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The Visualase V2 ™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of:

• a diode laser (energy source)
• a coolant pump to circulate saline through the laser application
• Visualase workstation which interfaces with MRI scanner's host computer
• Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; one monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections

The provided FDA 510(k) clearance letter for the Visualase V2 MRI-Guided Laser Ablation System does not contain the detailed information necessary to fully address all aspects of the request. Specifically, the document focuses on regulatory compliance, substantial equivalence to predicate devices, and general testing summaries (software V&V, system V&V, electrical safety). It does not include specific acceptance criteria with performance metrics, details of a clinical study (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies), or direct data proving the device met specific performance criteria.

The letter explicitly states: "A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population." This indicates that a prospective clinical performance study, often associated with detailed acceptance criteria and reported performance, was not the primary method for demonstrating substantial equivalence for this particular submission.

Therefore, many sections of your request cannot be fulfilled based on the provided document. I will fill in the information that is present and explicitly state where information is not available.

Acceptance Criteria and Device Performance for Visualase V2 MRI-Guided Laser Ablation System

Based on the provided FDA 510(k) clearance letter (K250307), the device's acceptance criteria and proven performance are primarily demonstrated through verification and validation activities for its software and system, and compliance with electrical safety standards. A formal clinical trial with quantitative performance metrics against specific acceptance criteria (e.g., sensitivity, specificity, accuracy) was not required for this submission to establish substantial equivalence, but rather clinical evidence was provided via a literature summary.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) for the Visualase V2 System as described in the document, performance acceptance criteria are focused on safety, functionality, and equivalence to predicate devices, rather than clinical efficacy metrics typically found in AI/diagnostic device submissions.

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "A clinical trial was not required to establish substantial equivalence. Clinical evidence provided in a literature summary format supports the safe use of the Visualase V2 System in the intended patient population."

Therefore, no specific "test set" sample size for a clinical performance study is reported in this document. The "testing summary" refers to internal verification and validation against design controls and standards, not a clinical data set for performance evaluation of an AI algorithm.

Data Provenance: Not applicable for a clinical test set in this context, as a clinical performance study was not the basis for substantial equivalence for this upgrade. The clinical evidence was a literature summary.

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

Not applicable, as a specific clinical test set for performance evaluation (e.g., for an AI algorithm's diagnostic accuracy which would require ground truth labeling) was not conducted as part of this 510(k) as described. The "ground truth" for the device's functionality and safety was established via engineering verification, validation, and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set requiring adjudication was not reported as part of this 510(k) as described.

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

No, a MRMC comparative effectiveness study was not reported in this 510(k) clearance letter. The submission focused on establishing substantial equivalence through other means (software/system V&V, safety testing, literature review) rather than demonstrating AI assistance performance improvement.

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

The Visualase V2 System is a medical device system that includes hardware and software for MRI-guided laser ablation, with software providing monitoring and control capabilities related to temperature and thermal damage estimation. It is not an AI diagnostic algorithm for which a standalone performance evaluation (e.g., AUC, sensitivity/specificity) would typically be required or reported in this format. The software's performance is intrinsically linked to the system's function and user interaction.

Therefore, a "standalone algorithm only" performance study in the sense of a diagnostic AI product is not applicable and not reported.

7. The Type of Ground Truth Used

For the system's functional and safety validation, the "ground truth" would be engineering specifications, design requirements, and established medical and electrical safety standards (e.g., IEC standards, 21 CFR 820.30 Design Controls).

For any inferred clinical claims from the "literature summary," the ground truth would originate from the clinical data reported in the summarized peer-reviewed literature, which could involve histological confirmation, long-term patient outcomes, or expert clinical diagnosis, but these details are not provided in the 510(k) letter itself.

8. The Sample Size for the Training Set

Not applicable. The document describes a medical device system update, not an AI algorithm developed using a specific training dataset in the machine learning sense. The "training" for the system's software would derive from its design and programming, verified through the V&V processes.

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

Not applicable, as this is not an AI algorithm developed through data-driven training in the machine learning sense. The "ground truth" for the device's design and engineering would be based on scientific and engineering principles, preclinical testing, and existing medical knowledge, as per design control procedures.

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The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.

The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides near real-time thermographic analysis of selected MRI images.

When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis. The intended patients are adults and pediatric from the age of 2 years and older.

The Monteris NeuroBlate System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.

The NeuroBlate System components consist of:

• Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone.
• Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position, stabilize and manipulate a probe, endoscope or other device within the target zone.
• An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Advanced and Robotic Probe Drivers and interconnections for the Laser Delivery Probes;
• A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation.
• A Control Workstation including the M-Vision™ and M-Vision Pro™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate procedures, and interfaces to the MRI and hardware subsystems.

The NeuroBlate System is utilized with stereotaxic frames and patient stabilization systems, such as:

The Monteris Cranial Bolt and Mini-Bolt fixation components, and

• The AtamA Stabilization System and MRI receive-only head coil, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, bone screws, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.

The provided text is an FDA 510(k) clearance letter for the Monteris Medical NeuroBlate System (K240877). This document primarily focuses on demonstrating substantial equivalence to a predicate device (K231061) and modifying the pediatric age range in the Indications for Use. It explicitly states that "no additional testing was required" because the changes are labeling-related and "no physical changes, manufacturing changes, process changes, materials changes, or technology changes" were made to the system.

Therefore, the document does not contain details about specific acceptance criteria, a study proving the device met those criteria, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies for this specific submission (K240877). The information provided heavily references data from the predicate device (K231061) and general clinical literature reviews.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document as no new acceptance criteria or device performance data were generated for this specific submission (K240877). The submission focuses on a labeling change to an existing device, relying on previous data.

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

This information is not provided for this specific submission as no new testing was required. The document mentions that "adult and pediatric data from Monteris' prospective LAANTERN Registry was also reviewed," but it does not specify the sample size from this registry or explicitly define it as a "test set" for this submission. The provenance is from Monteris' prospective registry.

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

This information is not provided for this specific submission as no new testing was required.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided for this specific submission as no new testing was required.

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

An MRMC study is not mentioned for this specific submission. The NeuroBlate System is a physical laser thermal therapy system with software for planning and monitoring, not an AI diagnostic tool for interpreting images for human readers.

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

A standalone performance study is not mentioned for this specific submission. The device is intended to be used by a "trained physician" for planning and monitoring, with patient management decisions "not made solely on the basis of the NeuroBlate System analysis," indicating a human-in-the-loop system.

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

This information is not explicitly stated for any data underlying the predicate device, other than general references to "LITT related clinical literature" and "NeuroBlate System commercial clinical experience," and data from the "LAANTERN Registry" (which would likely include outcomes data).

8. The sample size for the training set

This information is not provided for this specific submission as no new technical development or training of algorithms is indicated; the submission relies on previously established performance of the predicate device.

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

This information is not provided for this specific submission as no new technical development or training of algorithms is indicated.

Summary of Change in K240877 and Rationale:

The core of this 510(k) submission (K240877) is a labeling change to the existing Monteris Medical NeuroBlate System (predicate K231061). The change is to explicitly include "pediatric patients from the age of 2 years and older" in the "Indications for Use" statement, clarifying an existing "adult and pediatric" intended patient population.

The submission asserts that because "no physical changes, manufacturing changes, process changes, materials changes, or technology changes" were made to the device, and the "technical modes of action and technical principles remain the same," no additional testing (in-vitro or in-vivo) was required. The conclusion that the device remains safe and effective for this expanded age range is based on:

• Review of LITT related clinical literature.
• Review of Monteris' own NeuroBlate System commercial clinical experience.
• Review of adult and pediatric data from Monteris' prospective LAANTERN Registry.

The document explicitly states: "Monteris has concluded from these reviews that the NeuroBlate LITT system has been, and remains, an effective and safe tool for use in pediatric patients." This serves as the "study" for this submission, validating the labeling change rather than a new device performance study. However, specific details about the methods or data from these reviews are not included in this FDA letter.

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The TRANBERG®|Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm.

When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonancefrequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time.

The TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of analysis using the TRANBERG®|Thermoguide Therapy System.

The TRANBERG®|Thermoguide Therapy System is indicated for use in an MRI suite to perform soft tissue ablations under MRI guidance, it consists of three parts:

• 1. TRANBERG®|Mobile Laser Unit, cleared by K142216.
• 2. TRANBERG®|Laser applicator and introducer, cleared by K201466.
• 3. TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission.

The TRANBERG® Mobile Laser Unit includes a laser generator that operates at the wavelength of 1064nm, a continuous wave. The generated laser light is locally applied by means of a single use applicator kit (TRANBERG®)Laser applicator and introducer, cleared by K201466) through a minimally invasive surgical or percutaneous procedure. The energy from the laser generator is transmitted to tissue through the TRANBERG® Laser applicator and absorbed by the tissue surrounding the laser applicator, resulting in increased tissue temperature that necrotizes or coagulates soft tissue. The TRANBERG® Laser applicator is a 12m long optical fiber that allows the laser generator to be placed in the MRI control room. A workstation with software (TRANBERG®)Thermoguide Workstation) is used to extract temperature maps from magnetic resonance (MR) images and to calculate the thermal dose in treated tissue. Algorithms used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature.

The TRANBERG® Mobile Laser Unit has safety systems to prevent the use of a malfunctioning unit, including self-testing at startup and continuous monitoring of software and components that are critical for the unit and laser emission to function optimally. All laser safety requirements are met according to IEC 60601-2-22:2019.

The TRANBERG® Laser applicator utilizes an RFID tag which limits the maximum power and time (per applicator type) that can be used. It also ensures that an expired fiber, a reused fiber, or a fiber programmed for a different use cannot be used as a treatment fiber.

The TRANBERG®|Thermoguide Workstation has an interface for control of the TRANBERG®|Mobile Laser Unit output through the computer interface port of the laser control). It controls power and time settings on the laser unit, and it can start and stop the laser control and safety as per medical laser equipment requirements are managed by the TRANBERG®|Mobile Laser Unit.

Mandatory conditions must be satisfied to enable the laser unit and run a treatment. When one of more of these conditions are not met, the laser will not allow emitting laser radiation until all conditions are fulfilled:

• Real time images from the scanner are received at least every 5s. If Thermoguide Workstation detects update rates longer than 5s the laser emission is automatically interrupted.
• Laser unit enabled and the connection is verified, any loss of communication within 1.5s between the Laser unit and Thermoquide workstation or data incoherency automatically stops the laser emission.
• The use of the RFID tag is a mandatory condition to run a treatment and limits the maximum power and time (per applicator type).
• Laser Applicator type confirmed and received by TRANBERG®Thermoguide Workstation, the information is read on the RFID tag belonging to the fiber.
• Minimum 1 ROI (monitoring or guard) has been set.
• Baseline temperature (e.g., core body temperature) is set and confirmed
• B0 drift compensation: Reference baseline ROI is set and confirmed
• Placement of the High temperature guard ROI.
• Test dose successful and confirmed

Safety guard functionality: TRANBERG®Thermoguide Workstation can be used to prescribe limits for the temperature at certain points (ROIs) in the image which can, in turn, be used to deactivate the laser if the limits are reached.

The given text is a 510(k) summary for the TRANBERG®|Thermoguide Therapy System. It describes the device, its intended use, and lays out the argument for its substantial equivalence to a predicate device (Visualase™ Thermal Therapy system, K181859). The document focuses on technological comparisons and performance data obtained through bench testing and a pre-clinical animal study. However, it explicitly states: "No clinical data was provided in support of this submission."

Therefore, based on the provided document, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria using clinical data or human evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the performance data submitted for FDA clearance, which here consists of bench testing and preclinical animal studies.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is explicitly stated as not present:

Acceptance Criteria and Device Performance (Based on available data)

Since no clinical study involving acceptance criteria for diagnostic performance (like sensitivity, specificity, accuracy) is mentioned for human use, the "acceptance criteria" discussed here are related to the successful operation and performance of the device's thermometry algorithm and safety features during non-human testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the explicit statement "No clinical data was provided in support of this submission," the following sections cannot be fully answered or are marked as not applicable based on the provided document.

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

• Sample Size:
  • Bench Testing: Not specified in terms of numerical "sample size" for data points, but described in terms of tests performed to verify compliance and functionality.
  • Pre-clinical Animal Study: The document mentions "a prospective preclinical animal study under GLP conditions." The exact number of animals or data points from this study is not specified.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the manufacturer is "Clinical Laserthermia Systems AB, Lund, Sweden."
  • Retrospective or Prospective: The animal study was "prospective." Bench testing is inherently prospective in nature (tests are performed on the device).

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

• Not applicable for the reported performance studies. The "ground truth" for technical performance was established through physical measurements (for thermometry algorithm accuracy) and defined specifications (for functional tests). For the animal study, the ground truth would be based on direct measurements and pathological assessment of ablated tissue, not human expert consensus on images.
• The device's Indications for Use state, "When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy." However, no study involving human interpretation of the device's output for establishing clinical ground truth is described.

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

• Not applicable. This typically refers to the process of resolving discrepancies among multiple human readers in a diagnostic study. Since no human reader studies are described, no adjudication method was used.

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 document explicitly states: "No clinical data was provided in support of this submission."

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

• Yes, in essence, the "Thermometry Algorithm Accuracy" and "Near Real-time Performance" evaluations described under bench testing are standalone performance assessments. These tests evaluated the algorithm's ability to accurately calculate and display temperature maps and thermal dose independent of a human operator making clinical decisions based on the output. The pre-clinical animal study also assessed the device's performance in generating accurate thermal data without human intervention in the data generation process itself.

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

• Physical Measurements: For the accuracy of the thermometry algorithm, the ground truth was based on physical measurements of temperature.
• Defined Specifications: For functional testing and compliance, the ground truth was the satisfaction of predefined engineering and safety specifications (e.g., proper communication, correct power output, safety interlocks).
• Pathology/Tissue Assessment: For the pre-clinical animal study, the ground truth for thermal damage would typically be established through histological examination of the ablated tissue, comparing the predicted thermal damage to the actual tissue necrosis.

8. The sample size for the training set

• Not applicable / Not specified. This submission is for a medical device that includes software for processing MR images to display temperature and thermal dose. The document describes the algorithms used as "well established and described in scientific literature," implying that they are based on known physical principles (Proton Resonance-Frequency shift analysis, CEM43 algorithm) rather than being a deep learning or AI model trained on a large dataset in the conventional sense. Therefore, there's no "training set" in the context of machine learning model development specified here.

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

• Not applicable / Not specified. As noted above, the device seems to rely on established physics-based algorithms rather than a trained AI/ML model that would require a ground-truth-labeled training set. If the algorithms involved any parameter tuning or classical machine learning components, that data and its ground truth are not detailed in this summary.

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The Visualase MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064mm lasers.

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: a diode laser (energy source) a coolant pump to circulate saline through the laser application Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; two monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections Remote Presence software provides a non-clinical utility application for use by Medtronic only and is not accessible by the user

The provided text describes specific details about the Visualase MRI-Guided Laser Ablation System (SW 3.4) and its comparison to predicate devices, but it does not contain a table of acceptance criteria or a detailed study description with performance metrics in the format requested.

The "Testing Summary" section mentions in vivo testing to demonstrate accuracy and performance of MR Thermometry and Thermal Damage Estimate, as well as software and system verification and validation. However, it does not provide:

• Specific acceptance criteria values (e.g., "accuracy must be within X degrees Celsius").
• Reported device performance values against these criteria.
• Sample sizes for the test set.
• Data provenance.
• Details about expert involvement or adjudication.
• Information on MRMC studies or standalone AI performance.
• Details about the training set.

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

Here's a breakdown of what can be extracted and what is missing based on your request:

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

• Acceptance Criteria: Not explicitly stated with numeric values in the document. The general statement is "Testing demonstrated the accuracy and precision of the Visualase MRI-Guided Ablation System's Thermal Damage Estimate and MR Thermometry for its intended use."
• Reported Device Performance: Not provided (e.g., no specific accuracy values, precision values, or success rates are given).

2. Sample sized 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: The testing was "In vivo testing conducted 1.5T and 3.0T (in accordance with 21 CFR 58)". 21 CFR Part 58 refers to Good Laboratory Practice for nonclinical laboratory studies, which implies prospective in vivo studies, but does not specify the origin of the data (e.g., country).

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

• Not specified.

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

• Not specified.

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

• The document implies the device is a tool used by a neurosurgeon. It does not describe a comparative effectiveness study involving human readers with or without AI assistance, or any effect size for such a study.

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

• The document states the system "provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output." It is an MRI-guided system implying human-in-the-loop operation. No standalone algorithm-only performance is described.

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

• Given it's "in vivo testing" for "Thermal Damage Estimate" and "MR Thermometry," the ground truth likely involved a direct measurement method for temperature or thermal damage in the tissue, possibly through implanted probes or post-ablation pathological assessment, but the specific method is not detailed.

8. The sample size for the training set

• Not applicable as this document describes performance of a medical device (laser ablation system with software), not a machine learning model explicitly detailing training data. The software components are verified and validated, but no "training set" in the context of AI/ML is mentioned.

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

• Not applicable for the reasons stated above.

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