(66 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 Applied Medical Voyant Open Fusion instrument is designed for use with the Voyant ESG (cleared in K141288). This device is an advanced bipolar instrument that uses RF energy, provided by the generator, 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, useractuated blade for the division of sealed tissue.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing but does not explicitly state "acceptance criteria" in a tabular format with specific numerical targets. Instead, it frames the performance evaluation as comparing the subject device against a predicate device to demonstrate "substantial equivalence." The reported device performance is described qualitatively in relation to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Seal Quality Evaluation | Subject device performance found to be substantially equivalent to the predicate device. |
| Burst Pressures (Ex Vivo) | Subject device performance found to be substantially equivalent to the predicate device. |
| Thermal Damage (In Vivo) | Subject device performance found to be substantially equivalent to the predicate device. |
| Chronic Hemostasis (In Vivo) | Subject device performance was evaluated and found acceptable for the subject device. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Preclinical):
- Sample Size: Not explicitly stated with specific numbers of vessels or tissue bundles. The document mentions "ex vivo porcine vessels/tissue" and "in vivo porcine model."
- Data Provenance: Porcine (animal model). The nature of the study (ex vivo and in vivo) indicates prospective data collection for the purpose of this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The document describes laboratory and animal studies, not human expert evaluations for ground truth.
4. Adjudication Method for the Test Set:
- This information is not provided in the document. Given the preclinical nature of the tests (ex vivo and in vivo animal models), an adjudication method in the sense of human expert review is unlikely to have been directly used. The evaluation would likely have involved standardized measurement protocols and analysis by researchers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence." The comparison was between the subject device and a predicate device in preclinical settings.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable as the device is an electrosurgical device, not an AI algorithm. The performance described is for the physical device itself.
7. The Type of Ground Truth Used:
- Preclinical Bench Setup: Measured physical properties (e.g., burst pressures) of sealed vessels/tissue.
- In Vivo Animal Model: Direct observation of seal integrity, thermal damage, and chronic hemostasis in living porcine tissue.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical instrument (electrosurgical device), not a machine learning algorithm that requires a "training set" in the computational sense. The "training" for such devices involves design, engineering, and manufacturing processes, which are not detailed in terms of a data-driven training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the reasons stated above (not an AI algorithm).
§ 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.