The Parcus Draw Tight Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:
Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow: Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Device Description

The Parcus Draw Tight Anchors are designed for use in attachment of soft tissue to bone. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and Polyetheretherketone (PEEK), The construct of the Draw Tight Anchors is such that when inserted into bone and deployed via the included suture, a suture ball is created in the prepared socket that provides the necessary fixation. The Draw Tight Anchors are designed to accommodate both sliding and fixed sutures to be used for soft tissue fixation and are provided sterile.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Parcus Draw Tight Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the Parcus Draw Tight Anchors. Instead, it uses comparative language to claim substantial equivalence to predicate devices. The "reported device performance" is summarized qualitatively.

Acceptance Criterion (Implicit)	Reported Device Performance
Mechanical Performance (Pull-out Strength): Sufficient pull-out strength in bone to ensure fixation and efficacy. (Implicit: Comparable to predicate devices)	"The Parcus Draw Tight Anchors were placed in prepared holes and the pull out strength was measured... Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects."
Mechanical Performance (Cyclic Loading): Ability to withstand cyclic loading conditions without failure or significant degradation. (Implicit: Comparable to predicate devices)	"In addition to straight load to failure, the proposed device was also tested under cyclic loading conditions. Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects."
Safety and Efficacy: No new safety or efficacy concerns raised by the device, even in challenging conditions. (Implicit: Comparable to predicate devices)	"However, even in the worst case scenario the Draw Tight Anchors perform as intended and do not raise any concerns regarding the safety or efficacy of the device... Any differences between the Draw Tight Anchors and the predicate devices are considered minor and do not raise any safety and/or efficacy concerns."
Indications for Use: The device can be used for the specified orthopedic soft tissue to bone attachment procedures. (Implicit: Identical or comparable to predicate devices)	"all of the indications for the proposed device are either identical or comparable to that of the predicate."
Material Equivalence: Device materials are the same or similar to predicate devices.	"they are manufactured from the same or similar materials"
Method of Fixation Equivalence: The method of fixation is similar to at least one predicate device.	"While the method of fixation for the Draw Tight Anchor differs from that of the Parcus predicate devices, fixation due to a suture ball rather than a solid anchor body, it is very similar to that of the Biomet predicate device."
Suture Specifications Equivalence: Specifications for the suture portion are within those of the predicate.	"When compared to the Biomet predicate device, the specifications for the suture portion of the proposed device are included within that of the predicate."

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

Sample Size: The document does not specify the exact sample size (number of anchors tested) for the performance testing. It generically refers to "the data" and "test results."
Data Provenance: The document does not state the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for a medical device (suture anchor), it's highly likely to be prospective bench testing performed under controlled laboratory conditions, rather than a clinical study involving human patients.

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

This question is not applicable to the type of device and study described. The "ground truth" for a mechanical device like a suture anchor is typically based on objective physical measurements (e.g., force required for pull-out, cycles to failure) in a laboratory setting, not on expert consensus or interpretation of images.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods are typically used in clinical trials or studies where human interpretation or subjective assessment of outcomes is involved. For bench testing of a mechanical device, the results are derived from instrumentation and physics-based 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

This question is not applicable. The device is a mechanical suture anchor, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC study or AI-related metrics are irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a mechanical suture anchor, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this study was objective physical measurements related to the mechanical performance of the suture anchors. This includes:

Pull-out strength (force to failure)
Resistance to cyclic loading
These measurements are then compared to established performance benchmarks (predicate devices).

8. The Sample Size for the Training Set

This question is not applicable. This is a study of a mechanical device, not an AI algorithm that requires a "training set."

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

This question is not applicable. There is no training set for this type of device and study.

Summary

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k122805411

510(k) Summary

FEB 0 5 2013

Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941) 755-7965Fax: (941) 755-6543
Date Prepared:	February 4, 2013
Trade Name:	Parcus Draw Tight Anchor
Common Name:	Suture Anchor
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code MBI

Predicate Devices:

Parcus 3.5mm PEEK CF Push-in Suture Anchors (K102326) ●
Parcus Twist PEEK Suture Anchors (K120942) �
Biomet Sports Medicine Juggerknot™ Soft Anchor (K110145) .

Device Description:

Intended Use:

The Parcus Draw Tight Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Shoulder Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Knee Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Foot/Ankle Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Hand/Wrist Reconstruction, TFCC.

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Substantial Equivalence Summary:

The Parcus Draw Tight Anchors are similar to the predicate devices in that they are manufactured from the same or similar materials, presented to the end user in the same fashion and have the same or similar indications. When compared to the Parcus Twist PEEK Suture Anchors, the Draw Tight Anchors are identical in all of these aspects. While the method of fixation for the Draw Tight Anchor differs from that of the Parcus predicate devices, fixation due to a suture ball rather than a solid anchor body, it is very similar to that of the Biomet predicate device.

When compared to the Biomet predicate device, the specifications for the suture portion of the proposed device are included within that of the predicate. In addition, all of the indications for the proposed device are either identical or comparable to that of the predicate. As stated above, the method of fixation for both devices is similar in that it relies on the placement of suture into a prepared hole and the creation of a suture ball that holds the device in place.

From a performance point of view, the Draw Tight Anchors perform very comparably to that of the predicate devices. As shown in the data, the quality of the bone in which the device is implanted does affect the performance of the device. However, even in the worst case scenario the Draw Tight Anchors perform as intended and do not raise any concerns regarding the safety or efficacy of the device.

Therefore, the Parcus Draw Tight Anchors are substantially equivalent to the predicate devices listed above. Any differences between the Draw Tight Anchors and the predicate devices are considered minor and do not raise any safety and/or efficacy concerns.

Summary Performance Data:

The Parcus Draw Tight Anchors were placed in prepared holes and the pull out strength was measured. In addition to straight load to failure, the proposed device was also tested under cyclic loading conditions. Test results were compared to the results for the predicate devices and the Draw Tight Anchors demonstrated substantial equivalence in all aspects."

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Letter dated: February 5, 2013

Parcus Medical, LLC % Mr. Paul Vagts RA/OA Manger 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235

Re: K122805

Trade/Device Name: Parcus Draw Tight Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 10, 2013 Received: January 30, 2013

Dear Mr. Vagts:

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

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Page 2 - Mr. Paul Vagts

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (2) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/uccr 1158001,h1n farc the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Mark N. Melkerson

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):	K122805
Device Name:	Parcus Draw Tight Anchors

Indications for Use:

The Parcus Draw Tight Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder	Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Knee	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.
Foot/Ankle	Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Elbow	Tennis Elbow Repair, Biceps Tendon Reattachment.
Hand/Wrist	Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

AND/OR Prescription Use _ X (Part 21 CFR 801 Subpart D)

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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices 2013.02.05 13:37:13 -05'00' -

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.