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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.

Instruments 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic 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 describes a 510(k) premarket notification for a medical device called "Caiman Seal and Cut Technology." This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving de novo safety and effectiveness through a clinical performance study involving human subjects or AI-based image analysis.

Therefore, the information required to answer your prompt, which pertains to the acceptance criteria and study proving an AI/ML device's performance (including sample sizes, expert ground truth establishment, MRMC studies, etc.), is not present in the provided text.

The text details the following:

• Device Name: Caiman Seal and Cut Technology
• Regulatory Classification: Electrosurgical cutting and coagulation device and accessories (Class II, Product Code GEI, Regulation Number 21 CFR 878.4400)
• Purpose of Submission: K151858 – to demonstrate substantial equivalence to a previously cleared device (K140839).
• Device Description: Bipolar electrosurgical instruments (with a cutting blade) designed for vessel sealing, blunt dissection, grasping, and dividing tissue using RF energy. Used with a dedicated Lektrafuse RF Generator.
• Indications for Use: General surgery and gynecologic procedures where ligation and division of vessels up to 7mm are desired. Not for tubal sterilization.
• Performance Data: States that bench testing was performed on modified devices and found them substantially equivalent to predicate devices.
  • Tests performed: Seal Burst Pressure (on three tissue types), Visual Arcing, Jaw Adhesion, Thermal Spread. This is physical device performance testing, not AI/ML model performance.
• Compliance with Standards: IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1: 3rd Edition, IEC 62304.

In summary, this document is for a traditional electrosurgical device, not an AI/ML device. Therefore, the specific criteria and study details you've requested regarding AI/ML performance are not applicable and thus not found in this regulatory submission.

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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:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample size, data provenance, number of experts, adjudication method for an AI/algorithm's test set.
3. MRMC comparative effectiveness study results for AI assistance.
4. Standalone (algorithm-only) performance.
5. Type of ground truth used for AI/algorithm.
6. 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):

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.

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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

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

1. 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).

2. 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.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for this type of device testing.

4. 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.

5. 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.

6. 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."

7. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.

8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

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:

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).

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