(116 days)
The Multifunctional linear pen is a sterile, single use electrosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the AtriCure Ablation and Sensing Unit or to the ASU Source Switch in Ablation mode and the Multifunctional linear pen may be used 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 Multifunctional linear 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 AtriCure Ablation and Sensing Unit (ASU) directly or via the AtriCure ASU Source Switch in ablation mode, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the pen is connected to a commercially available temporary pacemaker or recorder the pen is used for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery.
The information provided describes a 510(k) submission for the AtriCure Multifunctional Linear Pen. A 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing acceptance criteria and conducting a detailed study with specific performance metrics against those criteria in the way a clinical trial would for a novel device.
The document states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. In-vitro and in-vivo testing demonstrated that the Multifunction linear pen is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the AtriCure Isolator Transpolar pen and the AtriCure Coolrail linear pen."
This indicates that the acceptance criteria are implicitly defined by the performance of the predicate devices: the AtriCure Isolator Transpolar pen (K050459, K061593) and the AtriCure Coolrail linear pen (K073605). The study's goal was to show similar performance. However, specific quantitative acceptance criteria and detailed performance metrics are not explicitly provided in this 510(k) summary.
Based on the provided text, a table of explicit acceptance criteria and reported performance cannot be fully constructed as it would be for a direct performance study against pre-defined thresholds. The submission focuses on substantial equivalence, meaning the new device's safety and effectiveness are similar to legally marketed predicate devices.
Here's an attempt to extract and present the information as requested, acknowledging the limitations of data from a 510(k) summary:
Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) premarket notification, the "acceptance criteria" are implicitly set by the performance and safety profiles of the legally marketed predicate devices. The study's objective was to demonstrate substantial equivalence rather than meeting specific numerical performance targets.
| Acceptance Criterion (Implicitly based on Predicate Devices) | Reported Device Performance (Summary in 510(k)) |
|---|---|
| Cardiac Ablation: Ability to ablate cardiac tissue using RF energy safely and effectively. | Demonstrated ability to ablate cardiac tissue "as safely and effectively as" the AtriCure Isolator Transpolar pen and AtriCure Coolrail linear pen (predicate devices). |
| Cardiac Pacing: Ability for temporary pacing during surgery. | Demonstrated ability to pace cardiac tissue "as safely and effectively as" the predicate devices. |
| Cardiac Sensing: Ability for temporary sensing during surgery. | Demonstrated ability to sense cardiac activity "as safely and effectively as" the predicate devices. |
| Cardiac Stimulation: Ability for temporary stimulation during surgery. | Demonstrated ability to stimulate cardiac tissue "as safely and effectively as" the predicate devices. |
| Biocompatibility: Materials suitable for intended use, no adverse biological reactions. | Materials suitable for intended use, testing conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility. |
| Conformance to Product Specification: Meeting engineering and design requirements. | "Appropriate product testing was conducted to evaluate conformance to product specification." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "in-vitro and in-vivo testing," but does not provide details on the number of samples, animals, or human subjects used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this 510(k) summary. The testing described is technical or preclinical (in-vitro/in-vivo) to demonstrate functional equivalence, not a clinical study requiring expert ground truth or consensus.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically relevant for clinical studies involving human subject data and interpretive assessments, which are not detailed in this submission.
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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. An MRMC study is not mentioned. This device is a surgical tool, not an AI diagnostic or interpretive device.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a medical device, not an algorithm. The testing described involves the device's physical functions (ablation, pacing, sensing, stimulation).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "in-vitro" and "in-vivo" testing, the ground truth would likely be based on established physiological measurements, histological analysis (for ablation efficacy), and direct observation of electrical signals (for pacing/sensing/stimulation).
- However, specific details on how this "ground truth" was established are not provided in the 510(k) summary. The primary "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.
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The sample size for the training set:
- Not applicable. This is a hardware medical device, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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.