(188 days)
The DRG Sherlock™ MF Self-Tapping and Self-Tapping/Self-Drilling Bone Screws are intended for craniofacial and mandibular trauma and reconstruction.
DRG Sherlock™ MF Bone Screw, Cocrmo Self-Tapping, Ti Alloy
I apologize, but the provided text from the FDA 510(k) summary for the "DRG Sherlock™ MF Bone Screw" does not contain the detailed information necessary to answer your request regarding acceptance criteria, study details, and performance metrics as if it were an AI/ML device.
The document is a clearance letter for a medical device (bone screw), and it focuses on:
- Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices. This is a regulatory pathway for traditional medical devices, not for AI/ML performance evaluation.
- Regulatory Class: It identifies the device's regulatory class (Class II) and product code (DZL).
- Intended Use: It specifies the indications for use for the bone screws (craniofacial and mandibular trauma and reconstruction).
- General Controls: It mentions compliance with general controls provisions like annual registration, good manufacturing practice (GMP), etc.
There is no mention of an algorithm or AI/ML performance, nor any data from a study that would include acceptance criteria, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.
Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance and study details based on the information provided in the input text.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.