(201 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 5mm 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 5mm 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 provided text is a 510(k) premarket notification for a medical device (Voyant Open Fusion Device). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for an AI/ML device. Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number and qualifications of experts, and details about MRMC studies are not applicable to this document.
However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.
Here's a breakdown of what can be inferred and what cannot, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present explicit acceptance criteria with numerical targets in the same way an AI/ML device approval might. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on performance testing. The performance indicators are related to the device's functional capabilities and safety.
| Performance Characteristic | Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|---|
| Vessel Sealing Performance | Must be equivalent to the predicate device in sealing vessels up to and including 5mm in diameter. | Demonstrated equivalence to the predicate device in seal quality and chronic hemostasis for vessels up to 5mm. |
| Tissue Bundle Sealing Performance | Must be equivalent to the predicate device in sealing tissue bundles that can be captured in the jaws. | Demonstrated equivalence to the predicate device in seal quality and chronic hemostasis for tissue bundles. |
| Local Tissue Effects (Thermal Damage) | Must be equivalent to the predicate device in terms of thermal damage to surrounding tissue. | Showed equivalent thermal damage compared to the predicate device. |
| Mechanical Capabilities | Must meet basic mechanical requirements for the device. | Satisfied through simulated repeated use testing. |
| Functional Capabilities | Must meet basic functional requirements for the device. | Satisfied through simulated repeated use testing. |
| Safety Systems | Must operate safely. | Passed safety systems testing. |
| Burst Pressures (Ex Vivo) | Must achieve burst pressures equivalent to or better than the predicate device. | Testing summarized to evaluate system safety and substantial equivalence. (Specific values not provided) |
2. Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated as a number of "samples" in the context of an AI/ML test set. The testing involved:
- Ex vivo porcine vessels/tissue: The quantity of vessels/tissue used is not specified.
- In vivo porcine model: Not specified how many animals or how many sealing procedures were performed.
- In vivo ovine model: Not specified how many animals or how many sealing procedures were performed.
- Data Provenance: The studies were conducted in a preclinical setting (laboratory and animal models). The country of origin is not specified, but the submission is to the U.S. FDA. The testing was prospective in nature, designed to evaluate the subject device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes a traditional medical device (electrosurgical) evaluation, not an AI/ML diagnostic or prognostic tool requiring expert ground truth labeling for a test set. The "ground truth" here is the physical performance of the device (seal quality, thermal damage, burst pressure) as observed and measured in the preclinical studies, often by engineers, researchers, and potentially veterinarians/surgeons involved in the animal studies.
4. Adjudication method for the test set:
- Not Applicable. As there are no "experts" establishing a "ground truth" through consensus or independent review in the AI/ML sense, there's no adjudication method described. Performance was assessed through direct measurement and observation in laboratory and animal settings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study is typically performed for imaging diagnostics to assess how human readers' performance improves with AI assistance. This is an electrosurgical device, not an imaging diagnostic, and no human readers or AI assistance are involved in its primary function or evaluation as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm. The performance evaluation is the "standalone" device performance, as it's a physical tool evaluated in isolation and comparison to a predicate device in a laboratory and animal setting.
7. The type of ground truth used:
- The "ground truth" for this device's performance evaluation was empirical observation and measurement in controlled preclinical studies:
- Seal quality evaluation: Visual inspection, potentially histological analysis.
- Burst pressures: Physical measurement of pressure resistance.
- Thermal damage: Histological analysis of tissue surrounding the seal.
- Chronic hemostasis: Observation in chronic animal studies.
- Mechanical and functional capabilities: Direct testing on the device.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device that uses a "training set" in the computational sense.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.