(34 days)
The Isolator™ Transpolar™ Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
The Isolator™ Transpolar™ pen System (Pen) is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator " Transpolar™ pen, a footswitch, and the ASB1 Source Switch accessor. The Pen is a hand-held, sterile, single patient use electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. When the Pen is connected to the ASU, either directly or via the ASB1 Source Switch set to the ASU port, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the ASB1 is set to the auxiliary port the pen may be used with a commercially available temporary pacemaker or recorder for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery, based on the function of the device to which it is connected. The two modes of operation, ablation and pacing/sensing cannot be active at the same time.
The provided text is a 510(k) summary for the AtriCure Isolator Transpolar Pen System, which is an electrosurgical device. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This type of document, particularly for electrosurgical devices, typically does not include detailed clinical study data with acceptance criteria, sample sizes for test sets, expert ground truth adjudication, or standalone algorithm performance as would be found in a submission for an AI/ML-based diagnostic device.
Therefore, many of the requested details are not present in the provided text. I will extract the information that is available and explicitly state when information is not provided.
Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as performance metrics in the provided text for this 510(k) summary. For medical devices like this, acceptance criteria often revolve around engineering specifications, safety testing (e.g., electrical safety, biocompatibility), and functional equivalence to predicate devices rather than clinical performance metrics (like sensitivity/specificity for diagnostic tools).
- Reported Device Performance: The document states, "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." No specific performance values (e.g., power output ranges, ablation lesion size, pacing accuracy) are reported in this summary.
| Criterion | Acceptance Value | Reported Performance |
|---|---|---|
| Clinical Performance Metrics | Not specified (N/A) | Not reported (N/A) |
| Substantial Equivalence | To predicate devices | Device is deemed substantially equivalent to predicate products for indications, function, and materials. |
| Material Biocompatibility | Conformance to ISO 10993-1 | Testing conducted in accordance with ISO 10993-1. |
| Product Specification Conformance | Conformance to internal product specifications | Appropriate product testing conducted. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided 510(k) summary. The testing mentioned appears to be primarily bench or engineering testing rather than a clinical trial with a defined "test set" of patients or cases in the context of diagnostic AI.
- Data Provenance: Not specified. Given the nature of the device (electrosurgical pen), provenance wouldn't be in terms of countries of origin for patient data but rather the location of engineering labs or test facilities. The document does not provide such details.
- Retrospective/Prospective: Not applicable in the context of this device's evaluation as described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The evaluation described is not based on expert-established ground truth for a diagnostic task.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no expert ground truth establishment or clinical test set adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is typically performed for imaging or diagnostic devices where human readers interpret data, often comparing AI-assisted vs. unassisted performance. This is an electrosurgical device, not a diagnostic one.
- Effect Size of Human Readers Improvement with AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not applicable. This device is a physical electrosurgical tool, not a software algorithm or AI model with standalone performance metrics.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the sense of expert consensus, pathology, or outcomes data for a diagnostic algorithm. The "ground truth" for this device's evaluation would be its adherence to engineering specifications, safety standards, and functional requirements, benchmarked against predicate devices and internal testing.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not developed using machine learning or AI models that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.
Summary of Study:
The "study" described in the 510(k) summary is not a clinical performance study with defined acceptance criteria and human reader evaluations as would be expected for AI/ML diagnostic devices. Instead, it's a regulatory submission demonstrating substantial equivalence to already legally marketed predicate devices.
The key points of the "testing" mentioned are:
- Evaluation of conformance to product specification.
- Evaluation of substantial equivalence to predicate devices.
- Biocompatibility testing in accordance with ISO 10993-1.
The conclusion is that the Isolator Transpolar Pen System is "substantially equivalent" to predicate products regarding its indications for use, basic overall function, and materials used. This means the device is considered as safe and effective as the predicate devices without requiring new clinical performance data to prove its efficacy, as its fundamental technology and application are already established.
§ 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.