(30 days)
The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation 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 Maryland Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), 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.
Acceptance Criteria and Study for the Voyant Maryland Fusion Device
This document describes the acceptance criteria and the studies that demonstrate the Voyant Maryland Fusion Device meets these criteria. It focuses on the information provided in the given text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details various tests conducted for the Voyant Maryland Fusion device and states that the device "met the predetermined acceptance criteria" for each. However, the specific quantitative acceptance criteria for each test are not explicitly defined in the provided document. The performance is generally reported as meeting pre-determined criteria and being "substantially equivalent" to the predicate device.
| Acceptance Criteria (Explicitly stated or Inferred) | Reported Device Performance |
|---|---|
| EMC, Electrical Safety, and Mechanical Testing: | |
| (Inferred: Compliance with IEC 60601 series standards) | Met all acceptance criteria. |
| Simulated Repeated-Use Testing: | |
| (Inferred: Maintained performance over multiple activations) | Met the predetermined acceptance criteria. |
| System Testing - Burst Pressure: | |
| (Inferred: Vessel burst pressure within acceptable limits, comparable to predicate) | Met the predetermined acceptance criteria and is substantially equivalent to the predicate device. |
| System Testing - Thermal Spread: | |
| (Inferred: Thermal spread damage within acceptable limits, comparable to predicate) | Met the predetermined acceptance criteria and is substantially equivalent to the predicate device. |
| Animal Testing (Chronic Survival Study): | |
| (Inferred: Long-term seal quality, device performance, absence of adverse effects on adjacent structures, hemostasis, and signs of hematoma within acceptable limits) | Met the predetermined acceptance criteria. |
| Software Verification: | |
| (Inferred: Correct design, implementation, and performance of the device software script) | (Outcome of unit, integration, and system level software testing, implying successful verification) |
2. Sample Size and Data Provenance
- Test Set Sample Size: The exact sample sizes for each test are not explicitly mentioned in the provided text.
- Burst pressure testing: "vessels representative of the devices' indications" were used.
- Thermal spread testing: No specific sample size given for tissues.
- Animal testing: "large porcine animal models" were used, but the number is not specified.
- Data Provenance: The text does not specify the country of origin for the data. The studies appear to be prospective as they were conducted as part of the device evaluation for 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
The provided text does not mention the number of experts used to establish ground truth or their qualifications for any of the performance tests.
4. Adjudication Method for the Test Set
The provided text does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The document focuses on the performance of the device itself, not human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study (algorithm/device only without human-in-the-loop performance) was completed for the Voyant Maryland Fusion device. The entire "Discussion of Performance Testing" section details laboratory and animal studies of the device's technical capabilities and clinical performance without human interaction being assessed as part of the primary endpoint.
7. Type of Ground Truth Used
- EMC, Electrical Safety, Mechanical Testing, Simulated Repeated-Use Testing, Software Verification: Ground truth for these tests would be based on engineering specifications, regulatory standards (e.g., IEC 60601 series), and predefined functional requirements.
- Burst Pressure Testing: Ground truth would be based on quantitative measurement of burst pressure of the sealed vessels, likely compared to a control or predicate device, and potentially established physiological limits for vessel integrity.
- Thermal Spread Testing: Ground truth would be based on quantitative measurement of tissue damage (e.g., area of necrosis), likely determined histologically or via thermal imaging, and compared to the predicate device.
- Animal Testing: Ground truth would be based on direct observation of physiological outcomes (e.g., hemostasis, presence/absence of hematoma, long-term seal quality, adverse effects on adjacent structures) by veterinary professionals or researchers, potentially supported by pathology (e.g., histological examination of sealed tissues post-mortem).
8. Sample Size for the Training Set
The provided text does not mention any "training set." This type of terminology is typically associated with machine learning or AI algorithm development. The Voyant Maryland Fusion device is described as an electrosurgical device with an "updated software script," but not as an AI-powered diagnostic or assistive tool that would require a distinct training set for algorithm development. The software verification focuses on its design, implementation, and performance, not on learning from data.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable based on the provided document. The software verification was likely based on standard software engineering principles and testing against established functional requirements and specifications.
§ 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.