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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 vessels (arteries, 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. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

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 shaft lengths: 30 cm, 37 cm, and 44 cm.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "CoolSeal Trinity," an electrosurgical instrument. It details the device's indications for use, comparison to a predicate device, and performance data submitted to support its substantial equivalence.

However, the request asks for specific information regarding acceptance criteria and a study proving the device meets these criteria, particularly focusing on elements common in studies for AI/software-based medical devices (e.g., sample size for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance).

Crucially, the provided document does NOT describe a study involving AI, machine learning, or software performance that would necessitate such detailed criteria or the specific study types listed in the prompt's requirements (e.g., sample sizes for training/test sets, expert ground truth for image data, MRMC studies, standalone algorithm performance).

The "performance data" mentioned in the document relates to:

• Electrical and Thermal Testing: Verifying the device performs as expected when connected to a new compatible generator (Da Vinci E-200).
• Ex-vivo Vessel Burst Pressure: Testing on excised fresh porcine blood vessels to demonstrate effective bipolar electrosurgical vessel sealing performance equivalent to the predicate device.

Therefore, many parts of your request about AI/software-specific study details cannot be answered from the provided text. The CoolSeal Trinity is a hardware electrosurgical instrument; the "study" described is a benchtop performance comparison to an existing predicate hardware device, not a clinical trial or AI model validation.

Based on the provided text, here is what can be inferred or stated regarding "acceptance criteria" and "study":

The core "acceptance criterion" for this 510(k) submission is substantial equivalence to a predicate device (CoolSeal™ Trinity K211579). This means demonstrating that the new device is as safe and effective as the predicate device and has the same technological characteristics. The only difference identified is the compatibility with a new electrosurgical generator (Da Vinci E-200).

The "study" described is a set of performance tests to support this substantial equivalence, particularly due to the identified difference.

Here's a breakdown based on your prompt, addressing what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics in the way one would for an AI/software device (e.g., "sensitivity > X%", "specificity > Y%"). Instead, the acceptance is qualitative: "performs as expected" and "effective...equivalent to the predicate device."

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

• Sample Size: Not explicitly stated for either electrical/thermal testing or ex-vivo burst pressure testing. The term "excised fresh porcine blood vessels" implies biological material was used, but the quantity of vessels is not specified.
• Data Provenance:
  • Country of Origin: Not specified, but "porcine" suggests animal tissue.
  • Retrospective or Prospective: These are laboratory benchtop tests, not clinical studies on human subjects, so the terms "retrospective" or "prospective" in the clinical sense don't strictly apply. The tests were likely conducted prospectively as part of the validation for the 510(k).

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

• Not Applicable. This is a hardware device performance test, not an AI/software diagnostic accuracy study involving human expert interpretation for ground truth. The "ground truth" for electrical/thermal testing would be instrument readings against specifications, and for burst pressure, it would be measured burst pressure.

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

• Not Applicable. See point 3.

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. This is not an AI/software device; therefore, no MRMC study or AI assistance evaluation would be relevant or performed.

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

• Not Applicable. This is a hardware device. There is no "algorithm" or "standalone performance" in the sense of a software-based diagnostic tool. The performance measured is that of the physical device.

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

• For Electrical/Thermal Testing: The "ground truth" would be established engineering specifications derived from the predicate device and general safety standards for electrosurgical equipment.
• For Ex-vivo Vessel Burst Pressure: The "ground truth" is the empirically measured burst pressure of the sealed vessels, likely compared against a pre-defined threshold or against measurements from the predicate device under similar conditions. This is a direct physical measurement.

8. The sample size for the training set:

• Not Applicable. This is not an AI/software device; there is no "training set."

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

• Not Applicable. See point 8.

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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 vessels (arteries, 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. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

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.

This document (K211579) describes a 510(k) premarket notification for the CoolSeal™ Trinity, a bipolar electrosurgical instrument. The information provided heavily focuses on the device's technical specifications, indications for use, and a comparison to predicate devices, along with general statements about safety and performance testing. However, it does not contain the specific details regarding acceptance criteria and the comprehensive study that proves the device meets those criteria, especially in the context of an AI/ML-based device.

The document confirms that mechanical, electrical, and functional testing was carried out, along with ex-vivo and in-vivo vessel burst pressure studies, in-vivo thermal spread comparison, and chronic animal studies. While these are performance studies, they are geared towards demonstrating the safety and effectiveness of a physical electrosurgical medical device and not an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device's performance from this document. The document primarily addresses the substantial equivalence of a surgical instrument to its predicates.

To answer your request, the document would need to contain information about:

• A specific algorithm or AI component.
• Performance metrics like sensitivity, specificity, AUC, or accuracy (for classification tasks).
• Details on test datasets (sample size, provenance, ground truth establishment, adjudication).
• Details on training datasets.
• MRMC study results, if applicable.

Since this information is not present, I must state that the document does not provide the necessary data to answer the request in the context of an AI/ML device.

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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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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 including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.

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.

The provided text is a 510(k) summary for the CoolSeal™ Trinity electrosurgical device. It outlines the device's indications for use, technological characteristics, and performance data submitted to demonstrate substantial equivalence to predicate devices. However, this document primarily focuses on regulatory submission and does NOT contain information about an AI/ML-based medical device.

Therefore, I cannot extract the acceptance criteria or study details for an AI/ML device from this document as it describes a physical electrosurgical instrument and its testing. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are specific to the evaluation of AI/ML algorithms and are not relevant to the CoolSeal™ Trinity device described here.

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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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