(93 days)
The Cardioblate Gemini-s surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy. The system is indicated for use, under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.
The Cardioblate Gemini-s surgical ablation device (Model 49351) is a hand-held, single-use, bipolar, radio-frequency (RF) ablation device for use in cardiac surgery. It has a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. This device is intended for intermittent operation.
The proposed Cardioblate Gemini-s device is intended for use with the Valleylab™ FT10 Energy Platform (VLFT10GEN) with software version 3.0.0 or higher.
The devices are provided sterile and nonpyrogenic, are disposable, and are for single use only. They are sterilized using ethylene oxide.
The Cardioblate Gemini-s is a bipolar electrode device that transmits radio frequency energy, generated by an external generator, between the two electrodes. The device has dual linear electrodes, 6.3 cm in length, with integral fluid delivery to the electrodes. The Gemini-s device is port accessible, intended for open or closed chest procedures to ablate tissue through resistive heating due to radiofrequency energy passing through tissue. The device is designed to reproduce the Cox-Maze lesion pattern by creating linear transmural lesions in both atria of the heart during cardiac procedures.
The Gemini-s surgical ablation device has a flexible neck design that provides the physician with the ability to access various anatomies utilizing a neck curve through the full range from 0 to 180-degree configuration.
Once the electrodes are correctly positioned, the parallel jaws lock by squeezing the handle. The electrodes have full contact with the tissue and the locking mechanism must be fully engaged to ensure accurate transmurality readings. Simultaneous with the actuation of the trigger and jaw closure is the opening of the (normally closed) fluid path to start the flow of saline. The device automatically shuts off the saline when the jaws are open and when the device is not in use.
The provided document is a 510(k) summary for the Medtronic Cardioblate Gemini-s Surgical Ablation Device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI/ML-enabled diagnostic device.
Therefore, the information required to answer your specific questions about acceptance criteria, study design, ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies is not present in this document. This submission is for an electrosurgical device, not an AI software.
However, I can extract and structure the information that is available regarding performance testing to show what kind of "acceptance criteria" and "study" were relevant for this type of device based on its nature.
Based on the provided Medtronic 510(k) Summary for the Cardioblate Gemini-s Surgical Ablation Device (K200514), here's what can be inferred about its "acceptance criteria" and "study" for regulatory approval:
Core Principle for Approval: The primary "acceptance criterion" for this Class II device, as outlined in the 510(k) process, is demonstrating substantial equivalence to a legally marketed predicate device (K121767 Cardioblate Gemini-s Surgical Ablation Device, Model 49260). This means the device must perform as safely and effectively as the predicate, and any differences must not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance (Inferred)
Since this is a substantial equivalence submission for an electrosurgical device, the "acceptance criteria" are not reported as quantitative metrics like sensitivity/specificity for a diagnostic AI. Instead, they are related to compliance with relevant standards and demonstrating comparable performance to the predicate.
| Acceptance Criterion (Inferred from Performance Testing) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Compliance: Adherence to IEC 60601-1 and IEC 60601-2-2 standards. | "Mechanical verification testing was conducted for components of the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 standard requirements and Medtronic self-enforced requirements." (Implies successful compliance) |
| Electrical Compliance: Adherence to IEC 60601-1 and IEC 60601-2-2 electrical requirements. | "Electrical verification testing was conducted for the subject devices to ensure compliance with current IEC 60601-1 and IEC 60601-2-2 electrical requirements." (Implies successful compliance) |
| Electromagnetic Compatibility (EMC): Adherence to IEC 60601-1-2 standard. | "Electromagnetic compatibility testing was completed for the subject devices to ensure compliance with current IEC 60601-1-2 standard requirements." (Implies successful compliance) |
| Benchtop Lesion Verification: Ablation performance comparable to predicate. | "Comparative lesion verification testing was performed using a soft tissue model to demonstrate the substantially equivalent ablation performance of the subject and predicate systems." (Implies successful demonstration of equivalence) |
| Usability: Verification and validation of usability requirements. | "Testing was performed to verify and validate the usability requirements of the subject devices as a system. Elements captured included normal use cases, a foreseeable worst-case use scenario, and testable requirements for primary operating functions." (Implies successful verification and validation) |
| Overall Substantial Equivalence: No new questions of safety or effectiveness. | "Verification and validation test results demonstrate that the subject devices are substantially equivalent to the predicates cleared in K121767. Differences between the subject and predicate devices do not raise different questions of safety and effectiveness. The intended use of the devices has not changed. Moreover, the fundamental scientific technology, operating principle, and design features are unchanged from that of the predicate." (This is the overarching conclusion of the submission, affirming all "acceptance criteria" for substantial equivalence were met.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an AI test set. For the benchtop lesion verification, the "sample size" would likely refer to the number of ablation attempts or tissue samples tested. This number is not provided.
- Data Provenance: The studies were non-clinical performance tests (mechanical, electrical, EMC, benchtop lesion verification, usability). They were not based on patient data in the sense of retrospective or prospective clinical studies. The "data" comes from engineering and benchtop laboratory testing.
3. Number of Experts and Qualifications for Ground Truth:
- Not Applicable: This type of submission relies on engineering and laboratory testing against established standards and predicate device performance, not expert human image interpretation to establish ground truth for an AI algorithm. Therefore, there's no mention of experts or their qualifications for ground truth establishment in this context.
4. Adjudication Method for the Test Set:
- Not Applicable: There is no "test set" in the sense of a dataset requiring human adjudication for ground truth for an AI algorithm.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No: An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance. This device is an electrosurgical tool, not an AI diagnostic, so an MRMC study was not performed or necessary.
6. If a Standalone (Algorithm Only) Performance Study was Done:
- Not Applicable: This is an electrosurgical device, not an AI algorithm. The performance studies evaluate the physical device's specifications and capabilities.
7. The Type of Ground Truth Used:
- Engineering Standards and Predicate Performance: The "ground truth" for this device's performance is compliance with established international standards (IEC 60601 series) for medical electrical equipment, and demonstrably equivalent performance to the predicate device in terms of mechanical function, electrical safety, EMC, and the ability to create lesions in a soft tissue model.
8. The Sample Size for the Training Set:
- Not Applicable: This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not Applicable: As there is no training set for an AI/ML model, this question does not apply.
In summary: The provided document is a 510(k) submission for a physical medical device (an electrosurgical ablation device) seeking clearance based on substantial equivalence to a predicate. The "acceptance criteria" and "studies" described primarily involve engineering and benchtop testing to demonstrate compliance with standards and comparable performance to the existing predicate device, rather than the rigorous clinical validation methodology (including AI-specific elements like ground truth establishment, expert adjudication, and MRMC studies) that would be required for an AI/ML software as a medical device (SaMD).
§ 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.