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Synthes (USA) Sternal Reconstruction System is intended for use in sternal repair and reconstruction.

The Synthes Sternal Reconstruction System is a cable-based system comprised of stainless steel cable, cannulated screws and plates. The system is designed to allow for multiple sternal repair and reconstruction options. It can be used as follows: Cable only; Cable and cannulated screws; Cable, cannulated screws, and plates

This document from Synthes (USA) for their Sternal Reconstruction System is a 510(k) Premarket Notification summary, which is a pre-market submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, i.e., substantially equivalent, to a legally marketed predicate device. This type of submission generally does not require extensive clinical studies or detailed performance criteria and studies in the same way a PMA (Premarket Approval) submission would.

Therefore, the provided text does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's a breakdown of why this information is absent, based on the nature of a 510(k) submission:

• Acceptance Criteria & Reported Performance: For 510(k) submissions, the primary "acceptance criterion" is often a demonstration of substantial equivalence to a predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics (often mechanical or bench testing for devices like this) to the predicate device. The document states "Comparative information presented supports substantial equivalence," but it does not provide a table of explicit acceptance criteria or reported device performance data beyond this general statement.
• Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): These elements are characteristic of clinical or diagnostic performance studies, which are generally not required for a 510(k) for a device like a sternal reconstruction system. Substantial equivalence is often established through non-clinical data (e.g., mechanical testing, materials characterization, biocompatibility) rather than human clinical trials.
  • No information on test set sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance is provided because these concept are not applicable to the 510(k) provided.
  • Ground Truth: For a mechanical device, "ground truth" would relate to its physical properties and functionality. The document doesn't detail how this was established, beyond the general statement of comparative information.
  • No information regarding training set for a study or how its ground truth was established is provided because a study of that nature was not done or required.

In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a 510(k) submission for a medical device (Sternal Reconstruction System) which primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical means, rather than presenting detailed clinical study results with acceptance criteria and performance data as typically found for diagnostic or AI-driven devices.

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