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The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal for these procedures.

The CoolSeal™ Reveal device is a sterile, single-use, hand-held bipolar vessel sealing device designed for use with the CoolSeal™ Generator. The CoolSeal™ Reveal is a hemostat-style design with a 5 mm shaft diameter and 10 cm shaft length. The jaw is a curved Maryland-style jaw that rotates. The Reveal creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure.

This is a 510(k) premarket notification for the CoolSeal Reveal electrosurgical cutting and coagulation device. The document does not describe the acceptance criteria and study for AI/ML performance. Instead, it focuses on the substantial equivalence of the CoolSeal Reveal device to predicate devices (LigaSure Exact Dissector, Nano-Coated and JustRight Sealer) based on various performance data types.

Therefore, the following information regarding AI/ML performance acceptance criteria and study specifics cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document details the following performance data to support substantial equivalence:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1.
• Electrical Safety and Electromagnetic Compatibility (EMC): Complies with ANSI/AAMI/EC 60601-2-2 and ANSI/AAMI/IEC 60601-1-2 standards.
• Mechanical and Functional Testing: Carried out to verify expected performance.
• Ex-vivo and In-vivo Vessel Burst Pressure:
  • Ex-vivo: Performed on excised fresh porcine blood vessels for both the subject device and the primary predicate.
  • In-vivo: Performed on lymphatics in live animals for both the subject device and the primary predicate.
• In-vivo Thermal Spread Comparison: Open laparotomy performed in porcine and ovine models, using both the subject device and the primary predicate device to seal vessels and tissue bundles. Samples were excised for three-dimensional histological assessments (length, width, and depth) to quantify thermal spread.
• Chronic Animal Study: A study of 23 days to assess the safety and performance of bipolar vessel sealing with the subject device. All animals survived without complications, and vessel sealing effects maintained chronic hemostasis and healed as anticipated.

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CoolSeal™ Trinity: The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on arteries up to and including 6 mm, veins, and vascular bundles up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. The CoolSeal™ Trinity has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures.

CoolSeal™ Mini: The CoolSeal™ Mini is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediations, wherever vessel ligation is required. The device is contraindicated for use in ENT procedures.

CoolSealTM Generator: The CoolSeal™ Generator is intended to provide Radio Frequency (RF) energy to compatible CoolSeal™ instruments for vessel-sealing applications. The specific application will depend on the compatible surgical device that is connected to the generator. This generator is designed to be used with only surgical devices compatible with the CoolSeal™ technology.

CoolSeal™ Generator: The CoolSeal™ Generator is a non-sterile, reusable device used outside the sterile field. The generator is designed to provide lower power bipolar Radio Frequency (RF) energy to CoolSeal™ vessel sealing devices for tissue-sealing applications.

CoolSeal™ Trinity: The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.

CoolSeal™ Mini: The CoolSeal™ Mini a Maryland Jaw Sealer, with a 3 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Mini is provided sterile and is a single-use disposable instrument. The Mini creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between its jaws. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Mini is only available in one shaft length: 20 cm.

The provided text describes the regulatory submission for the CoolSeal System, a set of electrosurgical devices. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and efficacy through strict acceptance criteria and a single, overarching study.

Therefore, the concept of a single "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the way one might evaluate a diagnostic AI system with specific performance metrics is not directly applicable here. Instead, a series of performance data and testing were conducted to show that the new device performs "as well as" or "equivalent to" the predicate devices.

However, I can interpret the request by outlining the types of performance tests conducted and the implied acceptance by demonstrating equivalence to existing, legally marketed devices.

Here's an attempt to structure the information based on your request, understanding that the context is a 510(k) submission for substantial equivalence:

Implied Acceptance Criteria and Reported Device Performance

Here are the answers to your specific questions based on the provided text, noting that much of this information is designed for software/AI device evaluation and not directly applicable to this hardware electrosurgical device submission:

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

   • See table above. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, and the "reported device performance" are the results of the various tests summarized in the "Performance Data" section.

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 describes ex-vivo (fresh excised porcine blood vessels) and in-vivo (porcine model) testing.
   • Specific sample sizes for these animal studies (e.g., number of vessels tested, number of animals) are not detailed in this summary.
   • The provenance is non-human animal studies (porcine model). The country of origin of the data is not specified. All studies appear to be prospective animal studies, as they were conducted specifically for this submission.

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 to this type of device submission. Ground truth for an electrosurgical device's performance often relates to physical measurements (e.g., burst pressure, thermal spread histology) rather than expert interpretation of images. The evaluation likely involved veterinary and surgical experts for performing the animal studies and pathologists for histological assessments, but their numbers or specific qualifications are not mentioned.

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

   • This is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-in-the-loop or diagnostic imaging studies when there are multiple expert opinions. Physical performance tests do not typically involve such 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

   • This is not applicable. This is an electrosurgical device, not a diagnostic imaging AI device that would involve human readers. Clinical studies (which might involve such comparative effectiveness) were explicitly stated as "not necessary to support this premarket notification."

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

   • This is not applicable in the context of an AI algorithm. For this device, "standalone performance" essentially refers to its performance in the ex-vivo and in-vivo tests, as described under "Performance Data." These tests evaluate the device's physical and functional characteristics.

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

   • For vessel burst pressure, the ground truth is a direct physical measurement.
   • For thermal spread, the ground truth was established through histological assessments (pathology) performed on excised samples from the animal model.
   • For the chronic animal study, the ground truth relates to observed biological outcomes (survival, presence/absence of complications, maintenance of hemostasis, healing as anticipated).

8. The sample size for the training set

   • This is not applicable. This is a hardware electrosurgical device, not a machine learning model that requires a training set.

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

   • This is not applicable, as there is no training set for a machine learning model.

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Generator: The E-100 is an electrosurgical generator for use with a compatible da Vinci Surgical System. It is an electrosurgical unit intended to deliver high-frequency energy (HF) for cutting, coagulation and vessel sealing of tissues.

Instrument: SynchroSeal is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping, dissection, sealing and transection of tissue. SynchroSeal can be used to seal vessels up to and including 5 mm in diameter and tissue bundles that fit in the jaws of the instrument. SynchroSeal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

Generator: The E-100 Electrosurgical Generator is an electrosurgical generator intended to deliver High Frequency (HF) energy for cutting/transection, coagulation and vessel sealing of tissues when used with compatible "Intuitive Surgical Advanced Energy" bipolar instruments - "SynchroSeal" and "Vessel Sealer Extend". The generator provides a single HF output port into which one of these compatible surgical instruments mav be plugged.

Instrument: SynchroSeal is a single-use, disposable, 8 mm instrument with an integrated cord that connects to the E-100 Electrosurgical Generator. An electrode sealing surface and a protruding cut electrode within the jaws enable sealing and cutting/transection functionality. SynchroSeal is an advanced, wristed, bipolar instrument that provides a unique energy mode to enable sealing and transection of vessels and tissue bundles with a single pedal press. In addition to this functionality, SynchroSeal has the ability to grasp, dissect and spot coagulate tissue, and to independently seal vessels.

The provided text describes a 510(k) premarket notification for the Intuitive Surgical E-100 Electrosurgical Generator and SynchroSeal instrument. A 510(k) submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the testing performed to demonstrate this substantial equivalence.

Here's an analysis of the provided text to extract the requested information:

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

The document doesn't explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative manner as one might find in a clinical trial report. Instead, it describes various tests and states that the device "meets the design input requirements" or "did not negatively impact the safety or effectiveness." The overall "acceptance criterion" for a 510(k) is substantial equivalence to the predicate device in terms of safety and effectiveness.

Here's a breakdown of the performance evaluations:

• Hardware Requirements (physical measurements, general functionality, electrical components, reliability)
• EMC and Safety requirements
• Software requirements (power on/self-test, communications monitoring, instrument detection/compatibility, energy delivery/control, user interface, hardware health monitoring, system communication) |
  | Design Validation (Animal/Cadaver) | Demonstrated that "design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, have been met." |
  | Chronic Animal Study (In-vivo) | Evaluated "clinical performance (long-term seal quality)" and "vascular healing response in a live animal model." The sealing performance of the VSE with the Erbe VIO dV (predicate) was used as the benchmark. |
  | Instrument (SynchroSeal) | |
  | Human Factors Testing | Performed (no specific quantitative outcome stated, but implies positive outcome). |
  | Biocompatibility Testing | Demonstrated that the instrument is "nonhemolytic, does not cause intracutaneous irritation, skin sensitization, acute systemic toxicity, and is non-pyrogenic." "No issues of safety or effectiveness and no new risks" identified. |
  | Sterilization Testing | Performed (implies positive outcome). |
  | Packaging and Transit Testing | Performed (implies positive outcome). |
  | Design Verification (Bench Testing) | Demonstrated that the device meets:
• Physical Specifications (critical dimensions, mass, material, jaw to failure)
• Mechanical Requirements (range of motion, grip force, transection/cut distance, alignment, reliability)
• Electrical Requirements (leakage, creepage & clearance, electrostatic discharge, isolation)
• User Interface Requirements
• Equipment Interface Requirements (data verification, instrument recognition, guided tool change, gravity compensation) |
  | Design Validation (Animal/Cadaver) | Demonstrated that "design outputs fulfill the user needs and that the intended use, including indicated vessel sizes, have been met." |
  | Chronic Animal Study (In-vivo) | Evaluated "clinical performance (long-term seal quality)" and "vascular healing response in a live animal model." Compared to predicate device (ERBE VIO generator and EndoWrist Vessel Sealer Extend). |
  | Overall Conclusion | "The E-100 Electrosurgical Generator and SynchroSeal instrument raise no new questions of safety or effectiveness. Based on their intended use, technical characteristics, and performance data, the E-100 Electrosurgical Generator and SynchroSeal instrument are equivalent to their respective predicate devices in terms of safety, effectiveness, and performance." |

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

• Sample Sizes: The document does not specify exact sample sizes for any of the tests (bench, animal, cadaver studies). It refers to "series of tests" and "porcine models."
• Data Provenance:
  • Country of Origin: Not explicitly stated, but given the FDA submission, the studies would likely be conducted in the US or in a manner compliant with US regulatory requirements.
  • Retrospective or Prospective: The studies described (design verification, design validation, chronic animal study) are inherently prospective as they are designed experiments to test the device's performance against pre-defined criteria.

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 information is not provided in the document. The text describes engineering and animal model testing, but not expert-driven ground truth establishment in a diagnostic context (e.g., radiologists interpreting images).

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

This information is not relevant or provided for the type of testing described (bench and animal studies for a surgical instrument). Adjudication methods like 2+1 or 3+1 are typical for human-read evaluations of diagnostic AI, where opinions need to be reconciled.

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

An MRMC study was not conducted as this is a surgical instrument and generator, not a diagnostic AI system that assists human readers. Therefore, there's no mention of human reader improvement with AI assistance.

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

The "standalone" performance in this context would be the performance of the E-100 Generator and SynchroSeal instrument as objectively measured in the bench tests and animal studies, independent of human interaction beyond operating the device. The text details extensive standalone (device-only) performance testing. For example:

• "The subject device, E-100 Electrosurgical Generator, was subjected to series of tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements."
• "The subject device, SynchroSeal, was subjected to series of bench tests to evaluate performance and to demonstrate that the design outputs meet the design input requirements."
• The chronic animal study measured "long-term seal quality" and "vascular healing response," which are objective, device-dependent outcomes.

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

The "ground truth" for this device's performance assessment appears to be a combination of:

• Engineering Specifications/Benchmarking: For hardware, electrical, mechanical, and software requirements, the "ground truth" is adherence to pre-defined specifications and expected performance characteristics.
• Physiological/Pathological Outcomes in Animal Models: For vessel sealing efficiency, hemostatic transection, and tissue healing, the "ground truth" is based on observed clinical performance in porcine models (in vivo and ex vivo) and cadavers, using the predicate device's performance as a benchmark for comparison. This likely involves assessment of seal integrity, burst pressure, and histological evaluation of tissue healing, although specific methods are not detailed.

8. The sample size for the training set

This question is not applicable as the device is not an AI/ML algorithm that requires a "training set" in the traditional sense. It's an electrosurgical device. The "training" here would refer to the engineering and design iterations, which are not based on a 'data set' for model learning.

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

Not applicable, as it's not an AI/ML algorithm with a training set.

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