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Small and Large Fragments Osteosynthesis System NEOFIX is intended for small and large bone fracture fixation, arthrodesis and osteotomy fixation. Examples include: fractures of the clavicle, scapula, humerus, olecranon, radius, ulna, carpals, metacarpals, distal femur, proximal tibia, tibial pilon, fibula, calcaneus, tarsals and metatarsals; small fragments of the hand and wrist; pelvis and acetabulum fractures; periprosthetic fractures; metatarsal and phalangeal osteotomies; and carpal, metacarpal, wrist and ankle arthrodesis. The use of locking plate/screw systems is suited for treatment of fractures in osteopenic bone. This system is not indicated for use in the spine.

Device Description

NEOFIX consists of plates and screws in a variety of designs and sizes and made from commercially pure titanium or Ti-6Al-4V alloy. Plates are provided in straight designs and in various geometric configurations that are commonly used in trauma and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws designs. Screws are provided in cortical (locking and non-locking) and cancellous thread designs in various diameters and lengths.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called "Small and Large Fragments Osteosynthesis System NEOFIX". This type of submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance validation against pre-defined acceptance criteria in a clinical study. Therefore, most of the requested information about acceptance criteria, study design, and ground truth establishment is not applicable in this context.

Here's a breakdown of the available information:

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

Acceptance Criteria: Not explicitly stated as performance metrics in a clinical study. The acceptance criteria for a 510(k) submission are primarily to demonstrate substantial equivalence to predicate devices. This is achieved through comparisons of intended use, technological characteristics, materials, design, packaging, and sterilization methods.
Reported Device Performance:
- Demonstrated through engineering analysis and mechanical testing.
- Standards referenced: ASTM F382 (Standard Specification for Osteosynthesis Plates) and ASTM F543 (Standard Specification for Metallic Medical Bone Screws).
- Conclusion from testing: "Any differences in the technological characteristics do not raise new issues of safety or efficacy."
- Overall similarities to predicates: Same intended use, operating principle, basic design, similar materials, similar packaging and sterilization.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (as demonstrated by the submission)
Equivalent Intended Use	The subject device has the same intended use as predicate devices.
Equivalent Operating Principle	The subject device uses the same operating principle as predicate devices.
Equivalent Basic Design	The subject device incorporates the same basic design as predicate devices.
Similar Materials	The subject device incorporates the same or very similar materials (commercially pure titanium or Ti-6Al-4V alloy) as predicate devices.
Similar Physical Dimensions	The subject device encompasses the same range of physical dimensions as predicate devices.
Similar Packaging and Sterilization	The subject device has similar packaging and is sterilized using the same materials and processes as predicate devices.
No New Issues of Safety or Efficacy	Engineering analysis and mechanical testing according to ASTM F382 and ASTM F543 demonstrated that any differences in technological characteristics do not raise new safety or efficacy issues.

2. Sample size used for the test set and the data provenance:

Not applicable. This was not a clinical study involving a test set of patient data. Performance was evaluated through mechanical testing of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no ground truth derived from expert consensus on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. There was no adjudication of clinical outcomes or expert readings.

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 an orthopedic implant (plates and screws), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. The "ground truth" equivalent for this type of submission is adherence to established engineering standards (ASTM F382, ASTM F543) and demonstrable equivalence to predicate devices, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set was used.

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