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Caiman Seal and Cut Technology System 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.

The Caiman 12 Plus (44cm) and the Caiman 5 (36cm and 44cm) are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) and the Caiman 5 (24cm) are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectory, adhesiolysis, bowel resection, and oophorectorny 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 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, blunt dissection, grasping, and dividing tissue enclosed within its dissection clips. This reason for this submission is to capture modifications to the caiman blunt instruments.

The provided text is a 510(k) summary for a medical device called the Aesculap Caiman 5 Seal and Cut Technology System. This document outlines the device's technical characteristics, intended use, and the results of non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the specific sample sizes for the test set used in the non-clinical performance tests (Tissue Related Performance, Burst Pressure, and Cutting Blade Activation). It refers to "testing and validation activities" and "design verification table" but does not provide details on the number of devices or trials performed for each test.

The data provenance is not mentioned. As this is a premarket notification for a medical device in the US (FDA 510(k)), the testing would typically be conducted by the manufacturer (Aesculap, Inc., based in Center Valley, Pennsylvania) or a contracted lab. The tests are non-clinical, implying laboratory or bench testing rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable. The performance testing described is for a surgical instrument (electrosurgical cutting and coagulation device). The "ground truth" for this type of device is established through objective physical and functional measurements (e.g., sealing time, thermal spread, cutting force, burst pressure on vessels), not through expert interpretation of images or other subjective assessments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are typically used in clinical studies or studies where subjective assessments (e.g., image interpretation) are made by multiple experts and a consensus is needed for ground truth. The tests described are objective, non-clinical performance tests.

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:

This is not applicable. The device is a surgical instrument, not an AI-powered diagnostic or interpretive tool that would involve human readers. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a physical surgical instrument, not an algorithm, and it operates with a human surgeon in the loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the non-clinical tests is based on objective physical measurements and engineering specifications, primarily related to the device's ability to:

• Perform a specified number of operational cycles (Life Cycle test).
• Achieve a certain burst pressure strength on sealed vessels (Burst Pressure test).
• Operate its cutting blade within a defined force range (Cutting Blade Activation test).
• Control thermal spread within set limits.
• Cut tissue completely without tags.

These are verifiable properties of the device's mechanical and electrical function as applied to tissue models, not clinical "outcomes data" or "pathology" in the diagnostic sense.

8. The sample size for the training set:

This is not applicable. The Aesculap Caiman 5 Seal and Cut Technology System is a physical electrosurgical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. Training for this type of device would involve design, manufacturing, and quality control processes.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set for an AI/ML algorithm. The ground truth for the device's functional performance是在bench测试中由工程规格和测量仪器的结果建立的。

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