(26 days)
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.
The Caiman 12 Plus (44cm) and the Caiman 5 are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) is indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.
Caiman Seal and Cut Technology has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
Caiman Seal and Cut Technology consists of the Lektrafuse RF Generator and the sterile, single use Caiman devices. These devices are capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The devices are designed to be used with the dedicated Lektrafuse RF Generator and create vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.
The provided text does not contain specific acceptance criteria or a detailed study proving device performance in a quantitative manner as typically found in medical device reports for AI/software products. Instead, it describes a traditional medical device (electrosurgical cutting and coagulation device).
Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to the information provided.
However, I can extract the information that is present:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Substantial Equivalence | Substantially equivalent to Caiman Seal and Cut Technology cleared via K130596. |
| Safety and Effectiveness | Modifications made do not raise any new issues of safety and effectiveness. |
| Bench Testing | Found to be substantially equivalent to predicate devices. |
| Standards Compliance | In compliance with IEC 60601-1 3rd edition, IEC 60601-1-2:2007, IEC 60601-2-2:2009, and IEC 62304 1st edition. |
Missing Information: The document does not provide specific numerical acceptance criteria (e.g., minimum seal strength, maximum thermal spread) or quantitative performance metrics for the modified device beyond stating "substantially equivalent" and "in compliance with standards."
Study Details for Device Performance
-
Sample size used for the test set and the data provenance: Not specified. The document states "Bench testing was performed on the modified devices," but does not provide details on the sample size of tested vessels/tissues or their origin (e.g., in vitro, ex vivo, animal, human, country of origin, retrospective/prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an electrosurgical instrument, not an AI/diagnostic imaging device. Ground truth, in this context, would involve physical measurements rather than expert consensus on diagnostic interpretations.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device testing.
-
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/diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical instrument that requires human operation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Based on the general nature of electrosurgical device testing, the ground truth for bench testing would likely involve objective physical measurements such as burst pressure of sealed vessels, thermal spread measurements, and impedance measurements. The document does not explicitly state the types of ground truth for its "bench testing."
-
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
-
How the ground truth for the training set was established: Not applicable.
§ 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.