(35 days)
Synthes Rapid Resorbable Tack System is intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton. In addition, Rapid Resorbable Tacks may be used in non-load bearing applications for maintaining the relative position of and/or containing bony fragments, bone grafts (autograft or allograft) or bone graft substitutes in reconstruction of the craniofacial or mandibular areas.
The Synthes Rapid Resorbable Tack System consists of resorbable tacks and accessory instruments, which are additional components of the Synthes Rapid Resorbable Fixation System. The Rapid Resorbable Tack System consists of 1.5 mm tacks and 1.7 mm emergency tacks and are available in lengths ranging from 4 - 6 mm.
This document is a 510(k) summary for the Synthes Rapid Resorbable Tack System, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study demonstrating performance against acceptance criteria for a new device.
Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets those criteria. The document is typical of a 510(k) submission, outlining device description, intended use, contraindications, and demonstrating equivalence to existing legally marketed devices, but it does not include detailed performance studies with acceptance criteria as one would expect for a novel device needing extensive validation.
Here's why the information you're looking for isn't present:
- 510(k) Substantial Equivalence: The primary purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing features, materials, and intended use, and may include limited performance testing to show that the new device performs as safely and effectively as the predicate, but it's not usually a full-blown clinical trial against predefined acceptance criteria for a novel technology.
- No Acceptance Criteria or Performance Study Details: The document explicitly states, "Documentation is provided which demonstrates that Synthes Rapid Resorbable Tack System is substantially equivalent to other legally marketed Synthes devices." It does not provide a table of acceptance criteria or a description of a study conducted to prove the device meets specific performance targets (like sensitivity, specificity, accuracy, etc., which are common for diagnostic or AI devices).
- Focus on Mechanical Equivalence: For a resorbable tack system, the "performance" likely relates to mechanical properties, biocompatibility, and degradation profiles, which would be compared to the predicate device. These tests are usually conducted in a lab environment rather than clinical studies with human readers or ground truth established by experts.
In summary, the provided document does not allow for answering most of your questions as it pertains to a 510(k) submission focused on substantial equivalence rather than a detailed performance study with explicit acceptance criteria.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.