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510(k) Data Aggregation
(177 days)
The Stealth AXIS Surgical System, with the Stealth AXIS Cranial clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and 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 Stealth AXIS Cranial clinical application works in conjunction with the Stealth AXIS Surgical System. The Stealth AXIS Cranial clinical application helps guide surgeons during cranial procedures such as biopsies, tumor resections, shunt placements and depth electrode and probe placement. The system tracks the position of instruments in relation to surgical anatomy and identifies this position on diagnostic or intraoperative images of the patient.
Patient images are transferred to the system, and the Stealth AXIS Cranial clinical application displays the image of the patient anatomy from a variety of perspectives (axial, sagittal, coronal, oblique) and 3-dimensional (3D) renderings of anatomical structures. During navigation, the Stealth AXIS Surgical 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 surgery and simulate progression along these trajectories. During surgery, the Stealth AXIS Cranial clinical application can display how the actual instrument tip position and trajectory relate to the pre-surgical plan, helping to guide the surgeon along the planned trajectory.
The provided FDA 510(k) clearance letter and summary for the Stealth AXiS Cranial clinical application offers surprisingly limited detail on the specific acceptance criteria and the study that proves the device meets them, especially concerning the AI/ML components. However, I will extract and infer as much as possible from the provided text to answer your questions.
It's important to note that the clearance letter itself doesn't present the full study details, but rather summarizes the findings that Medtronic provided to the FDA. Many of the specific details you requested (like exact sample sizes for test sets, data provenance, number and qualifications of experts, and adjudication methods for ground truth) are not explicitly stated in this public document. I will highlight what is present and what is missing.
Acceptance Criteria and Device Performance Study for Stealth AXiS Cranial Clinical Application
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on overall system accuracy requirements and general software validation. For the AI-enabled "Autotracts" feature, the acceptance criteria are less formally quantified in the provided text.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| System Accuracy (Non-AI Component) | |
| 3D positional accuracy ≤ 2.0 mm (mean error) | Demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm under representative worst-case configuration. |
| Trajectory angle accuracy ≤ 2.0 degrees (mean error) | Demonstrated performance in trajectory angle accuracy with a mean error ≤ 2.0 degrees under representative worst-case configuration. |
| Software Functionality (General) | |
| Product requirements met, device performs as intended | Software verification and validation testing verified the product requirements are met, and the device performs as intended. |
| Usability for intended users, uses, and use environments | Summative usability validation was performed by representative users. The summative evaluations demonstrated the Stealth AXiS™ Cranial clinical application to be substantially equivalent for the intended user, uses, and use environments. |
| AI-enabled Autotracts Feature Acceptance (Implicit) | |
| Reliability in generating patient-specific white matter tracts | "Performance was assessed leveraging expert review to ensure reliability." (No specific quantitative metrics for reliability are provided in this summary, such as sensitivity, specificity, Dice score, etc., which are common for segmentation or tractography models. It implies expert satisfaction with the output.) |
| User control over tract appearance | "Users retain control by adjusting tract appearance via probability thresholds, manually cropping tracts as needed, and ultimately verifying tracts before proceeding." (This is a design feature enabling user acceptance, rather than a quantifiable performance metric, but important for clinical integration.) |
| Spans normal and pathological cases | "Training and validation used hundreds of images from internal studies and public datasets, spanning normal and pathological cases..." (Implicitly, the model is expected to perform adequately across a variety of patient presentations, though specific performance differences between normal/pathological cases are not detailed.) |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the document for either the general system accuracy or the AI Autotracts feature. The document only mentions "withheld datasets" for validation of the AI model.
- Data Provenance:
- For System Accuracy: "representative worst-case configuration" implies laboratory testing, not patient data in this context.
- For AI Autotracts: "hundreds of images from internal studies and public datasets, spanning normal and pathological cases." The country of origin and whether the data was retrospective or prospective are not specified.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not explicitly stated. The document mentions "expert-reviewed gold standard annotations" for the training/validation of the Autotracts and "expert review" to assess performance.
- Qualifications of Experts: Not explicitly stated. It is implied that these are experts in brain anatomy, neuroimaging, and neuronavigation, but specific qualifications (e.g., "Radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated. For the expert-reviewed ground truth, it is unknown if a single expert provided the ground truth, if consensus was reached among multiple experts (e.g., 2+1, 3+1), or if there was no formal adjudication process described beyond "expert-reviewed."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was explicitly NOT performed. The document states, "No clinical testing was performed." The usability validation was done by "representative users," but this is distinct from a clinical MRMC study designed to measure the effect size of AI assistance on human reader performance.
- Effect Size of AI vs. Without AI Assistance: Since no clinical testing or MRMC study was performed, there is no reported effect size of how much human readers improve with AI vs. without AI assistance in this document.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: For the AI-enabled "Autotracts" feature, the description of "Performance was assessed leveraging expert review to ensure reliability" suggests some form of standalone evaluation against expert-derived ground truth. However, specific quantitative standalone metrics (e.g., sensitivity, Dice coefficient for segmentation, average distance error for tractography) are not provided. The phrase "Users retain control by adjusting tract appearance... and ultimately verifying tracts before proceeding" also highlights that the AI's output is intended for human-in-the-loop verification, not necessarily as a standalone diagnostic or planning output without review.
7. Type of Ground Truth Used
- For System Accuracy: Physical measurements against known standards in a "worst-case configuration."
- For AI Autotracts: "expert-reviewed gold standard annotations" for training and validation, and "expert review" for performance assessment. This implies expert consensus on the definition of white matter tracts based on diffusion MRI images. It does not mention pathology or outcomes data for ground truth for this specific AI feature.
8. Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated. The document mentions "Training and validation used hundreds of images from internal studies and public datasets." It does not separate the exact number for training versus validation.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: The ground truth for the AI Autotracts training set was established through "expert-reviewed gold standard annotations." This indicates that human experts manually identified or delineated the white matter tracts on the diffusion MRI images, and their work was considered the "gold standard" for the AI model to learn from.
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(167 days)
The Stealth AXiS™ Surgical System, with the Stealth AXiS™ ENT clinical application, is intended for precise positioning of surgical instruments and as an aid for locating anatomical structures in open, minimally invasive, and 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 Stealth AXiS ENT Clinical Application works in conjunction with the Stealth AXiS Surgical System, which consists of clinical software, surgical instruments, a referencing system, and platform/computer hardware. The Stealth AXiS™ ENT Clinical Application helps guide surgeons during ENT procedures such as functional endoscopic sinus surgery (FESS), endoscopic skull base procedures, and lateral skull base procedures. The system 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.
N/A
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(135 days)
The Stealth AXiS™ Surgical System is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. The Stealth AXiS™ Surgical System is indicated for medical conditions in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
The Stealth AXiS™ Surgical System is indicated for precise robotic positioning of surgical instruments or implants during orthopedic or neurosurgery. It may be used in open, minimally invasive, and percutaneous procedures.
The Stealth AXiS™ Surgical System, with the Stealth AXiS™ Spine clinical application, is intended for precise positioning of surgical instruments and as an aid for precisely locating anatomical structures in open, minimally invasive, and percutaneous procedures. Their use is indicated for medical conditions 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 procedures in adult patients, such as:
• Interbody device placement
• Pedicle screw placement
• Iliosacral screw placement
This can include the following spinal implant procedure in skeletally mature pediatric (adolescent) patients:
• Pedicle screw placement
The Stealth AXiS™ Surgical System is a computer-assisted surgery system that is composed of a platform, clinical application, surgical instruments, and a referencing system (which includes patient and instrument trackers). The system 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 Stealth AXiS™ Surgical System supports both optical and electromagnetic (EM) localization. Localization is also called navigation.
The Stealth AXiS™ Spine clinical application helps guide surgeons during spine procedures. Patient images can be displayed by the Spine clinical application 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 create and store one or more surgical plan trajectories before surgery and simulate progression along these trajectories. During surgery, the clinical application displays 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 Stealth AXiS™ Surgical System can serve to guide this judgment.
With the addition of the Stealth AXiS™ Autopilot to the Stealth AXiS™ Core, the Stealth AXiS™ Surgical System becomes a robotic-assisted surgery system.
Here's an analysis of the acceptance criteria and study information for the Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application, based on the provided 510(k) clearance letter:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy Requirements (General) | Mean positional error ≤ 2.0 mm Mean trajectory error ≤ 2 degrees |
| AI-enabled Automatic Planning | Provides patient-specific recommendations for pedicle screw placement closely aligned with expert decisions. Clinical users retain full control to review, modify, or override AI-generated plans. |
| AI-enabled Automatic Spine Segmentation | Accurately segments vertebrae from CT and CBCT (O-arm) images. Users review and can modify AI-generated segmentations. Model performance was evaluated by comparing AI-generated segmentations to clinician-reviewed ground truth, ensuring statistical confidence. |
| Hardware Performance | Product requirements are met, and the hardware performs as intended. |
| Software Performance | Product requirements are met, and the device performs as intended. |
| Usability | Summative usability validation demonstrated the system is suitable for the intended user, uses, and use environments. |
| Electrical Emissions & Immunity | Conforms to AAMI ES60601-1:2005/AMD1:2012, AAMI ES60601;1:2005/AMD2:2021 (IEC 60601-1:2005 + AMD1:2012 + AMD2:2020). |
| Electrical, Mechanical, & Thermal Safety | Conforms to IEC 60601-1-2:2014+ A1:2020. |
Study Information
1. Sample sized used for the test set and the data provenance:
- AI-enabled Automatic Planning: Test data was strictly separated from training data by site and included scans stratified by surgical approach and vertebra. Specific sample size is not provided in the document.
- AI-enabled Automatic Spine Segmentation: Test data was separated from training data. Specific sample size is not provided in the document.
- General System Accuracy: "Under representative worst-case configuration..." Specific sample size (e.g., number of measurements, cadavers) and data provenance (e.g., country of origin, retrospective or prospective) are not provided in the document.
- Clinical Testing: A retrospective clinical evaluation of published literature was performed. Specific details on the number of studies or patients are not provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- AI-enabled Automatic Planning: The model compared candidate screw placements to "expert standards" and identified solutions aligned with "expert decisions." These expert placements were from "Surgical Support Technicians." The number of experts or specific qualifications are not explicitly stated beyond "Surgical Support Technicians."
- AI-enabled Automatic Spine Segmentation: Ground truth was "clinician-reviewed." The number of clinicians or their specific qualifications (e.g., radiologist with X years of experience) are not provided.
- General System Accuracy: Not applicable as ground truth for "accuracy" typically refers to physical measurements against a known standard.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- AI-enabled Automatic Planning: Decision-making relies on the AI model identifying solutions similar to "expert decisions," with clinical users having full control to review, modify, or override. This implies an expert review step but does not specify a formal adjudication method like N+1.
- AI-enabled Automatic Spine Segmentation: Ground truth was "clinician-reviewed." This implies review, but a formal adjudication method (e.g., majority vote, consensus) is not specified.
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:
- A formal MRMC comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is not explicitly mentioned for either AI feature. The AI features are described as aids where the human user retains ultimate control. The document focuses on the standalone performance of the AI components and system accuracy rather than direct human performance improvement.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- AI-enabled Automatic Planning: The model outputs screw placement recommendations. While clinical users can modify these, the performance evaluation likely assesses the accuracy of the AI’s initial recommendations against expert standards, suggesting a standalone component to its evaluation.
- AI-enabled Automatic Spine Segmentation: Model performance was evaluated by comparing "AI-generated segmentations to clinician-reviewed ground truth," which indicates a standalone evaluation of the algorithm's segmentation output.
- General System Accuracy: Yes, the "3D positional accuracy" and "trajectory angle accuracy" are standalone performance metrics for the device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- AI-enabled Automatic Planning: "Expert standards" and "expert decisions" from "Surgical Support Technicians." This indicates expert consensus or labeled data from experts.
- AI-enabled Automatic Spine Segmentation: "Clinician-reviewed ground truth." This implies expert review or consensus.
- General System Accuracy: Ground truth for physical accuracy studies is typically established through high-precision metrology or physical measurements against a known standard, often in a lab setting, but not explicitly stated here.
7. The sample size for the training set:
- AI-enabled Automatic Planning: "expert screw placements from Surgical Support Technicians." Specific sample size is not provided.
- AI-enabled Automatic Spine Segmentation: "internal and public datasets." Specific sample size is not provided.
8. How the ground truth for the training set was established:
- AI-enabled Automatic Planning: Ground truth was established from "expert screw placements from Surgical Support Technicians," implying that these technicians provided the optimal screw placements used to train the model.
- AI-enabled Automatic Spine Segmentation: Ground truth was established using "internal and public datasets," with the implication that these datasets contained accurately segmented vertebrae, likely performed by clinicians or experts. The statement "clinician-reviewed ground truth" for validation suggests a similar approach for training data.
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(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
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(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.
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(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.
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(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."
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(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:
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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.
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for the same reason as above.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware medical device.
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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.
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The sample size for the training set: Not applicable. No training set is involved for this hardware device.
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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).
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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)
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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.
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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.
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(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.
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(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.
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