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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.

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.

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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.

Detailed Study Information (Based on Available Text)

1. 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.

2. 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.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not specified.

4. 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.

5. 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.

6. 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."

7. 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.

8. 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.

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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

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. |

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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.

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.

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