(199 days)
The AtriCure Bipolar System including Isolator Synergy Dual Electrode Clamps is intended for the ablation of cardiac tissue during surgery.
The AtriCure Bipolar System includes hand held, single use, dual electrode, bipolar radiofrequency (RF) surgical instruments (Isolator Synergy™ Clamps) intended for the ablation of cardiac tissue. The clamp handpieces are connected via an integral cable to the AtriCure reuseable Ablation and Sensing Unit (ASU2) and the accessory Isolator Switch Matrix (ASB3).
Here's an analysis of the provided text regarding the AtriCure Bipolar System, structured to address your specific questions.
Based on the provided text, the device is an electrosurgical cutting and coagulation device accessory intended for the ablation of cardiac tissue during surgery. The submission is a 510(k) Pre-Market Notification, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical studies with detailed acceptance criteria and performance statistics like a PMA (Pre-Market Approval) submission would.
Therefore, much of the requested information, particularly quantitative details on acceptance criteria and specific study designs as you might find for novel AI-powered diagnostic devices, is not explicitly present or relevant in this type of submission. The text emphasizes demonstrating equivalency to a predicate device.
Acceptance Criteria and Device Performance
There are no explicit, quantitative acceptance criteria defined in the provided text in the way one might expect for a new diagnostic or AI-powered device. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device, especially regarding lesion transmurality and safe/effective operation.
The text states: "Clinical study data has proven lesson transmurality using the AtriCure Bipolar System including Isolator Synergy Dual Electrode clamps via assessment of pulmonary vein isolation."
Since this is a 510(k) for a surgical ablation device, the "performance" is largely about its ability to safely and effectively create cardiac tissue lesions, specifically achieving transmurality (meaning the lesion extends fully through the heart wall). The "acceptance" is the FDA's determination of substantial equivalence.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Substantial Equivalence to Predicate Device | Demonstrated through testing, materials, intended use, and method of operation. |
| Lesion Transmurality | "Proven" via clinical study data and assessment of pulmonary vein isolation. |
| Safety and Efficacy (General) | All appropriate testing performed; components met required specifications. |
Detailed Study Information (Based on Available Text)
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The text only mentions "Clinical study data."
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified. It's safe to assume a clinical study for a surgical device would likely be prospective, but this is not explicitly stated.
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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. For a surgical ablation device, "ground truth" might be assessed by surgeons, electrophysiologists, or pathologists examining ablated tissue.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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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 is not applicable. The device is a surgical instrument (bipolar RF ablation clamps), not an AI-powered diagnostic or assistive tool for "human readers." Therefore, an MRMC study with "human readers" is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. This is a physical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The text mentions "assessment of pulmonary vein isolation" to prove lesion transmurality. This assessment method could involve:
- Electrophysiological testing (e.g., demonstrating no conduction across the ablation line post-procedure).
- Pathological examination of tissue samples (if an animal study) or resected human tissue (less common in this context).
- Imaging modalities to assess scar formation.
- The exact "type of ground truth" is not detailed beyond "assessment of pulmonary vein isolation."
- The text mentions "assessment of pulmonary vein isolation" to prove lesion transmurality. This assessment method could involve:
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The sample size for the training set
- Not applicable / Not specified. This device is hardware. There is no "training set" in the context of machine learning or AI algorithms. The term "training set" is not relevant here. The 'training' for this device would refer to non-clinical testing (e.g., engineering, bench, and animal studies) and then clinical study data.
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How the ground truth for the training set was established
- Not applicable. As above, there is no "training set" in the AI sense for this device. The "ground truth" for demonstrating safety and effectiveness relied on preclinical (chronic and acute animal studies) and clinical data demonstrating lesion transmurality and substantial equivalence to the predicate.
§ 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.