(22 days)
The intended use of Störk Instrumente GmbH's Bone Wires is the fixation of bone fractures and / or to guide other implants during insertion to the skeletal system.
Due to their design and used materials, which is either Stainless Steel acc. ASTM F 138 / 139 (316 L) or Titanium Alloy acc. to ASTM F 136, Grade 5, these devices can be used as implants.
Störk Instrumente GmbH delivers all Bone Wires in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.
Störk Instrumente GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.
Trade Name: Bone Wire Common Name: Kirschner Wire (K wire), Steinmann Wire, Bonell Wire (Pin), Cerclage Wire
The provided text is a 510(k) Summary for a medical device (Bone Wires), which primarily focuses on demonstrating substantial equivalence to existing predicate devices. It does not contain information about specific acceptance criteria, performance studies against those criteria, or clinical evaluation data that would typically be found in an AI/ML medical device submission.
Therefore, I cannot populate the requested table or answer most of the questions, as this document type does not involve such studies for this class of device.
Here's what I can extract based on the provided text, and what is missing:
Acceptance Criteria and Device Performance Table:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| MATERIAL COMPOSITION: | |
| Stainless Steel (ASTM F 138 / 139 (316 L)) | Meets Stainless Steel acc. ASTM F 138 / 139 (316 L) |
| Titanium Alloy (ASTM F 136, Grade 5) | Meets Titanium Alloy acc. to ASTM F 136, Grade 5 |
| BIOCOMPATIBILITY: | Biocompatibility is guaranteed by the composition of the used materials, which are also used in other legally marketed surgical implants (e.g., bone screws, plates, aneurysm clips, as cited in predicate 510(k)s: K983758, K000080, K003500). |
| SUBSTANTIAL EQUIVALENCE (Overall): | The device is substantially equivalent to legally marketed predicate bone wires (e.g., Kirschner Wires or Steinmann Pins) from companies like Syntec-Taichung Co., Ltd. (#K983121), Osteonics Corporation (#K971862), DePuy Inc. (#K960385), and Synvasive Technology Inc. (#961522). |
| STERILIZATION (User Recommendation): | Recommended to use a steam-sterilizer with a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes. |
| INTENDED USE: | Fixation of bone fractures and/or to guide other implants during insertion to the skeletal system. |
Detailed Response to Individual Questions:
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A table of acceptance criteria and the reported device performance
- See the table above. The "acceptance criteria" for a traditional 510(k) for a device like this are primarily based on material standards and substantial equivalence to legally marketed predicate devices, rather than a quantifiable performance metric derived from a specific study.
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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 document does not describe a "test set" in the context of performance testing or clinical studies. Substantial equivalence for this type of device is typically established through material property comparisons, design similarities, and intended use comparison with predicate devices, rather than a clinical performance study with a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. There is no "ground truth" establishment described in this document, as it's not a study evaluating diagnostic accuracy or clinical outcomes.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method is described.
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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 device (Bone Wire) is a physical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. No ground truth is established as there is no performance study of this nature. The "truth" for this submission is adherence to material standards and functional equivalence to predicate devices.
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The sample size for the training set
- N/A. There is no "training set" as this is not an AI/ML device requiring training data.
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How the ground truth for the training set was established
- N/A. No training set or ground truth for it is relevant or described.
§ 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.