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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 for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and 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 for sterilization procedures, and should not be used for these procedures.

The Voyant Open Fusion and Voyant 5mm Fusion devices are advanced bipolar instruments that use RF energy, provided by the Voyant Electrosurgical Generator (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 devices' jaws. Each device features a mechanical, user-actuated blade for the division of sealed tissue.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Voyant Open Fusion Device and Voyant 5mm Fusion Device.

It's important to note that the provided documents (FDA 510(k) summaries) typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed, comprehensive reports on a device's standalone performance or comparative effectiveness studies with human readers. Therefore, some of the requested information may not be explicitly present or might be inferred from the context of a 510(k) submission.

Acceptance Criteria and Reported Device Performance

The documents state that both devices "met all acceptance criteria" and "met the predetermined acceptance criteria" for various tests. However, the specific quantitative acceptance criteria and the precise performance metrics achieved are not explicitly detailed in the provided text. The submission focuses on stating that the criteria were met, implying satisfactory performance relative to either internal company standards, recognized industry standards, or performance established by the predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

1. Sample Sizes and Data Provenance

• Test Set (Clinical/Animal):

  • Animal Testing: "large porcine animal models" were used. The exact number of animals or vessels tested is not specified.
  • Burst Pressure Testing: Used "vessels representative of the devices' indications." The number of vessels is not specified.
  • Data Provenance: The studies were conducted by Applied Medical Resources Corp. (presumably within the US, as they are a US-based company submitting to the FDA). The studies appear to be prospective in nature, designed specifically to test the devices.

• Training Set (for Software/AI, if applicable): Not applicable. This device is an electrosurgical tool, not an AI/software-based diagnostic or imaging device in the sense that would require a large training dataset for pattern recognition. The software verification mentioned refers to the control software embedded within the device, not a machine learning algorithm trained on data. Therefore, questions 8 and 9 are not directly relevant in this context.

2. Number of Experts and Qualifications for Ground Truth

• Animal Testing: The evaluation of "hemostasis and signs of hematoma" would likely involve veterinary professionals or researchers with expertise in animal pathology and surgical outcomes. However, the number and specific qualifications of experts establishing ground truth are not provided in this summary.

• Other Testing: For burst pressure, thermal spread, electrical safety, and mechanical testing, the ground truth is established by objective physical measurements and engineering standards, not typically by expert consensus in the same way as a diagnostic medical image.

3. Adjudication Method for the Test Set

Given the nature of the studies (engineering performance, animal model outcomes), formal adjudication methods like "2+1" or "3+1" (common in clinical trial assessments for subjective endpoints or equivocal findings) are not mentioned and generally not applicable to these types of objective performance tests. The results would be based on direct measurements and observations, typically verified by technical experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how AI assistance impacts human reader performance in interpreting images or data. The Voyant devices are surgical tools, and their effectiveness is measured by their physical performance (sealing vessels, minimizing thermal spread), not by human interpretation of their output.

5. Standalone Performance Study (Algorithm Only)

• Yes (Implied for the device system): The performance testing described (burst pressure, thermal spread, animal studies, EMC, electrical safety, mechanical testing) assesses the device's inherent functionality and capabilities. While the software is a component, the "standalone" performance here refers to the device system itself without direct human "in-the-loop" decision-making augmentation, but rather as an operated tool. The software verification specifically assesses the algorithm/software components in a standalone context.

6. Type of Ground Truth Used

• Objective Measurements and Observation/Pathology in Animal Models:
  • Burst pressure: Objective physical measurements.
  • Thermal spread: Objective physical measurements/histology (implied).
  • EMC/Electrical Safety: Compliance with objective engineering standards.
  • Mechanical Testing: Objective performance metrics.
  • Animal testing: Direct observation of hemostasis and absence of hematoma, potentially supported by pathology or histological evaluation of tissue.

7. Sample Size for the Training Set

• Not applicable: As discussed above, this device does not utilize machine learning in a way that requires a "training set" of data for algorithm development. The "software" refers to control logic, not AI models.

8. How Ground Truth for Training Set was Established

• Not applicable: (See point 7).

Summary of Gaps in Information (from the perspective of the original prompt):

The provided 510(k) summary is designed to demonstrate substantial equivalence, not to provide a full scientific publication with detailed methodologies and results for each test. Key quantitative details like exact sample sizes for animal/vessel testing, specific numerical acceptance thresholds (e.g., minimum burst pressure in mmHg, maximum thermal spread in mm), and the precise qualifications of evaluators are not included in this high-level summary. This is typical for a 510(k) submission, where the focus is on the conclusion that acceptance criteria were met and substantial equivalence was achieved.

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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 Voyant® Open Fusion device is a bipolar electrosurgical instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288), in open procedures where the ligation and division of vessels up to and including 7 mm in diameter and tissue bundles are desired.

Based on the provided text, the device in question is the Voyant Open Fusion Device, an Bipolar Electrosurgical Sealer-Divider. The document describes its premarket notification (510(k)) to the FDA, asserting its substantial equivalence to a predicate device (Voyant® Open Fusion Device, K162676).

It's important to note that this document pertains to an electrosurgical device used for sealing and dividing vessels and tissue bundles, not an AI/algorithm-based diagnostic or prognostic device. Therefore, many of the typical acceptance criteria and study aspects listed in the prompt (e.g., sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of medical device submission.

The "study" described focuses on the device's physical and functional performance, rather than the performance of an AI algorithm.

Here's a breakdown of the requested information based on the provided text, highlighting what is applicable and what is not:

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

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

The text refers to "vessels representative of the devices' indications" for "Burst pressure testing," "Thermal spread testing," and the "chronic survival study." However, it does not specify the exact sample sizes (e.g., number of vessels, number of animals/subjects) used for these tests. It also does not directly state the data provenance in terms of country of origin or whether the studies were purely retrospective or prospective, though the description of preclinical studies implies a prospective design.

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 question is not applicable as this is a physical electrosurgical device, not an AI or diagnostic imaging device that requires expert-established ground truth from medical images. The "ground truth" for this device's performance would be direct measurements (burst pressure, thermal spread, observed hemostasis/hematoma) in laboratory and preclinical settings.

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

This question is not applicable for the same reasons as #3. Performance was measured objectively.

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

This question is not applicable as this is not an AI-assisted diagnostic device for human readers.

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

This question is not applicable as this is not an algorithm, but a physical electrosurgical tool operated by a surgeon.

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

The "ground truth" for this device's performance was established through direct physical measurements and observations in benchtop and preclinical animal studies. This includes:

• Quantitative measurements: Burst pressure (for seal strength), measurements of fused areas (for thermal spread).
• Qualitative observations: Evaluation for hemostasis and signs of hematoma in the chronic survival study.
• Compliance with standards: Electrical safety and EMC testing against IEC standards.

8. The sample size for the training set

This question is not applicable as this is not an AI/machine learning device requiring a "training set." The verification of the device's software focused on "unit, integration, and system level verification" rather than algorithm training.

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

This question is not applicable as there is no "training set" for this type of device.

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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.

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).

Ask a specific question about this device

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.

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.

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