(24 days)
Caiman Seal and Cut Technology System 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.
Instruments 36cm and 44cm in length are indicated for laparoscopic procedures and instruments 24 cm in length are 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 System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, grasping, and dividing tissue enclosed within its dissection clips.
The reason for this submission is to capture modifications to the caiman 12 (24cm and 44cm) instruments.
The provided text describes a 510(k) premarket notification for the "Aesculap Caiman 12 Seal and Cut Technology System". This is a regulatory submission for a medical device rather than an AI-driven system. Therefore, most of the requested information regarding AI-specific criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance) is not applicable or available in this document.
However, I can extract information related to the device's acceptance criteria and the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device, which is relevant to device performance and acceptance.
Here's the available information based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Instrument Cycling Test | |
| No pin walking shall be observed | Pass |
| Jaw Clamping Force Test | |
| Jaw clamping force must remain within | Pass |
| specification 170 N - 350 N |
Study Details (Non-Clinical Testing)
This document describes non-clinical testing verifying design changes to an electrosurgical device, not a study of an AI algorithm. Therefore, many of the AI-specific questions are not applicable.
- Sample size used for the test set and the data provenance: Not explicitly stated as this is non-clinical testing of a physical device. The testing was conducted to verify design changes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and electrical performance is established through engineering specifications and objective measurements, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical 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 document is not about AI assistance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI algorithm.
- The type of ground truth used: Engineering specifications and objective measurements based on the device's design and intended function (e.g., measuring force, observing mechanical stability).
- The sample size for the training set: Not applicable. This is for a physical medical device, not an AI model.
- How the ground truth for the training set was established: Not applicable.
Additional context from the document:
- Purpose of Testing: "Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure the design changes met the predetermined acceptance criteria."
- Methodology: "A risk analysis was completed to identify the risks associated with the modifications to the Caiman Seal and Cut Technology System. Verification testing was conducted to evaluate the modification."
- Conclusion: "The conclusions drawn from the nonclinical tests demonstrate that the modifications described in this submission do not affect the intended use of the device or alter the fundamental scientific technology of the 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.