(110 days)
The Isolator ™ Transpolar™ pen is a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Isolator Transpolar pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
This document is a 510(k) summary for the AtriCure Isolator™ Transpolar™ pen, a device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The submission aims to establish substantial equivalence to predicate devices rather than present a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met is not available in the provided text.
Here's a breakdown of what can and cannot be provided based on the input:
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The submission focuses on substantial equivalence based on function, materials, and intended use, not on specific performance metrics with acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available. The document states "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." However, no details on test protocols, sample sizes, or data provenance are provided. This is typical for a 510(k) summary relying on substantial equivalence to predicate devices, where extensive clinical trials or performance testing against specific acceptance criteria might not be required if the device is sufficiently similar to existing legally marketed devices.
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. No "test set" in the context of expert-adjudicated ground truth is mentioned or implied. The focus is on technical conformity and comparison to predicate devices, not on a clinical performance study with expert evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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 pen, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance of imaging systems or AI algorithms with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in this context is established as the submission relies on substantial equivalence rather than a clinical performance study with diagnostic endpoints.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of Substantial Equivalence Information Provided:
The provided documents primarily serve as a 510(k) summary for regulatory clearance, focusing on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study with specific performance acceptance criteria for a novel device.
- Predicate Devices: The Isolator™ Transpolar™ pen is deemed substantially equivalent to the Medtronic Cardioblate Pen (K013392), the Tissue Link Bipolar Sealer 2.3 (Bipolar Floating Ball) device (K032132), and the AtriCure Bipolar System (K020919).
- Basis for Substantial Equivalence: The submission states that the Isolator™ Transpolar™ pen is substantially equivalent in its:
- Indications for use.
- Basic overall function.
- Materials used.
- Testing: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." This included biocompatibility testing in accordance with ISO 10993-1. However, specific details of these "product specifications" or the results are not provided in this summary.
In essence, the "study" proving the device meets its requirements is the demonstration that it is sufficiently similar to already cleared devices, making it "substantially equivalent." This type of submission does not typically include detailed performance acceptance criteria or a clinical study in the way might be expected for novel devices or AI algorithms.
§ 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.