(919 days)
The AtriCure Bipolar (Transpolar) System is intended for the ablation of cardiac tissue during surgery.
The Atricure Bipolar System is comprised of a bipolar clamping hand-piece with integral cable (Isolator™), and a re-useable generator, (Ablation and Sensing Unit, ASU).
The provided text describes a 510(k) submission for the AtriCure Bipolar System, a device intended for the ablation of cardiac tissue during surgery. However, the document does not contain detailed information regarding specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, ground truth establishment, or expert qualifications in the way a clinical study report would.
The document states that "Appropriate preclinical product testing was conducted to evaluate conformance to the product specification and demonstrate substantial equivalence to predicate devices. Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided in support of this submission." This is a high-level summary and lacks the specific details requested.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or explicitly stated, and note where information is missing.
Acceptance Criteria and Device Performance Study
| Category | Description/Information |
|---|---|
| 1. Acceptance Criteria & Performance | Acceptance Criteria: The document implies that the acceptance criteria were primarily related to "conformance to the product specification" and "substantial equivalence to predicate devices," as well as "acute safety and [the] ability to create lines of electrical conduction block in the heart as assessed intraoperatively." Specific quantitative thresholds for these criteria are not provided. |
Reported Device Performance: The document generally states that "Appropriate preclinical product testing was conducted" and "Clinical data demonstrating the device's acute safety and ability to create lines of electrical conduction block in the heart as assessed intraoperatively were also provided." However, no quantitative results or specific performance metrics are reported in the summary provided. |
| 2. Sample Size (Test Set) & Data Provenance | Sample Size: The document states "Clinical data..." but does not specify the sample size for any clinical or test sets used.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "preclinical product testing" and "clinical data," indicating some prospective clinical testing was likely involved given the mention of "intraoperatively." |
| 3. Number & Qualifications of Experts (Ground Truth) | Number of Experts: The document does not specify the number of experts used to establish ground truth.
Qualifications of Experts: The document does not specify the qualifications of any experts involved in ground truth establishment. It only mentions "clinical data demonstrating... as assessed intraoperatively." |
| 4. Adjudication Method (Test Set) | The document does not describe any adjudication method used for a test set. |
| 5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study | Not Applicable/Not Reported: The document describes a medical device for cardiac tissue ablation, not a diagnostic imaging device typically associated with MRMC studies comparing human readers with and without AI assistance. Therefore, such a study is not mentioned and likely not relevant in this context. |
| 6. Standalone Performance (Algorithm Only) | Not Applicable/Not Reported: The AtriCure Bipolar System is a surgical device, not a software algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI/ML devices is not applicable and not reported. |
| 7. Type of Ground Truth Used | The document mentions "ability to create lines of electrical conduction block in the heart as assessed intraoperatively." This implies that the ground truth for device effectiveness was established through intraoperative assessment (likely physiological measurements/mapping) of electrical conduction block, which could be considered a form of physiological outcome data or direct expert observation within a clinical setting. |
| 8. Sample Size for Training Set | The document discusses "preclinical product testing" and "clinical data" but does not explicitly mention or specify any 'training set' sample size. This concept is more common in AI/ML device development and less so for traditional surgical devices, where the focus is on verification and validation testing. |
| 9. How Ground Truth for Training Set Was Established | As no explicit "training set" is mentioned in the context of AI/ML, the method for establishing its ground truth is not applicable/not detailed. For the overall device development, ground truth was implicitly established through standard engineering principles, preclinical studies, and clinical data showing conformance to specifications and desired physiological effects. |
§ 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.