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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.

Ask a specific question about this device

The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or perculaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate. Anatomical structures, such as those in 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.

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

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, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

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

This submission describes updates made to the Imageless Knee Module for the StealthStation to incorporate the AxiEM™ electromagnetic navigation technology.

The provided text is a 510(k) summary for the Medtronic (SNT) StealthStation AxiEM™ Imageless Knee Module. It does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document primarily focuses on the device description, indications for use, and a statement of substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study details (effect size)
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

Ask a specific question about this device

The indications for use for the Imageless Knee Module for the StealthStation® System are identical to the StealthStation® System indications for use. The indications for use are as follows:

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

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 Hiosacral Screws Stabilization and Repair of Pelvic Fractures (Including but not Limited to Acetabular Fractures)

Sinus procedures, such as Maxillary Antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid Explorations, Turbinate Resections, and Frontal Sinusotomies

This submission describes updates made to the StealthStation® System to include software algorithms that enable the establishment of stereotactic coordinates without the use of preoperative or intra-operative image datasets.

This document is a 510(k) premarket notification for a device modification, specifically the "Imageless Knee Module for the StealthStation® System." The document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical trial or performance study would.

Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices. The listed sections primarily cover:

• Manufacturing and Contact Information
• Product Name and Classification
• Date Summary Submitted
• Description of Device Modification: The key change is software algorithms to establish stereotactic coordinates without preoperative or intra-operative image datasets, which was previously required for the predicate device.
• Substantial Equivalence: This section explicitly states, "The Imageless Knee Module for the StealthStation® System was shown to be substantially equivalent to the StealthStation System cleared in previous 510(k)'s. As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This means the manufacturer believes the new software does not raise new questions of safety or effectiveness compared to the predicate.
• Indications for Use: These are identical to the predicate device.

Therefore, based on the provided text, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth, expert qualifications, or MRMC studies. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

If you are looking for this type of information, it would typically be found in a separate performance study report or verification and validation documentation, which is generally not included in the public 510(k) summary provided by the FDA.

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

Spinal Procedures:
Spinal Implant Procedures, such as Pedicle Screw

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

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

This submission allows a surgeon an image guided instrument to place catheter shunts. The Catheter Introducer for the StealthStation® System is technically equivalent to the StealthStation® System. All systems use either active(LED's), passive reflective markers or electromagnetic coils to track surgical instruments in relation to an image guided reference frame. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

The provided text is a 510(k) summary for a Catheter Introducer for the StealthStation® System. It describes the device, its indications for use, and a determination of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific device performance metrics, or details of a study demonstrating fulfillment of such criteria.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with defined acceptance criteria. Therefore, most of the requested information cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided input:

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

• Cannot be provided. The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates) or report detailed device performance metrics from a study against such criteria. The "verification and validation activities" mentioned generally indicate testing was done but no specific results or targets are shared.

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

• Cannot be provided. The document does not describe a clinical study or a test set, hence no sample size, data provenance, or study design (retrospective/prospective) is available.

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)

• Cannot be provided. No information about ground truth establishment or experts involved is present, as no specific test set is detailed.

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

• Cannot be provided. No adjudication method is mentioned, as no test set or expert review process is described.

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

• Cannot be provided. This document is for a surgical navigation system, not an AI diagnostic tool. No MRMC study is mentioned, nor is there any AI component that would involve human readers improving with AI assistance.

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

• Cannot be provided. This device is an instrument for a surgical navigation system, which inherently involves human interaction (a surgeon using the instrument). The concept of "standalone" algorithm performance without human-in-the-loop is not applicable in this context.

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

• Cannot be provided. No ground truth type is mentioned as no specific performance study is detailed.

8. The sample size for the training set

• Cannot be provided. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission. "Verification and validation activities" were performed, but these are typically engineering tests, not machine learning model training.

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

• Cannot be provided. As there is no training set for a machine learning model, this question is not applicable.

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.

The Hip Module for the StealthStation is intended to precisely position instruments and implants in example procedures such as but not limited to:

Orthopedic Procedures:

Minimally Invasive Orthopedic Procedures

Total Hip Replacement (Primary and Revision)

Tumor Resection and Bone/Joint Reconstruction

Placement of Iliosacral Screws

Femoral Revision

Stabilization and Repair of Pelvic Fractures (Including But Not Limited To Acetabular Fractures)

This submission allows a surgeon to utilize a modified version of the FluoroNav™ Software to place hip implants and repair and/or stabilize trauma sustained to the pelvic area. The Hip Module for the StealthStation® System is technically equivalent to the StealthStation® System, and the FluoroNav™ Module for the StealthStation®. All systems use either active or passive infrared markers to track a reference frame attached to the anatomy and to track surgical instruments. This information is correlated to the patient's CT, MR or fluoroscopic images of the anatomy.

This submission, K021980, pertains to the Hip Module Software for the StealthStation® System. The information provided is limited and focuses on establishing substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria for the new module. This is typical for a 510(k) submission where the primary goal is to demonstrate that a new device is as safe and effective as existing legally marketed devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, and expert validation are not explicitly present in the provided document. The document primarily states that "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This is a high-level statement that doesn't provide the granular detail requested.

Here's a breakdown based on the available information and what we can infer:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific, quantitative acceptance criteria and detailed device performance metrics for the Hip Module software itself are not explicitly stated. The document focuses on demonstrating substantial equivalence to predicate devices. This implies that the performance of the Hip Module is considered acceptable if it is comparable to that of the predicate devices.

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

• Sample Size for Test Set: Not explicitly stated.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission focused on equivalence, it's possible that internal testing data (e.g., in-house verification and validation) might have been used, but no details are provided about the nature or origin of this data.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The document mentions "designated individual(s)" performed verification and validation, but their specific qualifications (e.g., surgeon experience, engineering expertise) are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated.

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

• MRMC Study Conducted: Not stated and highly unlikely for this type of 510(k) submission focused on a software module's equivalence. MRMC studies are generally used for assessing the impact of new diagnostic tools on reader performance, which isn't the primary focus here.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no such study is indicated. This device is a navigation aid, not an AI for image interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Conducted: Not explicitly detailed in terms of performance metrics. The submission focuses on device functionality and equivalence within the surgical navigation workflow. It's implied that the software's algorithms function correctly and accurately when used as intended, but no specific "standalone" performance study results (e.g., accuracy of algorithmic calculations against a ground truth without human intervention as a separate study) are provided. The "verification and validation activities" would likely have covered this in a general sense.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not explicitly stated. For a surgical navigation system, ground truth during verification and validation would typically involve:
  • Phantom studies: Using precisely manufactured anatomical phantoms with known fiducial marker locations and instrument paths to assess accuracy.
  • Cadaveric studies: Using cadavers to simulate surgical scenarios and verify instrument accuracy.
  • Technical specifications: Comparing device output to known or expected engineering specifications and tolerances.
    The document only broadly refers to "verification and validation activities," implying these types of methods were used to confirm its function, but without specific details.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable in the context of this document. This is not an AI/machine learning model where a separate training set is typically discussed in this manner. The software is a navigation aid that processes imaging data (CT, MR, fluoroscopy) and tracks instruments. Its functionality is based on established geometric algorithms and image processing, not on learning from a "training set" of cases in the AI sense.

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

• Ground Truth for Training Set Establishment: Not applicable for the reasons stated above.

In summary: The provided document is a 510(k) summary for a software module, primarily focusing on demonstrating substantial equivalence to predicate devices. It does not contain the detailed performance study results, acceptance criteria, sample sizes, or expert validation methods that would be expected for a comprehensive clinical effectiveness or AI algorithm validation study. The statement "all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence" serves as the overarching conclusion regarding its safety and effectiveness.

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.

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, such as pedicle screw procedures

ENT Procedures: Transphenoidal procedures Intranasal procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures

Orthopedic Indications: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

This submission describes updates made to the StealthStation® System to include an optional software package that enables a user to merge a patient's pre-operative dataset with a patient's intra-operative dataset.

The provided text is a 510(k) summary for the StealthStation® with FluoroMerge™ Software. It describes updates to an existing device, focusing on substantial equivalence rather than presenting new clinical study data with specific acceptance criteria and performance metrics against them.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, and adjudication methods cannot be extracted from this document, as it falls outside the scope of a 510(k) summary for a device modification establishing substantial equivalence to a predicate. The document states:

• "As required by risk analysis, all verification and validation activities were performed by designated individual(s) and the results demonstrated substantial equivalence." This implies internal testing was done, but specific details or results are not provided for public review in this summary.
• The focus is on the "Description of Device Modification" and "Substantial Equivalence" to previously cleared StealthStation Systems. This suggests that the primary method of demonstrating safety and effectiveness was by showing that the modified device performs as intended and is no less safe or effective than the predicate.

Without specific performance studies and acceptance criteria detailed in the document, it's impossible to fill out the table and answer the subsequent questions.

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

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:

pedicle screw placement.

Spinal Procedures:

Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty

Spinal implant procedures, such as

This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications.

The provided text is a summary of safety and effectiveness for the Knee Module for the StealthStation® System, focusing on its substantial equivalence to predicate devices rather than a detailed study report with specific acceptance criteria or performance metrics. Therefore, much of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria or detailed performance metrics from a study. It states that "Performance data was provided to support the claim of substantial equivalence," but the data itself is not presented.

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

This information is not available in the provided text.

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)

This information is not available in the provided text.

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

This information is not available in the provided text.

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 is a navigation system for surgery, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC comparative effectiveness study involving human readers with or without AI assistance is not applicable in this context. The document does not mention any studies in this vein.

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

The device is a "Knee Module for the StealthStation® System," described as an "aid for precisely locating anatomical structures in either open or percutaneous procedures." This strongly implies human-in-the-loop performance during surgical navigation. The document does not describe a standalone performance study of an algorithm without human interaction.

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

This information is not available in the provided text. For a surgical navigation system, "ground truth" would typically relate to the accuracy of anatomical localization compared to actual anatomical structures, but the method of establishing this is not detailed here.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

In summary, the provided document focuses on the regulatory submission and FDA's determination of substantial equivalence for the Knee Module for the StealthStation® System. It does not contain the detailed study information regarding acceptance criteria, performance data, sample sizes, or ground truth establishment that would typically be found in a comprehensive clinical study report.

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