(165 days)
The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired.
The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.
The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.
The Voyant 5mm Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.
The medical device discussed is the Voyant 5mm Fusion Device, an electrosurgical device for laparoscopic procedures to ligate and divide vessels and tissue bundles.
Here's an analysis of its acceptance criteria and the study that proves it meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table with numerical acceptance criteria values alongside numerical reported device performance in the traditional sense of a diagnostic AI product. Instead, it describes compliance with standards and the outcome of specific bench tests.
| Acceptance Criteria Category | Reported Device Performance | Study Type |
|---|---|---|
| Mechanical Safety | Complies with IEC 60601-1:2005 | Mechanical Testing |
| Electrical Safety | Complies with IEC 60601-1:2005 and IEC 60601-2-2:2009 | Electrical Safety Testing |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2007 | EMC Testing |
| Burst Pressure (Vessel Sealing Strength) | Demonstrated that the subject device met the predetermined acceptance criteria (comparison to predicate on vessels up to 7mm). | Bench (Burst Pressure Testing) |
| Thermal Spread (Local Tissue Damage) | Analysis of measurements demonstrated that the subject device met the predetermined acceptance criteria (comparison to predicate). | Bench (Thermal Spread Testing) |
| Software Functionality | Unit, integration, and system level verification were conducted to evaluate the implementation and performance of the device software script. | Software Verification |
| Substantial Equivalence | The subject device is substantially equivalent in performance to the predicate Voyant 5mm Fusion Device with respect to intended use (i.e. vessel sealing performance and local tissue effects) and does not raise any new issues of safety and efficacy. | Overall conclusion based on all tests. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Bench Tests (Burst Pressure & Thermal Spread): The document states "Vessels representative of the devices' indications were sealed" but does not specify the number of vessels or samples used for the burst pressure and thermal spread tests.
- Data Provenance: Not specified. These are bench tests, so the "data" would be the results from the physical testing of the device on isolated vessels/tissue. Country of origin for such tests is typically the manufacturing or testing facility.
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 is not applicable as the device is a surgical instrument, not a diagnostic AI system requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for the performance tests (e.g., burst pressure, thermal spread) are objective measurements taken from the physical properties and effects of the device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device is not an AI diagnostic tool and does not involve human adjudication of results in the way clinical studies often do. The tests performed are objective, measurable physical tests.
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. The device is a surgical instrument, not an AI diagnostic tool that assists human readers. No MRMC study was mentioned or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a surgical instrument, not an AI algorithm. Its performance is inherent in its electrosurgical capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on objective physical measurements and compliance with established engineering and medical device standards.
- For burst pressure: The actual pressure at which a sealed vessel ruptures.
- For thermal spread: Direct measurements of the extent of thermal damage to tissue.
- For electrical safety and EMC: Compliance with specified international standards (IEC 60601 series).
8. The sample size for the training set
Not applicable. This device is a physical electrosurgical instrument, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.