Search Results

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.

Ask a specific question about this device

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 Medronic SteathStation® 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.

The provided text describes the DeGen Medical Navigated Instrumentation and its 510(k) summary, but does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document focuses on regulatory approval (510(k)) and establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria and detailed results.

Here's what can be extracted and what cannot:

Information Present in the Document:

• Device Name: DeGen Medical Navigated Instrumentation
• K Number: K203816
• Indications for Use: Intended to be used during the preparation and placement of DeGen Medical F1 MPS and E3 MIS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Specifically designed for use with the Medtronic StealthStation® System.
• Predicate Devices: K140454 Medtronic Navigated CD Horizon Solera Screwdriver / Taps and K172166 Astura Olympic Navigated Instruments.
• Non-Clinical Test Summary: "Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy." The document states, "The results of these evaluations indicate the subject device is equivalent to the predicate device."
• Type of Ground Truth Used (Indirectly): The "non-clinical test summary" mentions "navigation accuracy" and "anatomical simulated use," which implies that the ground truth for these tests would likely be based on physical measurements against established anatomical models or precise reference points, rather than expert consensus, pathology, or outcomes data in a clinical setting.

Information NOT Present in the Document:

• A table of acceptance criteria and reported device performance: The document only states that evaluations were conducted and "indicate the subject device is equivalent to the predicate device," but no specific numerical performance criteria or results are provided.
• Sample size used for the test set and data provenance: No details on the number of cases, specimens, or the origin (country, retrospective/prospective) of the data for the "anatomical simulated use and navigation accuracy" tests.
• Number of experts used to establish ground truth and their qualifications: Not applicable, as the ground truth appears to be based on physical measurements/simulations rather than human expert interpretation of images or clinical data.
• Adjudication method for the test set: Not applicable based on the information provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No indication of such a study. The device is a navigated instrumentation, not an AI diagnostic tool that would typically involve human readers.
• If a standalone (algorithm only without human-in-the-loop performance) was done: This device is physical instrumentation used with a navigation system, not an algorithm in the typical sense of AI standalone performance.
• The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML model that requires a training set.
• How the ground truth for the training set was established: Not applicable.

Summary based on the provided text:

The document is a 510(k) clearance letter and summary for a medical device. Its purpose is to demonstrate substantial equivalence to existing legally marketed devices, not to detail the performance of an AI/ML algorithm or a new diagnostic tool using a large-scale clinical study dataset. The "study" mentioned is a "Non-Clinical Test Summary" which included "Dimensional analysis compared to predicate Anatomical simulated use and navigation accuracy." The conclusion is that these evaluations demonstrated the device is "equivalent to the predicate device" in terms of safety and effectiveness, based on "technological characteristics and non-clinical performance data."

To answer your request comprehensively, you would need a more detailed performance report or study design document for the DeGen Medical Navigated Instrumentation, which is not included in these FDA communication pages.

Ask a specific question about this device