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The RadioCameras™ Biteblock System Head/Neck Application is indicated for use with a photon linear accelerator to perform Stereotactic Radiosurgery or Radiotherapy on head and neck theraputic targets that lie outside the cranium. It provides precise positioning of the treatment target at the Linear Accelerator's isocenter.

This submission describes a system that is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures on head and neck lesions outside the cranium. The RadioCameras™ Head/Neck Application uses fiducial markers on a biteblock to localize the treatment site on CT or MR scans and optical tracking of infrared markers on the biteblock as the method of locating the position of the treatment isocenter relative to the LINAC isocenter. The RadioCameras™ Biteblock System Head/Neck Application consists of a high resolution linear CCD camera array, computer workstation, a biteblock optical positioner, and an optical calibration jig.

The provided text is a 510(k) summary for the RadioCameras™ System Head/Neck Application and a clearance letter from the FDA. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. The document primarily focuses on regulatory classification, indications for use, and substantial equivalence to predicate devices, without detailing the technical validation studies performed.

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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.

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.

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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.

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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 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.

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The METRx™ Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the search and removal of nucleus material. It is intended for use in the lumbar spine. The endoscope is also indicated for use in the knee, shoulder, wrist and temporomandibular joint (TMJ).

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This 510(k) submission (K993021) is for an "Indications Modification" for the METRx™ Endoscope. It seeks to expand the existing indications for use to include the cervical spine. However, the provided documents do not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary (Document 0) states that this submission describes "a change to the indications for use and minor design changes" and that it "describes a modification to the METRx™ System indications for use to provide for use of the endoscope in the cervical spine."

However, the "Indications For Use" provided in Document 3 only lists the existing indications for the lumbar spine, knee, shoulder, wrist, and temporomandibular joint (TMJ), and does not include the cervical spine. This suggests that the proposed expansion to the cervical spine either did not require a new study because it was deemed substantially equivalent based on existing data or was not approved as part of this 510(k).

Therefore, I cannot provide the requested information as it is not present in the provided text. The document primarily focuses on the administrative process of the 510(k) clearance and notification from the FDA.

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The Image Analysis System is intended to provide a method of storing and providing remote viewing and analyzing access to diagnostic images via a LAN, the internet, or a modem. The system is also intended to provide the display of segmented anatomical structures based on the correlation of the image sets to atlas information. Examples of structures that may be segmented include but are not limited to: vertebral bodies, prostate, hippocampus, and the basal ganglia.

This submission describes a system to display, transfer, store, analyze and process patient image sets. The processing of image data includes the ability to segment anatomical structures.

This is a 510(k) summary for the "Image Analysis System" and does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided documents are primarily for regulatory clearance based on substantial equivalence to predicate devices, rather than a performance study report.

Therefore, I cannot fulfill your request with the information provided. The document states that "The substantial equivalence was established by comparison of functions and features" with predicate devices, but it does not describe a performance study with acceptance criteria, sample sizes, or ground truth establishment.

To answer your questions accurately, a different type of document, such as a validation study report or a more detailed technical submission, would be required.

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The ImMerge Image Correlation Software Version 2.0 is intended to provide precise spatial registration of two image sets for the purpose of enhancing the imaging information presented to a physician. The resulting image sets can then be used for diagnosis and planning treatments such as image guided surgery, stereotactic radiosurgery, or radiotherapy.

image correlation system

This 510(k) summary does not contain the typical level of detail required to thoroughly describe the acceptance criteria and the study proving the device meets them. This document is a very high-level summary that primarily focuses on demonstrating substantial equivalence to a predicate device.

However, based on the provided text, here's what can be extracted and what information is missing:

Acceptance Criteria and Study Details (Based on K991468 510(k) Summary)

The provided 510(k) summary for the ImMerge™ Image Correlation System Version 2.0 is highly condensed and focuses on demonstrating substantial equivalence to a predicate device (ImMerge V1.0, K970623). As such, it does not explicitly state specific quantitative acceptance criteria or detailed study results for device performance. The primary "proof" of meeting criteria in this type of submission is the demonstration that the modified device performs "the same as or similar to" the predicate device for its intended use.

Here's a breakdown of the requested information, indicating what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

• Missing Information: Specific quantitative metrics for "precise spatial registration" (e.g., target registration error, spatial accuracy thresholds) are not provided. There are no performance results like sensitivity, specificity, accuracy, or specific error rates.

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Missing Information: The number of cases, images, or subjects used to evaluate the automatic image correlation feature are not mentioned.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Missing Information: There is no mention of experts being involved in establishing a ground truth for any test set or how their qualifications were assessed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.
• Missing Information: Given the lack of a defined test set and experts, no adjudication method is described.

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

• MRMC Study Done: No, this type of study is not mentioned or described in the summary.
• Effect Size (AI vs. without AI): Not applicable, as no MRMC study is reported.
• Missing Information: MRMC studies are generally more recent requirements or for devices with a higher potential impact on interpretation. This older 510(k) summary is unlikely to include such a study.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study Done: Not explicitly stated as a separate, formal "standalone" study with specific metrics. However, the update is to provide an "automatic first attempt at image correlation," implying the algorithm's standalone function is what was modified and likely tested. The overall 510(k) process for this device type typically involves verifying that the algorithm itself performs as intended without human intervention for the automated task.
• Missing Information: While the function is "automatic," specific quantitative results or a dedicated standalone performance study with detailed metrics are not provided.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. For image correlation systems, ground truth often involves fiducial markers in phantoms, manually registered images by experts, or known anatomical landmarks.
• Missing Information: The method for establishing the true, correct registration is not described.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not specified.
• Missing Information: This 510(k) predates the common emphasis on deep learning and large-scale training sets for medical devices. If machine learning was used at all (unlikely for "V2.0" in 1999 to the extent seen today), the size of any training data would not typically be disclosed in such a summary from that era.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set: Not specified.
• Missing Information: Similar to point 8, this detail would not typically be found in a 510(k) summary from 1999, especially without explicit mention of machine learning.

Summary of the Document's Information:

The 510(k) summary for the ImMerge™ Image Correlation System Version 2.0 serves to demonstrate substantial equivalence to an earlier version (V1.0, K970623). The "study" referenced implicitly is the comparative analysis showing that the updated device, with its new "automatic first attempt at image correlation" feature, maintains the same or similar technological characteristics and performs comparably to the predicate device for its intended use of precise spatial registration for diagnosis and treatment planning. The document lacks specific quantitative performance data, sample sizes, expert involvement details, or ground truth methodologies that are common in more recent and detailed clinical study reports.

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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. 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 surgery based on a fluoroscopy based model of the anatomy.

The provided text for K990214, the "StealthStation® System - FluoroNav™ Module," is a 510(k) summary and FDA clearance letter. It states:

• "The StealthStation® System with the FluoroNav™ Module was shown to be substantially equivalent to the original StealthStation® System."
• "Performance data was provided to support the claim of substantial equivalence."

However, the provided document does not include the specific acceptance criteria, detailed results of performance studies, or information regarding sample sizes, ground truth establishment, or expert involvement.

In a 510(k) submission, the "Summary of Safety and Effectiveness" usually provides a high-level overview. Detailed performance data, acceptance criteria, and study methodologies (including statistical methods, sample sizes, ground truth, etc.) are typically found in the full 510(k) submission not included in this document.

Therefore,Based on the provided text, I cannot complete your request. The document only states that performance data was provided to support substantial equivalence but does not detail the acceptance criteria, the study itself, or its results.

To fulfill your request, I would need access to the detailed performance study report that was submitted as part of the K990214 510(k) application.

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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 StealthSERVER™ Image Storage and Communication System is used to store and provide remote viewing access to diagnostic images via a LAN, the internet or modem. In addition, the system can be used to remotely set surgical plans for stereotactic surgery that are compatible with and can be accessed by the StealthStation® Treatment Guidance Platform.

This submission describes a network server system that provides remote access to digital image sets for the purpose of reviewing the images and, optionally, for developing and storing a stereotactic surgical plan that is compatible with the StealthStation® Image Guided Treatment Platform. The submission includes the capability of the StealthStation® System to retrieve the surgical plans and image sets from the network server.

This 510(k) submission for the StealthSERVER™ Image Storage and Communication System does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.

The provided document is a summary and an FDA clearance letter, which focuses on:

• Device identification: StealthSERVER™ Image Storage and Communication System.
• Intended Use: Storing and providing remote viewing access to diagnostic images, and remotely setting surgical plans compatible with the StealthStation® Treatment Guidance Platform.
• Substantial Equivalence: Stating that the device was shown to be substantially equivalent to other commercially available medical image storage, review, and communication systems. The FDA clearance letter confirms this finding.

There is no mention of the following in the provided text:

• A table of acceptance criteria or reported device performance.
• Details about a study, including sample sizes, data provenance, ground truth establishment, or expert involvement.
• MRMC comparative effectiveness studies or standalone performance.

Therefore, I cannot provide the requested information based on the given input.

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