(28 days)
The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open 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® Open Fusion device is a bipolar electrosurgical instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), in open procedures where the ligation and division of vessels up to and including 7 mm in diameter and tissue bundles are desired.
Based on the provided text, the device in question is the Voyant Open Fusion Device, an Bipolar Electrosurgical Sealer-Divider. The document describes its premarket notification (510(k)) to the FDA, asserting its substantial equivalence to a predicate device (Voyant® Open Fusion Device, K162676).
It's important to note that this document pertains to an electrosurgical device used for sealing and dividing vessels and tissue bundles, not an AI/algorithm-based diagnostic or prognostic device. Therefore, many of the typical acceptance criteria and study aspects listed in the prompt (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.
The "study" described focuses on the device's physical and functional performance, rather than the performance of an AI algorithm.
Here's a breakdown of the requested information based on the provided text, highlighting what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | The Voyant Open Fusion Device complies with IEC 60601-1;ed.3.1;2012 and IEC 60601-2-2;ed.6;2017. |
| Electromagnetic Compatibility (EMC) | The Voyant Open Fusion Device complies with IEC 60601-1-2;ed.3;2007. |
| Mechanical Performance (Durability) | Durability testing was performed to verify the continued performance of the subject device over multiple device activations. The result of the study demonstrated that the subject device met the predetermined acceptance criteria. |
| Burst Pressure (Vessel Sealing Strength) | Burst pressure testing was conducted on the subject and predicate Voyant Open Fusion Devices. Vessels representative of the devices' indications were sealed and the burst pressure for each vessel was recorded. The results of the study demonstrated that the subject device met the predetermined acceptance criteria. |
| Thermal Spread | Thermal spread testing was performed to evaluate the thermal spread damage produced by the subject and predicate Voyant Open Fusion Devices. Vessels representative of the devices' indications were sealed and measurements of the fused areas were taken. Analysis of the measurements demonstrated that the subject device met the predetermined acceptance criteria. |
| Long-term Seal Quality (Preclinical Chronic Survival) | A chronic survival study was performed to evaluate long-term seal quality, device performance, and potential for adverse effects on adjacent structures. Vessels representative of the devices' indications were sealed and evaluated for hemostasis and signs of hematoma. The result of the study demonstrated that the subject device met the predetermined acceptance criteria. |
| Software Verification | Unit, integration, and system level verification were conducted to evaluate the implementation and performance of the device software script. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text refers to "vessels representative of the devices' indications" for "Burst pressure testing," "Thermal spread testing," and the "chronic survival study." However, it does not specify the exact sample sizes (e.g., number of vessels, number of animals/subjects) used for these tests. It also does not directly state the data provenance in terms of country of origin or whether the studies were purely retrospective or prospective, though the description of preclinical studies implies a prospective design.
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 question is not applicable as this is a physical electrosurgical device, not an AI or diagnostic imaging device that requires expert-established ground truth from medical images. The "ground truth" for this device's performance would be direct measurements (burst pressure, thermal spread, observed hemostasis/hematoma) in laboratory and preclinical settings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3. Performance was measured objectively.
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 question is not applicable as this is not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as this is not an algorithm, but a physical electrosurgical tool operated by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established through direct physical measurements and observations in benchtop and preclinical animal studies. This includes:
- Quantitative measurements: Burst pressure (for seal strength), measurements of fused areas (for thermal spread).
- Qualitative observations: Evaluation for hemostasis and signs of hematoma in the chronic survival study.
- Compliance with standards: Electrical safety and EMC testing against IEC standards.
8. The sample size for the training set
This question is not applicable as this is not an AI/machine learning device requiring a "training set." The verification of the device's software focused on "unit, integration, and system level verification" rather than algorithm training.
9. How the ground truth for the training set was established
This question is 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.