(68 days)
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
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance |
|---|---|
| CoolSeal™ Trinity: | |
| Biocompatibility (ISO 10993-1:2018 adherence) | Conducted and in accordance with ISO 10993-1:2018. |
| Electrical Safety (ANSI/AAMI/ES 60601-1, IEC 60601-2-2) | Complies with relevant clauses of ANSI/AAMI/ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-2:2017. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014. |
| Mechanical and Functional Performance | Performed as expected (verified through testing). |
| Ex-vivo Vessel Burst Pressure | Demonstrated equivalent bipolar electrosurgical vessel sealing performance to predicate device (LigaSure™ Maryland jaw Sealer/Divider) using fresh excised porcine blood vessels. |
| In-vivo Vessel Burst Pressure (Lymphatics) | Demonstrated equivalent bipolar electrosurgical vessel sealing performance to predicate device (LigaSure™ Maryland jaw Sealer/Divider) using lymphatics in a porcine model. |
| In-vivo Thermal Spread Comparison | Demonstrated the subject device is as safe and effective as the predicate device by quantifying thermal spread in seals created by both devices in a porcine model (excision and 3D histological assessments). |
| Chronic Animal Study (Safety & Performance) | All animals (porcine model) survived 28 days post-op without complications. All vessel sealing effects maintained chronic hemostasis and healed as anticipated. |
| CoolSeal™ Mini: | |
| Biocompatibility | Biocompatibility testing previously submitted for the predicate device (JustRight™ Sealer) is applicable, as design changes did not impact patient-contacting material. |
| Electrical Safety (ANSI/AAMI/ES 60601-1, IEC 60601-2-2) | Complies with relevant clauses of ANSI/AAMI/ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-2:2017 (as part of the CoolSeal™ system). |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014 (as part of the CoolSeal™ system). |
| Mechanical and Functional Performance | Performed as expected (verified through testing). |
| Ex-vivo Vessel Burst Pressure | Demonstrated bipolar electrosurgical vessel sealing performance to predicate device (JustRight™ Sealer) using fresh excised porcine blood vessels. (The text doesn't explicitly state "equivalence" for the Mini's ex-vivo but implies it by stating it was to "demonstrate bipolar electrosurgical vessel sealing performance" in the context of substantial equivalence). |
| CoolSeal™ Generator: | |
| Electrical Safety (ANSI/AAMI/ES 60601-1, IEC 60601-2-2) | Complies with relevant clauses of ANSI/AAMI/ES 60601-1:2005/(R)2012 and A1:2012 and IEC 60601-2-2:2017. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014. |
| Mechanical and Functional Performance | Performed as expected (verified through testing). |
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:
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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.
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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.
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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.
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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.
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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."
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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.
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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).
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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.
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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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.