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The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

The Syntec Non-Sterile Steinmann Pins System is modify from our own device from K983121-Non-Sterile Kirschner Wires and Steinmann Pins product systm. The modify Pins are fabricated from stainless steel (SUS316L) per ASTM F138-13.The design feature for the Non-Sterile Steinmann Pins System is similar to the predicate devices including dimensions, shape, style and sizes.

This document is a 510(k) premarket notification for the Syntec Non-Sterile Steinmann Pins System. It explicitly states that clinical data and conclusions were not needed for these devices and performance tests are not required to support substantial equivalence in special 510k.

Therefore, the provided text does not contain any information about:

• Acceptance criteria related to device performance in a clinical or non-clinical study.
• Reported device performance from such a study.
• Sample sizes used for test or training sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• MRMC studies, effect sizes, or standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K983121 - Non-Sterile Kirschner Wires and Steinmann Pins product system) based on:

1. Identical Intended Use and Indications for Use: The Steinmann pins are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, and as guide pins for insertion of other implants.
2. Technological Characteristics: The modified pins are fabricated from stainless steel (SUS316L) per ASTM F138-13, and their design features (dimensions, shape, style, and sizes) are similar to the predicate devices.
3. Conformance to Standards: The device was considered in conformance with dimensional and material mechanical property standards ASTM F138-13, ASTM F366-10, and ISO 5838-1.

In summary, the provided text does not describe a study involving performance testing against acceptance criteria. It's a regulatory submission demonstrating equivalence for a medical device that, due to its nature as a "Special 510(k)," did not require extensive clinical or non-clinical performance data for clearance.

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