(89 days)
The LactoSorb® Mini Interference Screw is indicated for use in soft tissue to bone fixation in the hand, wrist, and shoulder in the presence of appropriate protection or immobilization.
The LactoSorb® Mini Interference Screw is a resorbable screw that is preloaded on a driver much like those used with suture anchors. The screw is made out of LactoSorb®. The screw will be available in one size only.
This document, K021254, is a 510(k) premarket notification for the "LactoSorb® Mini Interference Screw." It claims substantial equivalence to a predicate device and does not involve clinical testing. Therefore, there are no specific acceptance criteria or a study proving the device meets them as would be found in a clinical trial or performance study.
Based on the provided text, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
Not applicable. This 510(k) relies on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria through clinical testing. The primary "performance" reported is related to its mechanical properties being similar to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific criteria were defined or tested clinically. | Device's technological characteristics (materials, design, sizing, indications) are similar to or identical to the predicate devices. |
| Mechanical equivalency to predicate device | Mechanical testing was performed to establish substantial equivalence. (Specific results are not provided in this summary document.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set was used. "Mechanical testing was performed" but details about sample size or data provenance for this testing are not provided in this summary. These would typically be included in a more detailed testing report, not usually summarized in the 510(k) letter itself.
3. 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 clinical test set or ground truth established by experts was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used.
5. 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 is a medical device (interference screw), not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (interference screw), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established or used for this 510(k). The "ground truth" for substantial equivalence was based on mechanical testing and comparison to an existing predicate device's design and materials.
8. The sample size for the training set
Not applicable. No training set was used as there was no clinical testing or machine learning involved.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.