Shoulder: Rotator Cuff Repair, Acromioclavicular Separation Repair, Biceps Tenair, 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 SLiK Anchors are designed for use in the attachment of soft tissue to bone. The devices are made from either Polyetheretherketone (PEEK) or Carbon Fiber Reinforced Polyetheretherketone (PEEK CF). The Parcus SLiK Anchors are provided sterile.

AI/ML Overview

The provided text is a 510(k) summary for the Parcus SLiK Anchors, a medical device intended for the attachment of soft tissue to bone. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study proving performance against specific acceptance criteria for a novel AI/ML or diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test/training sets, expert consensus, MRMC study, ground truth establishment) are not applicable to this type of device submission and the information provided. The "study" here refers to mechanical performance testing, not clinical performance or AI algorithm validation.

Here's an attempt to extract the relevant information and explicitly state what is not applicable based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format. Instead, it describes performance evaluations done to demonstrate substantial equivalence to predicate devices. The implied acceptance criterion for the Parcus SLiK Anchors is that their mechanical performance (strength, elongation, insertion torque, failure torque) is comparable to or better than the cleared predicate devices, thereby not raising new safety or efficacy concerns.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Comparable strength under cyclic loading to predicate devices.	"Devices were evaluated for strength and elongation under cycle loading... Results were compared with test data for the predicate devices and demonstrated substantial equivalency."
Mechanical Performance: Comparable elongation under cyclic loading to predicate devices.	"Devices were evaluated for strength and elongation under cycle loading... Results were compared with test data for the predicate devices and demonstrated substantial equivalency."
Mechanical Performance: Acceptable ultimate failure conditions comparable to predicate devices.	"Devices were evaluated for strength and elongation under... ultimate failure conditions. Results were compared with test data for the predicate devices and demonstrated substantial equivalency."
Insertion Safety: Sufficient safety factor during insertion based on insertion torque and failure torque values compared to predicate devices.	"In addition, insertion torque and failure torque values were determined in order to ensure the necessary safety factor exists during insertion of the device. Results were compared with test data for the predicate devices and demonstrated substantial equivalency."
Biocompatibility/Pyrogenicity: No additional concerns regarding pyrogenicity.	"LAL testing was conducted on a comparable device and it was concluded that the SLiK Anchors do not raise any addition concerns regarding pyrogenicity."

Study Details (as per the provided document)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document states "testing was conducted on the worst case configurations." It does not specify the exact number of devices tested for each configuration.
- Data Provenance: The testing was conducted by or for Parcus Medical, LLC (Sarasota, Florida, USA). It is a prospective engineering/mechanical test, not a retrospective analysis of clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, not an AI/ML or diagnostic imaging device requiring expert interpretation for ground truth. "Ground truth" in this context is the physical, measured performance of the anchors in a standardized test setup.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None Applicable. This is a mechanical device; there's no "adjudication" in the sense of reconciling human interpretations. The results are physical measurements.
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 implantable device, not a diagnostic or AI-assisted system. No human reader involvement or MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implantable device. There is no algorithm to test in a standalone manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this engineering study is the direct physical measurement of mechanical properties (strength, elongation, torque values) under defined test conditions, and comparison to the known performance of predicate devices. There is no clinical or biological "ground truth" beyond meeting design specifications and demonstrating comparable performance to the predicate.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for this device.

Summary

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

DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

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

March 30, 2017

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

Re: K170327

Trade/Device Name: Parcus SLiK 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 31, 2017 Received: February 2, 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

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

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,

Image /page/1/Picture/9 description: The image shows the name "Mark N. Melkerson -S" in a large, sans-serif font. The text is dark gray against a white background. The letters are evenly spaced and clearly legible.

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

Enclosure

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

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) K170327

Device Name Parcus SLiK Anchors

Indications for Use (Describe)

The Parcus SLIK 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, Biceps Tenair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid 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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is written in large, blue, sans-serif font. To the left of the word is a red square with a curved white line running through it. Below the word "PARCUS" is the phrase "MEDICAL, LLC." written in a smaller, blue, sans-serif font.

510(k) Summar

Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	January 31, 2017
Device Trade Name:	Parcus SLiK Anchor
Common Name:	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 35/45 Knotless PEEKCF Push-In Suture Anchors (K113730, cleared 1/17/12) andthe Parcus Twist PEEK Suture Anchors (K120942, cleared4/20/12)

Device Description:

Intended Use:

Call 1.941.755.7965

The Parcus SLiK Anchors are indicated for the attachment of soft tissue to bone. These products are intended for the following indications:

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

Substantial Equivalence Summary:

The Parcus SLiK Anchors 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 intended for the same indications. While the SLiK Anchors are offered without suture (like the Knothess predicate) and feature a thread-in insertion technique (like the Twist predicate), testing has shown that the

PARCUSMEDICAL.COM
6423 Parkland Drive, Sarasota, FL 34243
Page 16 of 226

Fax 1.941.755.6543

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

Image /page/4/Picture/0 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, blue, stylized letters. To the left of the word is a red square with a white curved line inside. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in smaller, blue letters.

combination of these features does not raise any concerns regarding the safety or efficacy of the device. LAL testing was conducted on a comparable device and it was concluded that the SLiK Anchors do not raise any addition concerns regarding pyrogenicity.

Summary Performance Data:

The SLiK Anchors were evaluated and testing was conducted on the worst case configurations. Devices were assembled per the DFU and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. In addition, insertion torque and failure torque values were determined in order to ensure the necessary safety factor exists during insertion of the device. Results were compared with test data for the predicate devices and demonstrated substantial equivalency.

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.