(139 days)
The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.
The PK J-Hook is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The device has an active "J" shaped tip and is activated via buttons on the handle, or by a foot pedal. 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 Gyrus ESG-400 Generator.
This document describes a 510(k) premarket notification for the "PK J-Hook," an electrosurgical cutting and coagulation device. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device. This type of regulatory submission does not involve proving the device meets acceptance criteria in the same way an AI/ML medical device would be evaluated for its diagnostic or prognostic accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a previously approved device.
Therefore, many of the requested categories for acceptance criteria and study details for an AI/ML device are not applicable to this 510(k) submission. Below, I will address the applicable points and explain why others cannot be answered from the provided text.
1. A table of acceptance criteria and the reported device performance
For a 510(k) for an electrosurgical device, the "acceptance criteria" are typically related to meeting established performance standards for electrosurgical devices and demonstrating equivalence to a predicate device across various parameters. The reported performance is generally a confirmation that the device meets these standards and functions equivalently.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Measurements | Confirmed |
| Cutting & Coagulation | Equivalency to predicate demonstrated |
| Expected Forces on Devices | Confirmed |
| Design Feature Testing | Rotation and button activation confirmed |
| Shelf Life | Three (3) years |
| Sterilization | Ethylene oxide method confirmed effectiveness |
| Biocompatibility | Passing results confirmed for all patient contact materials |
| Compliance to Standards | Confirmed compliance with listed ISO and IEC standards |
| Intended Use | Matches predicate and supports stated indication |
2. Sample size used for the test set and the data provenance
The document mentions "performance tests" and "bench testing." These are likely laboratory tests on physical samples of the device. The exact sample size for these tests is not specified in the provided text. The data provenance is internal testing by Gyrus ACMI, Inc. specific to the device being submitted. It is prospective testing of their device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to a 510(k) for an electrosurgical device. "Ground truth" in this context would be established by objective physical measurements and adherence to engineering and medical device standards rather than expert clinical consensus on interpretations or outcomes. The performance tests would be evaluated against pre-defined engineering specifications and relevant ISO/IEC standards.
4. Adjudication method for the test set
Not applicable in the context of this 510(k) submission for an electrosurgical device. Performance is assessed against objective engineering and safety standards, not by an adjudication process as would be used for subjective interpretations or diagnostic outcomes.
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 device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be defined by engineering specifications, established medical device standards (e.g., ISO, IEC), and objective physical measurements. For example, for "cutting and coagulation equivalency," the ground truth would be the measurable performance of the predicate device under controlled laboratory conditions. For "biocompatibility," the ground truth is defined by the passing criteria of the ISO 10993 series of standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.