(40 days)
Kirschner Wires are used for;
· As guide pins for insertion of other implants
· Bone reconstructions
· Fixation of bone fractures and osteotomies
· Implanted through the skin for traction applied to the skeletal system
Biomet Inc manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Biomet Kirschner Wires (K-wires) are rigid yet malleable wires with penetrating tips such that they may be inserted through tissue and into bone to alow for traction of bone fragments as desired or for alignment quides for other bone fixation implants. These wires are available in multiple diameters, same length and unthreaded (smooth) versions.
Biomet Kirschner Wires are single use and provided in both sterile configurations. Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.
The provided text describes a 510(k) premarket notification for Biomet Kirschner Wires (K-Wires). It states that the device is substantially equivalent to a predicate device based on its indications for use, technological characteristics, and conformance to specific standards.
However, the document does not contain the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data provenance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as these aspects are typically relevant for AI/ML-driven medical devices or diagnostic tools. The Biomet Kirschner Wires are described as "rigid yet malleable wires with penetrating tips," implying they are a physical medical device, not a software-based or AI-enabled device.
Therefore, many of the requested categories are not applicable to the information provided in the given text.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from conformity to standards) | Reported Device Performance |
|---|---|
| Mechanical property specifications of ASTM F138-19 | Biomet Kirschner Wires conform to ASTM F138-19 |
| Dimensional property specifications of ASTM F366-17 | Biomet Kirschner Wires conform to ASTM F366-17 |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. Testing for conformance to ASTM standards typically involves a defined sample size as per the specific standard, but this detail is not present in the document.
- Data Provenance: Not applicable in the context of device conformance to ASTM physical/mechanical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Conformance to ASTM standards is typically evaluated by technical testing against predefined specifications.
4. Adjudication method for the test set
- Not applicable. Conformance to ASTM standards involves objective measurement and comparison against specified limits, not expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- Not applicable. This is a physical bone fixation device, not a diagnostic imaging or AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm.
7. The type of ground truth used
- Ground Truth Type: Conformance to established industry standards (ASTM F138-19 for mechanical properties and ASTM F366-17 for dimensional properties). These standards themselves define the "ground truth" or acceptable parameters for such devices.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and materials science.
9. How the ground truth for the training set was established
- Not applicable. Since there is no training set for an algorithm, the method for establishing its ground truth is irrelevant. The "ground truth" for the device's characteristics is inherently defined by the ASTM standards it aims to meet.
§ 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.