(86 days)
NEWDEAL K WIRE is indicated for : - use in Fixation of bone fractures, - bone reconstruction, - as guide pins for insertion of other implants. - The size of the K WIRE should be adapted to the specific indication.
The NEWDEAL K WIRE is available in four different designs, with one or two sharp self-drilling tips either smooth or partially threaded. One part is fixed on a standard surgical power tool equipment for insertion. The NEWDEAL K WIRES are made out of stainless steel within the frame of the standard NF ISO 5832-1, ASTM F138. They are dedicated to fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants. The range of NEWDEAL K WIRE includes three different diameters 1.0 mm, 1.6 and 2.5 mm and four lengths 70, 100, 150 and 200 mm.
The provided text is a 510(k) summary for the NEWDEAL K WIRE, a Kirschner wire. It details the device's characteristics and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria or performance studies as typically found for complex medical devices requiring such validation.
Instead, the document explicitly states:
"SUMMARY OF STUDIES: NEWDEAL K WIRES are stainless steel wires with diameters not smaller than those featured in the predicate device systems Moreover, the NEWDEAL K WIRES conform to the international standard: ISO 5838-1 (1995). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires."
This indicates that the device's acceptance was based on its conformance to International Standard ISO 5838-1 (1995) and its material properties (316L stainless steel) and dimensions being comparable to already legally marketed predicate devices (DePuy Kirschner wires and Steinmann pins, and Syntec-Taichung Medical Instruments Kirschner wires and Steinmann pins). The FDA's 510(k) clearance letter confirms this approach, stating the device is "substantially equivalent" to predicate devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document because a dedicated performance study demonstrating the device meets acceptance criteria was deemed unnecessary for this type of medical device due to its substantial equivalence to existing products and adherence to relevant standards.
The closest information to what was requested is:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Conformity to international standard for surgical implants (ISO 5838-1) | Conforms to ISO 5838-1 (1995) |
| Material properties (316L Stainless Steel) | Made from 316L stainless steel |
| Comparable range of sizes and diameters to predicate devices | Has comparable ranges of sizes and diameters to predicate devices |
| Intended use (fixation of bone fractures, bone reconstruction, guide pins) | Indicated for use in fixation of bone fractures, bone reconstruction, as guide pins for insertion of other implants |
Summary of missing information:
- Sample sizes for test set: Not applicable, no specific test set beyond material and dimensional comparison.
- Data provenance: Not applicable.
- Number of experts used to establish ground truth: Not applicable.
- Qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- 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.