(30 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 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:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Compliance with ANSI/AAMI Standard HF-18/2001 | Achieved |
| Compliance with IEC Standard 60601-2-2/2001 | Achieved |
| Substantial equivalence to predicate device (Reflect Bipolar/Monopolar Needle Electrode) | Achieved; "All data gathered demonstrate this device as substantially equivalent." |
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.
§ 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.