(37 days)
The WMT Implantable K-Wires are indicated for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants. Additionally, WMT Implantable K-Wires are indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, mallet toe, and metatarsophalangeal joint instability.
The WMT Implantable K-Wires are offered in surgical grade stainless steel. A range of diameters are offered from the manufacturer and planning should be conducted prior to implantation to determine the best fit.
The provided document, K132895, describes the WMT Implantable K-Wires. However, it is a 510(k) summary for a medical device seeking substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, primarily through technological comparison and potentially non-clinical studies.
Crucially, this document does not contain information related to a study designed to prove the device meets specific acceptance criteria based on algorithm performance, human reader studies, or ground truth establishment, as would be common for AI/ML-based medical devices or diagnostic tools.
The document states:
- "Through mechanical analysis the new wires do not represent a new worst-case." (Non-Clinical Evidence)
- "A literature summary was provided to support the modified indications." (Non-Clinical Evidence)
- "N/A" for "Substantial Equivalence - Clinical Evidence".
Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided text does not describe such a study for this device.
Here's a breakdown of why this information is not available in the provided text in relation to your specific questions:
- A table of acceptance criteria and the reported device performance: Not available. The document discusses mechanical analysis and literature summary, but no specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: Not available. No "test set" in the context of an algorithm's performance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available. Ground truth establishment for a diagnostic algorithm is not part of this 510(k) summary.
- Adjudication method for the test set: Not applicable/available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not available. Clinical studies, especially MRMC studies, for comparative effectiveness are not described and are marked "N/A" for clinical evidence.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical K-wire, not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document relates to a traditional medical device (K-wires) seeking 510(k) clearance based on substantial equivalence, not an AI/ML-based device that would typically involve the types of studies and criteria you are asking about.
§ 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.