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510(k) Data Aggregation
(100 days)
The Intended Purpose of the NaviNetics D1 Stereotactic System is target localization and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures, for example; deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumor treatments.
The NaviNetics D1 Stereotactic System is a device used for minimally invasive neurosurgical procedures. During image acquisition and treatment, the system's Skull Anchor Key ("Key") achieves reduced weight and patient invasiveness versus common stereotactic head frames that travel extensively around the patient's head and are restrictive to the airway access when positioned.
The system consists of a Key that is affixed to the patient's skull with three titanium stand-off pins and four self-tapping bone anchor screws. The Key serves as the common attachment platform for the D1 Stereotactic Positioner and MRI and CT localizers. The system is based on established stereotactic center-of-arc principles with compatible interventional instruments rely on the active working length of 150 mm (arc radius) with stops and guide holders to ensure proper trajectory angle to the brain target. The two degrees of freedom of the arc-quadrant, the Arc and Collar angles, can be manipulated allowing the device to approach the target from a multitude of directions. Linear adjustments can move the arc-quadrant, medial/lateral (X), anterior/posterior (Y), and superior/inferior (Z) to bring the focus to the surgical target. The output of the third-party planning software provides the values of the target coordinates (XT, YT, ZT) and the surgical trajectory (CT, AT) which dictate the settings of the D1 stereotactic device.
The provided document is a 510(k) summary for the NaviNetics D1 Stereotactic System. It outlines the device's characteristics, intended use, and substantial equivalence to a predicate device, the Leksell® Vantage™ Stereotactic System.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance/Results |
|---|---|---|
| Accuracy | Mechanical Accuracy: Assembly to position known stereotactic test points at the focus of the arc-quadrant. | All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device. Stated mechanical accuracy: 0.9 mm. |
| Systemic Image Accuracy: Accuracy of selecting an image target on CT or MRI and positioning the selected point at the focus of the arc-quadrant. | All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device. | |
| Systemic Surgical Accuracy: Accuracy of placing a DBS lead, including implantation technique, as verified by post-implant CT scan. | All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device. | |
| Handling and process step accuracy (e.g., repeated mounting of parts to each other and scale setting accuracy) during mechanical and repeatability accuracy testing. | All test cases were shown acceptable for the expected outcome. Overall system accuracy is equivalent to the predicate device. | |
| Displacement due to head weight. | Skull anchor key design renders displacement due to head weight as inconsequential. | |
| MR Safety | Compliance with FDA guidance for MR environment safety and compatibility, including ASTM F2052, ASTM F2119, ASTM F2182, ASTM F2213, ASTM F2503. | Substantial equivalence to the predicate device is demonstrated through passing results to FDA guidance and these consensus standards. |
| Cleaning | Validation of manual cleaning and cleaning with a washer-disinfector methods using instructions in the IFU and artificial blood. | Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence. |
| Sterilization | Validation for steam sterilization at 132°C (270°F) for 4 minutes to obtain a sterility assurance level (SAL) of at least 10^-6. | Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence. |
| Biocompatibility | Evaluation of patient-contacting materials for biocompatibility according to ISO10993-1, ISO10993-5, ISO10993-10, and ISO10993-11. | Parts passed final validation and met all pre-determined acceptance criteria while demonstrating predicate device substantial evidence. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size or data provenance (e.g., country of origin, retrospective/prospective) for the accuracy tests. It only mentions "All test cases" for the accuracy results. This typically implies a limited, in-house testing setup rather than a large clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a physical stereotactic system, not an AI diagnostic tool, so such a study would not be applicable in the context of human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study for the device's accuracy was done, as indicated by the "Accuracy" section under "Summary of Non-Clinical Performance Data." However, this refers to the mechanical and systemic accuracy of the device itself, not an algorithm's standalone diagnostic performance. The device is a "Stereotaxic Instrument" and not an AI-powered diagnostic algorithm.
7. Type of Ground Truth Used
For the accuracy tests, the ground truth appears to be:
- Mechanical Accuracy: Known stereotactic test points. This implies a precisely manufactured phantom or reference system.
- Systemic Image Accuracy: Selected image targets on CT or MRI. This would rely on the accuracy of the imaging system and potentially human identification of targets as a reference for the device's ability to locate them.
- Systemic Surgical Accuracy: Post-implant CT scan verification for DBS lead placement. This uses objective imaging results as the ground truth for surgical outcome.
For the other tests (MR Safety, Cleaning, Sterilization, Biocompatibility), the 'ground truth' is compliance with established standards and protocols.
8. Sample Size for the Training Set
The document does not mention a training set, as the device is a mechanical stereotactic system and not a machine learning or AI model that requires training data.
9. How Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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