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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.

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.

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

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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