Search Results
Found 54 results
510(k) Data Aggregation
(176 days)
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.
N/A
Ask a specific question about this device
(290 days)
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:
- 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:
- 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.
- 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).
- 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.
- Adjudication method for the test set: Not applicable for mechanical/functional testing.
- 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.
- Stand-alone (algorithm only) performance: Not applicable; this is not an algorithm for diagnosis or image analysis.
- 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.
- Sample size for the training set: Not applicable; there is no "training set" as this is not a machine learning model.
- 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.
Ask a specific question about this device
(108 days)
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:
| Acceptance Criteria | Reported Device Performance (StealthStation Cranial Software Version 3.1.5) | Predicate Device Performance (StealthStation Cranial Software Version 3.1.4) |
|---|---|---|
| 3D Positional Accuracy (Mean Error) ≤ 2.0 mm | 0.824 mm | 1.27 mm |
| Trajectory Angle Accuracy (Mean Error) ≤ 2.0 degrees | 0.615 degrees | 1.02 degrees |
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.
Ask a specific question about this device
(27 days)
The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are available partially and fully threaded and are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The partially threaded screws are headed. The fully threaded and headless. The system provides accessory instruments designed for preparation of the and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile for single use. The instruments are provided non-sterile, reusable or single be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets. Sterile instruments are for single use only.
This document describes the 510(k) summary for the StealthFix Intraosseous Fixation System. It outlines the device, its intended use, and its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to a legally marketed predicate device (K220181). This typically means showing that the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Equivalence | Subject device screw implants and instruments have no change in materials compared to the predicate device. All screw implants are manufactured from Ti-6Al-4V alloy conforming to ASTM F136. Instruments are manufactured using Stainless Steel in conformance with ASTM F899. |
| Design Equivalence | Subject device staple implants are identical in design to the predicate device. |
| Intended Use/Indications for Use Equivalence | The subject device has the same intended use and Indications for Use as the predicate cleared under K220181. |
| Operating Principles Equivalence | The subject device uses the same operating principles as the predicate device. |
| Biocompatibility/Safety (Endotoxin) | Endotoxin testing was performed (LAL method, AAMI ST72, USP 161, USP 85) and results met the Endotoxin limit of ≤20 EU per device. |
| Mechanical Strength (Screws) | An engineering analysis was performed to compare the subject and predicate screws to demonstrate that the new screws do not create a new worst-case for screw mechanical strength (cross-sectional area) or screw fixation (thread substrate interface area). |
| Functionality/Usability | Device usability was evaluated through cadaveric testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of clinical or performance data for a diagnostic device. The evaluation primarily relied on engineering analysis, materials comparison, and cadaveric testing.
- Data Provenance:
- Engineering Analysis: Based on design comparisons and calculations.
- Cadaveric Testing: Implied to be prospective testing carried out for usability evaluation.
- Endotoxin Testing: Laboratory testing on device samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the context of this 510(k) summary, as it does not involve a diagnostic algorithm requiring expert-established ground truth on a test set. The assessment is based on physical and engineering properties, and direct comparison to a predicate device.
- Qualifications of Experts: Not specified or relevant for this type of submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation is not based on interpreting results from a test set that requires expert 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
- MRMC Study: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device (intraosseous fixation system), not a diagnostic artificial intelligence (AI) device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Type of Ground Truth: The "ground truth" in this context is established through:
- Material Specifications: Conformance to ASTM standards for Ti-6Al-4V alloy and Stainless Steel.
- Design Documentation: Verification of identical staple designs and comparison of screw designs to the predicate device.
- Engineering Principles: Analysis demonstrating mechanical equivalence or non-inferiority of new screw designs.
- Performance Standards: Meeting endotoxin limits.
- Functional Assessment: Cadaveric testing for usability.
- Predicate Device Performance: The safety and effectiveness of the predicate device (K220181) serves as the benchmark.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable. This device does not involve a "training set."
Ask a specific question about this device
(60 days)
The StealthFix Intraosseous Fixation System is indicated for fixation of bone fractures, fusions, or for bone reconstructions, including:
- · Arthrodesis in hand or foot surgery
- · Mono or bi-cortical osteotomies in the foot or hand
- · Fracture management in the foot or hand
- · Distal or proximal metatarsal or metacarpal osteotomies
- · Fixation of osteotomies for Hallux Valgus treatment such as scarf, chevron, etc.
The StealthFix Intraosseous Fixation System is an orthopedic intraosseous staple system consisting of staple and screw implants. The staples consist of two legs or posts connected by a bridge. The staples are available in post diameters of 2.5mm(mini), 3.5mm(small) and 4.5mm(standard). The 2.5mm staples are provided with a bridge span of 10mm and range in post length from 8mm to 12mm. The 3.5mm staples are provided with a bridge span of 15mm and range in post length from 14mm to 20mm. The 4.5mm staples are available in bridge spans of 15mm and 20mm and range in post length from 14mm to 32mm. The system provides crossing screws for optional fixation with the standard staple implants. Standard staples are designed with a screw slot to accept a crossing screw. The screws are 3.5mm in diameter with lengths ranging from 16mm to 38mm in 2mm increments. The system provides accessory instruments designed for preparation of the implant site and insertion of implants into bone, including implant specific inserters and targeting arms. The implants of the system are available packaged both sterile and non-sterile for single use. The instruments are provided non-sterile, reusable or non-sterile, single use and must be cleaned and sterilized by the end user prior to use. The system also provides some instruments sterile packaged, individually and in sets.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "StealthFix Intraosseous Fixation System." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/software device.
Therefore, many of the requested categories related to AI/software performance studies are not applicable to this type of regulatory submission. This document describes a traditional hardware medical device.
Here's the breakdown based on the provided information, with explanations for why certain sections are not applicable:
-
Table of Acceptance Criteria and Reported Device Performance: This document does not provide specific quantitative acceptance criteria or device performance metrics in the way an AI/software device would (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating equivalence through material, design, and mechanical properties.
Acceptance Criteria Category Specific Criteria (Not explicitly stated as quantitative values for a software device) Reported Device Performance Biocompatibility Endotoxin limit ≤ 20 EU per device Met the Endotoxin limit Mechanical Properties Not creating a new worst-case for: Engineering analysis performed; modified staples/screws do not create a new worst case for these tests. - Static and dynamic 4-point bend testing (staples) - Pullout force (staples) (ASTM F564) - Torsional strength (screws) (ASTM F543) - Pullout strength (screws) (ASTM F543) - Insertion performance (screws) (ASTM F543) Substantial Equivalence Equivalence in intended use, indications, material, design, sizes, mechanical properties to predicate device. Achieved; differences do not raise new safety/effectiveness questions. -
Sample sizes used for the test set and the data provenance: Not applicable. This is a hardware device. The "tests" mentioned were engineering analyses and biocompatibility testing, not clinical studies with patient data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set with ground truth established by experts is described for this hardware device submission.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reason as above.
-
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: Not applicable. This device is an orthopedic fixation system, not an AI/software diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance relies on engineering principles and biocompatibility standards, not clinical outcomes or expert consensus on diagnostic interpretations.
-
The sample size for the training set: Not applicable. No training set is involved for this hardware device.
-
How the ground truth for the training set was established: Not applicable. No training set or associated ground truth.
Study Proving the Device Meets Acceptance Criteria (as described in this 510(k) submission):
The primary "study" that proves this device meets the regulatory acceptance criteria for 510(k) clearance is a demonstration of Substantial Equivalence to a legally marketed predicate device (K163440 - Stealth Staple System, First Ray LLC).
-
Non-Clinical Testing:
- Biocompatibility: Endotoxin testing was performed using the Limulus Amebocyte Lysate (LAL) method according to AAMI ST72, USP 161, and USP 85. The results met the endotoxin limit of ≤20 EU per device.
- Mechanical Performance: An engineering analysis was conducted. This analysis ensured that modifications made to the subject device (increased internal thread length in staple posts, non-cannulated screws) did not create a new worst-case scenario for several mechanical tests that would typically be performed on such devices. These tests include:
- Static and dynamic 4-point bend testing (for staples)
- Pullout force (for staples, according to ASTM F564)
- Torsional strength (for screws, according to ASTM F543)
- Pullout strength (for screws, according to ASTM F543)
- Insertion performance (for screws, according to ASTM F543)
-
Clinical Testing: The submission explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the StealthFix Intraosseous Fixation System to the predicate device." This is a common aspect of 510(k) submissions where non-clinical data is deemed sufficient to establish equivalence.
-
Conclusion: The submission concludes that "The StealthFix Intraosseous Fixation System is substantially equivalent to the predicate devices regarding its intended use, material, design, sizes, and mechanical properties. Differences between the subject device system and the predicate device systems do not raise different types of safety and effectiveness questions." This statement is the ultimate proof that the device, for the purposes of this FDA submission, "meets the acceptance criteria" of being substantially equivalent to a predicate.
Ask a specific question about this device
(142 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 v2.0 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 white matter tractography (WMT) fiber tract creation for the brain referred to as diffusion Magnetic Resonance Imaging (dMRI) tractography. dMRI tractography will process diffusion-weighted MRI data into 3D fiber tract models that represent whitematter tracts. This will be marketed as a software option called Stealth™ Tractography.
- Addition of the Medtronic SenSight™ directional DBS lead to the existing list of view overlays.
- Minor changes to the software were made to address user preferences and to fix minor anomalies.
The provided text describes the performance testing and acceptance criteria for the Medtronic Navigation StealthStation S8 Cranial v2.0 software, particularly focusing on the new white matter tractography (WMT) feature.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Measure) | Threshold / Target | Reported Device Performance |
|---|---|---|
| System Accuracy (3D positional accuracy) | Mean error ≤ 2.0 mm | Mean error ≤ 2.0 mm |
| System Accuracy (Trajectory angle accuracy) | Mean error ≤ 2.0 degrees | Mean error ≤ 2.0 degrees |
| Software Functionality (dMRI tractography) | Correct creation and rendering of dMRI tracts in views and functionality of dMRI tractography feature requirements. | Performance testing demonstrated the design and implementation of the correct creation and rendering of dMRI tracts in views in the application and the functionality of the dMRI tractography feature requirements. |
| Usability (Summative Validation) | Safe and effective for intended users, uses, and use environments. | Summative evaluations demonstrated StealthStation™ Cranial Software v2.0 with Stealth™ Tractography has been found to be safe and effective for the intended users, uses and use environments. |
| Clinical Expert Evaluation (White Matter Tracts) | Assessment of rendering of white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation, and potential to aid clinical decision making. | Clinical experts assessed the rendering of the white matter tracts and their relationship to other key structures with respect to treatment planning, intraoperative navigation and the potential to aid clinical decision making. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the "datasets" used in summative usability validation and clinical expert evaluation. It states "datasets not used for development, composed of normal and abnormal brains in both pediatric and adult populations."
- Data Provenance: Not explicitly stated, but the mention of "datasets not used for development" suggests a separate, possibly curated, test set. There is no information on the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: The document refers to "clinical experts" (plural) but does not specify the exact number.
- Qualifications of Experts: Not explicitly stated (e.g., "radiologist with 10 years of experience"). It only identifies them as "representative users" and "clinical experts."
4. Adjudication method for the test set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that "Clinical expert evaluations included white matter tract generation and editing," implying direct assessment by these experts.
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 is mentioned. The study focuses on the device's performance and validation through usability and clinical expert evaluation of the tractography feature, not on human reader performance improvement with AI assistance. The device functions as an aid for locating anatomical structures and displays information; it doesn't appear to be an AI that assists human interpretation in a comparative effectiveness sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance test was done for the "System Accuracy" related to 3D positional accuracy and trajectory angle accuracy. This 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." This implies assessment of the system's ability to achieve these accuracy metrics independently of human interaction during the measurement. The "correct creation and rendering of dMRI tracts" also implies an algorithm-only assessment of the output.
7. The type of ground truth used:
- For System Accuracy (Positional and Trajectory): "Anatomically representative phantoms" were used. The ground truth would be the known, precisely measured dimensions and positions within these phantoms.
- For Software Functionality (dMRI tractography): The ground truth appears to be based on whether the software correctly creates and renders the dMRI tracts as per established specifications and expectations, as assessed by performance testing. Clinical experts further evaluated the quality and clinical utility of these rendered tracts in relation to other structures.
- For Usability and Clinical Expert Evaluation: The ground truth is effectively the consensus or expert judgment of the "representative users" and "clinical experts" regarding the safety, effectiveness, and clinical utility of the software and its new tractography feature. This is a form of expert consensus or clinical judgment. No mention of pathology or outcomes data for establishing ground truth is made in this context.
8. The sample size for the training set:
- The document does not provide any information about a training set since this is a regulatory submission for a software device, not an AI model that requires a distinct training phase. The new feature, dMRI tractography, processes diffusion-weighted MRI data into 3D fiber models. While the underlying algorithms would have been developed and "trained" (in a broader development sense), this document does not refer to a dedicated "training set" in the context of the device's clearance.
9. How the ground truth for the training set was established:
- Not applicable, as a "training set" distinct for an AI model is not described in this regulatory submission. The development and verification of the tractography algorithms would have involved internal processes and known physics/mathematics of dMRI data processing.
Ask a specific question about this device
(59 days)
The navigated instruments are specifically designed for use with the StealthStation™ 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 a skull, a long bone, or vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
When used with a Medtronic StealthStation™ Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery.
The Spinous Process Clamps are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The subject devices are designed for use with the StealthStation™ System and are intended to be reusable.
The provided text describes a 510(k) premarket notification for a medical device, the StealthStation™ Spinous Process Clamps. This document outlines the device's characteristics, intended use, and a comparison to a predicate device, along with a summary of performance testing.
However, the document does not describe an AI/ML-driven device or a study involving "human readers" improving with "AI vs without AI assistance." It pertains to a physical stereotaxic instrument used in spinal surgery for rigid attachment to a patient's anatomy for navigation.
Therefore, many of the specifics requested in your prompt (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for AI, training set details) are not applicable to this type of medical device submission.
The document discusses performance testing relevant to a mechanical device, such as functional verification, useful life testing, navigation accuracy testing, and packaging verification, as well as biological endpoint testing. These tests are to ensure the device's safety and effectiveness as a physical surgical tool and reference system, not as an AI diagnostic or assistive tool.
To answer your prompt, I will extract the information that is present and explicitly state when information is not applicable given the nature of the device.
Acceptance Criteria and Device Performance for Medtronic StealthStation™ Spinous Process Clamps
The device in question, the StealthStation™ Spinous Process Clamps, is a physical stereotaxic instrument, not an AI/ML-driven device. Therefore, the "acceptance criteria" and "study" described in the provided text relate to the mechanical and biological performance of this instrument, not to the performance of an AI algorithm or its impact on human reader performance.
The "studies" are performance tests designed to demonstrate the device's substantial equivalence to a predicate device and its safety and effectiveness for its intended use as a surgical instrument.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics like those typically seen for AI/ML device validations (e.g., sensitivity, specificity, AUC thresholds). Instead, the performance testing described is qualitative or refers to compliance with established standards for mechanical and biological safety.
| Category | Acceptance Criteria (Implied / Stated Objective) | Reported Device Performance (Summary) |
|---|---|---|
| Functional | Device satisfies functional requirements. | Functional Verification confirms the design satisfies functional requirements. |
| Useful Life | Device operates normally throughout its useful life. | Useful Life Testing confirms normal operation throughout its useful life. |
| Navigational Accuracy | Robustness and navigational accuracy are verified. | Navigation Accuracy Testing verifies robustness and navigational accuracy. |
| Packaging Integrity | Device can withstand ship testing per ASTM D4169 and ISTA 2A. | Packaging Verification confirms packaging withstands ship testing per ASTM D4169 and ISTA 2A. |
| Biocompatibility | Non-cytotoxic, non-sensitizing, non-irritating, non-toxic, non-pyrogenic; negligible risk of adverse biological effects to patients. | Biological endpoint testing (per ISO 10993-1:2018) indicates non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-pyrogenic. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data or algorithm testing. The performance testing likely involved a limited number of physical devices (e.g., clamps) for mechanical and biological evaluations. This is not a data-driven AI model.
- Data Provenance: Not applicable. The "data" comes from physical testing of the device, not from patient medical records or imaging scans. The testing would have occurred in a laboratory or manufacturing environment.
- Retrospective/Prospective: Not applicable. The testing is a controlled, experimental assessment of the device's physical properties and performance, not a study on historical or future patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This section is relevant for AI/ML applications where expert labeling is used to create ground truth for image classification, segmentation, etc. For a mechanical device, "ground truth" relates to engineering specifications, physical measurements, and compliance with industry standards, which are evaluated by engineers and technical specialists, not typically "experts" in the context of medical image interpretation.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used in studies involving human interpretation of complex medical data, especially for establishing ground truth in AI model development. This device's testing involves objective engineering and biological assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is specific to evaluating the impact of an AI algorithm on human reader performance, usually in diagnostics. This device is a physical surgical instrument, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, not applicable. This concept pertains to the performance of an AI algorithm by itself. The StealthStation™ Spinous Process Clamps are physical devices that are used with a navigation system and by a human surgeon. Their performance is inherently related to their physical interaction and functionality for surgical navigation.
7. The Type of Ground Truth Used
- Engineering Specifications and Standardized Test Methods: For functional verification, useful life, packaging, and navigational accuracy, the "ground truth" would be the pre-defined engineering specifications, design requirements, and objective measurements obtained using established test methodologies (e.g., ASTM, ISTA, internal quality standards).
- ISO 10993-1:2018 Standards: For biocompatibility, the ground truth is established by the accepted biological safety endpoints and testing protocols outlined in the ISO 10993 series of standards.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.
Ask a specific question about this device
(30 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 v1.3.2 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:
| Criteria/Feature | Acceptance Criteria (based on Predicate Device K201175) | Reported Device Performance (StealthStation™ Cranial Software v1.3.2) |
|---|---|---|
| System Accuracy | Mean 3D positional error ≤ 2.0 mm | Identical; no changes made to the StealthStation™ Cranial Software that would require System Accuracy testing for v1.3.2 |
| Mean trajectory angle accuracy ≤ 2.0 degrees | ||
| All other features | Functions and performs as described for the predicate device. | All other features are identical to the predicate device. |
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.
Ask a specific question about this device
(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.
Ask a specific question about this device
(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.
Ask a specific question about this device
Page 1 of 6