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The Veran SPIN VisionTM Single-Use Flexible Bronchoscope is intended to be used with the SPiN Vision™ Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Veran SPiN Vision™ Single-Use Flexible Bronchoscopes and SPiN Vision™ Video Processor are for use in hospitals, clinics, and/or urgent care centers by trained physicians.

The Veran SPiN Vision™ Bronchoscope System consists of the Veran SPiN Vision™ Single-Use Flexible Video Bronchoscope accessories (Model Nos. INS-7100 and INS-7130) and the Veran SPiN Vision™ Video Processor (Model: SYS-5100) for clinical image processing. The Veran SPiN Vision™ Single-Use Flexible Bronchoscope is introduced within the airways or tracheobronchial tree during Bronchoscopy. The Veran SPiN Vision™ Video Processor provides power and processes the images for medical electronic endoscope.

The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope is a sterile, single use flexible bronchoscope. The Veran SPiN Vision™ Video Processor is a reusable device.

The light emitted by the LED cold light source of the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Veran SPiN Vision™ Video Processor via the encoding circuit. The Veran SPiN Vision™ Video Processor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.

The Veran SPiN Vision™ Single-use Flexible Video Bronchoscope has the following physical and performance characteristics:

• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Working channel
• Sterilized by Ethylene Oxide
• For single use

The differences between the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope models are as follow:

• Working channel diameters
• Insertion tube outer diameter

The Veran SPiN Vision™ Video Processor has the following physical and performance characteristics:

• Provides images from the Veran SPiN Vision™ Single-use Flexible Video Bronchoscope for observation
• Can connect to an external monitor
• Reusable device

This document is a 510(k) Summary for the Veran SPiN Vision™ Bronchoscope System, which makes a claim of substantial equivalence to a predicate device. It does not contain the detailed acceptance criteria, device performance reports, or study methodologies typically associated with proving a device meets acceptance criteria through a standalone study or multi-reader multi-case comparative effectiveness study.

Therefore, many of the requested details cannot be extracted from this document, particularly those related to a standalone algorithm performance, MRMC studies, or robust data provenance for AI/algorithm-based performance claims.

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

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

The document lists performance tests conducted, but does not provide specific acceptance criteria or quantitative performance results for comparison. It only states, "All tests passed."

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

This information is not provided in the document. The performance data mentioned are for non-clinical bench testing, not clinical test sets or 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 applicable as the document describes non-clinical bench testing, not a clinical study involving experts establishing ground truth from patient data.

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

This information is not applicable as the document describes non-clinical bench testing, not a clinical study requiring adjudication of findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this document. The device is a bronchoscope system, not an AI or imaging diagnostic algorithm designed to assist human readers in interpretation.

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

A standalone performance study of an algorithm was not done or described. This submission is for a medical device (bronchoscope system) and its accessories, not a standalone algorithm.

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

The "ground truth" for the non-clinical tests would be the established engineering and safety standards (e.g., ISO, IEC, and internal specifications) against which the device's physical and electrical performance was measured. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable as there is no mention of an algorithm requiring a training set for machine learning.

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

This information is not applicable as there is no mention of an algorithm requiring a training set for machine learning.

Summary of available information:

The provided document is a 510(k) summary for the Veran SPiN Vision™ Bronchoscope System, focusing on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. It does not include details on clinical studies, AI algorithm performance, or human reader studies, which are typically where detailed acceptance criteria and performance metrics for AI-based medical devices are presented. The performance data provided relates to the physical, electrical, and sterile properties of the bronchoscope system itself.

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The SPIN Thoracic Navigation System is a stereotactic accessory for Computed Tomography (CT) and endosopic bronchoscope systems. The SPiN Thoracic Navigation System is indicated for displaying:

· An interventional instrument such as a biopsy needle, an aspiration needle on a computer monitor that also displays a CT-based model of the target organ(s).

· Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires in the pulmonary tract.

The SPiN Thoracic Navigation System compensates for the patient's respiratory phases.

The SPIN Thoracic Navigation System is in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

The SPiN Thoracic Navigation System enables marker placement in soft lung tissue.

The SPiN Thoracic Navigation System is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue. the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Thoracic Navigation System consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Thoracic Navigation System include Veran's Always-On Tip Tracked™ Guidewire, Sheath, Aspiration Needle, Brush, Forceps or View Peripheral Catheter. The SPiN Thoracic Navigation System also enables the placement of markers in soft tissue to guide radiosurgery and thoracic surgery. The SPiN View console/View Optical Probe is provided as an additional accessory for video visualization and is a complement to the EM tracking of the View Peripheral Catheter, enhancing the navigation of the device through the vocal chords and tracheobronchial tree.

Here's a summary of the acceptance criteria and the study information for the SPiN Thoracic Navigation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in terms of human subjects or patient data. The performance evaluations described are primarily focused on system-level testing, phantom studies, and accessory validation.

• Test Set (Phantom): Used a "static phantom" for navigational accuracy testing. The number of samples/runs on the phantom is not specified.
• Data Provenance: The document does not provide information about the country of origin of data or if it was retrospective or prospective, as the testing described focuses on device performance rather than patient studies.

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

The document does not mention the use of experts to establish ground truth for the test set in the context of clinical interpretation or diagnostic accuracy. The ground truth for the technical performance tests (e.g., electrical safety, EMC, sterilization, phantom accuracy) would be defined by engineering specifications and objective measurements against those specifications.

4. Adjudication Method (for the test set)

No adjudication method is described, as the testing outlined is technical verification and validation against objective criteria rather than subjective human interpretation.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on the technical performance and safety of the device itself, rather than comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document describes "Software verification and validation testing" which evaluated the algorithms' performance in fulfilling requirements and demonstrating navigational accuracy on a static phantom. This constitutes a standalone performance evaluation of the algorithms and system components in a controlled environment.

7. Type of Ground Truth Used

The ground truth used for the described studies is primarily:

• Engineering Specifications/Requirements: For software, electrical safety, EMC, and overall system functionality, the ground truth is defined by the established technical specifications and regulatory standards (e.g., IEC 60601 series).
• Physical Measurements: For navigational accuracy, the ground truth would be precise physical measurements on the static phantom.
• Laboratory Analysis: For sterilization and biocompatibility, the ground truth is determined by validated laboratory test methods and results (e.g., confirming sterility, assessing material compatibility).

8. Sample Size for the Training Set

The document does not provide information on the sample size for any training set for machine learning models. The device relies on electromagnetic tracking technology, not explicitly stated machine learning models that would require a "training set" in the conventional sense of AI development for image interpretation. The software development process mentioned involves "Software Requirement Specifications" and "Software Design Specifications," which guide traditional software engineering.

9. How Ground Truth for the Training Set Was Established

As no training set for machine learning is explicitly mentioned, the establishment of ground truth for a training set is not applicable to the information provided.

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The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:

• . An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
• . Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.

The ig4™ System compensates for the patient's respiratory phases.

The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

The SPiN Drive® is an accessory for a CT system that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CT-based model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The SPiN Drive® consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary pathway reconstruction and planning workstation. The EM tracking accessories that can be used with the SPiN Drive® include Veran's Always-On Tip Tracked™ guidewire, steerable catheter, sheath, aspiration needle, brush or forceps.

Here's an analysis of the provided text regarding the SPiN Drive® device, outlining the acceptance criteria and study details based on the given information:

Note: The provided document is a 510(k) summary for a medical device which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive details about specific acceptance criteria and detailed clinical studies as would be found in a full clinical trial report or a performance study for a novel device. As such, some of the requested information (like specific numerical acceptance criteria, detailed test set characteristics, expert qualifications, effect size of MRMC studies, or training set ground truth establishment) is not present in this type of regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to a predicate device (ig4™ Endobronchial, K091934). The core acceptance criteria revolve around showing that the SPiN Drive® is "as safe and effective" as the predicate for its intended use. Specific, quantitative acceptance criteria for performance metrics are not explicitly stated in this summary.

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

• Test Set Sample Size: Not explicitly stated for any of the tests. The bench accuracy testing was on a "static phantom," and airway segmentation validation was performed, but the number of phantoms or datasets used is not specified.
• Data Provenance: Not specified. Given the nature of bench testing and phantom studies, it's likely lab-generated data rather than patient data from a specific country. The study is retrospective in the sense that the data used for bench testing would be pre-defined inputs for the system's performance evaluation.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Adjudication Method: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study Done? No, a multi-reader multi-case (MRMC) comparative effectiveness study was not stated to have been done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the device." This implies no studies involving human readers and clinical cases were performed for this submission.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study Done? Yes, the performance tests described appear to be standalone algorithm/device performance studies:
  • "Bench accuracy testing was completed to demonstrate navigation accuracy on a static phantom."
  • "Airway segmentation validation was completed to demonstrate pulmonary planning function equivalence."
  • "Functional instrumentation testing was completed on new instrumentation."
    These types of tests evaluate the device's intrinsic performance against a known ground truth (e.g., precise phantom measurements, pre-segmented airway models) without human intervention in the loop.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • For navigation accuracy: The ground truth was based on a "static phantom," implying known, precise locations or trajectories within the phantom that the device's navigation was compared against. This would likely be metrology-based or precisely engineered phantom features.
  • For airway segmentation validation: The ground truth for "pulmonary planning function equivalence" would likely be a precisely defined "ideal" segmentation of an airway model, possibly generated manually by experts or from high-resolution scans.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. The document does not discuss the training of any machine learning models, as it predates the widespread regulatory focus on AI/ML. The "planning workstation" improvements are presented as incremental, suggesting refinement of existing algorithms rather than a new AI model requiring a dedicated training set.

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

• Ground Truth Establishment for Training Set: Not applicable/not specified. The document does not describe any machine learning components that would necessitate a dedicated training set with established ground truth. The technical changes are described as "incrementally improved planning workstation" and "additional navigated endoscopic instrumentation," which implies engineering improvements and functional validation rather than AI model training.

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The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle, on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System is additionally indicated for overlaying Ultrasound images onto the model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases.

The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography, 3D fluoroscopic x-ray, or ultrasound are currently used for visualizing such procedures.

The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. The system software allows additional data overlay of real-time Ultrasound images onto the model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles/Ultrasound probes or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

The provided document describes a 510(k) submission for the Veran Medical Technologies ig4™ Image Guided System with Ultrasound Overlay. The "study" mentioned refers to performance testing conducted to support the substantial equivalence claim.

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

   • Test Set Sample Size: Not explicitly stated. The document mentions "Bench accuracy testing... on a static phantom." This suggests a controlled laboratory environment rather than a large clinical test set.
   • Data Provenance: Not explicitly stated, but based on "Bench accuracy testing on a static phantom," the data would be considered prospective in a controlled lab setting, likely conducted internally by Veran Medical Technologies. No country of origin for the data is mentioned, but the company is based in St. Louis, MO, USA.

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

   • Not applicable. The "bench accuracy testing" likely refers to engineering or technical measurements against a known standard (the phantom itself) rather than expert opinion.

3. Adjudication method for the test set:

   • Not applicable. As noted above, the testing appears to be a technical measurement against a known standard.

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 MRMC comparative effectiveness study was done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the device." This device is an image-guided navigation system, not an AI for image interpretation or diagnosis.

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

   • Yes, in a sense. The "Bench accuracy testing" would represent the standalone performance of the system (algorithm and hardware) in navigating instruments relative to an ultrasound overlay on a static phantom. The results "demonstrated the safety and effectiveness of the device" in this context. However, specific quantitative metrics for standalone performance (e.g., mean accuracy, standard deviation) are not provided in this summary.

6. The type of ground truth used:

   • For the bench accuracy testing, the ground truth would be the known geometry and characteristics of the static phantom used for the test, likely established through precise manufacturing or measurement.

7. The sample size for the training set:

   • Not applicable. The document does not describe the use of machine learning models requiring a distinct "training set" in the context of this 510(k) submission. The ig4™ system is described as utilizing electromagnetic tracking technology and software for image overlay and instrument navigation.

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

   • Not applicable, as no training set for machine learning is described.

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The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:

• . An interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
• . Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.
  The ig4™ System compensates for the patient's respiratory phases.
  The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.

The ig4™ EndoBronchial is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate endoscopic tools, catheters and guidewires relative to a CTbased model of the tracheobronchial tree. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory, a patient referencing system, an EM field generator and tracking system, software, a computer system, and a pulmonary planning workstation. The EM tracking accessory consists of a navigation guidewire and may include additional navigated endoscopic tools.

The provided text describes the Veran Medical Technologies ig4™ EndoBronchial device, an accessory for CT and endoscopic bronchoscope systems. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of reported device performance metrics.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not explicitly provided in the document.

Here's an attempt to answer the questions based on the available information:

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

The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics (e.g., accuracy, sensitivity, specificity, etc.) for the ig4™ EndoBronchial in a clinical or benchmarked sense.

Instead, the performance evaluation is described qualitatively as:

• "Bench testing on a static phantom and animal testing were completed to demonstrate navigation accuracy."
• "Additionally, biological testing was completed on the EM navigation accessory to demonstrate that there are no biocompatibility issues."
• "As required by Veran Medical Technologies design control processes and risk analysis, all verification and validation activities have been completed by designated individuals and have demonstrated the safety and effectiveness of the device."

The focus of the 510(k) submission is on demonstrating "safety and effectiveness" through substantial equivalence to predicate devices rather than meeting predefined quantitative performance targets.

2. Sample sized 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 on a static phantom and animal testing," but it does not specify the sample sizes for these tests. It also does not provide information on the country of origin of the data or whether it was retrospective or prospective.

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 tests performed ("bench testing" and "animal testing") would not typically involve human experts establishing ground truth in the way described for diagnostics devices. For navigation accuracy, ground truth is usually established through precise measurement systems.

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

This information is not provided. Given the nature of the bench and animal tests, an adjudication method for a test set as typically understood for diagnostic imaging or AI performance is not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed. The device is an "image-guided system" and "stereotactic accessory," implying a tool for assisting procedures, not an AI diagnostic system directly improving human reader performance.

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

The device is an "image-guided system" and "stereotactic accessory" for "guiding endoscopic tools, catheters or guidewires." This implies it's fundamentally designed for human-in-the-loop use. Therefore, a standalone performance evaluation in the context of an AI algorithm is not applicable and was not performed, nor would it be relevant for this type of device.

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

For "navigation accuracy" in "bench testing on a static phantom and animal testing," the ground truth would likely be established through physical measurements against known spatial coordinates or anatomical landmarks. Expert consensus, pathology, or outcomes data would not be the primary ground truth for demonstrating navigation accuracy.

8. The sample size for the training set

The document does not mention a training set for an AI/machine learning model. The ig4™ EndoBronchial is described as utilizing "electromagnetic tracking technology" and software for navigation, not as a device employing machine learning that would require a distinct training set.

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

Since a training set for an AI model is not mentioned or implied, this question is not applicable.

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The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) or 3D fluoroscopic x-ray systems. The ig4 System is indicated for displaying an interventional instrument such as a biopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based or 3D fluoroscopic x-ray-based model of the target organ(s). The ig4™ System compensates for the patient's respiratory phases.

The ig4™ System is intended for use in clinical interventions and for anatomical structures where computed tomography or 3D fluoroscopic x-ray are currently used for visualizing such procedures.

The ig4™ Image Guided System is an accessory for a CT or 3D fluoroscopic x-ray System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CTbased or 3D fluoroscopic x-ray-based model of the patient anatomy. Due to system use to locate structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles or tip-tracked coaxial needle, a patient referencing system, an EM field generator and tracking system, software and a computer system.

The provided text describes the Veran Medical Technologies ig4™ Image Guided System, an accessory for CT or 3D fluoroscopic x-ray systems. The submission is for an expansion of its indications for use to include navigation with 3D fluoroscopic x-ray-based models.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or a specific table with numerical values for performance. Instead, it relies on demonstrating substantial equivalence to a previously cleared device (ig4™ Image Guided System, K060903) for the expanded indication.

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

• Test Set Sample Size: The document mentions "Bench accuracy testing... on a static phantom." It does not specify the number of tests or samples (e.g., number of measurements taken, different phantom configurations).
• Data Provenance: The testing was "bench accuracy testing," implying a controlled laboratory environment. The country of origin of the data is not specified, but the applicant's address is in St. Louis, MO, USA. The study was prospective in nature, as it was conducted specifically to support this regulatory submission.

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

Not applicable. The study involved bench accuracy testing on a static phantom, not a clinical study involving human patients or expert interpretation of diagnostic images. Therefore, the concept of "ground truth established by experts" as typically seen in image analysis studies does not apply here. The "ground truth" would be the known, precise physical dimensions and locations within the static phantom.

4. Adjudication Method for the Test Set:

Not applicable, as there was no expert review or human interpretation that would require adjudication. The bench accuracy testing would likely involve comparing the device's reported positions to the known, physical positions within the static phantom.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical tests were not required to demonstrate the safety and effectiveness of the device."

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

Yes, the "Bench accuracy testing" focused on the device's intrinsic 3D fluoroscopic x-ray navigation accuracy with a static phantom. This is a standalone performance evaluation, as it assesses the device's ability to accurately track and display without direct human intervention in the tracking mechanism itself, though a human would ultimately operate the system in a clinical setting.

7. The Type of Ground Truth Used:

For the "bench accuracy testing," the ground truth would be the known, precise physical dimensions and locations within the static phantom. This is a physical, measurable ground truth.

8. The Sample Size for the Training Set:

Not applicable. This device is a navigation system based on electromagnetic tracking and imaging, not a machine learning or AI-driven diagnostic algorithm that typically requires a separate training set. The system leverages existing algorithms and principles for localization and navigation, rather than being "trained" on a dataset in the way an AI model would be.

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

Not applicable, as there was no training set in the context of machine learning or AI.

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The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases.

The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.

The ig4TM Image Guided System is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CT-based model of the patient anatomy. Because the system is used to assist in locating structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles, a matrix of thoracic reference markers, an EM field generator and tracking system, software, and a computer system.

The provided text does not contain detailed information about specific acceptance criteria, a dedicated study proving these criteria, or the statistical aspects of such a study (sample sizes, ground truth establishment for test/training sets, expert qualifications, or MRMC studies). The document is a 510(k) summary for the ig4™ Image Guided System, primarily focusing on its intended use and substantial equivalence to predicate devices.

However, it does state: "In addition, bench and animal tests demonstrated that the ig4™ Image Guided System meets the performance requirements for its intended use." This indicates that some form of testing was performed to verify performance, but the details are not provided in this summary.

Therefore, most of the requested information cannot be extracted directly from the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

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

• Cannot be extracted. The document mentions "performance requirements" but does not define them or report specific performance metrics against them.

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

• Cannot be extracted. The document mentions "bench and animal tests" but does not provide sample sizes, and there's no mention of human test sets or data provenance (country, retrospective/prospective).

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)

• Cannot be extracted. There is no information about expert involvement in establishing ground truth for any test set.

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

• Cannot be extracted. No information on adjudication methods is present.

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

• Cannot be extracted. The document does not describe any MRMC studies or a comparison of human readers with or without AI assistance. The device is for image-guided intervention, not primarily for diagnostic interpretation by human readers.

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

• Partially inferable, but specific performance data is absent. The "bench and animal tests" would likely evaluate the standalone performance of the system's navigation and tracking accuracy. However, no specific performance metrics are provided. The device concept is inherently "human-in-the-loop" as it displays information for an interventionalist.

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

• Cannot be extracted. The document mentions "bench and animal tests" but does not specify how ground truth (e.g., actual needle tip position vs. displayed position) was established during these tests.

8. The sample size for the training set

• Cannot be extracted. There is no mention of a "training set," as the device appears to be primarily an electromagnetic tracking and navigation system, not a machine learning model that requires explicit training data in the same sense.

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

• Cannot be extracted. No training set is mentioned.

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