Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bicepair, Biceps Tenodesis, Capsular Shift or Capsulolabral Repair, Fictorial Sepairion Repair, SLAP Lesion Repair,

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Olique Ligament Repair, Extra Capsular Reconstruction, Lateral Conaleral Ligament Repar, Posterior Oblique Ligare
Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion

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 SLiK Fix Screws are designed for use in the attachment of soft tissue to bone. The screws are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyethersether only in Chiler Polyen Fiber PEEK) or Carbon Fiber Reinforced
Polyetheretherketone (PEEK CF) and utilize a PEEK washer for graft/suture positioning. The Parcus SLiK Fix Screws are provided sterile.

AI/ML Overview

This is a premarket notification for a medical device (K170877) and as such, it primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria via a clinical trial or algorithm performance study.

Based on the provided document, here's a breakdown of the available information regarding acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with specific quantitative thresholds for the new device's performance, nor does it provide detailed numerical results of those tests. Instead, it refers to "worst-case configurations" testing and a comparison to predicate devices to demonstrate "substantial equivalency."

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical strength and elongation under cyclic loading	Evaluated. Results were compared with the predicate device and "demonstrated substantial equivalency." (Specific values not provided)
Mechanical strength and elongation under ultimate failure conditions	Evaluated. Results were compared with the predicate device and "demonstrated substantial equivalency." (Specific values not provided)
Insertion torque	Determined. Values were compared to the predicate device to ensure "the necessary safety factor existed during insertion of the device." (Specific values not provided)
Failure torque	Determined. Values were compared to the predicate device to ensure "the necessary safety factor existed during insertion of the device." (Specific values not provided)
Pyrogenicity	Testing was conducted on a comparable device, and it was concluded that the SLiK Fix Screws do not raise any additional concerns regarding pyrogenicity. (Specific test results not provided, but the conclusion of non-pyrogenic is reported.)
Overall safety and efficacy (demonstration of substantial equivalence)	The device is "very similar to the predicate Parcus Medical devices in that they are comprised of the same materials, are manufactured in comparable fashions, and are intended for the same indications." Even though the SLiK Fix Screws are shorter and larger in diameter, testing (as described above) has shown "the combination of these features does not raise any concerns regarding the safety or efficacy of the device."

Sample size used for the test set and the data provenance:

The document doesn't specify the exact sample sizes (number of devices) used for the mechanical or pyrogenicity testing. It only mentions "Devices were assembled and testing was conducted on the worst case configurations."

The data provenance is internal testing performed by Parcus Medical, LLC. No information is given regarding country of origin of data or if it's retrospective/prospective, but given it's a premarket submission, it would be prospective testing specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a medical device (screw) submission, not an AI/imaging diagnostic device. Ground truth as typically understood for AI models (e.g., expert consensus on images, pathology results) is not relevant here. The "ground truth" for mechanical testing is derived from engineering principles and validated test methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 are used for expert review in diagnostic studies, not for mechanical testing of hardware.
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 a physical medical device (fixation screw), not an AI or imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance data, the "ground truth" is based on:
- Engineering Test Standards: Standardized mechanical testing protocols for strength, elongation, and torque.
- Predicate Device Performance: The performance of previously cleared devices (Parcus PEEK CF Interference Screws, Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors, Parcus Twist PEEK Suture Anchors) serves as the benchmark for "substantial equivalence."
- Biological Safety Standards: Pyrogenicity testing follows established standards for biocompatibility.
The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.
How the ground truth for the training set was established:

Not applicable. This is a physical medical device, not an AI model.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Parcus Medical, LLC Mr. Paul Vagts Director of Regulatory Affairs/Quality Assurance 6423 Parkland Drive Sarasota, Florida 34243

June 2, 2017

Re: K170877

Trade/Device Name: Parcus SLiK Fix Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 21, 2017 Received: March 24, 2017

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 of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K170877

Device Name Parcus SLiK Fix Screw

Indications for Use (Describe)

The Parces SLIK Fix Screw is in soft tissue to bone reattachment procedures. Specific indications are the
following:

Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Bicepair, Biceps Tenodesis, Capsular Shift or Capsulolabral Repair, Fictorial Sepairion Repair, SLAP Lesion 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.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 of information is estimated to average 79 hours per response, including the ling the ling the ling the ling the and review the collection. Send comments regarding the burden estimate of any omplete
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K170877 Page 1 of 2

Image /page/3/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo features a red square with a white curved line on the left side, followed by the word "PARCUS" in blue, block letters. Below "PARCUS" is the phrase "MEDICAL, LLC." also in blue.

510(k) Summary

Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Joan RubendallPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	May 30, 2017
Device Trade Name:	Parcus SLiK Fix Screw
Common Name:	Interference Screw/Suture Anchor
Device Class:	Class II
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR888.3040 - Product Code MBI
Predicate Device:	The predicate devices are the Parcus PEEK CF InterferenceScrews (K091093, cleared 9/30/09), the Parcus 35/45Knotless PEEK CF Push-In Suture Anchors (K113730,cleared 1/17/12) and the Parcus Twist PEEK Suture Anchors(K120942, cleared 4/20/12).

Device Description:

Intended Use:

The Parcus SLiK Fix Screws are intended for use in soft tissue to bone reattachment procedures.
Specific indications are the following: Specific indications are the following:

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.

Page 16 of 223

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Image /page/4/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is in blue and red. The text "K170877 Page 2 of 2" is in the upper right corner of the image.

Substantial Equivalence Summary:

The Parcus SLiK Fix Screws are very similar to the predicate Parcus Medical devices in that they are comprised of the same materials, are manufactured in comparable fashions, and are in they are
same indications. While the Slik Eix Screws are ebetashons, and are intended fo same indications. While the Science are shorter his comparable fashing Parcus I for the
and larger in diameter than existing Parcus Suture that the existing Parcus Interfer and larger in diameter than existing Parcus Suture Anchors, testing has shown that the combination of these features does not raise any concerns regarding the safety or efficacy of the device. List in the combination testing was conducted on a comparable device and it was concluded that the SLik .
raise any addition a comparable device and it was concluded that the SLiK Fix Screws do not raise any addition concerns regarding pyrogenicity.

Summary Performance Data:

The SLiK Fix Screws were evaluated and testing was conducted on the worst case configurations. Devices were assembled and testing was conducted on the worst case configuration
strength and elongation under well be discussion in a test fixture. Devices were evaluated f strength and elongation under cycle loading and ultimate failure conditions. In addition, insertion torque and failure torque values were determined in order the necessary safety factor existen
during insertion of the device were determined in order the necessary safety fac during insertion of the device. Results were compared with the necessary safety factor exis
demonstrated substantial equivalency demonstrated substantial equivalency.

Page 17 of 223

Fax 1.941.755.6543

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.