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The Synthes (USA) 2nd Generation Pelvic C-Clamp is intended for emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.

The Synthes 2nd Generation Pelvic C-Clamp is an emergency stabilization instrument for unstable injuries and fractures of the pelvic ring. It is an external fixation device comprised of four main parts: An inner rail, two outer rails, two upper side arms, and two lower side arms. It utilizes short or long cannulated nails and is stored preassembled.

The provided document describes a medical device, the Synthes (USA) 2nd Generation Pelvic C-Clamp, and its clearance process through the FDA's 510(k) pathway. This pathway establishes substantial equivalence to a legally marketed predicate device rather than independently proving performance against specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is available:

• Acceptance Criteria and Reported Device Performance (Point 1): The document does not list specific, quantifiable acceptance criteria for the device's performance (e.g., a certain force it must withstand, a specific range of motion it must allow/restrict, or clinical outcome measures) nor does it report performance data against such criteria. The 510(k) process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.

• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set (Points 2-9): These points refer to the design and conduct of a typical clinical or performance study that would generate efficacy or safety data. Since the 510(k) summary focuses on substantial equivalence to a predicate device, it does not describe such a study.

What the document does provide:

• Device Name: Synthes (USA) 2nd Generation Pelvic C-Clamp
• Intended Use: Emergency stabilization of sacrum fractures or disruptions of the sacroiliac joint with associated circulatory instability.
• Classification: Class II device, regulated under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Predicate Device: Synthes (USA) Pelvic C-Clamp. The primary mechanism for clearance is demonstrating "substantial equivalence" to this previously cleared device.
• Regulatory Pathway: 510(k) premarket notification. This pathway does not typically require new clinical studies to demonstrate safety and effectiveness if substantial equivalence can be shown.

In summary, the provided text is a 510(k) summary and FDA clearance letter, which details the regulatory process for a medical device by demonstrating its substantial equivalence to an existing predicate device. It does not include the results of a de novo study designed to establish and meet specific acceptance criteria through performance testing or clinical trials.

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