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, 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 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 (or soft tissue grafts), using #2 high-strength suture, back to the bone for reattachment. It is available in diameters of 3.5mm & 4.5mm 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 the Acumed Suture Anchor System, a medical device for soft tissue fixation to bone. The information primarily focuses on the device's description, intended use, indications for use, technological characteristics, and a comparison to a predicate device for substantial equivalence.

However, the provided text does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the way a diagnostic AI/ML device would. This document describes a traditional medical implant, where "performance data" refers to mechanical testing for strength and equivalence to an existing device, not diagnostic accuracy, sensitivity, or specificity.

Therefore, for your specific request that includes acceptance criteria, sample sizes for test sets, ground truth establishment, expert involvement, MRMC studies, or standalone algorithm performance, the provided document does not contain this information.

The "Performance Data" section states:

"The Acumed Suture Anchor System and the predicate were 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."

This indicates engineering/mechanical testing to show the new device performs similarly to a previously approved device (the predicate). It does not involve a clinical study with human patients, diagnostic performance metrics, or the establishment of ground truth in a diagnostic sense.

To directly answer your numbered points based on the provided text:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific engineering metrics. Instead, the criterion for approval is "substantial equivalence" to the predicate device based on mechanical performance.
Reported Device Performance: "The results demonstrate that the subject components are substantially equivalent to the predicate."

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Strength (Static and Dynamic Tension along/normal to screw axis)	Performance comparable to predicate device (Arthrex 3.7 mm Bio-Corkscrew (K061863))	Demonstrated substantial equivalence to the predicate.

Sample sized used for the test set and the data provenance: Not applicable. This was mechanical testing, not a clinical trial with a "test set" of patients or data provenance in the context of diagnostic AI.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for diagnostic AI (e.g., expert consensus on images, pathology reports) is not relevant for this mechanical testing.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, as it's not an algorithm/AI device.
The type of ground truth used: For mechanical testing, the "ground truth" would be the measured physical properties (e.g., tensile strength, fatigue resistance) of the devices under controlled conditions, compared against the known properties of the predicate device. This isn't "expert consensus" or "pathology" in the diagnostic sense.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a traditional medical device (a suture anchor), and the "performance data" described relates to mechanical testing for substantial equivalence, not the diagnostic performance criteria typically associated with AI/ML devices that would require the detailed information requested in your prompt.

Summary

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

K133469

Section 4: 510(k) SUMMARY

Device Trade Name:	Acumed Suture Anchor System
Date:	November 8th, 2013
Sponsor:	Acumed, LLC5885 NW Cornelius Pass RoadHillsboro, OR 97124Phone: (503) 627-9957Fax: (503) 520-9618
Contact Person:	Lino Tsai, Regulatory Specialist
Manufacturer:	Acumed, 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 fixationfastener
Device Regulation Panel:	Orthopedic
Device Product Code:	MRI

Device Description:

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.

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

K133469

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:

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.

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 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).

Technological Characteristics:

The Acumed Suture Anchor System possesses similar technological characteristics as the predicate. These include:

Basic design: threaded exterior surfaces for cortical & cancellous fixation .
. Material: UHMWPE suture
Sizing: available diameters are within the range of those offered in the predicate system .
Intended use: soft tissue fixation .

The Acumed Suture Anchor System possesses a modified technological characteristic in that body of the anchor is manufactured from PEEK Optima instead of bio-resorbable PLDLA (Arthrex Bio-Corkscrew).

Performance Data:

The Acumed Suture Anchor System and the predicate were 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.

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

K133469

Predicate Device: (modified to subject device)

Arthrex 3.7 mm Bio-Corkscrew (K061863)

Predicate Indications for Use:

r d

The Arthrex 3.7 mm Bio-Corkscrew System is indicated to be used for suture (soft tissue) fixation to bone in the foot , ankle, knee, hand, wrist, elbow, shoulder, and hip.

Based upon the similar technological characteristics of the Acumed Suture Anchor System and the predicate devices studied, the safety and effectiveness of the Acumed Suture Anchor System is substantially equivalent to the predicate devices compared.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird-like figure.

Public Health Service

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

March 10, 2014

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

Re: K133469

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: February 7, 2014 Received: February 10, 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: 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice 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/ReportaProblem/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. Wigqins

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

Enclosure

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

Section 3: INDICATIONS FOR USE

510(k) Number (if known): K133469

Device Name: Acumed Suture Anchor System

Indications for Use:

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 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.

Prescription Use	X
(21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use
(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

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.