(24 days)
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
| Acceptance Criteria (from recognized standards) | Reported Device Performance (as stated in submission) |
|---|---|
| Compliance with applicable sections of ANSI/AAMI American Standard for Electrosurgical Devices HF-18/2001. | "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." |
| Compliance with International Electrotechnical Commission Standard for Electrosurgical Devices, IEC 60601-2-2/2001. | "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." |
| Substantial Equivalence to the predicate device (Concerto™ Bipolar Needle Electrode). | "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." The text indicates the device "has been tested and compared to the predicate device." However, specific quantitative performance metrics comparing the modified device to the predicate are not provided in this summary. The stated performance is a qualitative declaration of substantial equivalence based on unspecified "data gathered" and comparison testing. |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.