(79 days)
The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
The APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
This 510(k) summary for the Medartis AG APTUS® K-Wire System (K092038) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
The document is a premarket notification for a medical device seeking clearance to market based on substantial equivalence to existing devices. It focuses on administrative information, device description, and a claim of equivalence to previously cleared predicate devices.
Here's a breakdown of what the document does provide, and why it doesn't meet your request:
Information Present in the Document:
- Manufacturer Name: Medartis AG
- Device Name: APTUS® K-Wire System
- Intended Use: "The APTUS® K-Wire System is intended for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants."
- Classification: Class II, Product Code HTY, Regulation 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
- Device Description: "The APTUS K-Wire System consists of stainless steel wires of various dimensions and characteristics intended to be used for fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants."
- Equivalence Claim: The document states the APTUS K-Wire System is substantially equivalent to previously cleared devices based on sharing the same intended use, operating principle, basic design, similar materials, and similar packaging/sterilization.
Why the Document Doesn't Meet Your Request:
The provided text describes a substantially equivalent pathway to FDA clearance for K092038. This pathway does not typically require the manufacturer to establish entirely new performance acceptance criteria and conduct extensive studies (like clinical trials or standalone performance studies with expert ground truth) to prove the device meets those criteria, as you would for a novel device or a PMA submission.
Instead, the core of a 510(k) relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by showing:
- Same intended use.
- Similar technological characteristics. (e.g., materials, operating principles, design).
- If there are differences in technological characteristics, demonstrating via performance data (e.g., bench testing, non-clinical tests) that these differences do not raise new questions of safety and effectiveness.
Therefore, the document explicitly states: "Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS K-Wire System is substantially equivalent to previously cleared devices." This suggests that the "proof" of meeting safety and effectiveness is tied to the predicate device's established performance, rather than the generation of new, extensive performance data against explicit, novel acceptance criteria for this specific device.
To directly answer your numbered points based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document states substantial equivalence based on material, design, and intended use similarities, not specific performance metrics against defined acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable/Not mentioned. No specific "test set" for performance evaluation is described in the context of substantial equivalence to the predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not mentioned. Ground truth for a test set is not discussed.
- Adjudication method for the test set: Not applicable/Not mentioned.
- 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 K-Wire system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a K-Wire system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not mentioned.
- The sample size for the training set: Not applicable/Not mentioned.
- How the ground truth for the training set was established: Not applicable/Not mentioned.
In summary, this 510(k) submission doesn't contain the type of performance study details you're looking for, as its basis for clearance is demonstrating substantial equivalence to a predicate, not demonstrating performance against specific, newly defined acceptance criteria through a clinical or algorithmic performance study.
§ 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.