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The RIWOtrack Navigation System is intended to continuously display the position and orientation of RIWOspine surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.

The use 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 spine or pelvis, can be identified relative to images of the anatomy.

This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:

· Transforaminal procedure

• Interlaminar procedure

The RIWOtrack Navigation System is an image guided surgery system, visualizing instrument positions on intraoperative fluoroscopy images (AP and LAT) utilizing electromagnetic tracking technology. The positions of the instrument and of the patient localizer, both equipped with sensors, are localized within an electromagnetic field, generated by a field generator, called navigation sensor. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field. The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the Navigation System determines the coordinate transformation between the physical position of the patient and the position of the patient in intraoperative scans by means of autodetection of x-ray marker of a device called MapperBridge. Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

Here's a breakdown of the acceptance criteria and study information for the RIWOtrack Navigation System, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

Study Details for Accuracy Bench Testing

The document mentions "Accuracy bench testing for each instrument probe and localizer" as a performance test. While it confirms the device met the specified criteria of "Position error < 2mm" and "Angular error < 2°", the detailed information regarding the test set, ground truth, and training set is not explicitly provided in this 510(k) summary.

Based on the information available:

• Sample size used for the test set and data provenance: Not explicitly stated. The description refers to "each instrument probe and localizer," suggesting multiple tests for different components, but specific quantities or origin (e.g., country, retrospective/prospective) are not provided.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not explicitly stated. For bench testing, ground truth is typically established through precise measurement devices rather than expert human interpretation.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a bench test where objective measurements are taken against a known standard.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. The tests performed were primarily technical performance assessments.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the accuracy bench testing assessed the system's performance directly, independent of human interaction during the measurement process, to determine its inherent accuracy in tracking position and orientation.
• The type of ground truth used: For accuracy bench testing, the ground truth would be established by highly precise measurement systems or calibrated references (e.g., optical trackers, coordinate measuring machines) against which the device's electromagnetic tracking measurements are compared. The document does not specify the exact method but implies a highly accurate reference.
• The sample size for the training set: Not applicable for this type of bench testing. The device is a navigation system that localizes physical objects using electromagnetic tracking, not a machine learning model that requires a training set for pattern recognition.
• How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for this type of performance evaluation.

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The VenSure™ Balloon Dilation System is used to access and treat the frontal ostia/recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian in adult patients using a transnasal approach.
The VenSure™ Nav Balloon Dilation System is additionally intended for use in conjunction with the Cube Navigation System during ENT procedures when surgical navigation or image-guided surgery may be necessary to locate the Eustachian tube or to locate tissue, bone or cartilaginous tissue surrounding the drainage of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The VenSure™ Light Balloon Dilation System is additionally used to locate, illuminate within, and transilluminate across, nasal and sinus structures in adults.

The VenSure Balloon Dilation Systems combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the Frontal, Maxillary, Sphenoid sinuses, and Eustachian tube using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and the Eustachian tube within the same patient. The devices come in an EO sterilized tray sealed inside of a Tyvek pouch with the bending tool, inflation device, and extension line included in the trav.
All VenSure versions enable a physician to track the device into the sinuses and eustachian tube using endoscopic visualization.
The VenSure™ Nav allows additionally for image-guided visualization when connected to the Cube Navigation System (manufactured by Fiagon). The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "blug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflation device to expand the outflow track of the targeted structure.
The VenSure™ Light additionally allows for LED light confirmation of the VenSure balloon through transillumination across nasal and sinus structures. The VenSure™ Light has an integrated flexible light fiber with battery powered LED light source designed to emit red light from the distal end of the VenSure balloon.
The VenSure™ ET is a 45°- pre-bent configuration of the basic VenSure (with straight balloon tip). The pre-bend to 45°bemt of the VenSure ET facilitates the use of the device when only used for treatment in the eustachian tube. The device however can also be reshaped to fit to the sinuses using the Bending tool.

The provided text describes the VenSure™ Balloon Dilation System, including the VenSure™ Light, VenSure™ Nav, and VenSure™ ET variants. These devices are used for balloon dilation of frontal ostial recesses, sphenoid sinus ostia, maxillary ostia/ethmoid infundibula, and the Eustachian tube in adults.

Here's an analysis of the acceptance criteria and the study information as requested:

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

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

The document mentions "Bench testing" and "Simulated use testing in clinical model." However, it does not specify sample sizes for the test sets used in performance data. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The reference to "clinical model" suggests a simulated environment rather than actual patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document. The studies described are primarily bench testing and simulated use, not those requiring expert interpretation of medical images or patient outcomes for ground truth establishment.

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

This information is not provided as the described studies do not involve expert adjudication of results in a clinical context.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The device in question is a physical medical device (balloon dilation system) and not an AI/software product requiring human reader performance studies.

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

This refers to an AI/software device. The VenSure™ Balloon Dilation System is a physical medical device. While the VenSure™ Nav includes "image-guided visualization" and "navigation software," the document does not describe "standalone" algorithm-only performance in the context of an FDA-cleared AI/software device. The navigation functionality is an aid for the physician using the physical device.

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

For the bench testing, the "ground truth" implicitly refers to engineering specifications and established physical properties (e.g., "dimensions of the balloon are as specified," "burst pressure at end of lifetime is above the rated in use pressure"). For biocompatibility, the ground truth is established by biocompatibility testing standards (ISO 10993-1:2018). For sterilization, the ground truth is sterilization validation standards (ISO 11135-1). For navigation compatibility, it's about functionality and compatibility with the Fiagon Navigation system meeting accuracy ratings of the predicate. This is based on objective, measurable physical and engineering endpoints rather than clinical ground truth (like pathology or expert consensus on a diagnosis).

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI/machine learning model that typically requires a training set.

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

This information is not applicable/not provided as there is no mention of a training set for an AI/machine learning model.

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The Cube Navigation System and its components are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Cube Navigation 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 in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures

The Cube Navigation System is an image guided surgery system, visualizing instrument positions on preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers are localized within an electromagnetic field, generated by a field generator, called navigation sensor within the Cube navigation system. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by surface matching performed by the user either tactile using an navigated instrument or non-tactile using the registration device VituEye. Thereafter the spation of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

The provided text is a 510(k) Summary for the Fiagon Cube Navigation System. It details the device's technical specifications, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a full clinical study with acceptance criteria and detailed performance of an AI-driven vision system.

Therefore, the document does not contain the specific information requested regarding acceptance criteria related to AI performance, sample sizes for test sets (beyond general bench testing), data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone algorithm performance, or ground truth establishment for training and test sets in an AI context.

The document primarily focuses on the device's accuracy as a navigation system, but this is a mechanical/electrical performance metric, not an AI diagnostic performance metric.

However, I can extract the relevant acceptance criterion and the reported performance for the device's accuracy:

Acceptance Criteria and Reported Device Performance (as related to accuracy):

Based on the provided text, the following information is NOT available:

• Sample size used for the test set and the data provenance: The document mentions "bench testing" but does not specify the sample size (e.g., number of measurements, number of anatomical models tested) or data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not relevant to the described bench accuracy testing of a navigation system, as ground truth for AI image analysis is not being established.
• Adjudication method for the test set: Not applicable for device accuracy testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a surgical navigation system, not an AI diagnostic/detection system designed to assist human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The accuracy testing described is effectively a standalone performance test of the navigation system. However, it's not "algorithm only" in the sense of a pure AI diagnostic algorithm.
• The type of ground truth used: For the accuracy testing, the ground truth would be the precisely known physical positions in the bench test setup, measured by calibrated instruments. It's not expert consensus, pathology, or outcomes data.
• The sample size for the training set: Not applicable, as this is not an AI machine learning model being trained.
• How the ground truth for the training set was established: Not applicable.

Summary of available information from the text that partially addresses the prompt:

• Acceptance Criteria for Accuracy: Mean position accuracy < 1.5mm.
• Reported Performance: Implicitly meets the < 1.5mm requirement, confirmed by bench testing.
• Study Type: Non-clinical bench testing, including "Anatomy orientated accuracy bench testing for each instrument probe and localizer without registration" and "Anatomy orientated accuracy bench testing after tactile registration photo based, non-tactile registration."
• Ground Truth (for accuracy testing): Precisely known physical positions in a controlled bench test environment.

The document states that the system's "tracking technology, system components, registration methods, and system functionality however are identical to the primary predicate." This suggests that the performance metrics of the previous devices serve as the benchmark for substantial equivalence. The modifications described are primarily dimensional, aesthetic, or related to updated internal hardware, with no new safety or effectiveness concerns raised.

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The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon Navigation System during sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation 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 in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.

Fiagon's VenSure™ Balloon Device and VenSure™ Nav Balloon Device are sterile, singleuse devices designed to remodel the bony structures within the sinuses. The device comes in two versions a navigation ready version (VenSure™ Nav) that is compatible with the Fiagon electromagnetic navigation system, and a basic non-navigation ready version (VenSure™).

The VenSure™ and VenSure™ Nav devices, combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the frontal, maxillary, and sphenoid sinuses using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

Both versions enable a physician to track the device into the sinuses using endoscopic visualization; while the VenSure™ Nav allows for image-guided visualization when connected to the Fiagon Navigation System. The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "plug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflator to expand the outflow track of the targeted sinus.

A suction tube may be connected directly to the proximal luer fitting of the basic VenSure™ balloon dilation device to provide active suction. Alternately, an Extension Line connected to a syringe may be connected directly to the proximal luer fitting to provide irrigation. Suction and irrigation are not possible on the VenSure™ Nav.

The provided text describes a 510(k) premarket notification for the VenSure™ Balloon Device and VenSure™ Nav Balloon Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as might be seen for novel devices or PMAs.

Therefore, the information requested, particularly regarding acceptance criteria, specific study designs (like MRMC), expert consensus, and detailed ground truth establishment, is largely not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.

However, I can extract the information that is available:

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests met the predefined acceptance criteria." and "All tests successfully met the required acceptance criteria". However, the specific quantitative acceptance criteria values themselves are not provided in the text. Only the categories of tests performed are mentioned.

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

The document specifies "Bench testing" and "Biocompatibility testing" were conducted. It does not provide specific sample sizes for these tests (e.g., number of balloons tested for dimensional integrity).

• Data Provenance: Bench testing would be conducted in a laboratory setting. Biocompatibility testing involved laboratory assays. The document does not specify a country of origin for the test data, but the submitter (Fiagon GmbH) is based in Germany. The tests are described as prospective in the sense that they were conducted specifically for this submission.

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. The tests described are largely objective laboratory and engineering tests (e.g., measuring balloon dimensions, pressure). For biocompatibility, the ground truth would be established by the results of standardized biological assays, not expert consensus in the clinical sense.

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

• This information is not provided and is generally not applicable to the types of bench and biocompatibility tests 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

• No, an MRMC comparative effectiveness study was not done. The devices described are physical surgical instruments (balloon dilation devices and their navigation-compatible versions), not AI/software intended for diagnostic interpretation or aiding human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.

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

• Not applicable. These are physical medical devices, not algorithms.

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

• For bench testing, the ground truth would be engineering specifications, material properties, and functionality requirements (e.g., specific dimensions, pressure resistance, inflation/deflation times).
• For biocompatibility testing, the ground truth would be the defined acceptable limits and criteria for cytotoxicity, irritation, sensitization, and acute systemic toxicity as per ISO 10993-1 and related sub-standards.
• For sterilization and shelf-life, the ground truth is established by the specified standards (e.g., ISO 11135 for sterilization, ASTM F1980 for accelerated aging, ISO 11607-1 for packaging).

8. The sample size for the training set

• Not applicable. These are physical medical devices, not machine learning algorithms that require training sets. The document describes pre-market testing for device safety and performance, not AI model development.

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

• Not applicable. As above, this concept refers to AI/ML development and is not relevant to this device submission.

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The devices FlexPointer 1.5 Single Use and FlexTube 3 Single Use are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The devices are indicated for use with the Fiagon Navigation system using electromagnetic navigation.

The devices are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures;
Transphenoidal access procedures.
Intranasal procedures.
Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies.
ENT related anterior skull base procedures.

The Fiagon Navigation - FlexPointer 1.5 Single Use and FlexTube 3 Single Use are disposable instruments intended to be used with the Fiagon Navigation system. The FlexPointer 1.5 Single Use is an electromagnetically navigated pointing device (malleable, sensor within the tip). The FlexTube 3 Single Use is an electromagnetically navigated suction device (malleable, sensor within the tip).

Each device incorporates a sensor device, which is tracked by the navigation system within the low-energy magnetic field of a field generator (part of the navigation system). The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy).

The provided text describes a 510(k) submission for the Fiagon Navigation - FlexPointer 1.5 Single Use and FlexTube 3 Single Use devices. The primary purpose of the submission is to gain clearance for modified versions of previously cleared instruments, specifically a change in material and a change from reprocessed to sterile, single-use, disposable devices. The FDA's review determines substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study proving compliance, based on the provided text:

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

The document does not explicitly present a table of acceptance criteria. However, it states the performance benchmark for accuracy.

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

• Test Set Sample Size: The protocol for the bench test on the anatomical skull phantom states: "total 15 x 15 fiducial markers are touched." This indicates 225 individual measurements/trials were conducted for the accuracy testing. It's important to note this is a measure of the device's accuracy in a controlled phantom setting, not a clinical patient sample size.
• Data Provenance: The study was a bench test performed in a laboratory setting. The country of origin of the data is not specified, but the applicant, Fiagon GmbH, is based in Hennigsdorf, Germany. This was a prospective test, as it was specifically performed to demonstrate the device's performance for this regulatory submission.

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)

The ground truth for the bench test was established by known positions of fiducial markers on an anatomical skull phantom. This type of ground truth does not typically involve human experts in the same way as, for example, expert radiological review. The "ground truth" here is the precisely engineered and known physical locations on the phantom.

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

Not applicable for this type of bench test. The comparison is between the device's reported position and the pre-defined, known position of the fiducial marker on the phantom. There is no human interpretation or adjudication involved in establishing the "correct" measurement.

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, an MRMC comparative effectiveness study was not performed. The device is a navigation instrument, not an AI-assisted diagnostic tool for image interpretation. The study focuses on the physical accuracy of the device itself.

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

The accuracy testing described is effectively a standalone device performance test. It evaluates the device's ability to accurately locate a point in space when used with the Fiagon Navigation system. While a human operator physically touches the fiducial markers, the "performance" being measured is the accuracy of the device and navigation system's calculation and display, independent of clinical human interpretation error.

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

The ground truth used was known, precisely manufactured positions of fiducial markers on an anatomical skull phantom. This is a highly controlled and objective physical ground truth.

8. The sample size for the training set

This document describes a 510(k) submission for a physical medical device (navigation instruments), not a software or AI algorithm that requires a training set in the conventional machine learning sense. Therefore, no training set sample size is applicable or mentioned.

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

As there is no training set for an AI algorithm mentioned, this question is not applicable.

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The Fiagon Navigation System is intended as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation 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 in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:

• Craniotomies/Craniectomies (e.g., Tumor Resection)
• Skull Base Procedures
• Cranial Biopsies
• General Catheter Shunt Placement
• Pediatric Catheter Shunt Placement

The user should consult the "Bench Accuracy" section of the User Manual to assess whether the accuracy of the system is suitable for their needs.

The Fiagon Navigation System displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The instrument with integrated sensor and the patient equipped with localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching. Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation is updated with a rate of 15 to 45 Hz.

The components of the navigation system are

1. Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 – 4 below.

• 2. Navigation sensor (Headrest with field generator)
• 3. Navigation instrument (ShuntPointer, BiopsyPointer190 and BiopsyPointer 250)

4. Patient reference localizer (Localizer Set Bone Anchor and Localizer Adhesive Pad)

The navigation unit is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) are imported to the system by means of CD-ROM, USB storage media or LAN network and displayed in appropriate way defined by the software.

The navigation unit includes the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient localizer and the navigation instrument.

The patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.

The patient reference localizer is fixed to the patient's anatomy and references it, while the instrument is tracked in relation to the patient localizer and thus to the patient's anatomy.

The provided text describes the Fiagon Navigation System, a stereotaxic instrument used as an aid for locating anatomical structures in neurosurgical procedures. The document focuses on demonstrating the substantial equivalence of this device to existing predicate devices, rather than a standalone AI-driven diagnostic system. As such, many of the requested elements pertaining to AI model validation, such as training set details, multi-reader multi-case studies, and expert consensus for ground truth, are not applicable to this type of medical device submission.

The document primarily details bench testing to assess the accuracy of the navigation system.

Here's an breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device appear to be implicitly defined by demonstrating accuracy similar to predicate devices. The key performance metrics are Target Registration Error (TRE) and Angular Registration Error (ARE).

The document states, "The results showed that the average Target Registration Error (TRE) for the device with Localizer Set Bone Anchor was 1.17 mm (99% Cl upper bound: 2.47 mm) and the average Angular Registration Error (ARE) was 1.45° (99% CI upper bound: 2.8°), which were similar to the accuracy of the predicate devices." A similar statement is made for the Adhesive Pads. The predicate devices are listed with "Mean bench accuracy: Position Mean: < 2mm; Angular: Mean: < 2º", which serves as the implicit acceptance threshold.

Details of the Study Proving Device Meets Acceptance Criteria

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

   • The document describes a bench test using a phantom model. It does not refer to a "test set" in the context of patient data or a dataset of medical images for an AI.
   • The sample size for the bench testing (e.g., number of measurements taken) is not explicitly stated.
   • Data Provenance: The data is generated from a physical phantom model and CT scans of that phantom. It is a prospective test conducted specifically for this submission, not retrospective patient data. There is no country of origin for the "data" as it's a bench test, not clinical data from patients.

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

   • This is not applicable for this type of device and study. The "ground truth" for the bench test was established by a Coordinate Measurement Machine (CMM) with an accuracy of 0.018 mm and the CT scans of the phantom with known reference points. This is a physical, measurable ground truth, not one established by human experts or clinical outcomes for an AI system.

3. Adjudication Method for the Test Set:

   • Not applicable. There was no human interpretation or adjudication involved in establishing the "ground truth" for the performance metrics. The accuracy was measured physically against known points on the phantom.

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

   • No. This type of study is typically performed for diagnostic or AI-assisted devices where human interpretation is a key component. This device is a navigation system used during surgery, and its evaluation focuses on its physical accuracy, not its impact on human reader performance in interpreting medical images.

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

   • Yes, in essence, the bench testing is a standalone performance study. The accuracy of the navigation system itself (the "algorithm" in a broad sense, though it's a physical tracking system) was measured independently of surgeons using it in a live setting. The measurements captured the system's ability to accurately register and track instruments against a known physical model.

6. The Type of Ground Truth Used:

   • Physical/Measured Ground Truth: The ground truth was established by precise measurements of target points on a phantom using a Coordinate Measurement Machine (CMM) and the known geometry derived from CT scans of the phantom. This is objective, physical data, not expert consensus or pathological findings.

7. The Sample Size for the Training Set:

   • Not applicable. This document describes a medical device (navigation system) with electromagnetic tracking, not a machine learning or artificial intelligence algorithm that requires a "training set." The system's functionality is based on established physical principles and engineering, not on learning from a dataset.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this device.

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The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are intended as aids for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation.

The instruments are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. Skull base procedures for ENT access

The Fiagon Navigation - PointerTube Straight and the PointerTube Keat are 10 time use instruments intended to be used with the Fiagon Navigation system.

Each device incorporates a sensor, which is tracked by the navigation system within the lowenergy magnetic field of a field generator (part of the navigation system). The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy).

The provided document is a 510(k) premarket notification letter and summary for the Fiagon Navigation - PointerTube Straight and PointerTube Keat. It addresses the substantial equivalence of these devices to previously cleared predicate devices.

Acceptance Criteria and Device Performance:

The document explicitly states that the purpose of the submission is for clearance of modified versions of existing instruments and that "Testing was performed in order to confirm continued precision and accuracy of the modified devices. Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system, as well as to confirm that the change in design of the modified instrument does not alter the performance characteristics of the device."

However, no specific acceptance criteria or quantitative performance data are provided in the document. The submission relies on the concept of "substantial equivalence" to predicate devices (Fiagon Navigation - PointerTube Straight (K141456) and PointerTube Sinus Frontalis (K141456)).

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text as this detailed information is not included.

Study Information Pertaining to Device Acceptance:

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified.

2. 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. This document describes a medical device (surgical tools) and its navigation system, not an AI or diagnostic imaging device that requires expert ground truth for interpretation. The testing likely involved engineering and performance validation rather than medical expert assessment of diagnostic accuracy.

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

   • Not applicable/Not specified. (See point 2).

4. 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 not an AI or diagnostic imaging device. It is a surgical navigation instrument. Therefore, an MRMC study is not relevant here.

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

   • Not applicable. This is a physical surgical instrument used with a navigation system, not a standalone algorithm. The device itself (PointerTube) is a tool for human use, and its performance is inherently tied to being "in-the-loop" with the human surgeon and the navigation system.

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

   • Not explicitly stated. Given the nature of the device (surgical navigation tools), the "ground truth" for performance testing would typically involve engineering metrics related to precision, accuracy, and functionality (e.g., tracking accuracy, mechanical integrity, compatibility with the navigation system). This is not a diagnostic device where pathology or expert consensus on images would be the ground truth.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. (See point 7).

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The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation 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 in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures: Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

The Fiagon Navigation System displays position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. The position of the instrument with integrated sensor and the patient equipped with localizers are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching. Thereafter the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the Fiagon Navigation System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance or clinical efficacy through the types of detailed studies typically associated with AI/ML model validation. Therefore, the document does not contain the information required to answer all parts of your request, particularly those related to AI/ML specific evaluations (like training set details, expert consensus for ground truth, MRMC studies, etc.).

However, I can extract the relevant information regarding acceptance criteria and performance data for this device as presented in the submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission focuses on bench testing to demonstrate that the modified device (with WiFi connectivity and iPad remote control with automatic registration) performs as intended and is substantially equivalent to its predicate. The "acceptance criteria" are implied by the types of tests conducted and their successful completion.

1. Table of Acceptance Criteria and the Reported Device Performance:

Study Details (as inferable from the document)

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

• The document mentions "bench testing" but does not specify sample sizes (e.g., number of tests, number of targets, number of wireless interferences) or data provenance (e.g., country of origin, retrospective/prospective). This level of detail is typically not required for a 510(k) submission focused on substantial equivalence of a modified hardware/software system.

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. The testing appears to be quantitative bench testing of accuracy and functionality, not a study requiring expert interpretation of medical images or clinical outcomes.

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

• This is not applicable to the type of bench testing 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:

• No, an MRMC study was not done. This device is a navigation system that displays instrument position relative to pre-operative scans, not an AI/ML diagnostic or assistive tool that would involve "human readers" interpreting images.

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

• The tests described ("Positioning accuracy test for target registration", "Wireless coexisting testing", "Software testing") are essentially standalone performance evaluations of the device's capabilities. However, this is not an AI algorithm in the contemporary sense. The "algorithm" here refers to the underlying calculations for electromagnetic tracking and image-to-patient registration.

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

• For positioning accuracy, the ground truth would likely be established by a precisely measured physical reference (e.g., a known target position in a phantom) rather than clinical expert consensus or pathology. For wireless coexistence and software testing, the ground truth is whether the system performs according to specifications.

8. The sample size for the training set:

• This is not applicable and not provided. This device is not described as an AI/ML system requiring a distinct "training set" in the context of deep learning.

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

• This is not applicable, as there's no mention of a "training set" for an AI/ML model for this device.

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The GuideWire 0.6 Single Use is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is indicated for use with the Fiagon Navigation system using electromagnetic navigation.

It is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

ENT Procedures; Transphenoidal access procedures. Intranasal procedures. Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies. ENT related anterior skull base procedures.

The Fiagon Navigation - GuideWire 0.6 Single Use is a disposable instrument intended to be used with the Fiagon Navigation system. The instrument is an electromagnetically navigated pointing device (malleable, sensor within the tip).

Each device incorporates a sensor device, which is tracked by the navigation system within the low-energy magnetic field of a field generator (part of the navigation system). The navigation software (part of the navigation system) displays the position of the instruments in preoperative scans (e.g., CT, MRI, fluoroscopy).

This document is a 510(k) summary for the Fiagon Navigation - GuideWire 0.6 Single Use. It's a special 510(k) to clear a modified version of an already cleared device, primarily changing from a reprocessed device to a sterile, single-use, disposable one. Therefore, the "study that proves the device meets the acceptance criteria" largely focuses on demonstrating that the modifications do not negatively impact the device's performance or raise new safety/effectiveness concerns compared to the predicate device.

Here's an attempt to extract the requested information based on the provided text, recognizing that a 510(k) summary is designed to summarize, not provide the full detail of, the underlying studies. As such, some specific details might be less granular than typically expected for AI/software device studies.

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

The document does not explicitly state numerical acceptance criteria with corresponding reported performance for the modified device in a table format. It generally states that "Testing was performed in order to determine device precision and accuracy of the modified device" and "Testing was also completed to ensure functionality and compatibility with the Fiagon Navigation system."

However, since this is a Special 510(k) for a modified version of a predicate device (Fiagon Navigation - Guidewire 0.6, K160369), the implied acceptance criterion is that the modified device's performance (precision, accuracy, functionality) must be comparable to or not worse than the predicate device. The conclusion states: "the GuideWire 0.6 Single Use has been shown to be substantially equivalent to the comparable device GuideWire 0.6 and the modified device does not present any new issues of safety or effectiveness." This implies the tests successfully demonstrated this equivalency.

Therefore, we can infer the following (with details inferred or generally stated due to lack of specificity in the summary):

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

The document does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective. It generally refers to "Testing was performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable (N/A) as the device is a stereotactic navigation guidewire, not an AI/software device that requires expert ground truth for interpretation of medical images or data. The "ground truth" for a guidewire's precision and accuracy would typically be established through physical measurements against reference standards in a controlled test environment.

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

N/A. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of performance testing for a physical medical device like a guidewire.

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. This is a physical medical device (guidewire) and not an AI/software device that would involve human readers or AI assistance for image interpretation.

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

N/A. This is a physical medical device, not an algorithm. The performance of the guidewire itself (precision, accuracy) would be evaluated in a standalone manner (without a human interpreting its output, but rather observing its physical performance or software-displayed position). The document states "Testing was performed in order to determine device precision and accuracy of the modified device."

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

For a device determining "precision and accuracy" of a physical instrument in navigation, the ground truth would typically be established by highly accurate physical measurement systems (e.g., optical tracking systems, mechanical fixtures with known dimensions, or other calibration tools) within a controlled laboratory setting. The document does not specify the exact methods but implies standard metrology for precision and accuracy.

8. The sample size for the training set

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

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

N/A. This is a physical guidewire, not an AI/software device requiring a training set.

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The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The Fiagon Navigation 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 in the field of cranial surgery can be identified relative to a CT or MR based model of the anatomy.

Example procedures include, but are not limited to:

Cranial Procedures:

• Craniotomies/Craniectomies (e.g., Tumor Resection)
• Skull Base Procedures
• Cranial Biopsies
• General Catheter Shunt Placement

The Fiagon Navigation System displays the position instruments in preoperative scans (e.g., CT, MRI, fluoroscopy) utilizing electromagnetic tracking technology. For cranial procedures, the use of this device is restricted to rigid fixation with a patient reference localizer attached directly to the skull clamp. The position of the instrument with integrated sensor and the patient referencing localizer (attached to the skull clamp) are localized within an electromagnetic field generated by a field generator. The principle of navigation is based on electromagnetic spatial measuring of localizer element in a generated electromagnetic field.

The display of navigation information requires an image-to-patient registration procedure. During registration procedure, the navigation system determines the coordinate transformation between the intraoperative position of the patient and the position of the preoperative scan by fiducial marker, anatomical landmark or surface matching.

Thereafter, the spatial position of the instrument is displayed superimposed to the image data. The navigation information is updated with a rate of 15 to 45 Hz.

The device Fiagon Navigation System utilizing similar technology than the proposed device has been previously cleared for a different intended use. This device is listed as a reference device.

The components of the navigation system are

• 1. Navigation unit with Navigation software. It has interfaces for screen, mouse and the components 2 - 4.
• 2. Navigation sensor (Headrest with field generator)
• 3. Navigation instrument

4. Patient reference localizer (with fixation of the localizer on the skull clamp using the adhesive pad)

The navigation unit is connected to a medical monitor. The unit runs the navigation software. Preoperative radiological images of the patient (DICOM CT, CBCT, MR) is imported to the system by means of CD-ROM. USB storage media or LAN network and displayed in appropriate way (defined by the software).

The navigation unit compromises the spatial measuring device electronics as well. This has connections to the field generating device (navigation sensor), the patient reference localizer and the navigation instrument.

Patient reference localizer and navigation instrument are tracked within the generated field by localizer elements integrated in the devices.

The patient reference localizer is fixed to the skull clamp and references the patient's anatomy, while the instrument is tracked in relation to the patient reference localizer and thus to the patient's anatomy.

Here's a breakdown of the acceptance criteria and study information for the "Fiagon Navigation System" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

The document mentions "Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism." However, it does not specify the sample size used for the test set (e.g., number of measurements, number of trials, or number of phantom setups).

The data provenance is from bench testing, meaning it was conducted in a controlled laboratory environment rather than on human subjects. The country of origin of the testing is not explicitly stated, but the company, Fiagon GmbH, is based in Germany. The study is a prospective test in the sense that the device was specifically designed and then tested to meet these criteria.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. Bench testing typically relies on metrology equipment to define ground truth.

4. Adjudication Method

The document does not mention an adjudication method as it relates to expert review. For bench testing, the "adjudication" is typically the comparison of the device's output against a known, highly accurate reference measurement performed by the testing equipment.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study primarily focuses on the interpretation and decision-making of human readers, which is not applicable to an image-guided navigation system's direct performance. The document focuses on the technical accuracy and precision of the device itself.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The entire "Performance Data" section describes bench tests performed on the device (the algorithm and hardware) to determine its precision and accuracy, without human interpretation or intervention in the measurement process. "Bench testing was conducted to determine the device accuracy and the performance of the electromagnetic field distortion mechanism."

7. Type of Ground Truth Used

The ground truth for the bench accuracy tests was established using technical measurements and co-ordinate measurement systems. For example, the document states: "measurement of technical accuracy with co-ordinate measurement system followed by measurement of positional and angular accuracy without registration to measure the angular accuracy of the instrument itself."

8. Sample Size for Training Set

The document does not mention a training set or its sample size. Image-guided navigation systems like the Fiagon Navigation System are typically engineered with deterministic algorithms and robust calibration methods, rather than being "trained" in the machine learning sense with large datasets. Their performance is validated through precision and accuracy testing against known physical benchmarks.

9. How Ground Truth for Training Set Was Established

Since a "training set" in the machine learning context is not mentioned or implied for this device, the question of how its ground truth was established is not applicable. The system's underlying principles are based on electromagnetic tracking and geometry, rather than data-driven learning from a labeled training set.

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