(53 days)
The Verticor K-Wire System is intended for use in fixation of bone fractures, fusion of joints or bone reconstruction, for osteotomies in the presence of adequate immobilization and as guide pins for insertion of other implants.
K-wires are sharpened or blunt, smooth stainless steel pins. They come in different sizes and are used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction. To ensure the multi-use of these devices, many different models are available. Threaded K-wires are available for situations where backing out of the pin is undesirable.
The provided text describes a 510(k) Summary for the Verticor K-Wire System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed acceptance criteria and a study to prove that a device meets those criteria in the same way one would for a novel device or software.
In the context of a 510(k), "acceptance criteria" are implied by the features and characteristics that need to be demonstrated as substantially equivalent to the predicate device. The "study that proves the device meets the acceptance criteria" is the substantial equivalence comparison and non-clinical testing rather than a traditional clinical study with defined performance metrics for the novel device.
Here's an analysis based on the provided text, structured to answer your questions as best as possible within the constraints of a 510(k) summary for a K-wire system:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" for K-wires in a 510(k) filing primarily revolves around demonstrating that the new device is as safe and effective as its predicate. This is achieved by showing comparable design, materials, function, and intended use. The table below outlines the key comparative features and notes on the Verticor K-Wire System's performance in relation to these accepted characteristics.
| Feature / Acceptance Criteria | Verticor K-Wire System Performance (compared to predicate) |
|---|---|
| Material (316L stainless steel per ASTM F138) | Meets 316L stainless steel specification, identical to predicates. |
| Length (mm) (within predicate range) | 150 up to 450mm (overlaps with KMedic's 102-305mm and SMT Schilling's 60-500mm). Falls within acceptable range. |
| Diameter (mm) (within predicate range) | 0.7 up to 1.6mm (identical to KMedic's range, within SMT Schilling's 0.6-6.35mm range). Falls within acceptable range. |
| Surface (smooth, threaded, or partial) | Complete or partial smooth and/or threaded (similar to predicates). |
| Tip Geometry (diamond, trocar, round, flat, spherical) | Diamond or trocar point, round, flat, with or without spherical shape (similar to predicates). |
| Sterility | Non-sterile, sterilized in hospital (identical to predicates). |
| Function (hold bone fragments, provide anchor for skeletal traction) | Stated function is identical to predicates. |
| Intended Use (fixation of bone fractures, fusion of joints or bone reconstruction, osteotomies, guide pins) | Stated intended use is identical to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the traditional sense of a clinical or performance study with a test set. This 510(k) relies on a comparison to predicate devices, supported by non-clinical verification of material and dimensional specifications.
- Data Provenance: Not applicable for a comparative equivalence submission of this nature. The "data" are the specifications and characteristics of the predicate devices already legally marketed in the U.S. and the specifications of the new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in this context, would be the established safety and effectiveness of the predicate devices, which is accepted by their prior 510(k) clearances. No new "ground truth" was established by experts for the Verticor K-Wire System for the purpose of this submission beyond the regulatory review process itself.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is a K-wire, which is a physical surgical instrument, not an AI or imaging diagnostic tool that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices (KMedic External Fixation Devices K030336 and SMT Schilling Kirschner/Guide Wires K100736), as accepted by their prior FDA clearances. The Verticor K-Wire System aims to demonstrate substantial equivalence to this pre-existing "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.