(81 days)
The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
The Coolrail Linear Pen is a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.
The provided text is a 510(k) summary for the Coolrail Linear Pen, which is an electrosurgery device. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific performance acceptance criteria for a new clinical indication or diagnostic accuracy.
Therefore, many of the requested sections about acceptance criteria, studies, sample sizes, and expert adjudication are not applicable or cannot be extracted from this document. The document describes the device, its indications for use, and confirms it meets general manufacturing, safety, and substantial equivalence requirements to existing devices.
Here's a breakdown of what information is available and what is not:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on indications for use, basic overall function, and materials, rather than setting specific performance acceptance criteria for a new device type and reporting performance against them.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not available. The document mentions "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices," but it does not detail specific acceptance criteria or the results of such testing in a quantitative manner suitable for a "test set" as would be used in a diagnostic device study. The focus is on demonstrating equivalence, implying that the established safety and efficacy of the predicate devices apply.
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):
This information is not applicable/available. The device is an electrosurgery tool, not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable/available. As above, there's no diagnostic test set requiring adjudication in this context.
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:
This information is not applicable/available. The Coolrail Linear Pen is an electrosurgery device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable/available. The device is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable/available in the context of a "ground truth" for a diagnostic study. For this device, the "ground truth" for its safety and effectiveness would be established through:
- Biocompatibility testing against ISO 10993-1.
- Performance testing to ensure it meets its intended function (e.g., ability to ablate tissue, proper energy delivery).
- Demonstration of substantial equivalence to predicate devices which have already established safety and effectiveness.
8. The sample size for the training set:
This information is not applicable/available. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established:
This information is not applicable/available. As above, no training set for an AI/ML algorithm is involved.
Summary of available information related to "acceptance criteria" (understood as criteria for substantial equivalence):
The primary "acceptance criteria" for the Coolrail Linear Pen in this 510(k) process were:
- Indications for Use: The device must have substantially equivalent indications for use as the predicate devices.
- Basic Overall Function: The device must have a basic overall function substantially equivalent to predicate devices.
- Materials: The materials used must be suitable for the intended use and demonstrate appropriate biocompatibility (conforming to ISO 10993-1).
- Performance: Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence (though specific quantitative criteria are not listed).
Table of Acceptance Criteria and Reported "Performance" (in the context of 510(k) equivalence):
| Acceptance Criteria (510(k) Equivalence) | Reported Device "Performance" / Finding |
|---|---|
| Indications for Use | Met: "The indications for use... are substantially equivalent." (Stated Indications: "The Coolrail™ Linear Pen (Coolrail Pen) is a sterile, single use electosurgery device intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.") |
| Basic Overall Function | Met: "The... basic overall function... are substantially equivalent." (Function: "a sterile, single use, electrosurgery device to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency current.") |
| Materials Suitability/Biocompatibility | Met: "All materials used... are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials." |
| Product Specification Conformance | Met (Implied): "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." (No specific quantitative results are provided in this summary, but the clearance implies these tests were successful.) |
| Substantial Equivalence | Met: FDA determined the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." Predicates include AtriCure Isolator Transpolar Pen (K050459), Medtronic Cardioblate Monopolar Pen (K013392), and Boston Scientific Flex 4 Ablation Probe (K003978). This is the overarching "performance" metric for a 510(k) submission. |
§ 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.