(87 days)
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are generally intended for a variety of pan facial indications. Specifically, they are intended for selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates are available in Mesh-, T-, L-, and Z- plate configurations, and attach to bone via 1.5 mm and 2.0 mm self-tapping screws, and 2.0 mm and 2.4 mm emergency screws.
The provided text describes a 510(k) submission for the "Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws." This is a medical device application that focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of diagnostic performance or clinical outcomes. The provided text is a regulatory filing for marketing clearance, not a clinical trial report.
Here's why the requested information is not available in the given text:
- Acceptance criteria and reported device performance: This type of information (e.g., sensitivity, specificity, accuracy, or other quantitative performance metrics) is typically found in clinical study reports. The 510(k) summary focuses on device description, intended use, and substantial equivalence to a predicate device, not on presenting novel performance data against pre-defined criteria.
- Sample size and data provenance: No clinical study is described, so no sample size for test sets or data provenance is mentioned.
- Number of experts and qualifications for ground truth: Since no clinical study with ground truth establishment is detailed, this information is absent.
- Adjudication method: Not applicable as no clinical study with ground truth adjudication is described.
- MRMC comparative effectiveness study: No such study is mentioned.
- Standalone performance study: Not mentioned, as the focus is on substantial equivalence to an existing device.
- Type of ground truth used: Not applicable.
- Training set sample size: Not applicable, as this is a medical device for fixation, not an algorithm that requires a training set in the sense of machine learning.
- How ground truth for training set was established: Not applicable.
The 510(k) process for devices like these typically relies on:
- Bench testing: To demonstrate mechanical properties, biocompatibility, and sterilization effectiveness.
- Comparison to a predicate device: To show that the new device is as safe and effective as a legally marketed device.
The provided document verifies that the Synthes 1.5 mm / 2.0 mm Orthognathic Maxillary Plates and Screws are substantially equivalent to the Synthes Midfacial System (K953806) for the stated indications. This "substantial equivalence" is the regulatory criterion met, rather than performance against a set of quantitative metrics for diagnostic accuracy or similar clinical outcomes.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.