(75 days)
Kirschner Wires are intended for use in skeletal traction for alignment and reduction of long bone fractures, and as guide wires in hip pinning, and as fracture fixation devices in certain other smallbone fractures.
Indications
- For use as guide wires in hip pinning procedures, .
- . For use in aligning and reducing long bone fractures,
- For use in securing non-long bone fractures such as olecranon fractures; patella fractures; . tibial plateau fractures; small hand and foot bone fractures; humeral, radial and ulnar fractures; etc.
- For use with cerclage wire/cable in treating greater trochanter fractures. .
The subject Kirschner Wires include both threaded and smooth components, and are available in a range of diameters and lengths. Both the threaded and smooth designs feature a trocar point. This submission includes both sterile and non-sterile product offerings.
This submission for the Osteonics® Acetabular Wedge System (Osteo Kirschner Wires) is a 510(k) premarket notification, indicating it's a submission for a device seeking to demonstrate substantial equivalence to a legally marketed predicate device. As such, the typical "acceptance criteria" and "study proving device meets acceptance criteria" as might be found for a novel device undergoing clinical trials or rigorous performance testing are not present in the same format.
Instead, the acceptance criteria for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device. The "study that proves the device meets acceptance criteria" in this context is the comparison between the proposed device and its predicate devices.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for 510(k) Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Same Intended Use | The subject and predicate devices share the same intended uses. |
| Same Technological Characteristics (Materials) | The subject and predicate devices are both manufactured from implantable stainless steel that complies with ASTM F-138-92. |
| Same Technological Characteristics (Design/Dimensions) | The subject Osteo Kirschner Wires come in threaded and smooth designs, as do the predicate devices cited. The subject devices come in diameters and lengths consistent with the range available for the predicate devices. |
| Performance (if significantly different characteristics) | "As the subject Osteo Kirschner Wires are stainless steel wires with diameters not smaller than those featured in the predicate device systems, testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner Wires." |
Study Details (as applicable to a 510(k) submission)
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Sample size used for the test set and the data provenance:
- Sample size: Not applicable in the context of a traditional performance study. The "test set" here is the comparison of the proposed device's specifications against those of the predicate devices. No new data from a patient cohort was generated for this comparison.
- Data provenance: The data provenance comes from the design specifications of the Osteo Kirschner Wires and the known specifications of the predicate devices. It is entirely retrospective in the sense that it relies on existing information about materials, dimensions, and intended uses. The manufacturer is Osteo AG, located in Switzerland.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in this context would be the established specifications and intended uses of the predicate devices, which are already legally marketed and accepted. No panel of experts was convened to establish a "ground truth" for this substantial equivalence determination.
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Adjudication method for the test set:
- Not applicable. There was no "test set" requiring adjudication in the sense of clinical outcomes or expert review of data. The FDA's review process itself acts as an adjudication of the substantial equivalence claim, comparing the submitted device's characteristics against the predicate's.
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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. This device is a physical medical instrument (Kirschner Wires), not an AI-powered diagnostic or treatment system. Therefore, an MRMC study and AI-related metrics are irrelevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software-only device.
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The type of ground truth used:
- The "ground truth" for this 510(k) submission is the established performance and safety profile of the legally marketed predicate devices. The argument is that because the Osteo Kirschner Wires are technologically equivalent (materials, design, intended use) and perform similarly to these predicates, they are equally safe and effective.
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The sample size for the training set:
- Not applicable. There is no concept of a "training set" for this type of mechanical device submission.
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How the ground truth for the training set was established:
- Not applicable. As explained above, there is no training set in this context.
§ 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.