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The Voyant [5mm/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 sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.

This FDA 510(k) summary for the Voyant 5mm Fusion Device and Voyant Maryland Fusion Device (K193292) does not contain information about a study with acceptance criteria and observed device performance in the way a clinical trial or algorithm performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K141288, K172624, K182653). The core argument for safety and efficacy relies on the fact that the subject devices are identical in material and technological characteristics to the predicates, and thus, the existing performance, sterility, shelf life, and electrical testing of the predicate devices are leveraged.

Therefore, the requested tables and details regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific submission as it's not a de novo study for a novel device or AI algorithm.

However, I can extract the acceptance criteria and "results" as presented in the document based on the performance testing of the predicate devices, which are deemed sufficient for the subject devices due to identical design.

Here's a breakdown of the information that is available (or not available) based on your request, framed within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission based on identical design, the "acceptance criteria" are implied by the standards and successful results achieved by the predicate devices. The document states that the predicate devices "met all acceptance criteria" for the listed tests.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the document for any of the tests. The document refers to "representative vessels" and "surgical sites" for the bench and animal testing, respectively, but does not provide numbers.
• Data Provenance: The data comes from prior testing associated with the predicate devices (K141288, K172624, K182653). The document does not specify the country of origin or if the studies were retrospective or prospective, though animal and bench testing are typically prospective experiments.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This submission is not evaluating an AI algorithm or diagnostic device requiring expert interpretation of results to establish ground truth. The tests are laboratory-based (biocompatibility, electrical, mechanical, bench) and animal studies, which have objective endpoints.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, no expert consensus or adjudication process is described for these types of engineering and biological tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This document does not describe any MRMC study. The device is an electrosurgical tool, not a diagnostic imaging device that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a surgical instrument. This concept is not applicable.

7. Type of Ground Truth Used:

• For biocompatibility tests: Standardized laboratory assays based on cell viability, immune response, etc.
• For electrical tests: Measurement against established IEC standards.
• For mechanical tests: Objective measurements of force, integrity, and electrical continuity.
• For bench testing: Measurements of burst pressure and thermal spread, which are objective physical parameters.
• For animal testing: Histological examination, observation of hemostasis, and absence of hematoma, likely evaluated by veterinary pathologists or study investigators based on established criteria.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI or machine learning device that requires a training set.

9. How Ground Truth for the Training Set Was Established:

• Not Applicable.

In summary: This 510(k) submission explicitly states that the subject devices are identical to predicate devices and therefore leverages the prior testing data of those predicates. It does not present new studies with a detailed breakdown of acceptance criteria and performance for a novel device or AI algorithm, but rather relies on the successful historical performance of prior substantially equivalent devices.

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The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in laparoscopic 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 5mm Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), 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.

The medical device discussed is the Voyant 5mm Fusion Device, an electrosurgical device for laparoscopic procedures to ligate and divide vessels and tissue bundles.

Here's an analysis of its acceptance criteria and the study that proves it meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table with numerical acceptance criteria values alongside numerical reported device performance in the traditional sense of a diagnostic AI product. Instead, it describes compliance with standards and the outcome of specific bench tests.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Bench Tests (Burst Pressure & Thermal Spread): The document states "Vessels representative of the devices' indications were sealed" but does not specify the number of vessels or samples used for the burst pressure and thermal spread tests.
• Data Provenance: Not specified. These are bench tests, so the "data" would be the results from the physical testing of the device on isolated vessels/tissue. Country of origin for such tests is typically the manufacturing or testing facility.

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 is not applicable as the device is a surgical instrument, not a diagnostic AI system requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for the performance tests (e.g., burst pressure, thermal spread) are objective measurements taken from the physical properties and effects of the device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This device is not an AI diagnostic tool and does not involve human adjudication of results in the way clinical studies often do. The tests performed are objective, measurable physical tests.

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

Not applicable. The device is a surgical instrument, not an AI diagnostic tool that assists human readers. No MRMC study was mentioned or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a surgical instrument, not an AI algorithm. Its performance is inherent in its electrosurgical capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on objective physical measurements and compliance with established engineering and medical device standards.

• For burst pressure: The actual pressure at which a sealed vessel ruptures.
• For thermal spread: Direct measurements of the extent of thermal damage to tissue.
• For electrical safety and EMC: Compliance with specified international standards (IEC 60601 series).

8. The sample size for the training set

Not applicable. This device is a physical electrosurgical instrument, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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