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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 [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 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.

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.

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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 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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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).

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The Voyant Fine Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures, including head and neck procedures, where 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 Applied Medical Voyant Fine 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 and in head and neck procedures. 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 for the Voyant Fine Fusion electrosurgical device. It details the device’s indications for use, its substantial equivalence to predicate devices, and the performance testing conducted.

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in a quantitative format for clinical effectiveness. Instead, it describes various tests and states whether the device "passed" or demonstrated "substantial equivalence" to a predicate device.

However, based on the Discussion of Performance Testing section, we can infer some criteria and outcomes:

Key takeaway: The primary "acceptance criteria" for this 510(k) submission is showing substantial equivalence to existing, legally marketed predicate devices, particularly the LigaSure Curved, Small Jaw, Open Sealer/Divider (K113572) and the previous Voyant Fine Fusion (K143536). Performance is demonstrated by comparing the subject device against these predicates in a laboratory and animal setting.

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

• Sample Size for Test Set:
  • Bench (ex vivo): "porcine vessels/tissue" were used, but a specific number is not provided.
  • Acute Animal (in vivo): "ovine model" was used, but a specific number of animals or vessels is not provided.
  • Chronic Animal (in vivo): "ovine and canine model" were used, but a specific number of animals is not provided.
• Data Provenance: The studies were preclinical (ex vivo and in vivo animal models). They are performed in a laboratory setting, not from human patients. The specific country of origin for the data is not provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is typically not applicable to preclinical bench or animal studies where objective measurements (e.g., burst pressure, thermal spread measurements, histological examination by veterinary pathologists) establish "truth" rather than expert consensus on imaging or clinical findings. The document does not mention the use of human experts to establish ground truth for the test set in the context of diagnostic performance.

4. Adjudication Method for the Test Set

Not applicable. This is not a human clinical trial involving subjective assessments that would require adjudication. Preclinical studies rely on objective measurements and established scientific methodologies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical: This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence."

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

Not applicable. This device is an electrosurgical instrument, not an AI or imaging algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The device's performance is intrinsically linked to its operation by a human surgeon.

7. The Type of Ground Truth Used

• For Biocompatibility, Sterilization, EMC, Electrical Safety: Ground truth is established by adherence to recognized consensus standards (e.g., ISO 10993 series, ISO 11137-2, AAMI TIR 33, IEC 60601 series).
• For Preclinical Bench (ex vivo): Ground truth is established through objective measurements such as seal evaluation methods and quantitative burst pressure measurements of vessels.
• For Preclinical Animal (in vivo): Ground truth is established through objective measurements and observations including seal evaluation, thermal damage and spread metrics (minimum, maximum, median, mode), and histological assessment for chronic hemostasis and lack of hematomas. Comparison against the predicate device's performance also serves as a benchmark.

8. The Sample Size for the Training Set

Not applicable. The Voyant Fine Fusion is a physical electrosurgical device, not a machine learning model. Therefore, there is no "training set" in the AI/ML sense. "Training" would refer to the engineering design and iteration process, not data-driven model training.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for an AI/ML model for this device. Ground truth in the context of product development for this type of device would relate to engineering specifications, material properties, and functional requirements, all established through standard engineering and scientific principles.

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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 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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The Voyant Fine Fusion 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 3mm 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 Fine 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 3mm 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.

Based on the provided text, the acceptance criteria and study details for the Voyant Fine Fusion device can be summarized as follows:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and the Data Provenance

• Test Set Sample Sizes:
  • Bench (Ex Vivo): "ex vivo porcine vessels/tissue" - specific number of vessels/tissue samples not provided.
  • Acute Animal Study (In Vivo): "in vivo canine model" - specific number of animals not provided.
  • Chronic Animal Study (In Vivo): "in vivo canine model" - specific number of animals not provided.
• Data Provenance:
  • The bench testing used "porcine vessels/tissue," indicating animal tissue.
  • The animal studies (acute and chronic) used an "in vivo canine model," indicating animal data.
  • The studies appear to be prospective as they were specifically performed to evaluate the new device and compare it against the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The document does not provide information on the number of experts, their qualifications, or their involvement in establishing ground truth for the performance testing. The "ground truth" for these tests seems to be defined by the direct measurements and observations from the experimental procedures (e.g., burst pressure, thermal spread, visual assessment of seals and hematomas).

4. Adjudication Method for the Test Set

The document does not describe any expert adjudication methods (e.g., 2+1, 3+1). The evaluation criteria suggest direct measurement and comparison rather than subjective human assessment requiring adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device, so such a study would not be applicable.

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

This question is not applicable. The Voyant Fine Fusion is a physical electrosurgical device, not an algorithm. Its performance is evaluated by its physical characteristics and its effect on tissue, not by an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance testing was primarily based on:

• Direct physical measurements: Such as mechanical strength, electrical safety parameters, burst pressures.
• Histological/Pathological observations: For thermal damage, seal quality, and absence of hematomas in animal tissue.
• Biological responses: Observed in chronic animal studies for hemostasis.

8. The Sample Size for the Training Set

There is no mention of a training set. This device is not an AI/ML-based device; therefore, the concept of a "training set" for an algorithm does not apply.

9. How the Ground Truth for the Training Set was Established

As there is no training set for an algorithm, this question is not applicable.

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The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation 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 Sealer/Divider 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.

This document is a 510(k) premarket notification for the Voyant Open Sealer/Divider Device. It does not contain information about acceptance criteria and device performance in the format requested. The document describes the device, its intended use, and summaries of performance testing conducted to demonstrate substantial equivalence to a predicate device.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, number of experts for ground truth, or adjudication methods for a test set.
3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
4. Information on a standalone (algorithm only) performance study.
5. The type of ground truth used (e.g., pathology, outcomes data) in a quantifiable manner for specific performance metrics.
6. Sample size for a training set or how ground truth for a training set was established.

Instead, the document focuses on:

• Device Description and Intended Use: The Voyant Open Sealer/Divider device is a bipolar, electrosurgical device for use with the Voyant electrosurgical generator in open procedures for the ligation and division of vessels and tissue bundles up to 5mm in diameter.
• Predicate Device: LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider (K123444).
• Performance Testing Summary (Non-clinical & Preclinical):
  • Non-clinical (Bench Testing): Mechanical strength, durability, destructive testing (per IEC 60601-1, IEC 60601-2-2), electrical safety, electromagnetic compatibility, and safety systems testing.
  • Preclinical (ex vivo porcine vessels/tissue and in vivo canine model): Evaluated system safety and efficacy. Side-by-side testing against the predicate focused on:
    • Seal evaluation
    • Thermal damage
    • Burst pressures (ex vivo)
    • Acute animal study (in vivo): Seal evaluation and thermal damage.
  • Chronic Study: An in vivo canine model was used to evaluate seal quality and chronic hemostasis for the subject device.
• Conclusion: The device is substantially equivalent in performance to the predicate device with respect to intended use (vessel sealing performance and local tissue effects).
• Clinical Data: The premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text, as this document outlines a traditional medical device 510(k) submission, not an AI/ML-based device submission that would typically have such detailed information about acceptance criteria, test sets, ground truth, and reader studies.

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