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· For adult and pediatric patients
· In combination with Merete Locking Plates
· Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
· Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone

Merete® Cannulated PCS

· For adult and pediatric patients
· Fixation of fresh fractures
· Revision procedures
· Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes

Merete® CS Cortical Screws

· For adult and pediatric patients
· Fixation of fresh fractures
· Revision procedures
· Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes

Merete® Cannulated HCS

· Fixation of fractures and reconstruction of various bones
· Osteotomies in the foot (as Hallux Valgus) or hand
· Athrodesis in hand, foot or ankle surgery
· Fixation of bone fragments in long bones or small bone fractures

DuoThread™ Scarf Screws

· Small bone fracture fixation
· Fixation and stabilization of bones of the feet
· Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Closing Wedge Osteotomy)
· Fusion (MPG-Athrodesis)
· Fixation of almost all common osteotomies of the first metatarsal

TwistCut™ Snap-Off Screws

· Fixation of fractures and reconstruction of bones
· Fixation of small bone fragments
· Mono cortical fixation
· Osteotomies (Weil-Osteotomy)
· Fracture fixation in the foot and hand

Device Description

MetaFix™ LS Locking Screws: The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm (Ø3.0 mm), 12 mm to 48 mm (Ø3.5 mm) and 10 mm to 48 mm (Ø3.8 mm).

Merete® Cannulated PCS: The Merete® Cannulated PCS screw is a partly threaded, self-tapping, self-drilling and cannulated compression screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 12 mm to 48 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.

Merete® CS Cortical Screws: The Merete® CS Cortical Screw is fully or partly threaded and self-tapping. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm (Ø3.0 mm or Ø3.5 mm). The wrench type of the screw is a torx socket.

Merete® Cannulated HCS: The Merete® Cannulated HCS screw is a partly threaded, self-tapping, self-drilling and cannulated headless compression screw. The screw is featured with a sinkable threaded head. The thread pitch of the shaft and the head are different to achieve a better compression. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 40 mm (Ø3.0 mm to 60 mm (Ø4.3 mm). The wrench type of the screw is a torx socket.

DuoThread™ Scarf Screws: The DuoThread™ Scarf screw is a partly or fully threaded, cannulated compression screw. The compression is obtained through a different thread pitch at the head of the screw. The screws are made of titanium (ASTM-F136) and are available in the lengths from 10 mm to 34 mm (Ø3.0 mm). The wrench type of the screw is a torx socket.

TwistCut™ Snap-Off Screws: The TwistCut™ Snap-Off screw is self-tapping and self-drilling. The screw has a shank to chuck it into a K-Wire pistol, which is cut off when the screw head hits the cortex. The screws are made of titanium (ASTM-F136) and are available in the lengths from 11 mm to 14 mm (Ø2.0 mm).

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding Merete Medical Incorporated's bone fixation fasteners. It does not provide information about a study proving the device meets specific acceptance criteria in the context of an AI/ML device, as it describes physical medical devices (screws) rather than a software or AI-driven system.

Therefore, most of the requested information (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this document.

However, I can extract the following relevant information based on the document's content:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance in accordance with ASTM F543 Standard	All screws passed mechanical testing, performing "as good as or better" than predicate devices.
Sterilization validated according to current standards	Sterilization process successfully validated.
Packaging system validated to protect screws and maintain sterility	Packaging system successfully validated.
Substantial Equivalence to legally marketed predicate devices	The devices are considered "substantially equivalent" to cleared predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to physical device testing (mechanical, sterilization, packaging) not a software test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would refer to material and mechanical engineering standards, not expert clinical interpretation.

4. Adjudication method for the test set: Not applicable. Testing was based on engineering standards (ASTM F543).

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 document is about physical bone fixation screws, not an AI system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: For mechanical performance, the ground truth is established by engineering standards, specifically ASTM F543. For sterilization and packaging, the ground truth is established by validated protocols and current standards.

8. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device testing in this context.

9. How the ground truth for the training set was established: Not applicable.

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