(80 days)
The AtriCure Bipolar System is intended for the ablation of cardiac tissue during surgery.
The AtriCure Bipolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument {Isolator Transpolar Clamps or Isolator Synergy Clamps} intended for the ablation of cardiac tissue and an accessory instrument guide (Glidepath™ Tape). The clamp handpieces are connected via an integral cable to the AtriCure re-usable Ablation and Sensing Unit (ASU2) and an Isolator Switch Matrix (ASB3) console. This 510(k) specifically seeks approval of a modification to AtriCure Bipolar System to include the Synergy Access Clamp. The only changes incorporated in the Synergy Access Clamp is the addition of mechanical features allowing for more surgical options due to surgeon preference and varying patient body habitus including a hinged jaw assembly allowing jaw position to be locked at the preferred angle and a passive proximal jaw allowing wider jaw aperture. There are no changes being made to the current Isolator Synergy Clamps, the Ablation and Sensing Unit or the Isolator Switch Matrix as part of this 510(k).
Here's an analysis of the provided text regarding the acceptance criteria and study information for the AtriCure Bipolar System:
Summary of Device and Study Information:
The provided document is a 510(k) summary for the AtriCure Bipolar System, specifically seeking approval for a modification to include the Synergy Access Clamp. The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through new clinical trials with defined acceptance criteria for disease detection/diagnosis. Therefore, the information provided focuses on engineering and biocompatibility testing, along with a statement of equivalence.
The document does not contain information related to a study that would typically establish acceptance criteria in the context of diagnostic or assistive AI devices (e.g., sensitivity, specificity, accuracy for a particular task). Instead, the "acceptance criteria" here would be implicitly conformance to product specifications and substantial equivalence to predicate devices. The study performed is a series of engineering verification and validation tests rather than a clinical trial measuring a device's performance in a diagnostic or treatment outcome context against a ground truth.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not define explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy that would be expected for an AI/diagnostic device. Instead, the general acceptance criteria are conformance to product specifications and substantial equivalence to predicate devices. The reported performance is that the device met these criteria.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Conformance to product specification (mechanical, electrical, reliability, transit, aging) | "complete design verification testing was performed including but not limited to mechanical testing, electrical safety and compliance testing, reliability testing per the device design life, transit, and aging to ensure the design outputs meets the design input specifications." |
| Biocompatibility (ISO 10993-1) | "All materials used in the manufacture of the AtriCure Bipolar System are suitable for their intended use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials." |
| Ability to ablate cardiac tissue safely and effectively | "In-vitro and in-vivo testing demonstrated that the proposed AtriCure Bipolar System is able to ablate cardiac tissue as safely and effectively as the previously approved AtriCure Bipolar System." (This implies the performance is at least equivalent to the predicate, even if specific numerical performance metrics are not given). |
| Substantial Equivalence to Predicate Devices | "The AtriCure Bipolar System is equivalent to the predicate products as shown through the device descriptions and provided performance data. The indications for use, basic overall function, and materials used are substantially equivalent to the predicate devices." (The FDA's 510(k) clearance confirms this finding: "We have reviewed... and have determined the device is substantially equivalent..."). |
Detailed Information on the "Study" (Verification and Validation Testing):
The document describes engineering verification and validation testing, not a clinical study in the typical sense of evaluating diagnostic or treatment efficacy with patient outcomes.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not explicitly stated in terms of number of devices or cardiac tissue samples. The text mentions "in-vitro and in-vivo testing," but details on the number of samples or subjects are not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a 510(k) for a surgical tool, the "data" largely refers to engineering test results and potentially animal (in-vivo) studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. The ground truth for this type of device (a surgical ablation tool undergoing 510(k) clearance) is typically objective measurements (e.g., temperature achieved, lesion size, electrical performance, material properties) and comparison to the performance of predicate devices, not expert consensus on diagnostic images or patient data.
4. Adjudication Method for the Test Set:
- Not applicable. This is not a study requiring adjudication of expert opinions or interpretations.
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 a surgical instrument, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a surgical device, not an algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for showing substantial equivalence for this device would be established through:
- Objective Engineering Measurements: Conformance to electrical, mechanical, and reliability specifications.
- Biocompatibility Testing: Results according to ISO 10993-1 standards.
- Pre-clinical Performance Characteristics: In-vitro and in-vivo data demonstrating the ability to ablate cardiac tissue, with performance comparable to predicate devices. This might involve measuring lesion characteristics in animal models or explanted tissue.
8. The Sample Size for the Training Set:
- Not applicable for this type of device and submission. There is no "training set" in the context of an AI/machine learning model. The device design is based on engineering principles and prior validated devices.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no training set for an AI model.
§ 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.