(15 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 is a 510(k) summary for the Caiman® Seal and Cut Technology. It describes a medical device, and the evaluation for such devices often involves proving substantial equivalence to a predicate device through performance data, not necessarily meeting a predefined set of acceptance criteria with reported device performance in the same way an AI/ML device would be evaluated.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not provided in the context of a 510(k) for a non-AI/ML surgical device.
Here's an attempt to answer based on the provided text, highlighting where information is not applicable or unavailable:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Aragon Surgical RF System Laparoscopic (L2) Instrument cleared via K090306, Aragon Surgical RF System Teleo Instrument cleared via K093075, Aragon Surgical RF System- 5mm Laparoscopic Instrument cleared via K110824) | "Bench testing was performed on the modified devices and found them to be substantially equivalent to the predicate devices." |
| Continued capability for vessel sealing, blunt dissection, grasping, and dividing tissue. | Demonstrated through bench testing to be substantially equivalent to predicate devices, implying these functionalities are maintained. |
| Creation of vessel ligation by bipolar electrical RF energy. | Demonstrated through bench testing to be substantially equivalent to predicate devices. |
| Tissue division with a cutting blade. | Demonstrated through bench testing to be substantially equivalent to predicate devices. |
| No new issues of safety and effectiveness from modifications. | "The modifications made to these devices do not raise any new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "Bench testing was performed on the modified devices." It doesn't detail the number of tests, specimens, or specific configurations tested.
- Data Provenance: Not specified, but generally, bench testing would be conducted in a laboratory setting by the manufacturer (Aesculap, Inc.). It is not typically "retrospective" or "prospective" in the same way clinical data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable to a 510(k) for a surgical device based on bench testing for substantial equivalence. "Ground truth" in this context would be objective measurements of physical properties and performance characteristics, not expert interpretation of outputs like in an AI/ML study.
4. Adjudication method for the test set:
- Not applicable. Performance is evaluated against objective standards and comparison to predicate devices, not through expert adjudication of disputed results.
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 is a non-AI/ML surgical device, so an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this type of device performance would be physical measurements of parameters like seal strength, burst pressure, cutting effectiveness, thermal spread, and electrical properties, compared against established standards or performance of the predicate devices. The document does not explicitly state the specific types of measurements, but refers to "Bench testing."
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable (as above).
§ 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.