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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 ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.

The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel features a touch screen GUI that displays current settings, connection status, and allows access to menus for editing settings, procedures, and preferences. Compatible accessories include previously cleared footswitches.

The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism opens and closes the jaws. A second control initiates bipolar energy delivery for sealing. A separate control activates a blade for tissue division.

The provided text details the 510(k) submission for the Olympus Electrosurgical Generator ESG-400 and Accessories, and the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The study described focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving direct performance against them in a traditional sense. The performance data provided is primarily in the context of comparative testing to established predicate devices.

Here's an attempt to extract the information requested, with indications where the information is not explicitly available in the provided document:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state specific numerical acceptance criteria for performance metrics (e.g., burst pressure in mmHG, or a specific range for coagulation time). Instead, it states that the device "met all acceptance criteria" for biocompatibility and that "performance requirements defined in the User Requirements Specification and Design Specification were met for both subject devices, and that they exhibit comparable performance characteristics to the predicate device and reference devices."

The performance is described qualitatively as being "comparable" or having "equivalent technology and performance" to predicate/reference devices. For example, for vessel sealing, the key performance indicator mentioned is "vessel burst pressure testing."

Therefore, a table of acceptance criteria and reported numerical performance values cannot be fully constructed from the provided text in the typical quantitative manner.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred and stated qualitatively)

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of cases or samples for the animal studies or bench testing (e.g., how many vessels were sealed for burst pressure testing). It only states that "ex-vivo Vessel Burst Pressure testing was conducted."
• Data Provenance (Country of Origin, Retrospective/Prospective): Not explicitly stated. The studies were likely conducted in a controlled lab or animal facility. The document refers to FDA guidance documents, which are for U.S. regulatory submissions, but doesn't specify where the actual testing took place. It also doesn't specify if the animal studies or bench tests were retrospective or prospective, though performance testing is generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is typically related to clinical studies involving human interpretation or pathology. The reported studies are primarily bench (ex-vivo) and animal studies. Therefore, this information is not applicable in the context of the provided document. The "ground truth" for these studies would be objective measurements (e.g., burst pressure from instrumentation) rather than expert consensus on clinical findings.

4. Adjudication method for the test set

This is also typically relevant for clinical studies with human interpretation. For bench and animal studies (e.g., measuring vessel burst pressure), the "adjudication" is typically through objective measurements and statistical analysis, not a consensus process among experts as described by methods like 2+1 or 3+1. Therefore, this information is not applicable in the context of the provided document.

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

• MRMC Study Done: No. This study is for an electrosurgical device, not an AI-assisted diagnostic tool involving human readers.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Not applicable to this type of device. The device itself is an electrosurgical tool, not an algorithm, and it is used by a human surgeon.

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

For the performance testing, the ground truth was established through objective physical measurements in bench and animal studies:

• Biocompatibility: In vitro and in vivo (animal tissue/systems) tests following ISO 10993 standards.
• Electrical/Thermal Safety & EMC: Measurements against IEC standards.
• Vessel Sealing Performance: Chronic and acute animal studies demonstrating seal performance, and ex-vivo vessel burst pressure testing. The "ground truth" here would be the measured burst pressure values and observed tissue effects.

8. The sample size for the training set

The document describes an electrosurgical device, not a machine learning or AI algorithm in the context of diagnostic imaging. Therefore, the concept of a "training set" in this context is not applicable. The "training" for such a device involves engineering design, prototyping, and testing against specifications and regulatory standards.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm being developed.

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