(50 days)
The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant Electrosurgical Generator in 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 (Model Numbers: EB015, EB016, EB017, EB215, EB216, EB217) is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288, 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.
This document is a 510(k) Premarket Notification from the FDA for a medical device, the Voyant Maryland Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's efficacy against a defined set of acceptance criteria in a clinical or diagnostic setting. Therefore, a direct answer to the prompt's request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of typical AI/diagnostic device validation cannot be fully provided from this document alone.
However, based on the provided text, we can infer and construct some approximations related to performance testing in the context of device safety and efficacy demonstration for a 510(k) submission.
Re-interpretation of Acceptance Criteria and Performance Study for a 510(k) Device:
For a 510(k) device, "acceptance criteria" largely revolve around demonstrating substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. The "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical performance testing conducted to support this claim of substantial equivalence.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a non-diagnostic device submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this electrosurgical device, the acceptance criteria are implicitly related to demonstrating performance that is substantially equivalent to the predicate device, particularly in terms of vessel sealing and minimizing thermal spread. Specific quantitative acceptance criteria or thresholds are not explicitly listed in this summary, but the outcome of the tests indicates equivalence.
| Performance Metric (Acceptance Criteria) | Reported Device Performance |
|---|---|
| Burst Pressure (Vessel Sealing Quality) | "The results of the study demonstrated that the subject has substantially equivalent performance to the predicate." |
| Thermal Spread (Tissue Damage) | "Analysis of the measurements demonstrated that the subject has substantially equivalent performance to the predicate." |
| Long-term Seal Quality / Hemostasis | "The result of the study demonstrated that the subject device met the predetermined acceptance criteria." |
| Adverse Effect on Adjacent Structures | "The result of the study demonstrated that the subject device met the predetermined acceptance criteria." |
| Mechanical Integrity (Jaw Force) | Tested to "verify the mechanical integrity of the subject device's jaws." (Implicitly, it met the requirements.) |
| EMC and Electrical Safety | "Designed and evaluated in accordance with relevant standards of the IEC 60601 series..." (Implicitly, it met standards.) |
| Software Functionality and Performance | "Unit, integration, and system level software testing were conducted to evaluate the design, implementation, and performance of the device software script." (Implicitly, it performed as designed.) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Sizes: Not explicitly stated for any of the tests (burst pressure, thermal spread, chronic survival study). The document mentions "vessels representative of the devices' indications" were used.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (in vitro, ex vivo, or animal studies as implied by "chronic survival study") and retrospective as they are conducted for a regulatory submission. They are not human clinical trials in the traditional sense discussed for diagnostic AI.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this device and its 510(k) submission. The "ground truth" here is objective physical measurements (like burst pressure, thermal spread, mechanical force) or direct observation of biological outcomes (hemostasis, hematoma) in pre-clinical models, not expert interpretations of medical images or patient data.
4. Adjudication Method for the Test Set
This is not applicable. As there are no human readings or interpretations involved in establishing the "ground truth" (instead, it's objective physical or biological measurements), no adjudication method (e.g., 2+1, 3+1) is described or needed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is not applicable. This is an electrosurgical device, not a diagnostic AI algorithm that assists human readers. Therefore, an MRMC study and effects on human reader performance are irrelevant.
6. Standalone (i.e., Algorithm Only Without Human-in-the Loop Performance) Study
This is not applicable in the sense of an "algorithm." The device itself has functionality (e.g., vessel sealing, tissue division). The performance studies conducted (burst pressure, thermal spread, chronic survival) are essentially "standalone" evaluations of the device's physical and functional capabilities, not an algorithmic output.
7. Type of Ground Truth Used
The ground truth used for performance evaluation appears to be:
- Objective Biophysical Measurements: Burst pressure, thermal spread, mechanical jaw force.
- Biological Outcome Data: Observation of hemostasis and absence of hematoma, and lack of adverse effects on adjacent structures from the "chronic survival study."
- Compliance with Standards: Electrical safety and EMC standards (IEC 60601 series).
8. Sample Size for the Training Set
This is not applicable. This document describes an electrosurgical device, not an AI/machine learning model that requires a "training set." The "software script" mentioned is likely embedded control software, not adaptive AI.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as 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.