(29 days)
The AtriCure Bipolar System is intended to ablate and coagulate soft tissue during General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
The system is comprised of the Bipolar Handpiece (single patient use) with integral cable and the re-usable Ablation and Sensing Unit (ASU).
The ASU is a portable reusable device that produces and delivers RF bipolar energy near the AM frequency band to coagulate and ablate biological tissue. The device consists of a RF PCB (printed circuit board), microprocessor PCB, measurement PCB, display PCB, AC power supply, power entry module, volume control, footswitch Interface, and Handpiece interface. Front panel indicators include an LED temperature display, a LCD graphics conductance display, and LED lamps indicating power on, fault condition, ready state, RF on, and conductance state. The ASU limits the amount of voltage, current and time at which power is output to the Handpiece. Upon reaching a threshold conductance, the ASU will light a visual indicator and sound an audible tone signaling that the conditions for a complete ablation have been satisfied. A footswitch is included in the Ablation System to activate RF energy delivery.
The system delivers Bipolar RF energy to tissue that is clamped between the Handpiece jaws. Pressing of the footswitch initiates the RF energy output. RF energy output is terminated by releasing the footswitch or upon expiration of the RF backup timer.
The Handpiece connects to the ASU and utilizes Bipolar RF energy to ablate tissue that is clamped between the instrument jaws. The Handpiece includes a set of jaws that are capable of grasping tissue up to 10mm in thickness. Each jaw is comprised of an electrode with surrounding insulators and imbedded temperature-sensing element allowing for the transfer of energy to tissue and the monitoring of temperature rise by the tissue. The handle includes a lever that applies a controlled force to the tissue in the jaws. At a predetermined force the jaws latch. A trigger is provided to release the latch at the end of the ablation.
The provided document is a 510(k) premarket notification for the AtriCure Bipolar System, dated April 19, 2002. It focuses on demonstrating substantial equivalence to predicate devices based on product description and adherence to performance standards. It is not a study that proves a device meets specific acceptance criteria in terms of clinical performance or algorithm accuracy.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical or AI-related study design and outcomes, which are not present here.
Here's a breakdown of what can be inferred and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a particular clinical outcome, nor does it report "device performance" against such criteria. Instead, it lists performance industrial/international standards that the AtriCure Bipolar System meets. This indicates compliance with safety and engineering specifications, rather than clinical efficacy metrics.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI HF 18 (Electrosurgical Devices) | Meets the standard |
| ISO 10993/EN 30993 (Biological Evaluation of Medical Devices) | Meets the standard |
| ISO 11607 (Packaging for Terminally Sterilized Medical Devices) | Meets the standard |
| ISO 11135 (Medical Devices, Validation and Routine Control of Ethylene Oxide Sterilization) | Meets the standard |
| IEC/EN 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety) | Meets the standard |
| IEC/EN 60601-1-1 (Medical Electrical Equipment - Collateral Standard: Safety Requirements for Medical Device Systems) | Meets the standard |
| IEC/EN 60601-1-2 (Medical Electrical Equipment - Part 1: General Requirements for Safety 2: Collateral Standard: Electromagnetic Compatibility - Requirements and Tests) | Meets the standard |
| IEC/EN 60601-2-2 (Medical Electrical Equipment - Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment) | Meets the standard |
| IEC/EN 60601-1-4 (Medical Electrical Equipment - Part 1-4: General Requirements for safety - Collateral Standard: Programmable Electrical Medical Systems) | Meets the standard |
| UL 2601-1 (Standard for Safety: Medical Electrical Equipment) | Meets the standard |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a test set of data. It's a regulatory submission for device clearance based on substantial equivalence to predicate devices and compliance with engineering standards.
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)
Not applicable, as no clinical study with a test set and ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical study with a test set and ground truth establishment is described.
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
Not applicable. This device is an electrosurgical device, not an AI-powered diagnostic tool, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical study with ground truth is described. The "ground truth" in this context would be the successful and safe operation of the device in accordance with its specifications, which is addressed by meeting the listed engineering and biological safety standards.
8. The sample size for the training set
Not applicable, as no AI model or training set is mentioned.
9. How the ground truth for the training set was established
Not applicable, as no AI model or training set is mentioned.
§ 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.