(27 days)
Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation 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 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparascopic procedures. The include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation 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 Caiman seal and cut devices which are provided as sterile, single use 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 5 mm instruments (not the generator) are the subject of this submission.
The provided text describes a medical device, the "Caiman Seal and Cut Technology," and its FDA 510(k) summary for substantial equivalence. However, the document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-driven medical device.
This document primarily focuses on the substantial equivalence of a modified electrosurgical cutting and coagulation device to a previously cleared predicate device, based on bench testing and compliance with safety standards.
Therefore, I cannot fulfill your request for information related to:
- A table of acceptance criteria and reported device performance for an AI/algorithm.
- Sample size, data provenance, number of experts, adjudication method for an AI/algorithm's test set.
- MRMC comparative effectiveness study results for AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used for AI/algorithm.
- Training set sample size and ground truth establishment for an AI/algorithm.
The document details the following about the Caiman Seal and Cut Technology, but again, not in the context of an AI/algorithm:
Acceptance Criteria and Study for the Caiman Seal and Cut Technology (Electrosurgical Device):
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the format typically seen for algorithms. Instead, it lists the types of bench tests performed to demonstrate substantial equivalence to a predicate device, implying that the acceptance criteria for these tests were met to show the modified device performs as intended and is as safe/effective as the predicate.
Here's a summary of the performance data and "study" (bench testing) mentioned:
1. Table of Acceptance Criteria and Reported Device Performance (as implied by the document):
| Test Performed (Implied Acceptance Criteria: Equivalent to Predicate) | Reported Device Performance |
|---|---|
| Articulation Angle/Torque | Found to be substantially equivalent to predicate devices. |
| Biocompatibility | Found to be substantially equivalent to predicate devices. |
| Cutter Advancement | Found to be substantially equivalent to predicate devices. |
| Cutting Blade Termination | Found to be substantially equivalent to predicate devices. |
| Dissection Distance | Found to be substantially equivalent to predicate devices. |
| Distal Jaw Gap | Found to be substantially equivalent to predicate devices. |
| Flow Rate | Found to be substantially equivalent to predicate devices. |
| Force to Lock and Release Jaw | Found to be substantially equivalent to predicate devices. |
| Instrument Life | Found to be substantially equivalent to predicate devices. |
| Jaw Adhesion | Found to be substantially equivalent to predicate devices. |
| Jaw Force (clamping compression) | Found to be substantially equivalent to predicate devices. |
| Jaw Grasp | Found to be substantially equivalent to predicate devices. |
| Tissue Resistance Test | Found to be substantially equivalent to predicate devices. |
| Sealing (length, size & time) | Found to be substantially equivalent to predicate devices. |
| Seal Burst Pressure on three different tissue types | Found to be substantially equivalent to predicate devices. |
| Thermal Spread | Found to be substantially equivalent to predicate devices. |
| Trocar Compatibility | Found to be substantially equivalent to predicate devices. |
| Visual Arcing | Found to be substantially equivalent to predicate devices. |
| Regrasp | Found to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance:
- The document states "Bench testing was performed." It does not specify the sample sizes (e.g., number of units tested, number of tissue samples) or the data provenance (e.g., country of origin, retrospective/prospective) for these tests. This information is typical for in vitro/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI/algorithm submission requiring expert-established ground truth for a test set. The validation relies on engineering and performance parameters measured in bench tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not an AI/algorithm submission.
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 device is an electrosurgical instrument, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- For the bench testing, the "ground truth" would be the established engineering specifications, performance metrics, and safety standards (e.g., IEC 60601 series) that the device must meet, often compared directly to the predicate device's established performance. The "ground truth" is therefore derived from objective physical measurements and comparisons, not expert consensus or pathology in a clinical imaging context.
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/algorithm.
§ 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.