The CompresSURE System is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above. The system is not intended for spinal use.

Device Description

The U.S. Implants CompresSURE Fracture Repair System is a fracture fixation screw, washer, nut-and-bolt system for cortical wall compression of a bone fracture across the fracture site and, as well, provides an alternative to a cancellous bone screw for fracture fixation in the ankle, knee - proximal tibia, distal femoral, patella, etc.. The screw/bolt and nut is cannulated for use over a 1.6mm guide pin allowing for accurate placement of the screw/nut assembly in conjuction with use of fluoroscopic image x-ray. A full range of sizes are available from 25mm to 67mm in 3mm increments. The screw/bolt, washers, and nut are manufactured from High Strength 6-4 ELI Titanium Alloy with an Anodized surface. Cannulated drills, countersinks, depth gauge, and driver instruments are available for use in insertion of the screw, washer, bolt-and-nut system. Removal (when necessary) of the device is carried out percutaneously. Pull-out and bending strength testing according to ASTM F543 & F1264 show over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the CompresSURE Fracture Repair System, based on the provided text:

Important Note: The provided text is a 510(k) summary for a medical device (a fracture repair system), not an AI algorithm. Therefore, many of the requested categories (like sample size for test/training sets, involvement of experts for ground truth, MRMC studies, standalone performance of an algorithm) concerning AI or software performance are not applicable to this document. This document describes a physical medical device and its mechanical testing.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Pull-out Strength	Over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws	This serves as a comparative performance metric, indicating superior strength compared to a common contemporary device.
Bending Strength	Over 2 times the strength to conventional standard 4.0mm cannulated cancellous screws	Similar to pull-out strength, this shows enhanced mechanical integrity.
Material	High Strength 6-4 ELI Titanium Alloy	Confirms the use of a recognized biocompatible and strong material suitable for implants.
Sterilization (Implicit)	Device is for surgical implantation, implying compliance with sterilization standards, although not explicitly stated as an "acceptance criterion" in this summary.
Biocompatibility (Implicit)	Use of Titanium Alloy implies biocompatibility.
Fit for Intended Use	Indicated for fracture fixation where fracture compression is desired, and where insertion does not increase morbidity. Also for compression between separate bones (syndesmosis).	The device meets its intended use as described in the Indications for Use.
Safety and Effectiveness	Shown to be safe and effective for use in fracture fixation in small and large bone and small and large bone fragments where precision placement is required.	This is a general statement of compliance, supported by the mechanical testing and substantial equivalence.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily mechanical testing against established ASTM (American Society for Testing and Materials) standards.

Sample Size Used for Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a number of devices or tests. The summary mentions "Pull-out and bending strength testing according to ASTM F543 & F1264." These ASTM standards specify procedures and typically require a certain number of samples for statistically valid results, but the exact count is not detailed in this 510(k) summary.
- Data Provenance: The testing was conducted "according to ASTM F543 & F1264," implying standardized laboratory testing. The location (country of origin) of the testing is not specified but would typically be conducted by the manufacturer or an accredited testing lab. Given the firm's address in Oviedo, FL, USA, it's likely the testing occurred within the USA or through a contracted lab. It is a prospective test in the sense that the new device was fabricated and then tested.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. For a physical device undergoing mechanical testing, "ground truth" is established by direct physical measurement and comparison to established engineering standards (ASTM F543 & F1264). There are no human experts "establishing ground truth" in the way one would for AI image analysis or clinical diagnosis. The "ground truth" here is the objective measurement of force, deformation, etc.
Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods are relevant for subjective assessments, such as expert consensus on medical images. For mechanical testing, the results are objective measurements from instruments.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is specifically designed for evaluating the performance of diagnostic aids, often involving human readers interpreting medical images with and without AI assistance. This document describes a physical surgical implant, not a diagnostic tool or AI.
If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm, so the concept does not apply.
The Type of Ground Truth Used:
- Objective Mechanical Measurements and Engineering Standards. The "ground truth" for the device's performance relies on physical measurements (e.g., force required for pull-out, load at which bending occurs) obtained through standardized testing methods (ASTM F543 & F1264). The comparison baseline ("conventional standard 4.0mm cannulated cancellous screws") also represents an objective, measurable performance.
Sample Size for the Training Set:
- Not Applicable. This is not an AI model, so there is no "training set." The device itself (physical product) is "trained" through design, engineering, and manufacturing processes, with the "data" being engineering principles, material properties, and iterative design improvements.
How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no AI training set, this question is irrelevant. The design and manufacturing "ground truth" is established through engineering specifications, material science, biomechanical principles, and quality control during production.

Summary

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Section XII: 510(k) Summary of Safety and Effectiveness

SAFE MEDICAL DEVICES ACT OF 1990

510(k) Summary

MAR 1 2 2009

NAME OF FIRM: U.S. Implant Solutions, LLC 650 South Central Avenue, Suite 1000 Oviedo, FL 32765

510(k) FIRM CONTACT:

Scott Garrett President U.S. Implants

TRADE NAME:

CompresSURE Fracture Repair System

HTN

COMMON NAME:

CLASSIFICATION:

Smooth or threaded metallic bone fixation fastener (see 21CFR, Sec. 888.3040)

Cannulated Fixation Bone Screw with Washer, Bolt Nut

Single/multiple component metallic bone fixation appliances and accessories (see 21 CFR. Sec. 888.3030)

HWC DEVICE PRODUCT CODE:

SUBSEQUENT PRODUCT CODE:

SUBSTANTIALLY EQUIVALENT DEVICES: Zimmer 878 Barr Bolt (Pre-amendment) Linvatec Corp. Washer, Bolt, Nut, Orthopedic (K954682) Biomet Cannulated Screw System (K024086) Osteonics Osteo 4.0 Cannulated Screw System (K983165) Synthes 4.5mm Cannulated Screw (K963172)

DEVICE DESCRIPTION:

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510(k) Summary Continued:

INTENDED USE:

Indications for use is where the CompresSURE is indicated for fracture fixation where fracture compression is desired, and where insertion of the nut-and-bolt system does not increase the risk of morbidity due to the need for surgical access to both sides of the compressed area. The device may also be used when compression between separate bones is desired (i.e.- the syndesmosis) as long as there is not increased morbidity associated with the insertion of a nut-and-bolt system, as discussed above.

K081813

The system is not intended for spinal use.

BASIS OF SUBSTANTIAL EQUIVALENCY:

The U.S. Implants CompresSURE Fracture Repair System is substantially equivalent to a Pre-amendment device from Zimmer. Also SE to the Linvatec, Biomet, Synthes, and Osteonics (now Stryker) Cannulated Screw Systems.

SUMMARY OF SAFETY AND EFFECTIVENESS:

The U.S. Implants CompresSURE Fracture Repair System is shown to be safe and effective for use in fracture fixation in small and large bone and small and large bone fragments where precision placement is required.

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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 stylized caduceus symbol on the right, which is a staff with two snakes coiled around it. To the left of the caduceus, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

MAR I 2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

US Implant Solutions, LLC % Mr. Scott Garrett 650 South Central Avenue, Suite 1000 Oviedo, FL 32765

Re: K081813

Trade/Device Name: CompresSURE Fracture Repair System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC, HTN Dated: March 2, 2009 Received: March 4, 2009

Dear Mr. Garrett:

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. Scott Garrett

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 the reporting 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,

for Ahmed. for.

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

Enclosure

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Indications for Use

510(k) NUMBER: DEVICE NAME: CompresSURE Fracture Repair System

INDICATIONS FOR USE:

The system is not intended for spinal use.

× Prescription Use AND/OR Over-The-Counter-Use (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDF Office of Bevice Evaluation (ODE) (Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number

Corporate Office 650 South Central Avenue, Suite 1000 Oviedo, FL 32765 Tel: 407-971-8054 407-971-8056

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.