(144 days)
ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series are indicated for cutting and coagulation in endoscopic, gynecological, and general abdominal and thoracic and general laparoscopic procedures.
This product is sterile, single-use, invasive instrument that used in laparoscopic surgery. There are two Version, one for Dissector and Scissors. The two models are same except for jaw. 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.
The provided document is a 510(k) summary for the ArtiSential Laparoscopic Instruments-Electrodes, Monopolar Series. It describes the device, its indications for use, and a comparison to predicate and reference devices. The document does not contain acceptance criteria in the traditional sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) that are typically used to evaluate the performance of diagnostic or AI-driven medical devices.
Instead, this document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K200501) and a reference device (K201063) by ensuring the new device meets established safety and performance standards for electrosurgical instruments. The "tests" here are primarily engineering and biocompatibility tests to prove the device is safe and performs its intended function reliably, not clinical performance metrics against a "ground truth" as would be seen for a diagnostic AI.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information provided in this document as it pertains to a physical surgical instrument, not an AI/diagnostic software.
Here's an attempt to extract relevant information given the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
Since specific numerical acceptance criteria (like accuracy percentages for AI models) are not provided for this type of device, the "acceptance criteria" are implied by the standards and categories of tests performed, aiming to show compliance and functionally equivalent performance to the predicate device.
| Category of Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 (Biological Evaluation of Medical Devices) for various endpoints. | Evaluated for Cytotoxicity, Sensitization, Intracutaneous reactivity, and Acute systemic toxicity. (Passed all assessed endpoints) |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, and IEC 60601-2-2. | Passed all performed electrical safety tests. |
| Sterilization | Provided sterile, single-use, EO-sterilization in accordance with ISO-11135. | Complies with ISO-11135. |
| Shelf Life | Maintenance of packaging integrity, sterility, and performance after storage (2 years accelerated aging). | Proposed expiration date is 2 years. Tests conducted at zero and 2-year accelerated aging points. Passed: Packaging integrity, Sealing strength (ASTM F 88), Dye penetration (ASTM F1929-15), Sterility (ISO 11737-2:2009), Appearance, Dimension, Operational test, Tensile Strength, Feedthrough test. (Passed all tests, demonstrating 2-year shelf life) |
| Performance Test | Satisfactory operational and physical characteristics. | Passed: Appearance, Dimension, Operational test, Tensile Strength, Feedthrough test. (Passed all performed tests) |
| Thermal Effect | Demonstrate intended cutting and coagulation effects at various power settings without adverse outcomes. | Thermal effects testing conducted on liver, kidney, abdominal muscle at three power settings (10W, 40W, 300W). Results demonstrate performance requirements were met and device performs as intended. The report concludes it has substantially equivalent performance characteristics to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically not provided for engineering and biocompatibility testing of physical medical devices. The "test set" here refers to the actual device units subjected to the various physical, electrical, and thermal tests mentioned. The number of units tested for each specific test is not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable in the context of these device verification studies.
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)
Not applicable. "Ground truth" in the context of diagnostic AI refers to a definitive correct answer for a medical condition. For a physical electrosurgical instrument, the "ground truth" is its ability to meet engineering specifications and functional performance (e.g., cutting and coagulating as intended), which is assessed through standardized tests and not by expert consensus on clinical cases. The thermal effects study likely involved technicians or engineers performing the tests and evaluating the tissue response according to predefined criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert interpretations. For engineering tests, results are typically objective measurements or observations against predefined pass/fail criteria.
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. MRMC studies are specific to diagnostic AI or imaging interpretation and are not relevant to the evaluation of a physical electrosurgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical tool, not an algorithm, and its use inherently involves a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As explained above, traditional "ground truth" for diagnostic AI is not applicable. For this device, the "ground truth" is defined by adherence to established engineering standards (e.g., IEC 60601, ISO 10993, ISO 11135, ASTM F88, ASTM F1929) and successful demonstration of functional performance characteristics (cutting and coagulation on tissue samples).
8. The sample size for the training set
Not applicable. This device is not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI model requiring a training set with established ground truth.
§ 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.