(150 days)
Wire devices (K-Wire, Cerclage Wires, Steinmann Pins)
- guide wire for osteosynthesis implants .
- accessories for external fixation (Steinmann Pin) .
- application as implant according to the AO/ASIF principles of fracture . management
The aap Wire Bone Portfolio consists of K-Wires, Steinmann Pin and Cerclage Wire. The devices have to be used as implants for the fixation of bone fractures, fusion of joints or bone reconstructions or as guide pins for insertion of other implants and are offered in a variety of lengths, diameters, tip styles, and threading. The devices are made of either Titanium alloy or implant stainless steel. The devices are delivered non-sterile and have to be sterilized before use. After fracture healing the implants have to be removed.
The aap Wire Bone Portfolio consists of:
• K-wire with trocar point, ø0.8 mm - ø3.0 mm, 60 mm - 430 mm
• K-wire with thread and trocar point, ø0.8 mm - ø3.0 mm; 45 mm - 380 mm
• K-wire with 2 trocar points, ø0.8 mm - ø3.0 mm; 70 mm - 310 mm
• Steinmann pin trocar, 3-flat end ø2.5 mm - ø6.0 mm; 120 mm - 350 mm
• Cerclage wire with eye, soft, ø0.8 mm - ø1.2 mm; 280 mm - 600 mm
Cerclage wire soft, coil, ø0.8 mm - ø1.5 mm, 10 m .
This document, a 510(k) premarket notification for the "aap Wire Bone" device, describes the device's characteristics and its substantial equivalence to predicate devices, rather than a study demonstrating its performance against specific acceptance criteria.
The core assertion for the aap Wire Bone is substantial equivalence to existing legally marketed predicate devices, not direct performance against new, explicitly defined acceptance criteria through a dedicated study.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable because the submission relies on demonstrating equivalence rather than novel performance testing.
Here's a breakdown of the available information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance General Safety and Effectiveness (Demonstrated via Substantial Equivalence) The aap Wire Bone (K-Wire, Cerclage Wire, Steinmann Pin) is claimed to be substantially equivalent to the predicate devices: Bone Wire from Störk Instrumente GmbH (K030665) and Kirschner/Guide Wires from SMT Schilling Metalltechnik GmbH (K100736). Conformity in Materials of Construction Met: The aap Wire Bone is made of Ti6Al4V (ASTM F136 or ISO 5832-3) or Stainless Steel (ASTM F138 or ISO 5832-1). These materials are consistent with those typically used in predicate bone fixation devices. The submission explicitly states: "The proposed devices are substantially equivalent to the identified predicate device in materials of construction..." and "The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices." Conformity in Physical Characteristics (Dimensions, Tip Styles, Threading) Met: The aap Wire Bone portfolio offers various lengths, diameters, tip styles (trocar, 2 trocar), and threading (with or without thread). The submission explicitly states: "The proposed devices are substantially equivalent to the identified predicate device in... physical characteristics..." and "The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices." Implicitly, these dimensions and styles align with the predicates. Conformity in Intended Use and Indications for Use Met: The device is intended for use as implants for fixation of bone fractures, fusion of joints, bone reconstructions, or as guide pins for insertion of other implants. Specifically, indications for use include: guide wire for osteosynthesis implants, accessories for external fixation (Steinmann Pin), and application as implant according to AO/ASIF principles of fracture management. These indications are stated to be substantially equivalent to the predicate devices: "The proposed devices are substantially equivalent to the identified predicate device in... intended use." Performance Data (Non-Clinical and/or Clinical Testing) Met (via equivalence): The submission states: "The non-clinical testing to be conducted on the aap Wire Bone will include material and dimensional verification. The aap Wire Bone are equivalent in physical dimensions and materials to the identified predicate devices. Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to the legally marketed predicate devices." It further states, "Documentation with respect to performance data to show the substantial equivalence and safety and effectiveness has been provided with this submission." This implies that the performance data for the predicate devices, combined with verification of material and dimensional similarity for the new device, is considered sufficient. No new specific performance study data (e.g., mechanical strength, biocompatibility testing results) for the new device is presented in this summary beyond the claim of equivalence. Sterilization requirements (prior to use) Met: The devices are delivered non-sterile and must be sterilized before use. This is a characteristic of the device design and common practice for such implants. Removal requirements (after fracture healing) Met: The implants have to be removed after fracture healing. This is a characteristic of the device's intended lifecycle and use. The study/justification that proves the device meets the acceptance criteria is the 510(k) submission itself, by demonstrating substantial equivalence to predicate devices which have already been deemed safe and effective.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This submission does not describe a performance study with a test set of data in the manner typically associated with AI/software devices. The "testing" mentioned is material and dimensional verification of the new device to establish its similarity to predicate devices. The data provenance for the predicate devices is not detailed in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. This is not an AI/software device and does not involve ground truth established by experts for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not applicable for this type of submission.
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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
- N/A. This is a physical medical device (bone fixation wires/pins), not an AI/software device, so MRMC studies are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. Not applicable for this type of submission, as it focuses on direct material and dimensional equivalence to existing devices rather than a diagnostic or predictive task. The "ground truth" here is essentially the established safety and effectiveness of the FDA-cleared predicate devices.
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The sample size for the training set
- N/A. This is not an AI/software device.
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How the ground truth for the training set was established
- N/A. This is not an AI/software device.
In summary, the "study" proving the device meets the acceptance criteria is the documentation provided in the 510(k) premarket notification, which argues for substantial equivalence based on material composition, physical dimensions, and intended use matching previously cleared predicate devices. No new clinical trials or extensive non-clinical performance studies beyond verification of similarity to predicates were deemed necessary or conducted for this specific submission, according to the provided text.
§ 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.