(49 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 Instruments are sterile single-use devices consisting of a handle, rotator knob and shaft. The handle activates the instrument jaws and scissor blades. The rotator knob provides 360 degrees of rotation for the instrument shaft and jaws. The shaft includes an external insulation that runs from the rotator knob to the instrument jaws and is provided in working diameters of 3 to 5 mm and lengths up to 33 cm. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.
The provided text describes a 510(k) premarket notification for a medical device, specifically the DANNIK Disposable Monopolar Laparoscopic Instrument.
However, the content does not include any information about acceptance criteria or a study proving that the device meets those criteria, as typically seen for AI/ML-based medical devices or devices requiring extensive performance evaluations. The submission is a "Special 510(k) Summary" which indicates a modification to a previously cleared device (from 5mm to 3mm working diameter). This type of submission relies heavily on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data for acceptance criteria.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and performance study from this document. The document explicitly states:
- "There were no clinical trials performed on these devices." (Page 5, Section 8. CLINICAL TESTS)
- "NONCLINICAL TESTS: Risk analysis was conducted to assess the impact of the change on the subject device using internal design control procedures. Assessments were completed for the risk associated with Electromagnetic Energy as related to the basic safety and essential performances as detailed in IEC 60601-1 and appropriate collateral and/or particular standards. Dimensional Analysis and verification of the shaft flexural strength was completed, which showed that the devices met the same requirements as the predicate device." (Page 4, Section 7. NONCLINICAL TESTS)
This indicates that the modifications were assessed through non-clinical testing (dimensional analysis, flexural strength, risk analysis related to electrosurgical safety) to demonstrate equivalence, and not through a study with acceptance criteria measuring specific performance metrics for diagnosis or treatment effectiveness in a clinical setting against a predefined ground truth.
To directly answer your numbered points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available or specified in the document. The filing focuses on demonstrating that the new 3mm diameter version meets the same physical/electrical safety requirements as the 5mm predicate.
- Sample sized used for the test set and the data provenance: Not applicable in the context of a clinical study. The non-clinical tests involved dimensional analysis and verification of shaft flexural strength; samples would be drawn from manufacturing lots for these tests, but specific sample sizes are not detailed beyond "showed that the devices met the same requirements as the predicate device." No patient data or clinical data provenance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established as no clinical trials or diagnostic performance studies were performed.
- Adjudication method for the test set: Not applicable.
- 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 not an AI/ML diagnostic or assistive device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a manual surgical instrument.
- The type of ground truth used: Not applicable in a clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications and safety standards (e.g., IEC 60601-1 for electrosurgical devices) that the predicate device also met.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.