(81 days)
The SLIC Screw Repair System is intended to provide fixation and anatomically reduce two bones or bone portions. Specifically, these indications include scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability.
The SLIC Screw Repair System consists of a headless, cannulated two-piece screw assembly. The two-piece design incorporates the use of distal and proximal screw components to anatomically reduce two bones. The purpose of this Special 510(k) is to modify the material, interconnection geometry and available sizes of the SLIC Screw. All components are made of 22-13-5 stainless steel conforming to ASTM F1314. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.
The provided text describes a medical device called the "SLIC Screw Repair System" and its Special 510(k) submission to the FDA. The submission focuses on modifications to the device's material, interconnection geometry, and available sizes.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Insertion Testing | To ensure proper functionality during surgical insertion. | Results demonstrate that acceptance criteria were met. |
| Pull-Apart Testing | To evaluate the strength and integrity of the screw assembly under tensile load. | Results demonstrate that acceptance criteria were met. |
| Pull-Out Strength Testing | To assess the force required to remove the screw from bone. | Results demonstrate that acceptance criteria were met. |
Note: The specific numerical acceptance criteria are not provided in the document. The statement "The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met" indicates that such criteria exist and were satisfied.
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Preclinical Testing" was performed. However, it does not provide details on the sample size used for the insertion testing, pull-apart testing, or pull-out strength testing.
The data provenance is preclinical testing directly on the device components, not human or animal data. It is therefore not applicable to country of origin or retrospective/prospective classification in the typical sense of clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the testing described is preclinical mechanical testing of hardware, not interpretation of medical images or clinical outcomes that would require expert ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable as the testing described is preclinical mechanical testing performed by technical personnel, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
This information is not applicable. The device described is a surgical implant (SLIC Screw Repair System), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. As mentioned above, this is a surgical implant, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The "ground truth" for the preclinical tests would be the engineering specifications and performance thresholds defined in the "Design Control Activities Summary." The tests measure objective mechanical properties directly, not subjective interpretations or clinical outcomes.
8. The Sample Size for the Training Set:
This information is not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 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.