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The Lactosorb® Tap Free Screw is indicated for use in the following midface and craniofacial procedures.
A. General Indication: trauma procedures of the midface or craniofacial skeleton Specific Indications:

1. Comminuted fractures of the naso-ethmoidal infraorbital areas
2. Comminuted fractures of the frontal sinus wall
3. Pediatric midface or craniofacial trauma
4. LeFort (I, II, II) fractures
5. Orbital floor fractures
6. Fractures of the maxilla, zygoma, zygomatic arch, orbital rim, nasal, ethmoid, and lacrimal bones.
7. Trauma of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones.
   B. General Indication: reconstructive procedures of the midface or craniofacial Skeleton
   Specific Indications:
8. Infant craniofacial surgery (i.e. craniosynostosis, congenital malformation, trauma, etc.)
9. LeFort (I, II, II) osteotomies
10. Tumor reconstruction in midface or craniofacial procedures
11. Bone graft procedures in the midface or craniofacial skeleton
12. Pediatric reconstructive procedures
13. Reconstructive procedures of the craniofacial skeleton including: frontal, parietal, temporal, sphenoid, and occipital bones
14. Craniotomy flap fixation
    This system is not designed for use in the mandible and/or full load bearing procedures.

The device is a screw having a non-threaded pin portion and a head portion. The Lactosorb® Tap Free Screw is designed with a slight helical groove that is cut into the major diameter. The head geometry, drive mechanism, major diameter, and tip geometry of the 1.5 x 4 mm Tap Free Screw is identical to that of the 1.5 x 4 mm Direct Drive Screw (K971870). The only difference between the two screws is the "thread" form.
Although the tap free screws are similar in design to the standard Lactosorb® direct drive screws (K971870), they function more like the Lactosorb® Push Screws (K002423). The push screws are designed with barbs that are pushed into a drilled hole that is slightly smaller than the diameter around the barbs. This press fit holds the push screw is place and provides adequate fixation. The tap-free screws are implanted by rotating the screws into a hole that is slightly smaller than the major diameter of the screws. The press fit between the implant and the hole provides the fixation.
Material: Lactosorb® (resorbable copolymer) - a polyester derivative of lactic and glycolic acids
Lactosorb® is made of 82% L-Lactide/18% Glycolide copolymer that degrades by hydrolysis into L-Lactic and glycolic acids. These hydrolytic products are then further degraded into carbon dioxide and water via the cellular Krebs cycle. Lactosorb® has been previously cleared by 510(k) notifications for use in bone plates (K992355, K992158, K971870, K960988, K955729) and bone screws (K002423, K981666, K960988) for cranial and maxillofacial use.
The modifications made to this device are not anticipated to significantly affect its safety and effectiveness.

The provided document is a 510(k) premarket notification for a medical device, the Lorenz Lactosorb® 1.5 mm x 4 mm Tap Free Screw. It details the device's indications for use, description, and the materials it's made from. It also includes the FDA's letter of substantial equivalence.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with predefined acceptance criteria. The document explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot provide the requested information from the given text. A robust study proving the device meets acceptance criteria and detailed performance metrics are typically part of a Premarket Approval (PMA) application or a more extensive clinical trial, neither of which appears to be documented here.

If this were a typical AI/ML device approval, such information would be mandatory. However, for this type of mechanical medical device, the focus of a 510(k) is heavily on demonstrating similarity to already approved devices.

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