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The Synthes (USA) In-Situ Bender/ Cutter is intended for use with Synthes resorbable fixation products in forming and/or cutting plates, meshes, screws, and tacks in-situ before, during, and after initial implantation.

The Synthes In-Situ Bender/ Cutter is a battery-powered disposable device for use with Synthes resorbable fixation products. The device consists of a pen-like welded body that will house the batteries, wiring, and switch. The plastic housing will come with changeable tips for bending or cutting the resorbable implants. The device will be packaged sterile and labeled for single use only.

The provided text describes a 510(k) summary for the Synthes (USA) In-Situ Bender/Cutter, a battery-powered disposable device for use with Synthes resorbable fixation products. The document focuses on regulatory approval and substantial equivalence to predicate devices rather than the results of performance studies against specific acceptance criteria.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text.

The document states:

• Device Name: Synthes (USA) In-Situ Bender/ Cutter
• Intended Use: "The Synthes (USA) In-Situ Bender/ Cutter is intended for use with Synthes resorbable fixation products in forming and/or cutting plates, meshes, sheets, screws, and tacks in-situ before, during, and after implantation."
• Technological Characteristics: "The Synthes In-Situ Bender/ Cutter has the same technological characteristics as the MacroPore predicate device identified above. Both are accessories for resorbable plating systems. The bodies of both devices are plastic with interchangeable cutting and bending tips. Both devices are battery powered and disposable, labeled for single-use only."
• Regulatory Mechanism: The device was submitted under a 510(k) premarket notification and determined to be substantially equivalent to legally marketed predicate devices. This indicates that its safety and effectiveness are established by demonstrating similarity to existing approved devices, rather than through extensive new performance studies against novel acceptance criteria.

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