(27 days)
The Kirschner Wires and Steinmann Pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.
This system makes up of non-sterile, shank and threaded Kirschner Wires and Steinmann Pins. The Kirschner Wires ranges in length from 101.6 to 300 mm and ranges in diameter from 0.7 to 1.6 mm. The Steinmann Pins ranges in length from 70 to 400 mm and ranges in diameter from 0.8 to 4.8 mm. They are available with four-point style: diamond, trocar, both ends diamond and both ends trocar. The 9 "(230 mm) shank and threaded Kirschner Wires and Steinmann Pins are usually available with fracture fixation fasteners.
This submission describes Kirschner Wires and Steinmann Pins, which are mechanical devices for bone fixation. The provided text is a 510(k) summary for these devices. For mechanical devices, acceptance criteria and performance are typically evaluated through bench testing (e.g., material strength, fatigue, bending), biocompatibility testing, and sometimes cadaveric studies, rather than through clinical studies with metrics like sensitivity, specificity, or reader agreement that are common for AI/diagnostic devices.
Based on the provided 510(k) document, there is no information about acceptance criteria or specific studies that 'prove' the device meets certain performance metrics in the way a diagnostic algorithm would. The 510(k) process for this type of device relies on demonstrating substantial equivalence to a legally marketed predicate device.
However, I can extract the information that is present concerning the device and its regulatory clearance:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as specific performance criteria in the provided document. For this type of device, typical acceptance criteria would involve
- Material Composition: Conforming to 316 LS stainless steel standards.
- Dimensions: Within specified ranges for length and diameter.
- Mechanical Properties: (e.g., tensile strength, bending strength, fatigue resistance, torsional strength) necessary for their intended use in fracture fixation. These would be compared against the predicate device or established standards.
- Biocompatibility: Demonstrated non-toxicity and compatibility with human tissue.
- Sterilization Compatibility: Ability to withstand recommended sterilization parameters.
- Reported Device Performance:
- Material: Manufactured from commercially 316 LS stainless steel.
- Dimensions:
- Kirschner Wires: Length from 101.6 to 300 mm, diameter from 0.7 to 1.6 mm.
- Steinmann Pins: Length from 70 to 400 mm, diameter from 0.8 to 4.8 mm.
- Available with "four-point style: diamond, trocar, both ends diamond and both ends trocar."
- Sterilization: Provided non-sterile, with recommended steam sterilization parameters (Vacuum cycle, 6 min, 132-135°C).
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This document pertains to a medical device (Kirschner Wires and Steinmann Pins) which is a physical implant, not a diagnostic or AI-based device that would typically involve a "test set" of data or patient cases. Performance is generally evaluated through bench testing (materials, mechanical properties) and comparison to a predicate device. The 510(k) process itself doesn't require a clinical "test set" in the context of data for an algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. See point 2. Ground truth in this context would relate to engineering specifications, material standards, and surgical usage, rather than expert-labeled diagnostic data.
4. Adjudication Method for the Test Set:
- Not Applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant for this type of physical medical device. These studies are typically performed for diagnostic devices (especially imaging-based ones) to assess the impact of an AI algorithm on human reader performance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Not Applicable in the traditional sense of an AI/diagnostic device. For this mechanical device, "ground truth" implicitly relies on:
- Engineering Specifications and Standards: Conformance to material standards (e.g., 316 LS stainless steel), dimensional specifications, and mechanical performance requirements (which would be derived from predicate devices and historical clinical use).
- Predicate Device Performance: The primary "ground truth" for substantial equivalence is the performance and safety profile of the legally marketed predicate device.
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.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. See point 8.
Summary of Device Clearance:
The device (Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins) received 510(k) clearance (K983121) on October 5, 1998, indicating that the FDA determined it was substantially equivalent to legally marketed predicate devices for the specified indications for use. This regulatory pathway does not typically involve clinical trials or performance studies as described for AI or diagnostic devices, but rather relies on non-clinical testing (material, mechanical) and a comparison to an already cleared device.
§ 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.