Search Results

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.

Spinal Procedures:

Spinal implant procedures, such as pedicle screw placement.

ENT Procedures:

Transphenoidal procedures. Intranasal procedures.

Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies./Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.

Not Found

The provided text is a 510(k) Summary for a device called the StealthStation® System, with a focus on an "Indications Modification." This document describes a change to the intended use of the device rather than a new device or significant technical modification. As such, it relies on previously submitted clinical data and the concept of substantial equivalence, rather than presenting new acceptance criteria or a specific study to prove new performance claims for this particular submission.

Therefore, many of the requested details about acceptance criteria and a new study are not present in this document, as this submission is for an indications modification based on existing data that supported previous clearances.

Here's an analysis based on the provided text, indicating where information is present and where it is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable/provided. This submission is for an indications modification of an existing, cleared device (StealthStation® System). It does not present new performance data or acceptance criteria for a new device or a new performance claim. It relies on the substantial equivalence to previously cleared versions (K954276/K972398/K974187) and the clinical study data originally submitted for K954276.

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

The document states, "A review of clinical study data originally submitted in K954276 was provided to support the claim of substantial equivalence." Since this is a modification to indications for use based on previously submitted data, the details of the sample size and provenance for that original K954276 study are not provided in this specific 510(k) summary.

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

This information is not provided in the current document. It would have been part of the original K954276 submission.

4. Adjudication Method for the Test Set

This information is not provided in the current document. It would have been part of the original K954276 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable/provided. This document focuses on an indications modification based on prior clearance and data. There is no mention of a new MRMC comparative effectiveness study to assess human readers with or without AI assistance. The StealthStation is a navigation system, not an AI-assisted diagnostic tool as typically understood in the context of MRMC studies involving image interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The StealthStation is a surgical navigation system, inherently designed for human-in-the-loop performance during surgical procedures. The concept of a "standalone" algorithm performance as typically applied to AI diagnostics is not relevant here.

7. Type of Ground Truth Used

The document mentions that the system aids in "precisely locating anatomical structures... relative to a CT or MR based model or fluoroscopy images of the anatomy." This implies that the ground truth for the original K954276 study would likely be the actual anatomical structures as confirmed by imaging (CT/MR/Fluoroscopy) or direct surgical observation. However, the specific methodology for establishing ground truth from the original study is not detailed in this summary.

8. Sample Size for the Training Set

Not applicable/provided. The StealthStation is a stereotactic instrument/navigation system. The concept of a "training set" as understood in machine learning for an AI-based diagnostic device is not directly applicable to this type of device based on the information provided. While there would have been internal validation during development, it wouldn't typically be described with a "training set" in the context of a 510(k) for an indications modification of a navigation device.

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

Not applicable/provided for the reasons stated in point 8.

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 fluoroscope images of the anatomy. The StealthStation® System with the ENT option is also indicated for intranasal or sinus use.

This submission describes a modification to the StealthStation® System to provide for image-guided tracking of a motorized instrument placement tool.

This document is a 510(k) premarket notification for the StealthStation® System - NATREX™ Device. It declares substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or an analytical study proving device performance against such criteria. The document focuses on regulatory approval based on demonstrating equivalence, rather than providing a performance study report with the requested details.

Therefore, I cannot provide a table of acceptance criteria and device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information based on the provided text.

The provided text only states:

• The device is a modification to the StealthStation® System to provide image-guided tracking of a motorized instrument placement tool.
• The device was shown to be substantially equivalent to the StealthStation® System with the SNT Image Guided Biopsy Needle and the Compass Stereotactic Positioning System.
• "Performance data was provided to support the claim of substantial equivalence," but these data are not presented in the provided text.

To answer your specific questions, a detailed performance study report would be required, which is not present in this 510(k) submission document.

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 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 Stealth Station™ System is also indicated for intranasal or sinus use.

The Ultrasonic Probe Option provides the user with supplemental real time imaging information to be used to monitor soft tissue locations relative to the CT or MR based model of the anatomy.

This submission describes updates made to the StealthStation™ System to provide for optical tracking of an ultrasonic probe and its associated image plane.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for the StealthStation™ System - Ultrasonic Probe Attachment, which primarily focuses on establishing substantial equivalence to a predicate device.

It lacks details such as:

• Specific acceptance criteria: While it mentions "Performance data was provided to support the claim of substantial equivalence," it doesn't quantify what those criteria were.
• Reported device performance values: No numerical performance metrics are provided.
• Details about the study: There is no description of a study design, sample sizes, data provenance, expert qualifications, or adjudication methods.
• Information on MRMC comparative effectiveness or standalone studies.
• Details about the ground truth or training set for any potential AI/algorithm evaluation.

The document states that the StealthStation™ System - Ultrasonic Probe Attachment was shown to be substantially equivalent to the tracking of general surgical instruments in the original StealthStation™ System. This suggests that the "study" was likely a comparison to the performance of the predicate device, rather than a de novo clinical trial with specific performance metrics against an established ground truth.

Therefore, I cannot generate the table or answer the specific questions based on the provided text.

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. The StealthStation™ System with the ENT option is also indicated for intranasal or sinus use.

This submission describes updates made to the StealthStation™ System to provide the option for providing pre-sterilized passive markers for the StealthStation™ instruments.

This 510(k) submission (K981684) is for "Sterile Passive Markers for the StealthStation™ System" and primarily describes updates to provide pre-sterilized passive markers for the StealthStation™ instruments. It states that the indications for use for the StealthStation™ System have not changed. The submission declares substantial equivalence to the "Passive Marker Option for the StealthStation™ System" cleared in K972398.

Based on the provided text, the document focuses on the regulatory aspects of introducing pre-sterilized markers and does not contain detailed information about a study proving device performance against specific acceptance criteria for the navigation system's overall accuracy or clinical effectiveness.

Therefore, most of the requested information cannot be extracted directly from this document. However, I can still address the relevant points based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document does not specify performance acceptance criteria for the sterile passive markers or the StealthStation™ System concerning, for example, accuracy specifications. It focuses on the substantial equivalence of the new pre-sterilized markers to previously cleared markers.

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

This information is not provided in the given 510(k) summary. The document does not describe a performance study with a test set of data.

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

This information is not provided in the given 510(k) summary. No test set or ground truth establishment process is described.

4. Adjudication method for the test set

This information is not provided in the given 510(k) summary. No test set or adjudication method 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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided 510(k) summary. This document is related to an image-guided surgery system's markers, not an AI-assisted diagnostic or interpretative system that would typically involve human readers.

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

A standalone performance study for an algorithm is not mentioned in the provided 510(k) summary. The device is a surgical navigation system, which inherently involves human interaction, and the submission is about passive markers for this system.

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

This information is not provided in the given 510(k) summary. No ground truth is described as the document does not detail a performance study.

8. The sample size for the training set

This information is not provided in the given 510(k) summary. The document does not describe an algorithm development process that would involve a training set.

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

This information is not provided in the given 510(k) summary. No training set or ground truth establishment is described.

Summary of what the document does provide:

• Device: Sterile Passive Markers for the StealthStation™ System.
• Purpose: To offer pre-sterilized passive markers for the StealthStation™ instruments.
• Indications for Use: The StealthStation™ System is intended as an aid for precisely locating anatomical locations in either open or percutaneous procedures, where a reference to a rigid anatomical structure can be identified relative to a CT or MR based model of the anatomy. The ENT option is also indicated for intranasal or sinus use. These indications are unchanged from the predicate device.
• Predicate Device: Passive Marker Option for the StealthStation™ System (cleared in K972398).
• Basis for Clearance: Substantial equivalence to the predicate device. The 510(k) process for this device relies on demonstrating that the new sterile markers are as safe and effective as the previously cleared non-sterile markers, typically through material biocompatibility, sterility validation, and ensuring unchanged functionality in tracking performance. The document implies that these updated markers maintain the established performance of the StealthStation™ System.

Ask a specific question about this device