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The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide Optical Head platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).

The CLEAR GUIDE SCENERGY is a medical guidance and navigation software system that provides image fusion, instrument tracking, marker tracking, and target planning functionalities to operators during imageguided diagnostic or interventional procedures. The system uses data from multiple compatible imaging modalities that includes computed-tomography (CT), magnetic resonance imaging (MRI), or diagnostic ultrasound (US).

The CLEAR GUIDE SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data. the CLEAR GUIDE SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are ning that new inputs (e.g., a new CT or MRI) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

The provided text describes the Clear Guide SCENERGY device and its K234030 510(k) submission, confirming its substantial equivalence to a predicate device. However, the document does not contain detailed acceptance criteria or a comprehensive study report with specific performance metrics (e.g., sensitivity, specificity, accuracy) for the Clear Guide SCENERGY device itself beyond a general statement about clinical validation and intended use.

The clinical study mentioned (NCT05573048, "A Study of Optical Fusion Trans-Perineal Grid") focused on validating the workflow and characterizing the intervention accuracy of the device's modifications, specifically the new "PLAN" user interface and support for the SteriGRID accessory. It confirmed that the device "accurately achieved its intended use" without adverse effects or new risks, and that its performance was within the existing device performance. However, specific numerical acceptance criteria (e.g., target accuracy in millimeters) and the device's reported performance against those criteria are not detailed in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific numerical acceptance criteria for performance metrics (such as accuracy, sensitivity, specificity, etc.) for the Clear Guide SCENERGY device, nor does it present reported device performance against such metrics. It generally states that the device "accurately achieved its intended use" and that its performance was "within the existing device performance."

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

• Test Set Sample Size: 10 patients
• Data Provenance: Clinical data from a "small clinical testing" study (NCT05573048, "A Study of Optical Fusion Trans-Perineal Grid"). The country of origin is not explicitly stated, but clinicaltrials.gov is a US-based registry, suggesting it was likely conducted in the US or a region adhering to similar clinical trial standards. The study was prospective in nature, as it was a "clinical validation study" run to "further test the safety and effectiveness of the modifications."

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

This information is not provided in the given text. While it mentions the study was run to test safety and effectiveness, it does not detail how ground truth for accuracy was established, nor the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set:

This information is not provided in the given text.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned as being done for the K234030 submission. The clinical testing focused on validating the workflow and intervention accuracy of the modifications to the device itself, not on comparing human reader performance with and without AI assistance.

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

The document states that the "segmentation and registration algorithms are automated." The clinical testing focused on the overall device performance in a clinical workflow, which would inherently include human interaction with the system. While the algorithms themselves are automated, the described clinical study is not presented as a standalone, algorithm-only performance evaluation, but rather a validation of the modified device (which incorporates the algorithms) in a clinical context. The text does not provide specific metrics solely for the algorithmic performance in isolation.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The document mentions that the study "characterized the intervention accuracy within the existing device performance." It also refers to experiments using a "perineal template to facilitate needle localization for focal laser ablation of cadaveric prostate" as a comparison, which implies a physical measurement of accuracy. However, the specific method for establishing ground truth (e.g., direct measurement, post-procedure imaging, pathology confirmation) for the 10-patient clinical study is not detailed.

8. Sample Size for the Training Set:

This information is not provided in the given text. The document states that the "segmentation and registration algorithms are automated" and "proprietary," but it does not disclose details about their training.

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

This information is not provided in the given text.

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The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting, in patients of sufficient size (at least 25 kg).

The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.q., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

The Clear Guide SCENERGY is a software device that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. The device utilizes optical detection technology to identify and track objects, overlaying instrument positioning data onto existing ultrasound images through proprietary software algorithms for segmentation and registration.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the type of tests performed rather than specific numerical acceptance criteria. However, it indicates that the device's performance was evaluated to ensure its safe and effective operation compared to its predicate.

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

• Segmentation Testing: "phantom datasets" (specific number not provided). Data provenance is synthetic (phantom).
• Fusion Testing: Utilized phantoms. (Specific number of phantom datasets not provided). Data provenance is synthetic (phantom).
• Systematic Error (Tip-to-Tip) Testing: "Phantom datasets were utilized for this evaluation." (Specific number not provided). Data provenance is synthetic (phantom).
• Clinical Testing: "A small safety study was run... The study included patients ranging in age (5 to 17) and weight (11.9 to 78.9 kg) to demonstrate use in children and adolescents." (Specific number of patients not provided, but implies a prospective clinical study involving human subjects). The country of origin for this clinical data is not specified. It's a prospective study.

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

The document does not explicitly state the number of experts used for establishing ground truth or their qualifications.

• For Segmentation Testing, ground truth for fiducial markers was established by "manual selection." It's implied this was done by human experts, but their number and qualifications are not provided.
• For Fusion Testing and Systematic Error Testing, ground truth was based on measurements from phantom datasets and comparison to "ground truth CT (or MR)." The process for establishing this phantom-based ground truth or any expert involvement in verifying it is not detailed.
• For the Clinical Testing, the safety assessment would have involved clinicians, but their role in establishing ground truth for device performance measurements (if any were taken) is not specified.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test sets. For tests involving "manual selection" or comparison to "ground truth CT/MR," it implies a singular reference standard rather than an adjudicated consensus process.

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 MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The studies focus on the standalone performance of the device and its safety.

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

Yes, standalone performance (algorithm only) was assessed for:

• Segmentation Testing: Comparison of software outputs to manual selection in phantom datasets.
• Fusion Testing: Evaluation of the device's ability to provide fused images and assessment of Tissue Registration Error (TRE) using phantom datasets.
• Systematic Error (Tip-to-Tip) Testing: Measurement of cumulative error by comparing the device's displayed guidance to ground truth CT/MR needle points in phantom datasets.

These tests evaluate the device's algorithmic performance in isolation.

7. The Type of Ground Truth Used:

• Segmentation Testing: Ground truth was established by "manual selection" in phantom datasets, implying expert human judgment on fiducial markers.
• Fusion Testing: Ground truth was based on identifiable landmarks or surfaces on ultrasound and CT/MR in phantom datasets.
• Systematic Error (Tip-to-Tip) Testing: Ground truth was based on the "needle point seen by ground truth CT (or MR)" in phantom datasets.
• Clinical Testing: The "small safety study" would likely have relied on clinical observations and assessments by healthcare professionals for safety endpoints.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size used for the training set for the segmentation, registration, or fusion algorithms.

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

The document does not provide details on how the ground truth for the training set was established, as no information on the training set itself is given.

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The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.

The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

Here's a breakdown of the acceptance criteria and study information for the Clear Guide SCENERGY device based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the types of testing performed but does not explicitly state quantitative acceptance criteria or reported device performance metrics in a clear, tabular format. It states that "Performance testing of the Clear Guide SCENERGY device demonstrates that the product accurately achieves its intended use, while also showing that differences in technological features from the predicate device did not affect device performance." And, "Results of performance testing show that the subject device is as safe and as effective as the predicate device."

However, it describes the metrics used for evaluation:

Important Note: The document does not provide specific numerical values for TRE, "tip-to-tip" distance, or segmentation accuracy. It relies on a qualitative statement of meeting its intended function and being "as safe and as effective as the predicate device."

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

• Sample Size for Test Set: The document states that "Phantom datasets were utilized for this evaluation" for Systematic Error Testing, and "phantom datasets" were also used for Segmentation Testing. However, no specific number or size of these phantom datasets is provided.
• Data Provenance: "Phantom datasets" were used. This indicates simulated or artificial data, not human patient data. The document does not specify the country of origin for these phantom datasets, nor whether they are retrospective or prospective. Given they are phantoms, the latter distinction is less relevant.

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

• The document mentions "manual selection" for segmentation testing and "ground truth CT (or MR)" for systematic error testing. It implies that these "ground truths" are objective measures or expert-derived, but it does not specify the number of experts, their qualifications, or how they established the ground truth.

4. Adjudication Method:

• The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document primarily focuses on technical performance testing against a predicate device's established safety and effectiveness. It does not mention human reader performance or improvements with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes, standalone performance testing was done. The described "Segmentation Testing," "Fusion Testing," and "Systematic Error (Tip-to-Tip) Testing" evaluate the device's algorithmic performance (e.g., software outputs compared to manual selection, distance measurements for fusion and guidance accuracy) directly without human-in-the-loop interaction for the reported metrics. The device's segmentation and registration algorithms are described as "automated."

7. Type of Ground Truth Used:

• For Segmentation Testing: "Manual selection in phantom datasets." This implies an expert-derived ground truth.
• For Fusion Testing: "Identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR." This suggests comparison against established anatomical structures or markers within the imaging modalities.
• For Systematic Error (Tip-to-Tip) Testing: "Ground truth CT (or MR)." This indicates reference imaging data as the standard.

Overall, the ground truth appears to be a combination of expert-derived measurements/selections and reference imaging data (CT/MR).

8. Sample Size for the Training Set:

• The document does not provide any information regarding the sample size used for the training set. It focuses on the validation of the device.

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

• The document does not provide any information regarding how the ground truth for the training set was established, as it does not discuss the training phase of the algorithms.

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The Clear Guide SCENERGY is software that provides fusion of images from Computed Tomography (CT), Magnetic Resonance (MR), and Ultrasound (US) modalities. US images can be fused with either CT or MR.

The Clear Guide SCENERGY utilizes the Clear Guide CORE and Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide SCENERGY might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or an ablation needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.

The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from multiple modalities (e.g., ultrasound and computed-tomography (CT), ultrasound and magnetic resonance (MR)). The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated. Segmentation results are deterministic, meaning that new inputs (e.g., new CT or MR) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

Acceptance Criteria and Study for Clear Guide SCENERGY

This document describes the acceptance criteria and the study that demonstrates the Clear Guide SCENERGY device meets these criteria. The information is extracted from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes performance testing without explicitly stating numerical acceptance criteria with pass/fail thresholds. However, it indicates that the device's performance was evaluated against the intended function and compared to the predicate device. The performance categories are inferred from the "Performance Data" and "Software Verification and Validation Testing" sections.

Study Details:

The provided text details various performance tests conducted to demonstrate the substantial equivalence of the Clear Guide SCENERGY to its predicate device. This appears to be a standalone performance study focused on the device's functional capabilities.

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

• Sample Size for Test Set:
  • Segmentation Testing: "phantom datasets" (specific number not provided).
  • Fusion Testing: No specific number of datasets mentioned, but "identifiable landmarks or surfaces" were used.
  • Systematic Error (Tip-to-Tip) Testing: "Phantom datasets were utilized" (specific number not provided).
• Data Provenance: The study primarily used phantom datasets. There is no mention of human subject data, country of origin, or whether the data was retrospective or prospective.

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

• Segmentation Testing: "manual selection in phantom datasets" was used as ground truth. The number and qualifications of experts performing this manual selection are not provided.
• Fusion Testing: "identifiable landmarks or surfaces seen on ultrasound and CT, or ultrasound and MR" were used for TRE assessment. It is not specified how these identifiable landmarks were established or if expert input was involved in defining them.
• Systematic Error (Tip-to-Tip) Testing: "ground truth CT (or MR)" was used to define the actual needle point. It is not specified how this ground truth was established or if experts were involved.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating disagreements, as expert consensus is not explicitly detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study focused on technical performance rather than human reader improvement with or without AI assistance.

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

Yes, a standalone performance study was done. The described "Performance Data" and "Software Verification and Validation Testing," including "Segmentation Testing," "Fusion Testing," and "Systematic Error (Tip-to-Tip) Testing," all evaluate the algorithm's performance directly against established ground truth (e.g., manual selection, identifiable landmarks, ground truth CT/MR needle point) without human interaction being part of the primary measurement of the device's accuracy.

7. The Type of Ground Truth Used

• Segmentation Testing: Ground truth was established by manual selection in phantom datasets.
• Fusion Testing: Ground truth for TRE assessment relied on identifiable landmarks or surfaces within fused images.
• Systematic Error (Tip-to-Tip) Testing: Ground truth was based on the needle point seen by ground truth CT (or MR) in phantom datasets.

In all cases, the ground truth was based on objective measurements or established references within phantom models, rather than pathology or patient outcomes.

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set. The descriptions focus solely on performance "testing" using phantom datasets.

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

Since information regarding a training set is not provided, the method for establishing its ground truth is also not specified. The details are centered on the evaluation of the device as a pre-trained system.

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The Clear Guide Scenergy is a stereotaxic accessory for the fusion of images from Computed Tomography (CT) and Ultrasound (US) modalities.

The Clear Guide Scenergy utilizes the Clear Guide SuperPROBE platform to display images of the target regions and the projected path of the interventional instrument, while taking into account patient movement and deformation. Instrumentation used with the Clear Guide Scenergy might include an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle. The device is intended to be used in any interventional or diagnostic procedure where the combination of these modalities is used for visualization, except for procedures on the brain. The device is intended for use in a clinical setting.

The Clear Guide SCENERGY guidance system is intended to be an accessory to existing ultrasound imaging systems, to provide image fusion, instrument tracking, and image/instrument guidance functionality to operators during image-guided medical interventions that utilize data from ultrasound and CT modalities. The Clear Guide SCENERGY uses optical detection technology to identify and track objects in the field of view. By pairing this information with the aforementioned imaging data, the Clear Guide SCENERGY executes proprietary software algorithms to display fused images in real-time to the clinician. These segmentation and registration algorithms are automated, and the user cannot modify either result. Segmentation results are deterministic, meaning that new inputs (e.g., a new CT) would be required to change the segmentation output. Registration can be reset by the user at any time during use.

Here's a breakdown of the acceptance criteria and study information for the Clear Guide SCENERGY, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it generally states that tests yielded "passing results" or were "within acceptable limits/criteria." However, it does describe the metrics used and confirms successful performance.

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

The document states that phantom, animal, and human datasets were used for various tests (Segmentation, Registration, Fusion, Deformation). However, it does not specify the exact sample sizes for each of these categories (e.g., number of CT scans, number of animals, number of human subjects).

The data provenance is generally described as:

• Phantom datasets: Used for Segmentation, Registration, Fusion, Systematic Error testing.
• Animal datasets (in-vivo porcine): Used for Segmentation, Registration, Fusion, Deformation testing.
• Human datasets: Used for Segmentation, Registration, Fusion testing.

The country of origin is not explicitly stated, nor is whether the data was retrospective or prospective. Given the nature of a 510(k) submission and the use of animal and human datasets, it's likely a mix of prospective (as part of the validation study) and potentially some retrospective data, but this is not confirmed.

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

The document mentions "manual selection" as the ground truth for segmentation testing but does not specify the number of experts who performed this manual selection, nor their qualifications (e.g., radiologist with X years of experience).

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth or resolving discrepancies, beyond stating that software outputs were compared to "manual selection" for segmentation.

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

The document does not report a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of how human readers improve with AI vs. without AI assistance. The performance data focuses on the device's accuracy and functionality in performing its tasks.

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

Yes, the testing described appears to be largely standalone algorithm performance from the perspective of accuracy of segmentation, registration, guidance, and fusion. For example, "Segmentation error and detection rate were analyzed, with passing results (per acceptability criteria)" directly assesses algorithms' outputs against ground truth. The "Guidance (Tip-to-Target) Testing" also assesses the device's ability to facilitate hitting a desired target. The entire section on "Performance Data" describes how the device itself (its software algorithms) performs.

7. The Type of Ground Truth Used

The types of ground truth used include:

• Manual Selection: Mentioned for Segmentation Testing (comparing software outputs to manual selection in phantom, animal, and human datasets).
• CT: Implied as the reference for "tip-to-tip" distance in Systematic Error Testing ("needle point seen by ground truth CT").
• Identifiable landmarks seen on ultrasound and CT: Used for Fusion Testing (Tissue Registration Error (TRE)).

It does not explicitly mention pathology or outcomes data as ground truth for these specific performance tests.

8. The Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for the Clear Guide SCENERGY's algorithms.

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

The document does not provide any information on how the ground truth for the training set was established. It only discusses the ground truth used for the validation/test sets.

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