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The SNN System is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN System is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.

The SNN Fluoro Navigation Module is also indicated for situations where reference to a rigid anatomical structure such as the skull, a long bone or vertebra can be identified relative to a fluoroscopic image of the anatomy.

The SNN Fluoro Navigation System is a module of the SNN System to provide image-guided surgery based on an intra-operative fluoroscopic image of the patient anatomy.

The provided document describes the SNN Fluoro Navigation System (K993673), an image-guided surgical system that uses intra-operative fluoroscopic images for localization and navigation.

Unfortunately, the document does not contain any information regarding acceptance criteria, study details, performance data, or ground truth establishment.

The document primarily consists of:

• 510(k) Summary: This section provides a brief description of the device, its intended use, a comparison to predicate devices, and contact information for the submitter.
• FDA Clearance Letter: This letter from the FDA confirms the device's substantial equivalence to previously marketed devices and grants permission to market it.
• Indications for Use: This section outlines the medical conditions and scenarios for which the device is intended.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, and performance based on the provided text.

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The SNN Scout is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The SNN Scout is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.

The passive sensor feature is an addition to the SNN Scout image-guided surgical system. This feature is designed to improve the ergonomics of the user/device interaction by eliminating the cable connections between the tracked surgical instruments and the computer workstation.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided text does not contain a table of acceptance criteria or specific reported device performance metrics for the SNN Scout image-guided surgical system, particularly regarding the passive sensor feature. The document is primarily a 510(k) summary and an FDA clearance letter, which focuses on substantial equivalence to a predicate device rather than detailed performance specifications.

The 510(k) summary states: "The intended use and technological characteristics of the SNN Scout image-guided device including the passive sensor feature are substantially equivalent, in the opinion of I.S.G. Technologies, to those of the predicate device and do not pose any new issues of safety and effectiveness." This implies that the device is deemed acceptable because it performs comparably to an already cleared device, but it doesn't provide the specific performance criteria or results.

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

The provided text does not disclose any information about the sample size used for a test set, nor does it mention data provenance (e.g., country of origin, retrospective/prospective study design). This type of detail is typically found in a more comprehensive clinical study report, which is not part of this 510(k) summary.

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

The provided text does not mention any experts used to establish ground truth or their qualifications. As no specific performance study results for the SNN Scout are presented, there is no discussion of how ground truth might have been established for such a study.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method as there is no mention of a specific test set or performance evaluation in the clinical sense.

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

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no discussion of human reader performance, with or without AI assistance, or any effect size.

6. Standalone (Algorithm Only) Performance Study

The provided text does not specifically describe a standalone (algorithm only) performance study. The device is an "image-guided surgical system" that includes a "passive sensor feature" to improve ergonomics. While its functionality relies on technology, the document focuses on its substantial equivalence to a predicate device rather than a detailed, quantitative standalone performance evaluation of an algorithm.

7. Type of Ground Truth Used

The provided text does not specify the type of ground truth used. Given the nature of the device (image-guided surgical system), if performance were evaluated, ground truth would likely be established through surgical outcomes, anatomical verification during surgery, or possibly highly accurate imaging modalities as a reference. However, these details are not present.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. This device documentation does not describe a machine learning model where a distinct training set would be explicitly referenced.

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

Since there is no mention of a training set, the provided text does not describe how ground truth for a training set was established.

Summary of Missing Information:

It's crucial to understand that 510(k) summaries, especially from 1998, often focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed, quantitative clinical study results with specific acceptance criteria and performance metrics as might be found in a modern premarket approval (PMA) application or a more recent 510(k) for an AI/ML powered device. The information provided heavily emphasizes the "substantially equivalent" argument from ISG Technologies.

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VR SOFTSTORE is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).

VR SOFTSTORE may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).

The VR NetServe software module is an addition to the VR SOFTSTORE medical image archive system which allows the user to access patient images using web server technology to query the database and display retrieved images. The intended use of the VR SOFTSTORE system containing this module has not been modified by this addition.

This 510(k) submission describes the VR NetServe, a software module that adds web access capabilities to the existing VR SOFTSTORE medical image archive system.

Here's an analysis of the provided information regarding acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria or a performance study in the typical sense for a medical device that analyzes patient data.

This submission is for a PACS component software (image storage device) that allows web access to archived medical images. The core claim is substantial equivalence to a predicate device (VR SOFTSTORE, ID.Store image archive software device) and that the addition of the VR NetServe module does not modify the intended use and does not pose any new issues of safety and effectiveness.

Therefore, the "acceptance criteria" here are implied by the FDA's substantial equivalence determination process for this type of device, which focuses on:

• Maintaining the intended use of the predicate device.
• Not introducing new technological characteristics that raise new questions of safety or effectiveness.
• Performing its described functions (lossless archival storage and retrieval of digital medical images, including web access).

Given this context, a table of acceptance criteria and reported performance would look like this:

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

The document does not describe a test set involving patient data or clinical images for performance evaluation. This device is a PACS component software primarily concerned with image storage, retrieval, and access. As such, a clinical performance study with a test set of patient data, as would be common for diagnostic AI, is not mentioned or required for this type of submission.

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

Not applicable. As no test set involving clinical interpretation was performed, no experts were used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set involving clinical interpretation was performed.

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

No. An MRMC study is relevant for devices that assist human readers in diagnostic tasks. This device is a PACS component for archiving and access, not a diagnostic aid.

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

No. The device's primary function is to provide web access for archived images, not to perform independent analysis or diagnosis. Its performance measurement would likely be functional (e.g., successful image retrieval, network accessibility, data integrity) rather than diagnostic accuracy.

7. The Type of Ground Truth Used

Not applicable. For this type of device (PACS component for storage and access), "ground truth" in the diagnostic sense is not relevant. The system's "truth" lies in its ability to accurately store, retrieve, and display the original data without loss or corruption, and to function as described.

8. The Sample Size for the Training Set

Not applicable. This device is an image archiving and access software module, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm requiring a training set with established ground truth.

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ID.Store is a software device intended to direct the lossless archival storage and retrieval, including the use of pre-fetching and auto-routing capabilities, of digital medical images within a Picture Archiving and Communications System (PACS).

ID.Store may be used for the permanent storage and subsequent retrieval of any medical imaging data presented in DICOM or other supported format, within a Picture Archiving and Communications System (PACS).

The ID.Store device is a software package composed of several application modules which work in tandem using a distributed storage architecture to control the archival storage and retrieval of digitized medical images. The ID.gate (gateway), ID.store (archiving), and ID.dbs (image database manager) modules communicate with each other using the dedicated administrative communication protocol ImageTalk. Permanent archival storage media supported include CD-R, WORM, MOD/WORM, DVD, etc. Recommended hardware are standard general purpose equipment, e.g. Sun Sparc or UltraSparc CPU's, and RAID devices for temporary data storage.

The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them. The document is primarily a 510(k) summary for the "ID.Store" device, focusing on its intended use, description, comparison to a predicate device, and regulatory approval.

Specifically, the text is a 510(k) summary for the "ID.Store" (PACS Component Software) and letters from the FDA regarding its clearance. It describes the device's function as software for archival storage and retrieval of digital medical images within a PACS, and states its substantial equivalence to a predicate device (Kodak Medical Image and Information Library (MIIL)).

Therefore, I cannot provide the requested information, which typically involves performance metrics, study design, and ground truth establishment. This type of information is usually found in detailed performance studies or validation reports, which are not part of this 510(k) summary.

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The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used pre-operatively and intraoperatively to perform the following functions:

• process and display pre-operatively radiographic images on a monitor; .
• provide intra-operative image information based on the position and orientation of a user directed . probe:
• allow for the optical integration and usage of different position sensing technologies (e.g. articulated arm, infrared freehand) and surgical probes (handheld pointers);
• store/retrieve image data on computer access media (e.g. hard disks, archive media); and
• transmit data over local area and wide area networks.

The Family of Viewing Wands is intended to be used pre-operatively:

• when more than one approach (e.g. entry point, transtony, craniotomy size, screw placement) is being considered:
• when determining the size of any instrumentation:

and intra-operatively, when:

• the target, trajectory, or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy (e.g. scoliosis, fractures, deformity);
• the target, traiectory, or approach is not entirely exposed (e.g. costerior approach for screw placement):
• the target, trajectory, or approach is in a region where the normal landmarks have been distorted either by disease (e.g. degenerative disease, osteophytes) or by previous surgery;
• the target, trajectory, or approach is in close proximity to critical structures (e.g. venous sinuses, air sinuses, spinal nerve roots or blood vessels) which must be avoided or negotiated; or
• a the target's delineation is important and will not move significantly during the approach (e.g. skull based tumors, sinus diseases, corpus callosotomies, spinal cord tumors).

The Family of Viewing Wands is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head.

It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations in the spine.

The Family of Viewing Wands is contraindicated for patients suspected of having Creutzfeld-Jakob's disease if adequate sterilization of the instrument cannot be assured.

The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intraoperative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.

This document is a 510(k) summary for the ISG Family of Viewing Wands, a medical imaging workstation integrated with a position-sensing user-directed probe. It describes the device, its intended use, and its substantial equivalence to other devices.

The document does not contain information regarding detailed acceptance criteria, study methodologies, or performance metrics that would be typically found in a clinical study report. It is a regulatory submission for premarket notification, focusing on the device description, indications for use, and a claim of substantial equivalence to a predicate device (Stealth Station - K954276).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. The document explicitly states that the spinal application is a "line (application) extension" and is substantially equivalent to existing devices, implying that specific clinical studies demonstrating performance against novel acceptance criteria may not have been required for this particular submission.

Summary of available information relevant to your request, and what is missing:

1. Table of acceptance criteria and the reported device performance:

   • N/A. This document does not specify acceptance criteria for performance nor does it report detailed performance metrics. It asserts substantial equivalence to a predicate device.

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

   • N/A. No information on a test set sample size or data provenance is provided.

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):

   • N/A. No information on experts or ground truth for a test set is provided.

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

   • N/A. No information on adjudication methods for a test set is 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:

   • N/A. No MRMC study is mentioned. This device is a surgical navigation system, not an AI-assisted diagnostic tool for human readers in the context of comparative effectiveness.

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

   • N/A. The device is described as an "integrated with a position-sensing user directed probe," inherently implying human interaction. Standalone algorithm performance is not applicable or discussed.

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

   • N/A. Ground truth for any testing is not mentioned. The system correlates pre-operative CT/MR imaging data with the intraoperative situation, implying the 3D imaging data itself serves as a reference.

8. The sample size for the training set:

   • N/A. This document does not describe a machine learning algorithm requiring a training set in the modern sense. It's a system for image-guided surgery.

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

   • N/A. Not applicable, as there's no mention of a traditional machine learning training set.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence to a predicate device and describing the device's functionality and intended use rather than providing detailed clinical study results with acceptance criteria.

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Not Found

The ISG Family of Viewing Wands is comprised of a medical imaging workstation that is integrated with a position-sensing user directed probe. This allows for the provision of information pertaining to the current position of the probe related to the surrounding anatomy by correlating pre-operative CT and/or MR imaging data with the intra-operative situation. Once a patient's CT or MR images have been transferred to the workstation, the patient is correlated to that image dataset. The system then displays the orientation of the probe and the position of the tip on the corresponding image, updating the display in real-time as the probe is moved.

The provided 510(k) summary for the ISG Family of Viewing Wands does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria, a dedicated study proving performance against those criteria, or details about training and ground truth for such a study.

This document describes a surgical navigation system that correlates pre-operative CT/MR images with intra-operative probe position. Its function is to display the orientation and position of a probe on corresponding images in real-time. It is not an algorithm designed to diagnose conditions or interpret medical images in an automated fashion, but rather a tool to aid a surgeon. Therefore, the concept of "device performance" in this context is likely related to accuracy of localization and real-time display, rather than diagnostic metrics like sensitivity, specificity, or AUC.

Here's a breakdown of what can be extracted based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state specific acceptance criteria or report performance metrics in a quantitative manner (e.g., accuracy, precision) for the Family of Viewing Wands. It states: "Standards are defined and tested under the specifications included in this submittal." However, these specifications are not provided in the excerpt.

Given the device's function, potential implied performance characteristics would involve:

• Localization Accuracy: How precisely the system can determine and display the probe tip's position relative to the imaging data.
• Real-time Update Speed: How quickly the display updates as the probe moves.
• Image Processing and Display Quality: How accurately the pre-operative images are rendered and how well the probe's position is superimposed.

The remaining questions relate to a 'study' that would prove the device meets acceptance criteria. Since no such study with quantifiable performance metrics is described, many of these questions cannot be answered from the provided text.

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

• Not specified. The document does not describe a clinical or technical validation study with a test set.

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)

• Not applicable/Not specified. As there's no described test set or study aiming to establish diagnostic performance, there's no mention of experts establishing a ground truth for interpretation.

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

• Not applicable/Not specified.

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. This is a surgical navigation system, not an AI diagnostic algorithm for image interpretation. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's described function and is not mentioned.

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

• Not applicable/Not specified in detail. The device is a system that works with a human operating a probe. Its function is to provide information to the human, not to act standalone in a diagnostic capacity. While its internal localization algorithms would function "standalone" in terms of computing coordinates, there's no standalone performance evaluation described as if it were a diagnostic AI.

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

• Not specified. For a surgical navigation system, "ground truth" would likely involve highly precise physical measurements of probe tip location compared to the system's displayed location, potentially using phantoms or cadaveric models. This is not detailed in the provided text.

8. The sample size for the training set

• Not applicable/Not specified. This device isn't described as using machine learning or AI that requires a "training set" in the conventional sense (e.g., for image classification). Its core functionality is based on known physical principles of position sensing and image display.

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

• Not applicable/Not specified. (See point 8).

Summary of Device and its Purpose:

The ISG Family of Viewing Wands is a surgical navigation system. Its primary function is to:

• Process and display pre-operative radiographic images (CT and/or MR).
• Provide real-time intra-operative tracking of a user-directed probe, correlating its position and orientation with the pre-operative imaging data.

It is classified as a Class II diagnostic device accessory and is substantially equivalent to existing viewing wands and surgical navigation systems on the market. The submission focuses on describing its components (workstation, localizing device, communications, archive storage) and general functionality, rather than presenting a performance study with detailed acceptance criteria and results.

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