(23 days)
The Craniofacial Anchor-Push Screw's are indicated for use to assist resorbable suture in open and endoscopic brow lift procedures.
The Craniofacial Anchor-Push Screw is a resorbable (LactoSorb®) screw. The device is a screw that is directly inserted into a pre-drilled hole. The Push Screws utilize the same auxiliary break-off hex head as the cleared LactoSorb® Craniofacial Anchors.
The provided text is a 510(k) summary for a medical device called the LactoSorb® Craniofacial Anchor-Push Screw. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria through clinical studies in the way modern AI/ML devices might.
Therefore, many of the requested sections related to acceptance criteria, ground truth, sample sizes, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document. The study described is a non-clinical, mechanical testing study to establish substantial equivalence.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document states: "Non-Clinical Testing: Mechanical testing was completed to determine substantial equivalence. Clinical Testing: Clinical testing was not used to determine substantial equivalence."
The criteria for "substantial equivalence" are legal/regulatory, not performance metrics. The specific results of the mechanical testing are not provided in this summary.
2. 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 of clinical data was used. Mechanical testing methods and sample sizes are not detailed in this summary.
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 ground truth based on expert review was established as clinical testing was not performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication was involved.
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 device is a resorbable screw, not an AI/ML diagnostic or assistive device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical surgical screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established as clinical testing was not performed. The "ground truth" for substantial equivalence was based on mechanical testing compared to the predicate device.
8. The sample size for the training set
Not applicable. No training set was used as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth was established.
§ 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.