(55 days)
The SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
SBI K-Wires are provided non-sterile. They range in diameter from 0.9mm - 2.0mm and are 150mm long. They are available in single point, double point, and threaded single point.
The provided text is a 510(k) summary for the SBI K-Wires, indicating clearance by the FDA based on substantial equivalence to predicate devices. It describes the device, its intended use, and materials.
However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria. The 510(k) process for devices like K-wires typically focuses on demonstrating substantial equivalence to existing, legally marketed devices, rather than requiring the submission of a diagnostic performance study with specific acceptance criteria as would be expected for an AI/ML-based diagnostic device.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method: Not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable to this type of device and not provided.
- Standalone performance: Not applicable to this type of device and not provided.
- Type of ground truth used: Not applicable and not provided.
- Sample size for the training set: Not applicable (no AI/ML algorithm involved) and not provided.
- How the ground truth for the training set was established: Not applicable and not provided.
The 510(k) summary primarily states that "Documentation is provided which demonstrated the SBI K -Wires to be substantially equivalent to other legally marketed devices." This implies that the device's characteristics and performance are comparable to devices already on the market, which is how its "acceptance" by the FDA is established for market clearance.
§ 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.