(89 days)
The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication.
The In2Bones® Kirschner wire is a metallic wire available in four point styles: sharp, partially threaded, lanceolate, both ends sharp. One part is fixed on standard surgical power tool equipment for insertion. Sizes: The In2Bones® Kirschner wire is available in various diameters (0.8mm to 2.5mm) and length (70mm to 300mm). Material: The In2Bones® Kirschner wire is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138-13. It does not have any coating. Single use: The In2Bones® Kirschner wire is designed for single use only. Sterilization: The In2Bones® Kirschner wire is supplied sterile and non-sterile. The sterile In2Bones® Kirschner wire is sterilized using gamma radiation. The non-sterile In2Bones® Kirschner wire must be steam sterilized before use. Place of use: The In2Bones® Kirschner wire is indicated for use in a hospital, or outpatient surgery center, where sterile field may be created and maintained.
The document provided is a 510(k) summary for a medical device called the "In2Bones® Kirschner wire." It does not present a study with acceptance criteria and device performance results in the context of an AI/algorithm-driven device.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, indications for use, and a statement about conformity to an international standard. There is no mention of an AI/algorithm component in this device.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable for this type of device and submission.
- Sample size used for the test set and the data provenance: No test set in the context of an AI/algorithm study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide regarding "performance":
The document states:
- "The In2Bones® Kirschner wires are stainless steel wires with diameters and lengths comparable to those featured in the predicate device systems. The design and indications of the In2Bones® Kirschner wires are substantially equivalent to the predicate devices identified in the 510(k) submission. No new materials or processes are used in the development of this implant. Moreover, the In2Bones® Kirschner wires conform to the international standard ISO 5838-1 (2013). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires."
This indicates that the "performance" verification relies on:
- Substantial equivalence: The device is similar in design, materials, and intended use to already legally marketed devices (NEWDEAL K WIRE (K022599) and Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins (K983121)).
- Conformity to international standards: The device conforms to ISO 5838-1 (2013), which is a standard for implantable devices for surgery - metallic materials.
In essence, for this specific K-wire device, the "acceptance criteria" and "proof" presented are based on its similarity to existing devices and adherence to relevant material standards, not on a study with performance metrics in the way one would describe for an AI or diagnostic 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.