(127 days)
It is intended for use in internal fixation of small bones including the hand and foot secondary to trauma or for reconstruction.
This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 3.5 mm and lengths ranging from 2 mm to 40 mm. These devices are for single use only.
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:
This 510(k) summary for the "Leibinger^(H) - Luhr^(H) Small Orthopedic Bone Screw System" does not contain any information about acceptance criteria or a study designed to prove the device meets those criteria.
Instead, this document is a predicate device comparison summary, a common approach for 510(k) submissions. In this type of submission, the manufacturer asserts substantial equivalence to a legally marketed device (the predicate device) by demonstrating similarities in:
- Intended Use: The purpose for which the device is used.
- Material: The components from which the device is made.
- Design: The physical specifications and configuration of the device.
- Operational Principle: How the device achieves its intended effect.
Since the submission relies on demonstrating equivalence rather than providing performance data against specific acceptance criteria, the detailed questions about studies, sample sizes, ground truth, and expert involvement are not applicable to the information provided.
Therefore, I cannot populate the table or answer the specific questions about studies from the given text.
However, I can explain why these details are missing based on the nature of the 510(k) submission:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission does not define specific performance acceptance criteria for this new device. It relies on the predicate devices having already met their regulatory requirements.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set data is presented.
- 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): Not applicable. No ground truth establishment for a test set is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set analysis requiring adjudication is described.
- 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 bone screw system, not an AI-powered diagnostic or assistive technology.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This question pertains to AI/software performance, which is not relevant to a bone screw.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth definition is provided as no primary performance study is described.
- The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
- How the ground truth for the training set was established: Not applicable. As above, no training set or ground truth for it is relevant here.
In summary, the provided 510(k) uses the "Substantial Equivalence" pathway, which means it demonstrates that the new device is as safe and effective as a legally marketed predicate device, rather than providing new performance study data against pre-defined acceptance criteria.
§ 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.