(127 days)
The DANNIK Disposable Monopolar Laparoscopic Instrument have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection and transection of tissue.
The DANNIK Disposable Monopolar Laparoscopic Instrument consists of Handle which activates the instruments jaws and scissor blades, Rotator knob that provides 360 degrees rotation , both handle and rotation knob are made of ABS thermoplastic, and a Shaft made from Medical grade Stainless Steel and insulated with high-density polyethylene PE. 5mm in diameter with a working length of 33cm. RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with appropriate ground electrode.
This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
The provided text describes the DANNIK Disposable Monopolar Laparoscopic Instrument, which is a medical device. The document does not describe a study that uses acceptance criteria in the context of an AI/ML powered medical device, but rather provides information related to the 510(k) premarket notification process for a physical medical instrument.
Therefore, many of the requested elements for an AI/ML powered device, such as sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or cannot be extracted from this document.
However, I can extract information about the non-clinical tests performed, which could be considered analogous to "acceptance criteria" in a broad sense for a physical device, and how the device meets them through testing.
Here's the information that can be extracted, framed as closely as possible to your request, with an explicit note where the information is not applicable to the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Evaluation Parameters) | Reported Device Performance (Evaluation Method) |
|---|---|
| Thermal effects on Tissue | Evaluated by Design Engineers through performance and functionality evaluations. |
| Connection strength | Evaluated by Design Engineers through performance and functionality evaluations. |
| Clamping performance | Evaluated by Design Engineers through performance and functionality evaluations. |
| Cable connection | Evaluated by Design Engineers through performance and functionality evaluations. |
| Open and close performance | Evaluated by Design Engineers through performance and functionality evaluations. |
| Hardness | Evaluated by Design Engineers through performance and functionality evaluations. |
| Corrosion resistance | Evaluated by Design Engineers through performance and functionality evaluations. |
| Outward (likely referring to outward appearance/integrity) | Evaluated by Design Engineers through performance and functionality evaluations. |
| Biocompatibility | Conforms to ISO 10993. |
| Sterilization | Achieved by Ethylene Oxide (ETO) according to ISO 11135-1. |
2. Sample size used for the test set and the data provenance
Not applicable. This document pertains to the 510(k) clearance of a physical medical instrument, not an AI/ML powered device. The "tests" mentioned are non-clinical engineering evaluations, not studies with test sets in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluations were performed by "Design Engineers." Specific numbers or detailed qualifications are not provided beyond this title. Ground truth in the AI/ML sense (e.g., expert consensus on image interpretation) is not relevant here.
4. Adjudication method for the test set
Not applicable. This concept (e.g., 2+1, 3+1) is for reconciling discrepancies in expert opinions for AI/ML ground truth, which is not relevant to the non-clinical engineering evaluations described.
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 not an AI/ML powered device, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is implied to be engineering specifications, performance standards (like ISO 10993, ISO 11135-1), and functionality requirements validated through direct testing by design engineers. There is no "ground truth" as typically defined for AI/ML models (e.g., pathology, expert consensus).
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered 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.