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The StealthStation® System, with StealthStation® Cranial Software, is intended to aid in 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
• 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 user should consult the "Navigational Accuracy" section of the User Manual to assess if the accuracy of the system is suitable for their needs.

The StealthStation® System, with Station® Cranial v3.0 software helps guide surgeons during cranial surgical procedures such as biopsies, tumor resections, and shunt and lead placements. The StealthStation® Cranial v3.0 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 v3.0 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.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size (e.g., number of phantoms, number of trials) used for the performance testing. It mentions using "anatomically representative phantoms" and "a subset of system components and features that represent the worst-case combinations."

The data provenance is from laboratory and simulated use settings, implying prospective testing conducted by Medtronic Navigation, Inc. The country of origin is not explicitly stated, but the company is located in Louisville, Colorado, USA.

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

The document does not mention the use of experts to establish ground truth for the performance validation tests. The "ground truth" for positional and trajectory accuracy in this context would likely be established by precise measurements within the engineered phantoms themselves, not by human experts.

4. Adjudication Method for the Test Set

Not applicable. The performance validation used objective measurements against engineered phantoms, not human assessment 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, an MRMC comparative effectiveness study involving human readers or AI assistance in that context was not performed. This device is an image-guided surgery system, not an AI diagnostic tool that assists human readers in interpreting images. Its function is to provide real-time navigation during surgical procedures based on pre-operative imaging.

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

Yes, the performance validation described is a standalone evaluation of the algorithm and system's accuracy. The tests measured the system's ability to accurately determine 3D positional and trajectory angle, independent of direct human-in-the-loop performance during the measurement process. It's evaluating the mechanical and software accuracy of the navigation system itself.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used was based on engineered phantoms with known anatomical representations and precise target locations. The "ground truth" for accuracy measurements would be the known, precisely defined coordinates and trajectories within these phantoms.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. This implies that the device's accuracy is being verified against its design specifications, likely through a deterministic system or one with pre-calibrated components, rather than a machine learning model that requires a distinct training phase.

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

Not applicable, as a distinct "training set" and associated ground truth establishment for a machine learning model are not described in the context of this device's validation. The device's performance is driven by its inherent design and calibration, not by learning from a training dataset.

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This submission does not change the indications for use for the StealthStation System.

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

For the optical-based and EM-based system, example procedures include, but are not limited to:

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

Orthopaedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

ENT Procedures: Transphenoidal Procedures Intranasal Procedures Orbital Nerve Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary Antrostomies. Ethmoidectornies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Additional example procedures for the optical-based system include, but are not limited to:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Minimally Invasive Orthopaedic Procedures Pediatric Orthopaedics Total Hip Replacement (Primary and Revision) Periacetabular Osteotomies Tumor Resection and Bone/Joint Reconstruction Femoral Revision Placement of Iliosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not limited to Acetabular Fractures)

This submission provides an update to the StealthStation® System, including a new computer hardware and operating system options, a passive-only optical digitizer option, new cranial reference frame and EM reference frame.

I am sorry, but the provided text from K050438, "Summary of Safety and Effectiveness StealthStation® System Update," does not contain the specific details about acceptance criteria, device performance, or human study methodologies that you've requested.

This document primarily focuses on:

• Device Identification: Naming the device, classification, and contact information.
• Device Modification: Describing the updates to the StealthStation® System (new computer hardware, operating system, digitizer options, and reference frames).
• Substantial Equivalence: Stating that the updated system was shown to be substantially equivalent to previously cleared versions and that verification and validation activities were performed.
• Indications for Use: Reiterating the established indications for use for the StealthStation System, which remain unchanged by this update, and listing various cranial, spinal, ENT, and orthopaedic procedures for which it is indicated.
• FDA Correspondence: The FDA's letter confirming the 510(k) clearance and substantial equivalence.

There is no information within this document about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number/qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes for human improvement with AI.
• Standalone algorithm performance studies.
• The type of ground truth used.
• Sample size for the training set or how its ground truth was established.

This document describes a regulatory submission for a device update, asserting substantial equivalence rather than presenting detailed performance study data against specific acceptance criteria.

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The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

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

ENT Procedures:
Transphenoidal Procedures
Intranasal Procedures
Orbital Nerve Decompression Procedures
Optic Nerve Decompression Procedures
Polyposis Procedures
Endoscopic Dacryocystorhinostomy
Encephalocele Procedures
Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw Placement

Orthopedic Procedures:
Total Knee Arthroplasty (Primary and Revision)
Unicompartmental Knee Arthroplasty
Minimally Invasive Orthopedic Procedures
Total Hip Replacement (Primary and Revision)
Tumor Resection and Bone/Joint Reconstruction
Femoral Revision
Placement of Iliosacral Screws
Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

This submission describes updates made to the StealthStation® System to include software algorithms that facilitates a different registration method.

Acceptance Criteria and Study for StealthStation® System Advanced Contour Registration Software Module

Unfortunately, the provided document {0} - {4} does not contain information related to specific acceptance criteria or an explicit study proving the device meets particular performance metrics. The document is a 510(k) summary for the StealthStation® System Advanced Contour Registration Software Module, focusing on its substantial equivalence to a predicate device and its indications for use.

It primarily states: "As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." While this confirms that some form of testing was done, the specifics of those tests, including quantitative acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert involvement, are not detailed in this summary.

Therefore, I cannot populate the requested table and answer many of the questions directly. The information below reflects what can be inferred or is explicitly stated within the provided text, along with the acknowledgement of missing crucial details.

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria or quantitative performance metrics are provided in the document. The document only states that "verification and validation activities were performed... and the results demonstrated substantial equivalence."

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

Not specified in the provided document. The document mentions "verification and validation activities" but does not detail the sample sizes for any test sets used, nor the provenance (country of origin, retrospective/prospective) of any data used for testing.

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

Not specified in the provided document. The document does not mention the use of experts for establishing ground truth or their qualifications.

4. Adjudication method for the test set

Not specified in the provided document. No details are provided regarding any adjudication methods used for a test set.

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

Not specified and highly unlikely for this type of device and submission. The provided document is a 510(k) summary for a software module facilitating a different registration method for a stereotactic navigation system. It does not describe an AI system, nor does it mention any MRMC study comparing human performance with and without the device. The focus is on the device's ability to aid in precise anatomical localization during surgery.

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

Not explicitly described. The device is a "software module" for a "StealthStation® System," described as "an aid for precisely locating anatomical structures in either open or percutaneous procedures." This implies human-in-the-loop use. While the algorithm itself would have been tested in a standalone fashion for its function, the document does not distinguish between standalone algorithm testing and system-level performance. The testing for "substantial equivalence" would have focused on the full system's performance, which is inherently with a human operator.

7. The type of ground truth used

Not specified in the provided document. The document does not provide details on how ground truth was established for any verification or validation activities. For a stereotactic system, common ground truths might involve physical measurements against known phantoms, cadaver studies with implanted markers, or intraoperative imaging correlations, but none are mentioned here.

8. The sample size for the training set

Not applicable/Not specified. The document describes a "software module that facilitates a different registration method" and focuses on "substantial equivalence." There is no indication that this device uses machine learning or requires a "training set" in the modern sense of AI/ML. The "verification and validation activities" would likely involve testing the software's functionality and accuracy, not training an algorithm.

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

Not applicable/Not specified, as no training set is indicated.

Ask a specific question about this device

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System 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, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures: Cranial Biopsies, Tumor Resections, Craniotomies/ Craniectomies, Skull Base procedures, Thalamotomies/Pallidotomies, Pituitary Tumor Removal, CSF Leak Repair

Spinal Procedures: Spinal Implant Procedures, such as Pedicle Screw Placement

ENT Procedures: Transphenoidal Procedures, Intranasal Procedures, Orbital Decompression Procedures, Optic Nerve Decompression Procedures, Polyposis Procedures, Endoscopic Dacryocystorhinostomy, Encephalocele Procedures, Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision), Unicompartmental Knee Arthroplasty

This submission describes updates made to the StealthStation® System to include an interface that enables the StealthStation® System to cohesively communicate with a Three Dimensional C-Arm.

The provided text is a 510(k) summary for the StealthStation® System Three Dimensional C-Arm Interface. It describes a device modification and claims substantial equivalence to previously cleared devices. However, it does not contain any information regarding acceptance criteria, device performance metrics, or any specific study results demonstrating that the device meets defined acceptance criteria.

The document primarily focuses on:

• Identification of the device and manufacturer.
• Contact information.
• Product name and classification.
• Description of the device modification: an interface enabling communication between the StealthStation® System and a Three Dimensional C-Arm.
• Claim of substantial equivalence to previous StealthStation® System devices, stating that "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence."
• Indications for Use, which are identical to the predicate device.
• FDA's clearance letter, confirming substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I populate the table. The provided text lacks the necessary information for these points.

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The StealthStation™ System with the Universal Attachment is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation™ System is also indicated for intranasal or sinus use.

This submission describes a Universal Attachment with infrared markers that allows a StealthStation® System user to image guide rigid surgical instruments.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device met those criteria. It is a 510(k) summary and an FDA clearance letter for a "Universal Attachment for the StealthStation® System."

The submission focuses primarily on demonstrating substantial equivalence to previously cleared devices (the original StealthStation® System and the BrainLAB VectorVision™ System), rather than presenting a performance study with detailed acceptance criteria. Substantial equivalence is a regulatory standard, not a performance metric defined by specific numerical criteria.

Therefore, many of the requested details, such as specific performance metrics, sample sizes, expert qualifications, and adjudication methods for a standalone study, are not present in the provided documents.

Here's an attempt to answer based only on the information provided, with the understanding that much requested information is missing:

Acceptance Criteria and Device Performance Study (Based on Provided Text)

The provided documents describe a 510(k) premarket notification for a "Universal Attachment for the StealthStation® System." The primary "acceptance criteria" discussed implicitly within the context of a 510(k) submission is substantial equivalence to predicate devices. The study conducted to meet this regulatory requirement is a comparison against those predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are not numerical performance targets but rather the regulatory standard of being sufficiently similar in intended use, technology, and performance characteristics to a legally marketed predicate device such that it can be considered equally safe and effective. The "reported device performance" is the statement of substantial equivalence.

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

• Sample Size for the Test Set: Not specified in the provided documents. It is highly likely that comparisons were made based on design specifications, functional testing, and potentially some limited performance data, but specific sample sizes for a "test set" in the context of a clinical or performance study are not mentioned.
• Data Provenance: Not specified. Given the regulatory submission, any data would typically be generated by the manufacturer (Surgical Navigation Technologies). The documents do not specify if it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Given the nature of a 510(k) submission focused on substantial equivalence, the "ground truth" would likely relate to engineering specifications, functional tests, and comparisons to predicate device specifications, rather than a clinical expert consensus on complex diagnostic or interventional outcomes.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. This level of detail is typically not included in a 510(k) summary focused on substantial equivalence where clinical adjudication might not be the primary evaluation method.

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

• MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any evaluation of how human readers improve with AI vs. without AI assistance. The device in question is a surgical navigation attachment, not an AI-powered diagnostic or interpretive tool.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No, there is no mention of a standalone (algorithm only) performance study. The device is a physical attachment for a surgical navigation system, not a standalone algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated, but based on the nature of a 510(k) for a surgical attachment, the "ground truth" for demonstrating substantial equivalence would likely involve:
  • Engineering Specifications: Comparing the design, materials, and mechanical properties to predicate devices.
  • Functional Testing: Verifying the attachment's ability to hold instruments and integrate with the StealthStation® system for image-guided navigation, likely measured against established engineering tolerances and specifications.
  • Performance Metrics (potentially): Could include accuracy, precision, or stability measurements, but these are not detailed.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical attachment and is not described as involving machine learning or algorithms that require a "training set" of data in the typical sense.

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

• Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning algorithm.

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The StealthStation® System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

This submission describes changes made to the StealthStation™ System to include the use of a camera array utilizing two 2-dimensional cameras as an alternative to the originally cleared camera array utilizing three 3-dimensional cameras.

The provided text is a 510(k) summary for a digitizer change to the StealthStation® System, indicating substantial equivalence to a previously cleared device. It does not contain primary study data or explicit acceptance criteria with specific performance metrics as would be found in a detailed clinical or technical study report.

Therefore, many of the requested elements about acceptance criteria, detailed study design, and performance metrics cannot be found in this document.

Here's an analysis based on the available information:

Acceptance Criteria and Device Performance

Based on the provided document, the primary "acceptance criterion" is a demonstration of substantial equivalence to the original StealthStation® System (cleared in K954276) despite a change in the digitizer.

Important Note: The specific performance metrics (e.g., accuracy, precision measurements) that were used to demonstrate substantial equivalence are not detailed in this summary. The summary only states that "Performance data was provided to support the claim of substantial equivalence."

Study Information (Based on available text)

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

   • Not provided. The document states "Performance data was provided," but does not specify any sample sizes, data provenance (e.g., country of origin), or whether the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not provided. This type of information is not typically found in a 510(k) summary focused on hardware changes for an existing device.

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

   • Not provided.

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:

   • Not applicable/Not done (based on the device type and context). The device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers. The change described is a digitizer hardware change.

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

   • Not applicable in the typical sense of "algorithm only." The "device" is a physical system involving hardware (digitizers) and software for surgical navigation. While its performance would be evaluated as a system, the concept of a "standalone algorithm" in the context of AI without human-in-the-loop doesn't directly apply here. The "performance data" mentioned would likely pertain to the accuracy and reliability of the navigation system's output.

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

   • Not explicitly stated in relation to specific "ground truth" establishment. For a surgical navigation system, "ground truth" would typically relate to known physical measurements, phantom studies, or potentially cadaveric studies with precise fiducial markers. The document does not specify the method used for the "performance data."

7. The sample size for the training set:

   • Not applicable/Not provided. This device is a hardware/software system for surgical navigation, not a machine learning model that undergoes a "training set" in the common sense.

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

   • Not applicable/Not provided. (See point 7)

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The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy. The StealthStation System with the ENT option is also indicated for intranasal or sinus use.

This submission describes a revised indications statement for the StealthStation System to provide specifically for the ENT application of intranasal or sinus use.

I'm sorry, but based on the provided text, I cannot extract the detailed information required to fill out the table and answer all the questions about acceptance criteria and a study proving device performance. The document is a 510(k) summary for a revised indication (ENT application) of an existing device, the StealthStation System. It primarily focuses on demonstrating substantial equivalence to the original device.

Here's what I can and cannot infer:

Information I can provide (partially):

• 1. A table of acceptance criteria and the reported device performance: The document states, "The StealthStation System ENT Application was shown to be substantially equivalent to the original StealthStation System. Clinical data was provided to support the claim of substantial equivalence." This is the core "acceptance criteria" (substantial equivalence to a predicate device) and the "reported device performance" (it met this criteria). However, it does not provide specific quantitative performance metrics (like accuracy, precision, sensitivity, specificity, etc.) that would typically be found in an acceptance criteria table alongside numerical results.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is described as "an aid for precisely locating anatomical locations in either open or percutaneous procedures." This strongly implies it's a tool used by a human surgeon. The concept of "standalone" performance without human interaction doesn't directly apply here as it's a surgical navigation system, not an autonomous diagnostic algorithm.
• 7. The type of ground truth used: The system identifies anatomical structures relative to a "CT or MR based model of the anatomy." This strongly suggests the ground truth for positioning would be based on these imaging modalities.

Information I cannot provide from the given text:

• 2. Sample sized used for the test set and the data provenance: The document mentions "clinical data was provided" but does not specify the sample size, number of cases, or the origin (country, retrospective/prospective nature) of this data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is completely absent.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No details on adjudication are provided.
• 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: This type of study is not mentioned, and the device is a navigation system, not a diagnostic AI intended to assist "readers."
• 8. The sample size for the training set: This information is not provided.
• 9. How the ground truth for the training set was established: This information is not provided.

Summary of available information:

Study Details:

• Sample size for the test set & data provenance: Not specified. "Clinical data was provided."
• Number of experts for ground truth & qualifications: Not specified.
• Adjudication method for the test set: Not specified.
• MRMC comparative effectiveness study: Not applicable/not mentioned. This is a surgical navigation aid, not a diagnostic AI for human reader improvement studies.
• Standalone algorithm performance: Not applicable. The device is an aid for human surgeons.
• Type of ground truth used: Likely based on CT or MR imaging models of the anatomy, given the description "reference to a rigid anatomical structure... identified relative to a CT or MR based model of the anatomy."
• Sample size for the training set: Not specified.
• How ground truth for training set was established: Not specified.

Ask a specific question about this device

The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures. The StealthStation™ System is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model of the anatomy.

This submission is an addendum to K954276 which allows the StealthStation™ to track a powered surgical drill. The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276.

The provided text describes an addendum to an existing 510(k) submission (K954276) for the StealthStation™ Drill Attachment (K974161). This addendum aims to allow the StealthStation™ to track a powered surgical drill.

However, the provided text does not contain enough information to answer many of the specific questions regarding acceptance criteria and a study proving device performance in detail. The document is primarily a regulatory approval letter and a summary of safety and effectiveness for a device addendum, not a detailed study report.

Here's what can be extracted and what cannot:

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

Missing Information:

• The specific quantitative metrics for "substantially equivalent" are not provided (e.g., accuracy, precision tolerances). The document only states that it was shown to be substantially equivalent.
• The actual performance values (e.g., "device achieved tracking accuracy of X mm") are not reported.

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

Missing Information: This information is not present in the provided text. The document refers to "the method used to track other optical probes specified in 510(k) No. K954276," suggesting a comparison, but details of that study or any new study for the drill attachment's tracking ability are absent.

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)

Missing Information: This information is not present in the provided text. No mention is made of human experts establishing ground truth for any test.

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

Missing Information: This information is not present in the provided text. No adjudication method is mentioned, as the nature of the "study" is unclear and focused on technical tracking rather than diagnostic or interpretative tasks.

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

Missing Information: This information is not present in the provided text. The device is a surgical navigation system component, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device's function as described.

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

Likely Applicable Based on Context: Yes, the essence of the "study" mentioned for the StealthStation™ Drill Attachment is a standalone evaluation of its tracking capabilities. The text states: "The StealthStation™ Drill Attachment's ability to track a drill bit of known length was shown to be substantially equivalent to the method used to track other optical probes specified in 510(k) No. K954276." This implies a technical performance evaluation of the device itself, independent of a human-in-the-loop scenario.

Missing Information: Specific details of how this standalone performance was measured (e.g., the test setup, measurement equipment, environmental conditions) are not provided.

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

Inferred Ground Truth: For tracking a drill bit of known length, the ground truth would likely be the known physical length of the drill bit and its true spatial position/orientation as measured by a highly accurate external reference system (e.g., a precision optical tracker, coordinate measuring machine) during the test.

Missing Information: Specifics on how this ground truth was established or measured are not provided.

8. The sample size for the training set

Not Applicable/Missing Information: This device involves a tracking system, not a machine learning or AI model in the modern sense that typically requires a separate training set. Even if there were internal calibration/configuration processes, they wouldn't be referred to as a "training set" in the context of an AI/ML device.

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

Not Applicable/Missing Information: As above, a "training set" as understood for AI/ML is not applicable here.

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Not Found

This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission.

This document is a 510(k) summary for the StealthStation™ System Sterilization, which describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System.

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, clinical outcomes, or AI/algorithm performance. It primarily focuses on the sterilization validation of a medical device.

Therefore, I cannot provide the requested information in the table or answer the specific questions related to acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.

The only relevant information from the provided text is:

• Study type: Sterilization validation.
• Standard followed: AAMI TIR No. 12-1994, "Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers."
• Validation performed by: An independent laboratory.

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