The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

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

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

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

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

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

Device Description

The Acumed Suture Anchor System is a system for anchoring soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 4.5 mm & 5.5 mm in order to accommodate differing anatomic requirements.

The anchor is a screw designed to provide fixation to bone that comes with two, #2 high-strength suture (pre-attached) in order to secure soft tissue (or soft tissue grafts) to the anchor. The system includes Class 1 instruments.

AI/ML Overview

The provided document describes a medical device, the Acumed Suture Anchor System, and its acceptance criteria for 510(k) clearance. However, the study supporting this clearance is a preclinical testing rather than a study involving human subjects or AI algorithms. As such, many of the requested categories related to AI performance, human expert involvement, and ground truth establishment are not applicable.

Here's the information derived from the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device K133469 in indications, design, function, and materials.	The modified Suture Anchor demonstrated substantial equivalence to the predicate in static and dynamic tension along and normal to the screw axis.

Study Details

Sample Size used for the test set and the data provenance:
- Not applicable. The study involved preclinical testing of the modified suture anchor, not a test set of data or human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth was based on the physical properties and performance of the device in preclinical testing. No human experts were used to establish a ground truth for a test set.
Adjudication method for the test set:
- Not applicable. This was preclinical testing, not a study requiring adjudication of a test set.
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 was preclinical testing of a medical device, not an MRMC study involving human readers or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This was preclinical testing of a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Preclinical Testing Results: The ground truth was established through physical testing (static and dynamic tension tests) comparing the modified device's performance to the predicate device.
The sample size for the training set:
- Not applicable. There was no training set, as this was preclinical testing of a physical device.
How the ground truth for the training set was established:
- Not applicable. There was no training set. The "ground truth" for the preclinical performance was established via engineering and biomechanical testing standards.

Summary

{0}------------------------------------------------

MAY 2 0 2014

1. 510(k) Summary

Device Trade Name:	Acumed Suture Anchor System
Date:	April 9, 2014
Sponsor:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 627-9957Fax: (503) 520-9618
Contact Person:Manufacturer:	Lino Tsai, Regulatory SpecialistAcumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 207 1370Fax: (503) 520-9618
Common Name:	Screw, Fixation, Bone
Device Classification:	Class II
Classification Name:	Screw, Fixation, Bone
Regulation:	21 CFR 888.3040, Smooth or threaded metallic bone fixation fastener
Device Regulation Panel:	Orthopedic
Device Product Code:	MBI

Device Description:

Intended Use:

The Acumed Suture Anchor System is designed to be used for soft tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Indications for Use:

{1}------------------------------------------------

The Acumed Suture Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

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

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

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

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

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

Materials:

The Acumed Suture Anchor System components are manufactured from PEEK Optima as described in ASTM F2026 and UHMWPE (High-strength suture).

Predicate Device:

A modification comparison of the proposed Suture Anchors and the predicate Suture Anchors (K133469) is provided in below Table:

K133469 Parts	Core Diameter	Outside Diameter	Description
55-0015	3.25 mm	5.5 mm	3.5 mm Suture Anchor
55-0016	4.25 mm	6.5 mm	4.5 mm Suture Anchor
Modified Parts
55-0015	3.25 mm	4.5 mm	4.5 mm Suture Anchor
55-0016	4.25 mm	5.5 mm	5.5 mm Suture Anchor

The subject 4.5 mm and 5.5 mm Suture Anchors are substantially equivalent to predicate anchors (K133469) with respect to indications, design, function, and materials.

{2}------------------------------------------------

Preclinical Testing:

The modified Suture Anchor was subjected to static and dynamic tension along the axis of the screw as well as static and dynamic tension normal to the axis of the screw. The results demonstrate that the subject components are substantially equivalent to the predicate

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the left side of the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2014

Acumed, LLC Ms. Lino Tsai Regulatory Specialist 5885 NW Cornelius Pass Road Hillsboro. Oregon 97124

Re: K140925

Trade/Device Name: Acumed 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: April 22, 2014 Received: April 23, 2014

Dear Ms. Tsai:

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: CDRFI 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 l'ederal 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practive requirements as set

{4}------------------------------------------------

Page 2 - Ms. Lino Tsai

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Lori A. Wiqqins

for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use 4.

510(k) Number (if known): K140925

Device Name: Acumed Suture Anchor System

The Acumed Soft Tissue Anchor System is intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, and shoulder.

Shoulder: Rotator Cuff Repair, Bankhart 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/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair. Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

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

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

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic 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.