(132 days)
The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.
This 2 in 1 device has a pencil type handle and combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator. The proposed device is comprised of a mixture of plastics, metals, heatshrink and epoxy.
I am sorry, but the provided text does not contain the detailed information needed to answer your request about the acceptance criteria and the study proving the device meets them. The document is a 510(k) premarket notification summarizing the device, its intended use, comparison to predicate devices, and general performance testing for regulatory approval.
Here's a breakdown of what's missing:
- Specific Acceptance Criteria and Reported Performance: While various tests are listed (Dimensional Measurements, Expected Forces, Overall Design Testing, Biocompatibility, Packaging, ex-vivo bench top testing), the document does not report specific quantitative acceptance criteria or the numerical results/performance metrics for the PK AIM device. It simply states "All devices tested met specification and were graded as Pass" or "All devices passed ISO 10993 acceptance criteria and were graded as Pass," or "All ex-vivo results showed substantially equivalent results to the predicate devices."
- Study Design Details: The document mentions "ex-vivo bench top testing" but provides no details on:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number or qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set (if applicable, as this is a physical device, not an AI/ML diagnostic).
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, design, and scientific technology, supported by general performance testing results that "met specification" or were "substantially equivalent." It does not provide the detailed study information you've requested.
§ 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.