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The Voyant Maryland Fusion Device with Single-Step Activation 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 with Single Step 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.

The medical device in question is the Voyant® Maryland Fusion Device with Single-Step Activation. It is an electrosurgical device intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissue bundles up to 7mm in diameter.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that the devices "met all acceptance criteria" or that results were "sufficient to represent the subject device is safe and effective."

Note: The document generally indicates that the device "met all acceptance criteria" without specifying the exact numerical thresholds for many of these criteria. This type of summary is common in 510(k) submissions where the focus is on demonstrating substantial equivalence rather than presenting a detailed performance report.

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

The document does not explicitly state the exact sample sizes for all test sets. However, it provides some information:

• Burst pressure testing: "vessels representative of the devices' indications" were used. (No specific number mentioned).
• Thermal spread testing: (No specific number mentioned).
• Simulated repeated-use testing: (No specific number mentioned for activations or devices).
• Animal testing: "large porcine animal models" were used. The number of animals or vessels tested is not specified.

Data Provenance:

• Country of Origin: Not explicitly stated, but typically these studies are conducted by the manufacturer or contract research organizations, often in the country where the manufacturer is based (USA, in this case).
• Retrospective or Prospective: The testing described (simulated repeated-use, system testing, animal testing, software verification) are all prospective studies, designed and executed to evaluate the new or modified device. The reference to the predicate device's data suggests that previously collected prospective data from the predicate was leveraged.

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the described performance tests. For electrosurgical devices, "ground truth" often refers to objective measurements (e.g., burst pressure, thermal spread measurements, histopathological analysis in animal studies) rather than subjective expert interpretations like in imaging studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given that most of the described tests are objective measurements (e.g., electrical parameters, burst pressure, thermal spread, software testing), an adjudication method as typically understood in studies involving human interpretation (like imaging reads) would not be applicable. For animal studies, evaluation of hemostasis and hematoma would typically follow pre-defined histological or gross pathology criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a direct-use surgical instrument, not an AI-based diagnostic tool requiring human interpretation/reading. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the term "standalone" typically refers to AI algorithms, in the context of this electrosurgical device, the device itself is a "standalone" instrument. The performance tests (electrical, mechanical, system, animal) described are evaluating the performance of the device only (or the device in combination with its specified generator), without a human-in-the-loop actively assisting in output. The software verification tests are also standalone evaluations of the algorithm's performance within the device's control systems.

7. The Type of Ground Truth Used

The ground truth used for various tests includes:

• Objective Measurements: For burst pressure (quantifiable pressure values), thermal spread (measurable tissue damage), and electrical safety/EMC (compliance with quantifiable standards).
• Biological/Pathological Outcomes: For animal studies, this would involve macroscopic and potentially microscopic examination of sealed vessels and surrounding tissues to assess hemostasis, presence of hematoma, and tissue damage, serving as the "ground truth" for seal quality and safety.
• Software Design Specifications: For software verification, the "ground truth" is adherence to predefined design requirements and functional specifications.

8. The Sample Size for the Training Set

The document describes performance testing for an electrosurgical device, not an AI/ML product. Therefore, the concept of a "training set" (used for training machine learning models) is not applicable to this submission.

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

As the concept of a "training set" is not applicable, the question of how its ground truth was established is also not applicable.

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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.

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.

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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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