(101 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 Hook and Spatula. 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 text is a 510(k) premarket notification for a medical device: "ArtiSential Laparoscopic Instruments-Electrodes." This document primarily focuses on establishing substantial equivalence to a predicate device, as required by the FDA. As such, it details physical and electrical performance characteristics of the device rather than the results of a clinical study involving human or AI interpretation of medical images.
Therefore, many of the requested points regarding acceptance criteria for AI/human reader performance in a clinical setting, sample sizes for test sets in a clinical study, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for training sets in AI models are not applicable or find no direct mention in this document.
The document discusses engineering and safety tests for a physical instrument, not a diagnostic AI system or a comparative study of human readers.
However, I can extract and present the acceptance criteria and performance data that are relevant to the described device and its specified tests:
Acceptance Criteria and Reported Device Performance for ArtiSential Laparoscopic Instruments-Electrodes
The device under review is an electrosurgical instrument, not an AI or imaging device requiring human reader studies. Therefore, the "acceptance criteria" and "device performance" relate to physical, electrical, and mechanical integrity and function, rather than diagnostic accuracy or human interpretation.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Clause and Test Requirement | Test Specification | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Appearance | |||
| No defects in the appearance; no problem in use. | Visual observation | No crack, stain, or substances on the surface of the product. | "No crack, stain or no substances on the surface of the product" (Passed) |
| Dimension | |||
| Within ± 5% of the indicated dimensional value. | Measure by Vernier calipers and dial gauge etc. | Within ± 5% of the indicated value. | "Pass" (Referenced Attachment #11 for detailed test result, but summary states pass). |
| Operational test | |||
| End-tip and hub can bend up, down, left, right above ±80° and rotate 360°. | Adjusting the end-tip by manipulating the grip and control ring and measure the angle. | End-tip and hub bend up, down, left, right within above 80° and rotate 360°. | "The end-tip and hub are bent up, down, left and right within above 80° and can rotate 360°." (Passed) |
| Tensile strength | |||
| End-tip and shaft connections shall not be damaged from pulling of 20 N. | Hold the end-tip and shaft connections respectively and apply a force of 20 N. | No damage to the connection when applying a force of 20N. | "No damage to the connection when applying a force of 20N" (Passed) |
| Feedthrough test | |||
| Electricity should be transmitted between the electrode tip and the connector. | Electrical conduction between the electrode tip and the connector is tested using a DMM. | Resistance value between the electrode tip and the connector is less than 1Ω. | "The resistance value between the electrode tip and the connector is less than 1Ω" (Passed) |
| Biocompatibility (General safety evaluation) | ISO 10993-1 | Acceptable results for cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, pyrogenicity. | "The device has been evaluated for its biological safety according to ISO 10993-1... Following endpoints have been assessed... (all listed above)" (Implied passed for substantial equivalence) |
| Electrical Safety | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, IEC 60601-2-2 | Compliance with all relevant clauses for active accessory insulation, hf leakage, hf dielectric strength, mains frequency dielectric strength, and feedthrough. | "The device had passed all performed tests." |
| Sterilization | ISO 11135 | Device provided sterile; single-use, EO-sterilization in accordance with ISO 11135. | "This product is EO-Sterilization in accordance with ISO-11135." (Passed) |
| Shelf-life (Proposed) | Not specified (real-time testing to be performed) | 3 years from manufacturing date. | "The proposed expiration date is 3 years from the manufacturing date. The real-time testing will be performed to confirm the shelf-life for 3 years." (Ongoing/Proposed) |
2. Sample size used for the test set and the data provenance:
The document does not refer to a "test set" in the context of clinical images or data provenance (e.g., country of origin, retrospective/prospective) because this device is a physical surgical instrument being evaluated for its engineering and safety characteristics. The tests described are laboratory and bench studies (e.g., measuring dimensions, tensile strength, electrical resistance) on samples of the manufactured device. Specific sample sizes for each test are not explicitly stated in this summary, but implied to be sufficient for engineering validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert review in the context of diagnostic performance are irrelevant for the evaluation of this physical electrosurgical instrument. The "ground truth" for these tests is based on established engineering standards and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this refers to adjudication of discrepancies in expert medical interpretation, which is not part of this device's evaluation.
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 a surgical instrument, not an AI or diagnostic imaging tool. MRMC studies are used to assess the impact of AI on human diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance evaluation is based on engineering specifications, standardized test methods (e.g., ISO, IEC standards for biocompatibility and electrical safety), and objective physical measurements (e.g., dimensions, force, resistance, angles).
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. There is no "training set" or "ground truth" in the AI sense for this device.
§ 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.