(109 days)
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.
§ 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.