(14 days)
Indications for use include electrosurgical coagulation, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
The ArtiSential Laparoscopic Instruments - Electrodes, Bipolar series are sterile, single-use, invasive instruments that used in laparoscopic surgery. There are three versions, ABF01 series and ABD02 series. Three versions are same except for jaw shape. This product is a specific component, but not the entire electrosurgical device. The device is not intended to be marketed with multiple components, accessories, and as part of a system.
This document concerns the 510(k) premarket notification for the ArtiSential Laparoscopic Instruments-Electrodes. This is a medical device for electrosurgical cutting and coagulation and is a Class II device. The document is a Special 510(k) Summary, indicating that the device has minor modifications compared to a previously cleared predicate device (K200875).
Here's an analysis of the acceptance criteria and study information provided, focusing on what's available in the document:
1. A table of acceptance criteria and the reported device performance:
The document describes performance tests as having been conducted and met, but it does not provide specific quantitative acceptance criteria or detailed reported performance values in a table. Instead, it states that "The device had passed all performed tests" and "Based on these performance characteristics, the results demonstrate that the performance requirements were met, the device performs as intended and that the subject device has substantially equivalent performance characteristics to the predicate devices."
The types of performance tests mentioned are:
| Acceptance Test Category | Reported Device Performance |
|---|---|
| Appearance | Passed |
| Dimension | Passed |
| Operational test | Passed |
| Tensile strength | Passed |
| Feedthrough test | Passed |
| Grasping Force | Passed |
| Force to jaw failure | Passed |
In addition, the following characteristics were declared the same as the predicate device (K200875):
- Biocompatibility: Same as predicate.
- Electrical Safety: Tested according to IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and IEC 60601-2-2. Active accessory insulation, HF leakage, HF dielectric strength, and mains frequency dielectric strength, and feedthrough test were reportedly performed and are the same as the predicate.
- Sterilization: EO (Ethylene Oxide) sterilization, same as predicate.
- Shelf life: 2 years, same as predicate.
2. Sample size used for the test set and the data provenance:
The document does not specify the sample size used for the performance tests. There is no information regarding the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The device is a surgical instrument, and its performance tests are primarily objective physical, electrical, and mechanical evaluations, not diagnostic assessments requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided as the tests are objective engineering evaluations, not subjective assessments requiring adjudication.
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 information is not applicable and not provided. This is a surgical instrument, not an AI-assisted diagnostic device, so MRMC studies or AI assistance effect sizes are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. This is a manually operated surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This is not applicable in the sense of clinical ground truth for diagnostic accuracy since the device is a surgical instrument. The "ground truth" for the performance tests would be established by engineering specifications, regulatory standards (e.g., IEC standards for electrical safety), and industry best practices for mechanical and functional performance testing of such devices.
8. The sample size for the training set:
This information is not applicable and not provided as this is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided (see point 8).
§ 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.