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ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.

The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.

The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.

The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.

Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.

The K053610 submission for ABARIS describes a computer-assisted image-guided surgery system. The submission does not contain a study to prove acceptance criteria in the format requested. Instead, it relies on substantial equivalence to predicate devices. It states that "The technological characteristics of the ABARIS are the same or similar to those found in the predicate devices."

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for a training set was established.

The submission is a 510(k) premarket notification, which often demonstrates substantial equivalence rather than presenting new clinical study data with explicit acceptance criteria. The FDA's letter (APR 19 2006) confirms this by stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

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The InstaTrak 3500 Plus System (K983529, originally cleared under the product name InstaTrak 3000) is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.

The InstaTrak system with Multiple Dataset Navigation provides the same capability as the existing system, with the additional functionality of utilizing two sets of medical images instead of one. By providing information from multiple datasets, the user can locate and visualize anatomical structures using different imaging modalities. The InstaTrak 3500 Plus System allows the user to view the medical images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and medical images is accomplished through the registration process. In all types of surgery the goal is the same, to display to the surgeon based on the medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. With the additional capability of multiple dataset navigation, the surgeon can now view the position of the tracked instrument using two sets of medical images instead of one. The Multiple Dataset Navigation will provide the user with the ability to co-reqister (fuse) images from multiple datasets such as CT and MR. Using the existing InstaTrak 3500 Plus System software, the user will register one of the datasets, referred to as the Reference Dataset, to the patient. Navigation is then possible on the fused images, with secondary (registered) dataset(s) acting as a visualization enhancement for both surgical planning and intra-operative quidance. The sensors and instruments used for navigation are identical to those utilized by the existing InstaTrak system. Navigation will be disabled until the datasets have been successfully co-registered. Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529. The current system provides displays for a single set of medical images. The Multiple Dataset Navigation option will provide displays for multiple sets of medical images. The addition of the Multiple Dataset Navigation operating mode does not change any of the major components of the InstaTrak System. There are no new receivers, transmitters, or instrument attachment configurations associated with this operational mode. Addition of the Multiple Dataset Navigation mode is a software change only.

The provided 510(k) summary for the GE Medical Systems Navigation and Visualization InstaTrak 3500 Plus with Multiple Dataset Navigation does not contain the specific information requested about acceptance criteria, device performance tables, sample sizes, ground truth establishment, or study designs (MRMC, standalone).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical description of performance validation studies.

Here's what can be extracted based on the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of reported device performance metrics in the way typically seen for diagnostic or AI algorithms (e.g., sensitivity, specificity, accuracy). Instead, it focuses on the equivalence of its registration process and navigation capabilities to existing systems.

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

This information is not provided in the 510(k) summary. The document states that the patient registration method and resulting accuracy for the primary (reference) dataset are "identical to that described in K983529." To find any details about testing or sample sizes, one would need to refer to the K983529 submission, which is not included here.

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

This information is not provided in the 510(k) summary. Given the device's function as an image-guided surgical system for localization, ground truth would likely involve physical measurements or intraoperative verification, rather than expert interpretation of images for diagnosis.

4. Adjudication Method for the Test Set:

This information is not provided.

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

This type of study is typically conducted for diagnostic devices where human readers interpret images. For an image-guided surgical navigation system that aids in locating anatomical structures, an MRMC study in the traditional sense would likely not be relevant or performed. The document focuses on the technical capability of fusing multiple datasets and the accuracy of registration as being equivalent to a predicate. It does not assess the diagnostic performance of human readers with or without AI assistance.

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

The document describes the "Multiple Dataset Navigation" as a software change that provides the "ability to co-register (fuse) images from multiple datasets." The navigation is then "possible on the fused images." The core function described relates to the accuracy of registration. The document states: "Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529." This implies that the accuracy of the underlying registration algorithm (a standalone component) would have been assessed as part of the original K983529 submission. However, specific details of that assessment are not provided in this summary.

7. The Type of Ground Truth Used:

For the core function of image registration, ground truth would typically involve physical phantoms with known fiducial markers, where the true alignment is precisely measurable. For clinical application, ground truth for actual navigation accuracy is often derived from intraoperative verification using physical measurements or comparison to anatomical landmarks during surgery. The document itself does not specify the type of ground truth used for the claim of "identical accuracy" to K983529.

8. The Sample Size for the Training Set:

This information is not provided. As this device predates the widespread use of deep learning, the concept of a "training set" in the modern AI sense might not apply. The software change focuses on a new capability (multiple dataset navigation) building upon an existing, validated system.

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

This information is not provided.

Summary of Device and Evidence Presented in Document:

The 510(k) summary describes the "InstaTrak 3500 Plus with Multiple Dataset Navigation" as an upgrade (software change only) to an existing image-guided surgical system (InstaTrak 3500 Plus, K983529). The primary new functionality is the ability to co-register (fuse) and navigate using two sets of medical images (e.g., CT and MR) instead of one.

The document claims substantial equivalence to predicate devices (BrainLAB's Vectorvision iPlan and Medtronic's StealthStation with StealthMerge) that also offer multiple dataset fusion.

The key statement regarding performance is:
"Patient registration is the process by which the coordinate systems of the medical images and the pointing instrument are aligned. This is performed on the primary (reference) dataset. Both the method of registration on the primary (reference) dataset and the resulting accuracy are identical to that described in K983529."

This statement implicitly argues that because the underlying patient registration method and its accuracy are unchanged from the previously cleared device (K983529), and the new multiple dataset navigation builds upon this existing, validated platform, no new safety or effectiveness concerns are raised. The validation for the core accuracy would therefore refer back to the K983529 submission, which is not detailed here.

Therefore, this document does not present a standalone study with new acceptance criteria and performance data for this particular software upgrade, but rather leverages the established performance of the base system and the equivalence to predicate devices for the new functionality.

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The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT, MR, or Xray.

The InstaTrak 3000 System is an image guidance system indicated for use during sinus, skull base, cranial and axial skeletal procedures. The InstaTrak 3000 with FluoroTrak is similar to the InstaTrak 3000 System cleared under K983529. The changes to the system include software enhancements and the addition of a calibration fixture. Using the InstaTrak 3000, the surgeon can readily identify the immediate location and position of the surgical instrument during the indicated procedure. The InstaTrak 3000 assists the surgeon in avoiding critical nerves and other anatomical structures. The InstaTrak 3000 offers multiple modes of operation that includes sinus, skull base, cranial, axial skeletal, to the user based on the indications the user desires. Software is available to the user for using any one, two, or all three of the operational modes. A selection of the operational modes is made by the user prior to the procedure depending needs of the user. The original InstaTrak 3000 System allows the user to view the reconstructed 2D images of the patient's anatomy in response to the mouse or the tracked surgical instrument. Alignment of the patient and images is accomplished through the registration process. In all types of surgery the goal is the same, to indicate to the surgeon based on the pre-operative medical images, where the position of a tracked surgical tool is with regard to the patient's anatomy. The InstaTrak 3000 with FluoroTrak is based on the same hardware and software used in the original InstaTrak System and provides all of the above features. It utilizes the same clinically proven electromagnetic tracking technology as its predecessor.

Here's an analysis of the provided text regarding the acceptance criteria and study for the InstaTrak 3000 System with FluoroTrak Module:

Unfortunately, the provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your prompt. The document is a 510(k) summary for premarket notification, which focuses on establishing substantial equivalence to predicate devices rather than providing a full performance study report with quantitative acceptance criteria and detailed statistical results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states "within the specification" but does not explicitly list the quantitative acceptance criteria (e.g., specific accuracy thresholds in millimeters) for location, surgical instrument position, or any other performance metric.

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

The document states: "Testing was performed using the new component of the InstaTrak 3000 with FluoroTrak to determine if the new component affected device accuracy."

Missing Information:

• Sample Size: The number of tests, cases, or subjects used for this testing is not mentioned.
• Data Provenance: There is no information about whether the data was prospective or retrospective, or the country of origin.

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

Missing Information: The document does not describe the methodology for establishing ground truth for the performance testing, nor does it mention the involvement or qualifications of any experts for this purpose.

4. Adjudication Method for the Test Set

Missing Information: No adjudication method (e.g., 2+1, 3+1, none) is mentioned as part of the performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or implied in this document. This device is an image-guided surgical system, not an AI diagnostic tool that assists human readers in interpreting images.

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

The performance testing described focuses on the device (InstaTrak 3000 with FluoroTrak module) and its accuracy when using a new component. It is implied to be a standalone performance evaluation of the system, not specifically an algorithm-only study in the context of AI. The core function of the device is image guidance for a surgeon, so human-in-the-loop

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The aspirators and pointers are accessories of the previously cleared InstaTrak 3000 System, (K983529) and therefore have the same intended use.

The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

The aspirators and pointers described above are aspiration and/or localization devices supplied as accessories with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion of the instrument the devices are the same as the predicate.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K990919 device submission:

Based on the provided K990919 submission for "Straight Aspirator, 45 Degree Aspirator, 90 Degree Aspirator, 7 French Aspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer, and 4.7 cm Straight Pointer" (accessories for the InstaTrak 3000 System), the information regarding performance criteria and studies is very limited and primarily focuses on equivalence to predicate devices, rather than detailed performance metrics. This is typical for 510(k) submissions for accessories that are substantially equivalent, where rigorous clinical trials with quantifiable performance metrics are often not required if the new device doesn't introduce new risks or fundamental changes in technology.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (accessories with asserted substantial equivalence), the "acceptance criteria" are not reported as numerical performance targets (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly tied to maintaining the same functional and safety characteristics as the predicate devices. The "performance data" provided confirms these characteristics.

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

The document does not specify a sample size for any clinical test set in the conventional sense (e.g., number of patients, cases, or image data). The testing mentioned is solely "testing... to demonstrate their ability to be cleaned and sterilized and to confirm functionality after multiple reuse cycles." This suggests bench testing rather than a study involving human subjects or medical data.

Therefore:

• Sample size for test set: Not applicable/not specified for clinical performance. The testing was likely on a sample of the manufactured devices for cleaning/sterilization validation.
• Data provenance: Not applicable. The "testing" refers to internal validation activities by the manufacturer (Visualization Technology, Inc.), likely in a lab setting, to confirm physical and functional integrity.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided and is not applicable to the type of testing described. The "ground truth" for chemical (cleaning/sterilization) and mechanical (functionality after reuse) testing is typically established by established laboratory protocols and standards, not by expert medical review.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable. Since no clinical test set or expert review for diagnostic/treatment performance is described, there's no need for an adjudication method.

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

No, an MRMC comparative effectiveness study was not done.

The submission focuses on establishing substantial equivalence of accessories based on design, materials, and functional testing (cleaning/sterilization/reuse), not on the comparative clinical performance with or without AI assistance. The InstaTrak 3000 system itself is a surgical navigation system, and the accessories are tools used with it; their primary "performance" is mechanical integrity and compatibility, not diagnostic accuracy or interpretation improvement.

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

This question is not applicable as the device (aspirators and pointers) is not an algorithm or an AI-powered device. It is a set of physical surgical accessories. The InstaTrak 3000 itself is a computer-aided system, but the submission is for its accessories.

7. The Type of Ground Truth Used

The "ground truth" for the described testing would be:

• Sterility Validation: Confirmation that sterilization processes render the devices sterile according to established microbiological standards (e.g., AAMI, ISO standards).
• Cleanliness Validation: Confirmation that cleaning protocols effectively remove biological and other contaminants to acceptable levels.
• Functional Integrity: Confirmation that the devices maintain their physical properties and intended function after multiple cleaning and sterilization cycles (e.g., no material degradation, no loss of structural integrity).

This is established through laboratory testing and adherence to recognized standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI/algorithm-based system that requires a "training set" of data.

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

This information is not applicable as there is no training set for this type of device.

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