The Parcus Titanium Interference Screw is a cannulated, tapered fastener for use in interference fixation of ligaments and tendons in patients requiring ligament or tendon repair. The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7-12mm in diameter and 20-35mm in length.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Parcus Titanium Interference Screw. This is a medical device, not an AI/ML powered device, so many of the questions related to AI/ML studies are not applicable. However, I can provide information based on the performance data presented for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Equivalent pull-out strength to predicate devices	"results of the... pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices."
Equivalent insertion torque to predicate devices	"results of the insertion torque testing... demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices."
No significant differences in safety and effectiveness compared to predicate devices	"Any differences between the Titanium Interference Screw and the predicate devices are considered minor and do not raise questions concerning safety and effectiveness." (This is a general statement rather than a specific performance metric, but it reflects the overall acceptance for 510(k) clearance.)

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

Sample Size: The document states that "the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size" were measured, and "side by side comparisons were done with the predicate devices." However, the exact number of screws tested for each size or the specific number of predicate devices used for comparison is not provided.
Data Provenance: The study was conducted by Parcus Medical, LLC for regulatory submission. The document does not specify the country of origin of the data beyond the manufacturer's location in Sturgeon Bay, WI, USA. This was likely a prospective in-vitro study designed to compare the new device to existing predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable as the study involved the physical testing of mechanical properties (pull-out strength and insertion torque) of a medical device, not an AI/ML algorithm requiring expert interpretation or ground truth labeling.

4. Adjudication Method

This question is not applicable as adjudication is typically used in clinical studies or for ground truth establishment in AI/ML tasks. The study involved direct mechanical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This question is not applicable as the study involves a physical medical device, not an AI/ML system or human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the study involves a physical medical device, not an AI/ML algorithm. The performance described (pull-out strength, insertion torque) is inherent to the device itself.

7. The Type of Ground Truth Used

The "ground truth" for this study would be the objective mechanical measurements of pull-out strength and insertion torque. These are quantitative physical properties measured directly from the devices using established testing methods. Essentially, the "truth" is the measured value from the test equipment.

8. The Sample Size for the Training Set

This question is not applicable. The Parcus Titanium Interference Screw is a physical medical device, not an AI/ML model that requires a training set.

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

This question is not applicable for the same reason as above.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for PARCUS Medical, LLC. Above the logo is the text "K083619 (pg. 1 of 2)". The logo is black and white and features the company name in a bold, sans-serif font.

SURGICAL INNOVATION >> VALUE DRIVEN

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:	December 1, 2008
Trade Name:	Parcus Titanium Interference Screw
Common Name:	Interference Screw
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code HWC and MBI

Predicate Devices:

Arthrex Interference Screw (K062466) �
Smith & Nephew BioRCI Screw (K032224)
Smith & Nephew Titanium Interference Screws (K040331)

Device Description:

Intended Use:

The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Substantial Equivalence Summary:

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

Page 15 of 97

839 S NEENAH AVE., STURGEON BAY, WI 54235

1-877-746-2972

www.parcusmedical.com

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

K083619 (pg. 2 of 2)

PARCUS Medical, LLC

SURGICAL INNOVATION >> VALUE DRIVEN

Summary Performance Data:

The pull out strength and insertion torque was measured for the smallest (7mm) and largest (12mm) Parcus Titanium Interference Screws as well as an intermediate size. Side by side comparisons were done with the predicate devices and results of the insertion torque testing and pullout force demonstrated that there were no significant differences between the Parcus Titanium Interference Screw and the predicate devices.

Page 16 of 97

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Parcus Medical, LLC % Mr. Barton Bracy 839 South Neenah Avenue Sturgeon Bay, Wisconsin 54234

6 2009 MAR

Re: K083619

Trade/Device Name: Parcus Titanium Interference Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, MBI Dated: December 1, 2008 Received: December 8, 2008

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.

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

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. Millman

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

Enclosure

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

Indications for Use

510(k) Number (if known): _ KO8 3619

Device Name: _Parcus Titanium Interference Screw

Indications for Use:

The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

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)

(Division Sign-Oil) Division of General, Restorative, and Neurological Device

510(k) Number

Page 13 of 97

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.