(56 days)
The DeGen Medical Navigated Instrumentation is intended to be used during the preparation and placement of DeGen Medical F 1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. DeGen Medical Navigated Instrumentation is specifically designed for use with the Medtronic System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure such as vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The DeGen Navigated Instrumentation is nonsterile, reusable drivers that are intended to be used with the Medtronic StealthStation® Application 1.2.0 (1.2.0-20) and are manufactured from stainless steel per ASTM F899.
I'm sorry, but this document does not contain the detailed information necessary to answer your request about the acceptance criteria and the study proving the device meets those criteria. Specifically, the document is a 510(k) clearance letter and summary, which confirms regulatory clearance but does not include:
- A table of acceptance criteria and reported device performance. The document mentions "Anatomical simulated use and navigation accuracy" as a non-clinical test, but no specific performance metrics or acceptance thresholds are provided.
- The sample size used for the test set or its provenance.
- The number and qualifications of experts used to establish ground truth.
- The adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human improvement with AI assistance.
- Whether standalone (algorithm only) performance was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.), though it implies simulated use.
- The sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, indications for use, design, function, technology, and non-clinical tests (dimensional analysis and anatomical simulated use/navigation accuracy). It concludes that the device is "as safe and effective" as the predicate based on these comparisons, but does not provide the specific performance data you are looking for.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).