(113 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 12.5 cm, 17 cm, and 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic 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, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices 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 be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.
The Caiman® 5 Maryland instruments are 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 provided document is a 510(k) premarket notification for a medical device, the Caiman® 5 Maryland, an electrosurgical cutting and coagulation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials. Therefore, the document primarily details performance testing related to the device's technical specifications and safety, not a study evaluating human reader performance with or without AI assistance, or the performance of an AI algorithm.
Based on the provided text, here's an analysis of the acceptance criteria and the "study" (which are more accurately described as performance tests and verification activities) that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a quantitative, target-based manner (e.g., "burst pressure must be > X mmHg for Y% of samples"). Instead, it lists various performance tests and their outcomes, indicating a "Pass" result for each. The acceptance criteria are implicitly met by achieving a "Pass" in these design verification tests, which are presumably designed to demonstrate equivalence to the predicate and ensure safety and effectiveness.
| Test Acceptance Criteria (Implicit - Resulting in "Pass") | Reported Device Performance |
|---|---|
| Tissue-related performance test for arteries: Device performs according to technical requirements and user needs, demonstrating life cycle for typical applications. | Pass |
| Burst Pressure testing for veins: Device generates burst pressure data for relevant vein diameters consistent with safe and effective sealing. | Pass |
| Jaw Tissue stress test: Durability of Maryland instruments is comparable to predicate devices under specified load conditions. | Pass |
| Validation of usability: User needs related to usability are met through structured user survey, demonstrating usability in accordance with applicable standards. | Pass |
| Electrical Safety: Conforms to IEC 60601-2-2, IEC 60601-1-2, IEC 60601-1, and IEC 60601-2-18 standards. | Conforms (Indicated by compliance with listed standards) |
| Biocompatibility: Conforms to ISO 10993-1. | Conforms (Indicated by compliance with listed standard) |
| Sterilization: Sterilization process is in accordance with ISO 11137-2 - method 1, and instruments remain sterile. | Conforms (Indicated by compliance with listed standard and no changes from predicate) |
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 specify the sample sizes used for the design verification tests (e.g., how many arteries/veins were tested, how many instruments were used for stress testing). The data provenance (country of origin, retrospective/prospective) is also not stated. These tests are typically conducted in a laboratory setting as part of product development and verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not involve a study where "ground truth" is established by experts in the context of medical image interpretation or clinical diagnosis. The performance tests described (tissue-related performance, burst pressure, jaw stress) are objective engineering and material science tests. For the "Validation of usability" test, a "user survey" was conducted, implying involvement of potential users (likely surgeons or healthcare professionals), but the number and qualifications of these users are not specified.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant to studies where human interpretation of data (e.g., medical images) is being assessed, often to establish a consensus ground truth. This document describes performance tests for a surgical instrument, not an AI algorithm or diagnostic tool involving human interpretation of complex medical data. Therefore, an adjudication method is not applicable here.
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
No MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a surgical instrument, not an AI-powered diagnostic or assistive tool. Thus, there is no mention of human readers, AI assistance, or effect sizes related to such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. As mentioned, this submission is for a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical and electrical performance tests, the "ground truth" is based on established engineering principles, material science properties, and adherence to relevant international standards (e.g., IEC, ISO). For the "Usability" test, the ground truth is based on user feedback collected via a survey, indicating whether the device meets user needs for usability. There is no biological or diagnostic ground truth (like pathology or outcomes data) in the context of this submission.
8. The sample size for the training set
There is no mention of a training set or machine learning algorithms in this document. Therefore, no sample size for a training set is applicable.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, there is no ground truth establishment process for it described in this document.
§ 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.