The Parcus V-LoX™ Titanium Suture 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.
Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.

Acetabular Labral Repair Hip

Device Description

The Parcus V-LoX Titanium Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissue to bone. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136). It comes preloaded with two #2 sutures either with or without attached needles, and is available in two different diameters, 5mm and 6.5mm.

AI/ML Overview

The provided document describes the Parcus V-LoX™ Titanium Suture Anchor and its substantial equivalence to predicate devices, focusing on mechanical performance rather than algorithm-based device performance. Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this documentation.

However, I can provide information based on the mechanical testing described for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance	Study Conclusion
Pullout Strength	Measured and compared to predicate devices.	No significant differences compared to predicate devices.
Insertion Torque	Measured and compared to predicate devices.	No significant differences compared to predicate devices.

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

The document does not specify the exact sample size used for the mechanical testing (pullout strength and insertion torque). It mentions "side by side comparisons were done with the Smith & Nephew predicate device."

Test Set Sample Size: Not specified.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing performed by Parcus Medical, LLC. It is a prospective study in the sense that the new device was manufactured and then tested.

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

Not applicable. This device is a mechanical implant, and its performance is evaluated through physical measurements (pullout strength, insertion torque) against established engineering standards or predicate device performance, not against expert-established ground truth like in image analysis or diagnostic algorithms.

4. Adjudication Method for the Test Set

Not applicable. Mechanical testing does not involve subjective adjudication by experts. The results are objective 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

Not applicable. This is a medical implant, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on:

Measured physical properties: Direct measurements of pullout strength and insertion torque.
Comparison to predicate devices: The established performance of existing, legally marketed suture anchors (e.g., Smith & Nephew Suture Anchor, Arthrex Corkscrew FT II Suture Anchor, ConMed Linvatec Bio Mini-Revo Suture Anchor) serves as the benchmark for "substantial equivalence."
Published literature: The document states that "The published literature was reviewed," suggesting that general performance expectations for such devices were also considered.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for a mechanical medical device in the context of algorithm development.

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

Not applicable. There is no "training set" or "ground truth" in the AI/algorithm sense for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "PARCUS Medical, LLC". The logo is in a sans-serif font and is a dark gray color. The word "PARCUS" is in large letters, and the words "Medical, LLC" are in smaller letters to the right of the word "PARCUS".

SURGICAL INNOVATION >> VALUE DRIVEN

K090075

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510(k) Summary

Submitter:	Parcus Medical, LLC839 South Neenah Ave.Sturgeon Bay, WI 54234	MAR 6 2009
Company Contact:	Barton BracyPhone: (920) 746-2972Fax: (920) 746-8665
Date Prepared:	January 9, 2009
Trade Name:	Parcus V-LoX™ Titanium Suture Anchor
Common Name:	Suture Anchor
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code HWC and MBI

Predicate Devices:

Smith & Nephew Suture Anchor (K003599) .
Arthrex Corkscrew FT II Suture Anchor (K050358) .
ConMed Linvatec Bio Mini-Revo Suture Anchor (K072291) .

Device Description:

Intended Use:

The Parcus V-LoX™ Titanium Suture 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 Shoulder Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.
Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Knee Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

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Image /page/1/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. The logo features a stylized letter 'P' followed by the word 'PARCUS' in a bold, sans-serif font. To the right of 'PARCUS' is the text 'Medical, LLC' in a smaller, lighter font.

SURGICAL INNOVATION >> VALUE DRIVEN

K090075

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Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valqus Reconstruction, Metatarsal Ligament Repair. Elbow Tennis Elbow Repair, Biceps Tendon Reattachment. Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.
Hip Acetabular Labral Repair

Substantial Equivalence Summary:

The Parcus V-LoX Titanium Suture Anchor is substantially equivalent to the predicate devices listed above in which the basic features and intended uses are the same. Any differences between the V-LoX Titanium Suture Anchor and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness.

Summary Performance Data:

The pull out strength and insertion torque was measured for the Parcus V-LoX Titanium Suture Anchors. The published literature was reviewed and side by side comparisons were done with the Smith & Nephew predicate device. The results of the insertion torque testing, pullout force, and the literature review demonstrated that there were no significant differences between the Parcus V-LoX Titanium Suture Anchors and the predicate devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is centered horizontally and appears to be the heading of a document or publication. The words are all capitalized and evenly spaced.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Parcus Medical, LLC. % Mr. Barton Bracy 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54235

MAR 6 2009

Re: K090075

Trade/Device Name: Parcus V-LoX Titanium Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: January 9, 2009 Received: January 12, 2009

Dear Mr. Bracy:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 – Mr. Barton Bracy -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Millerson

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

Enclosure

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Indications for Use

510(k) Number (if known): K090075

Device Name: _Parcus V-LoX™ Titanium Suture Anchor

Indications for Use:

The Parcus V-LoX™ Titanium Suture 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.
Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Foot/Ankle Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.
Tennis Elbow Repair, Biceps Tendon Reattachment. Elbow
Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Hand/Wrist Ligament Reconstruction, TFCC.

Acetabular Labral Repair Hip

(Division Signold) Division of General, Restorative, and Neurological Devices

510(k) Number

Number K090075

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)

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.