(28 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.
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.
§ 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.