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510(k) Data Aggregation
(99 days)
The StealthStation FlexENT™ System, with the StealthStation™ ENT Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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 the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following procedures:
- Functional Endoscopic Sinus Surgery (FESS)
- Endoscopic Skull Base procedures
- Lateral Skull Base procedures
The Medtronic SteathStation FlexENT™ computer-assisted surgery system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous ENT procedures. Their use 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 the skull, can be identified relative to images of the anatomy.
The StealthStation FlexENT™ is an electromagnetic based surgical guidance platform that supports use of special application software (StealthStation™ S8 ENT Software 1.3 and associated instruments.
The StealthStation™ S8 ENT Software 1.3 helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. StealthStation™ S8 ENT Software 1.3 functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
Patient images can be displayed by the StealthStation™ S8 ENT Software 1.3 from a variety of perspectives (axial, sagittal, coronal, oblique) and 3dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and traiectory of the tracked instrument on images and models the user has selected to display. The surgeon may also create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the software can display how the actual instrument tip position and trajectory relate to the plan, helping to guide the surgeon along the planned trajectory. While the surgeon's judgment remains the ultimate authority, realtime positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide. The StealthStation™ S8 ENT v1.3 Software can be run on both the StealthStation FlexENT™ and StealthStation™ S8 Platforms.
The StealthStation™ System is an Image Guided System (IGS), comprised of a platform (StealthStation FlexENT™ or StealthStation™ S8), clinical software, surgical instruments, and a referencing system (which includes patient and instrument trackers). The IGS tracks the position of instruments in relation to the surgical anatomy, known as localization, and then identifies this position on preoperative or intraoperative images of a patient.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (mean error) | Reported Performance (StealthStation FlexENT™) | Reported Performance (StealthStation™ S8) | Reported Performance (Predicate: StealthStation™ S8 ENT v1.0) |
|---|---|---|---|---|
| 3D Positional Accuracy | ≤ 2.0 mm | 0.93 mm | 1.04 mm | 0.88 mm |
| Trajectory Angle Accuracy | ≤ 2.0 degrees | 0.55° | 1.31° | 0.73° |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Testing was performed under the representative worst-case configuration... utilizing a subset of system components and features that represent the worst-case combinations of all potential system components." It does not specify a numerical sample size for the test set (e.g., number of phantoms or trials).
The data provenance is not explicitly stated in terms of country of origin. The test appears to be a prospective bench study conducted by the manufacturer, Medtronic Navigation, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish ground truth for this accuracy testing. The ground truth for positional and trajectory accuracy would typically be established by precise measurements on the anatomically representative phantoms using highly accurate measurement systems, not by expert consensus.
4. Adjudication Method for the Test Set:
Not applicable, as this was a bench accuracy test with directly measurable metrics, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not conducted. The study focuses on the standalone accuracy of the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone performance study was done. The accuracy testing described ("3D positional accuracy" and "trajectory angle accuracy") measures the device's inherent accuracy in locating anatomical structures and guiding trajectories, independent of human interaction during the measurement process. The system tracks instruments and displays their position and trajectory on images without direct human interpretation being part of the measurement for these accuracy metrics.
7. The Type of Ground Truth Used:
The ground truth used for this accuracy study was derived from precise physical measurements taken on "anatomically representative phantoms." This implies that the true position and trajectory were known and used as reference points against which the device's reports were compared.
8. The Sample Size for the Training Set:
The document does not provide information about a training set since the study described is a performance validation of a medical device's accuracy, not a machine learning model that would require a dedicated training set. The software likely undergoes extensive internal development and testing, but separate "training set" details are not provided in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set information is provided or relevant for this type of accuracy study.
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(33 days)
The StealthStation™ System, with StealthStation™ Cranial Software, is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. Their use 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 the skull, can be identified relative to images of the anatomy.
This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
- · Tumor resections
- General ventricular catheter placement
- · Pediatric ventricular catheter placement
- · Depth electrode, lead, and probe placement
- · Cranial biopsies
The StealthStation™ Cranial Software v1.3.0 works in conjunction with an Image Guided System (IGS) which consists of clinical software, surgical instruments, a referencing system and platform/computer hardware. Image guidance, also called navigation, tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient. During surgery, positions of specialized surgical instruments are continuously updated on these images either by optical tracking or electromagnetic tracking.
Cranial software functionality is described in terms of its feature sets which are categorized as imaging modalities, registration, planning, interfaces with medical devices, and views. Feature sets include functionality that contributes to clinical decision making and are necessary to achieve system performance.
The changes to the currently cleared StealthStation S8 Cranial Software are as follows:
- . Addition of an optional image display that allows the user to see through outer layers to increase the visibility of other models.
- . Update the imaging protocol to support overlapping slices.
- . Minor changes to the software were made to address user preferences and to fix minor anomalies.
The provided document is a 510(k) premarket notification summary for Medtronic's StealthStation Cranial Software v1.3.0. It describes the device, its intended use, and a comparison to a predicate device, along with performance testing.
Here's an analysis to address your specific questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy Requirements | |
| 3D Positional Accuracy: mean error ≤ 2.0 mm | Mean error ≤ 2.0 mm |
| Trajectory Angle Accuracy: mean error ≤ 2.0 degrees | Mean error ≤ 2.0 degrees |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size (e.g., number of cases or images) for the performance testing. It states that the performance was determined "using anatomically representative phantoms and utilizing a subset of system components and features that represent the worst-case combinations of all potential system components."
Regarding data provenance, the testing was conducted in "laboratory and simulated use settings" using "anatomically representative phantoms." This indicates that the data was generated specifically for testing purposes, likely in a controlled environment, rather than being derived from real patient scans. The country of origin for the data is not specified, but the applicant company, Medtronic Navigation Inc., is based in Louisville, Colorado, USA. The testing appears to be prospective in nature, as it was specifically carried out to demonstrate equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the involvement of human experts for establishing ground truth for the performance testing. The accuracy measurements (3D positional and trajectory angle) are typically derived from physical measurements against known ground truth (e.g., phantom dimensions, known instrument positions) in the context of navigation systems, not by expert consensus on image interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The performance testing described is objective measurement against physical phantoms, not subjective assessment by experts requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "Clinical testing was not considered necessary prior to release as this is not new technology." This device is an image-guided surgery system software, not an AI-assisted diagnostic tool that would typically undergo MRMC studies. The changes in this version (v1.3.0) are described as "minor changes to the software were made to address user preferences and to fix minor anomalies" and "Addition of an optional image display that allows the user to see through outer layers," suggesting incremental updates rather than a fundamentally new AI algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance testing was effectively "standalone" in the sense that the system's accuracy was measured against a known physical ground truth (phantoms) rather than evaluating human performance with the system. The reported accuracy metrics describe the device's inherent precision in tracking and navigation, independent of user interaction during the measurement process itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was based on known physical properties of anatomically representative phantoms. This means that a physical phantom with precisely known dimensions and features was used, and the device's ability to accurately locate points and trajectories within that known physical structure was measured. This is a common and appropriate method for validating the accuracy of surgical navigation systems.
8. The sample size for the training set
Not applicable. This device, as described, is a software for image-guided surgery, not an AI/ML model that would typically have a "training set" in the context of deep learning. The changes are described as minor software updates and an optional display feature, not a new algorithm requiring a training phase from data.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML model in this submission.
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(237 days)
The Visualase™ Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064mm.
When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase™ system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.
The Visualase™ Thermal Therapy System is compatible with General Electric Medical Systems Signa model MR scanners and with Siemens Medical Solutions Magnetom Espree systems. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase™ analysis.
The Visualase Thermal Therapy System comprises of hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: a diode laser (energy source); a coolant pump to circulate saline through the laser application; Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; two monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections.
Remote Presence software provides a non-clinical utility application for use by Medtronic only and is not accessible by the user.
The provided document is a 510(k) summary for the Medtronic Visualase Thermal Therapy System. It describes labeling changes to the device manual and explicitly states that no new performance testing was required as there are no changes to the device itself. Therefore, the document does not contain information about studies specifically conducted to prove the device meets acceptance criteria for its current performance.
The document indicates that this 510(k) submission is for labeling changes only, primarily adding new warnings and information that were previously distributed via field corrective actions. It confirms that these changes do not affect the intended use or fundamental technology of the Visualase Thermal Therapy System.
Consequently, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met because this 510(k) submission does not include such a study for the current device. The acceptance criteria and performance data would have been established and submitted during earlier 510(k) clearances for the device itself (e.g., K081656), not for this labeling update.
The request for information on multi-reader multi-case (MRMC) studies, effect sizes, standalone performance, training sets, and ground truth establishment are also not applicable to this specific submission, which focuses solely on labeling updates.
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