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Concerto™ Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete able them of nonresectable liver lesions.

The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue. The device consists of a needle with two electrically independent opposing arrays that are contained within an insulated delivery cannula. The arrays are attached to a handle mechanism that allows the arrays to be individually deployed out from the cannula into the targeted tissue. The Concerto™ Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the tissue surrounding and in between the arrays. No grounding pads are required due to the device's Bipolar technology.

The provided text describes a Special 510(k) for a modified Concerto™ Bipolar Needle Electrode. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to the predicate device. It usually focuses on demonstrating that the modifications do not raise new issues of safety or effectiveness and often relies on performance standards rather than extensive clinical studies or AI algorithm performance evaluations.

Based on the provided text, the device is a hardware product (an electrosurgical needle electrode), not an AI/ML powered medical device. Therefore, much of the requested information regarding AI-specific criteria (like AI algorithm performance, test/training sets, experts for ground truth, MRMC studies) is not applicable.

Here's an analysis of the provided text with respect to the questions, focusing on what is available and noting what is not applicable:

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

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

This information is not provided in the given text. The filing is a Special 510(k), which focuses on design changes and compliance with performance standards for hardware, not typically on extensive clinical data or algorithm performance. The device is tested and compared to the predicate device, but details of this testing (sample sizes, prospective/retrospective nature, data provenance) are not included in the summary.

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 question is not applicable as the device is a hardware medical device (electrosurgical needle electrode), not an AI/ML powered device requiring expert-established ground truth for a test set in the traditional sense of image analysis or diagnostic AI. The "ground truth" for this device would refer to its performance against engineering specifications and its ability to achieve thermal coagulation necrosis as intended, assessed through engineering and possibly animal/cadaveric bench testing, rather than expert clinical interpretation of data.

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

This question is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies or AI/ML evaluations where there is a need to resolve discrepancies in expert interpretations or diagnoses.

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

This question is not applicable. An MRMC study is relevant for evaluating the clinical utility of diagnostic aids, especially AI algorithms, on human reader performance. This device is an interventional electrosurgical tool, not a diagnostic imaging or AI tool.

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

This question is not applicable. The device is an electrosurgical needle electrode, which is a physical tool operated by a clinician, not a standalone algorithm.

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

Given this is a hardware device, the "ground truth" would likely refer to:

• Engineering specifications and measurements: Verifying electrical conductivity, insulation integrity, deployment mechanism, material properties, and dimensional accuracy.
• Bench testing: In vitro models to demonstrate coagulation zone formation and temperature profiles.
• Pre-clinical (animal/cadaveric) studies: To assess tissue effects, coagulation necrosis size, and safety.

The text states, "The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent." This implies that the ground truth for comparison was established through performance testing against the predicate and established standards, rather than expert consensus on diagnostic images or pathology reports with respect to an AI output.

8. The sample size for the training set

This question is not applicable. As a hardware medical device, there is no "training set" in the context of machine learning.

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

This question is not applicable for the same reason as point 8.

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Concerto™ Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue. The device consists of a needle with two electrically independent opposing arrays that are contained within an insulated delivery cannula. The arrays are attached to a handle mechanism that allows the arrays to be individually deployed out from the cannula into the targeted tissue. The ConcertoTM Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the tissue surrounding and in between the arrays. No grounding pads are required due to the device's Bipolar technology.

The provided document is a 510(k) Summary for a medical device called the "Concerto™ Bipolar Needle Electrode." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study with specific acceptance criteria and performance metrics for a new device or algorithm in the way a clinical trial or performance study report would.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and MRMC studies are not present in this type of regulatory submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present quantitative acceptance criteria or specific performance metrics in the format of a table as typically seen for AI device evaluations. Instead, it asserts substantial equivalence to a predicate device.

The "Performance Standards" section states:

• "The modified Concerto Bipolar Needle Electrode has been designed to comply with the applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18/2001 and the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001."

The "Summary of Substantial Equivalence" section states:

• "The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised."

These statements imply that the acceptance criterion for this submission was demonstrating compliance with the referenced industry standards and showing that the modified device performs similarly, without raising new safety or efficacy concerns, compared to its predicate. The "reported device performance" is implicitly that it meets these standards and is substantially equivalent to the predicate.

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

Not applicable. This is a 510(k) premarket notification for a modified physical medical device, not a data-driven AI algorithm. The "test set" would refer to specific engineering and performance tests conducted to ensure compliance with standards and equivalence to the predicate, but detailed sample sizes for these tests are not provided in this summary.

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

Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or similar AI-related tasks.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving expert interpretation, typically for AI or diagnostic devices. This document is for a physical electrosurgical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. MRMC studies are specific to evaluating diagnostic devices, especially those incorporating AI, and their impact on human reader performance. This document is not about such a device.

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

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device would be defined by engineering specifications, material properties, electrical performance criteria, and the clinical outcomes/safety profile of the predicate device. Compliance with the specified ANSI/AAMI and IEC standards serve as the "ground truth" for demonstrating device safety and performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm that undergoes training on a dataset.

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

Not applicable.

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Concerto™ Bipolar Needle Electrode is intended to be used in conjunction with a Boston Scientific radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

The Concerto™ Bipolar Needle Electrode is a disposable, electrosurgical device used for coagulation necrosis of soft tissue. The device consists of a needle with two electrically independent opposing arrays that are contained within an insulated delivery cannula. The arrays are attached to a handle mechanism that allows the arrays to be individually deployed out from the cannula into the targeted tissue. The ConcertoTM Bipolar Needle Electrode is connected to Boston Scientific radiofrequency (RF) generator so that energy passes between the two arrays and heats the tissue surrounding and in between the arrays. No grounding pads are required due to the device's Bipolar technology.

This document does not contain the detailed information necessary to complete all sections of your request. It is a 510(k) summary for a medical device (Concerto™ Bipolar Needle Electrode) seeking substantial equivalence to a predicate device, not a study report detailing specific acceptance criteria and performance data.

Here's what can be extracted and what cannot:

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

The document states: "The Concerto™ Bipolar Needle Electrode has been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent." and that the device "has been designed to comply with the applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18/2001 and the International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001."

However, specific numerical acceptance criteria (e.g., minimum power output, maximum temperature, lesion size, etc.) and the precise reported performance values against these criteria are not provided in this summary. It only states that the device was found substantially equivalent.

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.

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.

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

This information is not provided in the document.

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

This device is an electrosurgical needle electrode, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers/AI assistance is not applicable and not mentioned.

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

This refers to AI performance. Since this is a physical medical device (electrode),
"standalone" algorithm performance is not applicable.

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

This information is not provided in the document. For a physical device like this, ground truth would likely involve measurements of ablation size, temperature profiles, impedance, and other physical parameters, rather than expert consensus on images or pathology as seen in diagnostic AI.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of available information:

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

Missing Information: Specific numerical acceptance criteria, detailed performance metrics (e.g., precise ablation volumes, temperature maximums, power delivery characteristics) for both the predicate and the new device are not disclosed in this 510(k) summary.

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

• Sample Size: Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not provided as the ground truth for a physical device like this would typically be based on physical measurements and engineering tests, not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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, this type of study is not applicable to this device, which is an electrosurgical electrode and not an AI-based diagnostic tool.

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

• No, this is not applicable to a physical electrosurgical device.

7. The type of ground truth used:

• This would likely involve various engineering and preclinical measurements related to the device's technical specifications and tissue ablation characteristics (e.g., power output, temperature distribution, lesion size in ex vivo/in vivo models). However, the specific types of ground truth used are not detailed in this summary.

8. The sample size for the training set:

• Not applicable/Not provided.

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

• Not applicable/Not provided.

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