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The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures in adult and skeletally mature pediatric (adolescent) patients. 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 spine or pelvis, can be identified relative to images of the anatomy.

This can include the following spinal implant procedures in adult patients, such as:

• Pedicle Screw Placement
• Iliosacral Screw Placement
• Interbody Device Placement

This can include the following spinal implant procedures in skeletally mature pediatric (adolescent) patients:

• Pedicle Screw Placement

StealthStation S8 Spine Software helps guide surgeons during spine surgical procedures. The subject software works in conjunction with a navigation system, surgical instruments, a referencing system, and computer hardware. Navigation tracks the position of instruments in relation to the surgical anatomy and identifies this position on pre-operative or intraoperative images of the patient. The mouse, keyboard, touchscreen monitor, and footswitch of the StealthStation platforms are used to move through the software workflow. Patient images are displayed by the software from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display on the monitor. The surgeon may also create and store one or more surgical plan trajectories before and during 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.

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Stealth™ Spine Clamps

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer-assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The Stealth™ spine clamps are indicated for skeletally mature patients.

ModuLeX™ Shank Mounts

When used with Medtronic computer assisted surgery systems, defined as including the Stealth™ System, the following indications of use are applicable:

• The spine referencing devices are intended to provide rigid fixation between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable.
• The navigated instruments are specifically designed for use with Medtronic computer assisted surgery systems, which are indicated for any medical condition in which the use of stereotactic surgery may be appropriate or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
• The ModuLeX™ shank mounts are indicated to be used with the CD Horizon™ ModuLeX™ Spinal System during surgery.
• The ModuLeX™ shank mounts are indicated for skeletally mature patients.

The Stealth™ Spine Clamps are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

The ModuLeX™ Shank Mounts are intended to provide rigid attachment between the patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the Stealth™ System and are intended to be reusable.

This document, an FDA 510(k) Clearance Letter, does not contain the specific details about acceptance criteria and study data that would be found in a full submission. 510(k) summary documents typically provide a high-level overview.

Based on the provided text, here's what can be extracted and what information is not available:

Information from the document:

• Device Type: Stealth™ Spine Clamps and ModuLeX™ Shank Mounts, which are orthopedic stereotaxic instruments used with computer-assisted surgery systems (specifically the Medtronic Stealth™ System).
• Purpose: To provide rigid fixation between the patient and a patient reference frame for the duration of spine surgery, and to serve as navigated instruments for surgical guidance.
• Predicate Devices:
  • Stealth™ Spine Clamps: StealthStation™ Spinous Process Clamps (K211442)
  • ModuLeX™ Shank Mounts: Rod Clamps (K131425)
• Testing Summary (XI. Discussion of the Performance Testing):
  • Mechanical Robustness and Navigation Accuracy
  • Functional Verification
  • Useful Life Testing
  • Packaging Verification
  • Design Validation
  • Summative Usability
  • Biocompatibility (non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic)

Information NOT available in the provided document (and why):

This 510(k) summary describes physical medical devices (clamps and mounts) used in conjunction with a computer-assisted surgery system, but it does not describe an AI/software device whose performance is measured in terms of accuracy, sensitivity, or specificity for diagnostic or guidance purposes. Therefore, many of the requested points related to AI performance, ground truth, and reader studies are not applicable or not detailed in this type of submission.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance (with specific numerical metrics for "Navigation Accuracy"): While "Navigation Accuracy" is listed as a test conducted, the actual acceptance criteria (e.g., "accuracy must be within X mm") and the quantitative results are not provided in this summary. This would typically be in a detailed test report within the full 510(k) submission.
2. Sample sizes used for the test set and data provenance: No information on the number of units tested, or if any patient data was used for "Navigation Accuracy" (it's likely bench testing).
3. Number of experts used to establish ground truth and their qualifications: Not applicable as this is a mechanical device submission, not an AI diagnostic submission. Ground truth for mechanical accuracy would be established by precise measurement tools, not human experts in this context.
4. Adjudication method for the test set: Not applicable for mechanical/functional testing.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned or applicable. This type of study is for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance.
6. Stand-alone (algorithm only) performance: Not applicable; this is not an algorithm for diagnosis or image analysis.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For "Navigation Accuracy," the ground truth would be based on highly precise measurement systems (e.g., optical tracking validation) in a lab setting, not clinical outcomes or expert consensus.
8. Sample size for the training set: Not applicable; there is no "training set" as this is not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

Summary of what is known concerning acceptance criteria and proof of adherence:

• Acceptance Criteria/Proof (General): The document states that "Testing conducted to demonstrate equivalency of the subject device to the predicate is summarized as follows: Mechanical Robustness and Navigation Accuracy, Functional Verification, Useful Life Testing, Packaging Verification, Design Validation, Summative Usability, Biocompatibility."
• Implied Acceptance: The FDA's clearance (K242464) indicates that Medtronic successfully demonstrated that the new devices are "substantially equivalent" to predicate devices based on the submitted testing. This means the performance met the FDA's expectations for safety and effectiveness, likely by demonstrating equivalent or better performance against the predicates in the specified tests (e.g., meeting established benchmarks for sterility, material strength, and precision when interfaced with the navigation system). However, the specific numerical criteria for "Navigation Accuracy" are not disclosed in this summary letter.

Conclusion based on the provided text:

This 510(k) summary is for a Class II mechanical stereotaxic instrument and, as such, focuses on demonstrating mechanical, functional, and biocompatibility equivalency to predicate devices. It does not contain the detailed performance metrics, ground truth establishment methods, or human reader study results that would be pertinent to an AI/software medical device submission.

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The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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):

• Cranial biopsies (including stereotactic)
• Deep brain stimulation (DBS) lead placement
• Depth electrode placement
• Tumor resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF leak repair
• Pediatric Ventricular Catheter Placement
• General Ventricular Catheter Placement

The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial Software 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. StealthStation 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 furnished document is a 510(k) premarket notification for the StealthStation Cranial Software, version 3.1.5. It details the device's indications for use, technological characteristics, and substantiates its equivalence to a predicate device through performance testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "System accuracy validation testing" was conducted. However, it does not specify the sample size for this test set (e.g., number of cases, images, or measurements).

Regarding data provenance, the document does not explicitly state the country of origin of the data nor whether the data used for accuracy testing was retrospective or prospective. The study focuses on demonstrating substantial equivalence through testing against predefined accuracy thresholds rather than utilizing patient-specific clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts used to establish ground truth for the system accuracy validation testing, nor their specific qualifications. It mentions "User exploratory testing to explore clinical workflows, including standard and unusual clinically relevant workflows. This testing will include subject matter experts, internal and field support personnel," but this refers to a different type of testing (usability/workflow exploration) rather than objective ground truth establishment for accuracy measurements.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the system accuracy validation testing. The accuracy measurements appear to be objective, derived from controlled testing environments rather than subjective expert interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as part of this submission. The testing described is focused on the standalone performance of the device's accuracy in a controlled environment, not on how human readers perform with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance):

Yes, standalone performance testing was done. The "System accuracy validation testing" directly assesses the algorithm's performance in achieving specific positional and angular accuracy. The reported "Positional Error - 0.824 mm" and "Trajectory Error - 0.615 degrees" are metrics of the standalone algorithm's accuracy without direct human intervention in the measurement process itself, although the device is ultimately used by humans in a clinical context.

7. Type of Ground Truth Used:

The ground truth for the system accuracy validation testing appears to be based on objective, controlled measurements within a testing environment, likely involving phantom models or precise physical setups where the true position and orientation are known or can be measured with high precision. This is implied by the nature of "3D positional accuracy" and "trajectory angle accuracy" measurements, which are typically determined against a known, precise reference. It is not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. This is because the StealthStation Cranial Software is a navigation system that uses image processing and registration algorithms, rather than a machine learning model that requires a distinct training dataset in the traditional sense. The software's development likely involves engineering principles and rigorous testing against design specifications, not iterative learning from data.

9. How the Ground Truth for the Training Set Was Established:

As the device does not appear to be an AI/ML model that undergoes a machine learning "training" phase with a labeled dataset in the conventional understanding for medical imaging analysis, the concept of establishing ground truth for a training set is not applicable in this context. The software's functionality is based on established algorithms for image registration and instrument tracking, which are then validated through performance testing against pre-defined accuracy thresholds.

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Synergy Cranial v2.2.9:
The StealthStation System, with Synergy Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures:

• Cranial Biopsies
• Tumor Resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF Leak Repair
• Pediatric Catheter Shunt Placement
• General Catheter Shunt Placement

StealthStation Cranial Software v3.1.4:
The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure 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):

• Cranial biopsies (including stereotactic)
• Deep brain stimulation (DBS) lead placement
• Depth electrode placement
• Tumor resections
• Craniotomies/Craniectomies
• Skull Base Procedures
• Transsphenoidal Procedures
• Thalamotomies/Pallidotomies
• Pituitary Tumor Removal
• CSF leak repair
• Pediatric Ventricular Catheter Placement
• General Ventricular Catheter Placement

The StealthStation System, with StealthStation Cranial software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation Cranial software 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. StealthStation 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 Medtronic Navigation, Inc. StealthStation Cranial Software (v3.1.4) and Synergy Cranial Software (v2.2.9) are image-guided surgery (IGS) systems intended to aid in precisely locating anatomical structures during neurosurgical procedures.

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for both software versions are related to system accuracy in 3D positional and trajectory angle measurements.

Note: The document refers to "StealthStation Cranial v3.1.3" and also "StealthStation Cranial v3.0 Software" in the testing section for the newer version's accuracy. Assuming v3.1.3 is the subject device and v3.0 is a close predecessor or the system version used for the test. The "v3.1.4" in the 510(k) letter is likely a minor update from v3.1.3, and the reported performance for v3.1.3 is considered representative.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size (number of patients or phantom configurations) used for the quantitative accuracy testing (test set). It mentions:

• "Under representative worst-case configuration"
• "utilizing a subset of system components and features that represent the worst-case combinations of all potential system components."
• "Test configurations included CT images with slice spacing and thickness ranging between 0.6 mm to 1.25 mm and T1-weighted MR images with slice spacing and thickness ranging between 1.0 mm to 3.0 mm."

Data Provenance: The data appears to be prospective as it was generated through laboratory and simulated use settings with "anatomically representative phantoms." The country of origin is not explicitly stated, but given Medtronic Navigation, Inc. is located in Louisville, Colorado, USA, it's highly probable the testing was conducted in the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document indicates that the accuracy was determined using "anatomically representative phantoms." This implies that the ground truth for positional and angular accuracy was engineered and precisely measured within a controlled phantom environment, rather than established by human experts interpreting clinical data. Therefore, human experts were likely involved in designing and validating the phantom setup and measurement methodologies, but not in directly establishing ground truth from patient data. The qualifications of these individuals are not specified but would typically be engineers, physicists, or metrology specialists.

4. Adjudication Method for the Test Set

Given that the ground truth was established through a designed phantom and precise measurements, an adjudication method for human interpretation is not applicable here. The measurements are objective and quantitative.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned for human readers improving with AI vs. without AI assistance. The device is a surgical navigation system, aiding in real-time guidance, not an AI-assisted diagnostic tool that would typically undergo MRMC studies.

6. Standalone (i.e., algorithm only without human-in-the-loop performance)

Yes, a standalone performance was done for the system's accuracy. The reported positional and trajectory angle errors are measures of the system's inherent accuracy, independent of a specific human-in-the-loop scenario. The study describes "Design verification and validation was performed using the StealthStation Cranial software in laboratory and simulated use settings."

7. The Type of Ground Truth Used

The ground truth used was engineered truth derived from precisely measured anatomical phantoms. This is a highly controlled and quantitative method, suitable for measuring the accuracy of a navigation system.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning model. The device is referred to as "software" for an Image Guided System (IGS), which typically relies on established algorithms for image processing, registration, and tracking, rather than deep learning models that require large training datasets with ground truth labels in the conventional sense. The "training" for such a system would involve rigorous formal verification and validation of these algorithms.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" and its associated ground truth, as typically applied to AI/machine learning, does not appear to be directly applicable to the description of this device's development as presented in the 510(k) summary. The development involved "Software verification and validation testing for each requirement specification" and "System integration performance testing for cranial surgical procedures using anatomical phantoms," suggesting traditional software engineering and testing methodologies rather than machine learning training.

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The Visualase MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064mm lasers.

The Visualase MRI-Guided Laser Ablation System comprises 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 text describes specific details about the Visualase MRI-Guided Laser Ablation System (SW 3.4) and its comparison to predicate devices, but it does not contain a table of acceptance criteria or a detailed study description with performance metrics in the format requested.

The "Testing Summary" section mentions in vivo testing to demonstrate accuracy and performance of MR Thermometry and Thermal Damage Estimate, as well as software and system verification and validation. However, it does not provide:

• Specific acceptance criteria values (e.g., "accuracy must be within X degrees Celsius").
• Reported device performance values against these criteria.
• Sample sizes for the test set.
• Data provenance.
• Details about expert involvement or adjudication.
• Information on MRMC studies or standalone AI performance.
• Details about the training set.

Therefore, most of the requested information cannot be extracted from the given text.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated with numeric values in the document. The general statement is "Testing demonstrated the accuracy and precision of the Visualase MRI-Guided Ablation System's Thermal Damage Estimate and MR Thermometry for its intended use."
• Reported Device Performance: Not provided (e.g., no specific accuracy values, precision values, or success rates are given).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified.
• Data Provenance: The testing was "In vivo testing conducted 1.5T and 3.0T (in accordance with 21 CFR 58)". 21 CFR Part 58 refers to Good Laboratory Practice for nonclinical laboratory studies, which implies prospective in vivo studies, but does not specify the origin of the data (e.g., country).

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)

• Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not specified.

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

• The document implies the device is a tool used by a neurosurgeon. It does not describe a comparative effectiveness study involving human readers with or without AI assistance, or any effect size for such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document states the system "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." It is an MRI-guided system implying human-in-the-loop operation. No standalone algorithm-only performance is described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Given it's "in vivo testing" for "Thermal Damage Estimate" and "MR Thermometry," the ground truth likely involved a direct measurement method for temperature or thermal damage in the tissue, possibly through implanted probes or post-ablation pathological assessment, but the specific method is not detailed.

8. The sample size for the training set

• Not applicable as this document describes performance of a medical device (laser ablation system with software), not a machine learning model explicitly detailing training data. The software components are verified and validated, but no "training set" in the context of AI/ML is mentioned.

9. How the ground truth for the training set was established

• Not applicable for the reasons stated above.

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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 v1.3.2 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 acceptance criteria for the StealthStation™ Cranial Software v1.3.2 are not explicitly detailed in the provided document beyond the general statement of "System Accuracy Requirements" being "Identical" to the predicate device. The performance characteristics of the predicate device, StealthStation™ Cranial Software v1.3.0, are stated as the benchmark for system accuracy.

Here's the information extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document states that "Software verification testing for each requirement specification" was conducted and "Design verification was performed using the StealthStation™ System with Station™ Cranial Software v1.3.2 in laboratory."
• No specific sample size for a test set is mentioned. The testing described is software verification and design verification, not a clinical study on patient data for performance evaluation in the typical sense of AI/ML devices.
• Data provenance is not applicable or not disclosed as the document indicates "Clinical testing was not considered necessary prior to release as this is not new technology."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The testing described is software and design verification rather than a clinical performance study requiring expert ground truth establishment from patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This information is relevant for clinical studies involving multiple reviewers adjudicating findings, which was not performed.

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. An MRMC comparative effectiveness study was not performed. The device is a navigation system and not an AI-assisted diagnostic tool that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. The device is a surgical navigation system, which is inherently a human-in-the-loop tool. The performance evaluation focuses on its accuracy specifications within that use case during design verification.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For the system accuracy, the ground truth would be precise measurements taken in a laboratory setting for the navigational accuracy, rather than clinical ground truth from patient data like pathology or outcomes.

8. The sample size for the training set:

• Not applicable. The document describes a software update for a stereotaxic instrument, not an AI/ML device that undergoes model training with a dataset.

9. How the ground truth for the training set was established:

• Not applicable. As the device is not described as an AI/ML system requiring a training set, the establishment of ground truth for such a set is not relevant.

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The StealthStation™ System, with StealthStation™ Spine Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic 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 spine or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as:

o Pedicle Screw Placement

• o Iliosacral Screw Placement
  o Interbody Device Placement

The StealthStation System, also known as an Image Guided System (IGS), is comprised of a platform, clinical software, surgical instruments and a referencing system. The IGS tracks the position of instruments in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient. The StealthStation Spine software helps guide surgeons during spine procedures such as spinal fusion and trauma treatments. StealthStation Spine 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.

Based on the provided text, the acceptance criteria and study proving the device meets these criteria for the StealthStation S8 Spine Software v1.3.0 can be summarized as follows:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify a numerical sample size for the test set used for the accuracy performance. It mentions "anatomically representative phantoms" were used.
• Data Provenance: The study was conducted using "anatomically representative phantoms." The country of origin of the data is not specified, but the applicant company is Medtronic Navigation, Inc., located in Louisville, Colorado, USA. The study design is implied to be prospective testing on phantoms rather than retrospective patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The accuracy testing was performed on phantoms, which typically rely on engineered and measurable ground truth, not expert consensus on anatomical structures or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided in the document, as the ground truth for phantom testing is typically established by the design of the phantom and measurement techniques, not human 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 MRMC comparative effectiveness study was mentioned. The device, StealthStation S8 Spine Software, is an image-guided surgery system, not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human reader performance. The software aids surgeons in precisely locating anatomical structures.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device's performance was evaluated in terms of its ability to measure positional and trajectory accuracy on phantoms. This can be considered a form of standalone performance assessment as it evaluates the system's inherent accuracy capabilities, albeit in a simulated (phantom) environment, without directly measuring human-in-the-loop clinical workflow improvement. The text refers to "System integration performance testing for spine surgical procedures using anatomical phantoms."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth was established by the design and measurement capabilities of the "anatomically representative phantoms." This type of ground truth is based on precise, engineered physical properties and known measurements of the phantom. It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not provided in the document. The document describes a software update (v1.3.0) to an existing device, and the focus of the 510(k) summary is on performance testing for substantial equivalence, not on the training data used for the algorithm's development.

9. How the ground truth for the training set was established:

This information is not provided in the document. As this document is a 510(k) summary for a software update, details about the original model training and ground truth establishment are typically not included unless significant changes related to the algorithm's core functionality or AI components are introduced which necessitate new data for training or re-training.

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The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.

Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.
Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.

The provided text describes the Medtronic Stealth Autoguide System and Midas Rex Legend Depth Stop System. It includes information on performance testing for the Stealth Autoguide System, but lacks specific details on acceptance criteria and a study to prove the device meets all acceptance criteria in a comprehensive format. It also doesn't contain the requested information about training sets, expert ground truth development, MRMC studies, or standalone performance.

However, based on the provided text, I can extract the following information concerning the performance testing for the Stealth Autoguide System's accuracy:

Acceptance Criteria and Reported Device Performance for Stealth Autoguide™ System

Details of the Accuracy Study:

1. Sample size used for the test set and the data provenance: The document states that performance was determined using "overall end-to-end worst-case system level accuracy testing which incorporated clinically relevant anatomical phantoms." Further specifics about the sample size (e.g., number of phantoms, number of measurement points per phantom) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document. The accuracy testing seems to be based on direct physical measurements against defined targets on phantoms rather than expert interpretation of images.

3. Adjudication method for the test set: This information is not provided. Given the nature of the accuracy testing (physical measurements), traditional adjudication methods for image interpretation would likely not apply.

4. 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: This information is not provided. The assessment described is a technical accuracy validation of the device's navigation and positioning capabilities, not a study involving human readers or AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Stealth Autoguide™ System" is described as a "robotic positioning and guidance system" and the accuracy validation focuses on its "performance in 3D positional accuracy" and "trajectory angle accuracy." This implies standalone technical performance testing of the system's ability to achieve planned trajectories, before a human surgeon uses it to guide instruments. The system is designed to "robotically position and orient instrument holders or tool guides," suggesting its core function is algorithm-driven positioning. However, the evaluation here focuses on the accuracy of the guidance provided, which would then be utilized by a surgeon.

6. The type of ground truth used: The ground truth for the accuracy study was established by defining "clinically relevant anatomical phantoms" and measuring the device's "performance in 3D positional accuracy" and "trajectory angle accuracy" against the known positions and trajectories on these phantoms. This is a phantom-based measurement ground truth.

7. The sample size for the training set: This information is not provided. The document describes an accuracy validation study, not the development or training of an AI algorithm.

8. How the ground truth for the training set was established: This information is not provided, as details about a training set are not included in the document.

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The StealthStation™ System, with StealthStation™ ENT software, is intended as an aid for 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 StealthStation™ ENT software helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The StealthStation™ ENT software runs on the StealthStation™ S8 Platform. The StealthStation system is an Image Guided System (IGS), comprised of a platform, 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.

The ENT software can display patient images from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures can also be displayed. During navigation, the system identifies the tip location and trajectory of the tracked instrument on images and models the user has selected to display. The surgeon may also use the ENT software to 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, real-time positional information obtained through the StealthStation™ System can serve to validate this judgment as well as guide.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the StealthStation™ S8 ENT Software:

Acceptance Criteria and Device Performance

Note: The reported performance metrics meet the acceptance criteria (0.88mm ≤ 2.0mm and 0.73° ≤ 2.0°).

Study Details

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients." The testing involved "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations of all potential system components." The text does not provide a specific numerical sample size for the test set.
   • Data Provenance: The data provenance is from "anatomically representative phantoms" and "laboratory and simulated use settings." It's not human patient data. As such, country of origin is not applicable in the typical sense; the data is generated from simulated environments. This is not retrospective or prospective clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The provided text does not mention the use of human experts to establish ground truth for the test set. The ground truth for positional and trajectory accuracy is inherent in the design and measurement capabilities of the "anatomically representative phantoms" and the testing methodology itself, which would involve precise physical measurements.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. The ground truth was established through physical measurements on phantoms, not through expert consensus requiring adjudication.

4. 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, an MRMC comparative effectiveness study was not done. The device is a navigation system that aids surgeons, and the performance testing focuses on its accuracy rather than its impact on human reader (or surgeon) diagnostic/interpretative performance in a comparative study. Clinical testing "was not considered necessary prior to release as this is not new technology."

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the accuracy testing described (positional error and trajectory error) represents the standalone performance of the algorithm and system, as measured on phantoms. This is the performance of the StealthStation™ S8 ENT Software itself in tracking and displaying anatomical information accurately, independent of direct human judgment during the measurement process.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the performance testing (accuracy) was established through physical measurements and known parameters of "anatomically representative phantoms." The expected or "true" position and trajectory within the phantom were precisely known, allowing for the calculation of measurement errors.

7. The sample size for the training set:

   • Not applicable. The StealthStation™ S8 ENT Software is an Image Guided System (IGS) that relies on tracking and displaying pre-acquired patient images and instrument positions. It is not an AI/ML algorithm that requires a separate "training set" in the traditional sense of machine learning for classification or prediction tasks. Its functionality is based on established engineering principles and algorithms, not a trained model from a specific data set. The document refers to "Software Verification and Validation testing" which implies testing against requirements, not training data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm that predicts or classifies. The software's functionality is deterministic based on its programming and inputs (like imaging data and tracker signals).

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The StealthConnect® System is web-based software to remotely access the StealthStation® Cranial software for viewing, stereotactic surgery planning and collaborating by trained professionals such as physicians, technologists and nurses.

The StealthConnect® system has not been validated for primary diagnostic reading of Digital Imaging and Communications in Medicine (DICOM) images.

The StealthConnect® Remote Viewing, Planning and Collaboration System is an accessory to the StealthStation® System. It provides a web- based client interface to securely access encrypted storage of DICOM-compliant images via a LAN, and/or the internet using general-purpose computers, and by one or more authorized people. It provides for communication, storage, reformating, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI. In addition, the system provides access to the surgical planning aspects of StealthStation® software, and can be used to set or review surgical plans for stereotactic surgeries that are compatible with and can be transferred to a StealthStation® System or any DICOM-compliant PACS system.

StealthConnect® is not to be used for mammography.

The StealthConnect™ System enables web clients on users' computers to interact with a version of the existing StealthStation Cranial planning software that is running on a cloud-based server. The StealthConnect System enables Secure remote access for one or more authorized users simultaneously, with each accessing different patients (multi-user concurrent planning sessions) via the server-based cranial software using a web browser on user-supplied, general-purpose client computers. A safe environment to access, control, and share images on a secure Health Insurance Portability and Accountability Act (HIPAA) and Health Information Technology for Economic and Clinical Health Act (HITECH) compliance-ready infrastructure. Authorization and access control, which is provided by integration with the user facility's Lightweight Directory Access Protocol (LDAP) or Windows Active Directory (AD) credentialing system (single sign on).

The Medtronic StealthConnect Remote Viewing, Planning and Collaboration System is a web-based software designed to remotely access the StealthStation Cranial software for viewing, stereotactic surgery planning, and collaboration by trained professionals.

Here's the breakdown of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to predicate devices rather than defining explicit numerical acceptance criteria for a new clinical performance claim. Instead, the "acceptance" is demonstrated through comparative testing against established predicate performance.

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not specify precise sample sizes (e.g., number of cases or patients) for the "test set" in the context of a typical AI/ML study. The performance testing described suggests a verification and validation approach rather than a large-scale clinical test set.

• Test Set Sample Size: Not explicitly stated as a number of cases or patients. The tests are described as "laboratory and simulated use settings."
• Data Provenance: Not explicitly stated (e.g., country of origin). Given Medtronic's presence and the FDA 510(k) submission, it is highly likely the testing was conducted in the US or under US-equivalent standards. The testing was performed in "laboratory and simulated use settings," implying synthetic or internal data, or potentially clinical data within Medtronic's environment, but not specified. The study is retrospective in nature as it is a verification and validation of a device's performance against pre-established requirements or predicate device performance, not a prospective trial to gather new efficacy data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish a "ground truth" in the typical sense for a diagnostic device. The device is for planning and collaboration, not primary diagnosis. The accuracy and display effectiveness testing would likely have used quantitative measurements or comparisons against the predicate device's output, rather than expert consensus on a diagnostic outcome. For instance, the "Accuracy testing for planning components" would compare the StealthConnect's output (e.g., calculated positional/trajectory error) to the known/expected values or those of the predicate device, not against expert labels of medical conditions.

4. Adjudication Method for the Test Set:

Not applicable. Since there's no mention of expert readers assessing "ground truth" for diagnostic outcomes, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The document describes verification and validation testing, including "Display Effectiveness testing" to show sufficiency for planning, and accuracy testing comparative to the predicate, but not a study to quantify human reader improvement with AI assistance. The device is an accessory for planning and collaboration, not an AI diagnostic tool intended to assist human readers in image interpretation for primary diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, in a way. The "performance testing" described (e.g., "Accuracy testing for planning components" and "Functional testing of the PureWeb component") assessed the device's functional performance independently of human interaction, as it aimed to verify that the software and its components perform as intended. However, the device's overall intended use inherently involves human interaction (professionals using it for viewing, planning, and collaboration). There isn't a direct "standalone diagnostic performance" report as typically seen for AI image analysis algorithms.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance assessment appears to be:

• Predicate Device Performance: For accuracy (e.g., positional and trajectory error) and display effectiveness, the performance was compared to the predicate StealthStation Cranial v 3.0.
• Design Requirements/Specifications: The testing was conducted to ensure the product performs "as intended according to the outlined design requirements."
• Established Industry Standards: Usability testing was conducted in accordance with IEC 62366.
• Functional Equivalence: For components like PureWeb, the "ground truth" was its known functionality as part of the ResolutionMD predicate.

There is no mention of pathology or outcomes data being used for ground truth.

8. The Sample Size for the Training Set:

Not applicable. The document describes a traditional software verification and validation process for a medical device that established substantial equivalence to predicate devices. It does not describe an AI/Machine Learning model that required a "training set." The "PureWeb component" mentioned is a primary component of a predicate device (ResolutionMD), implying it's a developed software part, not an AI model that undergoes training on data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no indication that this device developed or utilized an AI/Machine Learning model that required a training set or associated ground truth labeling.

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