, Ph.D. 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)

K202153

Device Name

Responsive Arthroscopy Knotless Push-In Suture Anchors

Indications for Use (Describe)

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion 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: 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)

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510(K) SUMMARY

SUBMITTER:

Submitted By:

Company Name:Address:	Responsive Arthroscopy LLC701 N. 3rd Street, Suite 208Minneapolis, MN 55401
Telephone:	858-720-1847
CONTACT PERSON:	Kristen Peña
TRADE NAME:	Responsive Arthroscopy Knotless Push-In Suture Anchors
COMMON NAME:	Knotless Push-In Suture Anchor System
CLASSIFICATION NAME:	Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
PRODUCT CODE:	MBI

SUBSTANTIAL EQUIVALENCE:

The Responsive Arthroscopy Knotless Push-In Suture Anchor System is substantially equivalent to the predicate device in all facets including; function, design, performance, material, and intended use.

Primary Predicate Device:	Responsive Arthroscopy Suture Anchor System (K180951)
Reference Devices:	HS Fiber (Polyblend); RiverBond (Polyester); RiverSilk (Silk); RiverPro(Polypropylene); RiverLon (Nylon) (K100006)
	HS SutureTape (K153307)

DEVICE DESCRIPTION:

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MATERIALS:

The Responsive Arthroscopy Knotless Push-In Suture Anchors are machined from extruded PEEK per ASTM F2026. Implantable repair sutures are either Riverpoint Medical #2 HS Fiber ultra-high molecular weight polyethylene suture previously cleared under K100006 or Riverpoint Medical ultra-high molecular weight polyethylene HS SutureTape previously cleared under K153307.

INDICATIONS FOR USE:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion 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: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.

Hip: Capsular Repair, Acetabular Labral Repair.

PERFORMANCE TESTING:

The following bench testing was performed on the Responsive Arthroscopy Knotless Push-In Suture Anchor System:

Insertion Force Testing Static & Cyclic Pullout Force Testing Suture Locking Force Testing Suture Characterization (previously cleared device reference) Biocompatibility Risk Assessment Bacterial Endotoxin Risk Assessment Sterilization, Cleaning, and Shelf-Life Adoptions

In summary, mechanical testing of the Responsive Arthroscopy Knotless Push-In Suture Anchor System indicated no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate.

CONCLUSION:

The Responsive Arthroscopy Knotless Push-In Suture Anchor System is substantially equivalent to a legally marketed predicate based on indications for use, technological characteristics, performance testing, and comparison to a predicate device.

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.