(135 days)
The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.
The PK Needle is a bipolar electrosurgical instrument with the capability to resect soft tissue and blood vessels in laparoscopic and general surgical procedures. 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 blunt needle shaped tip and is activated via a button 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 is a 510(k) premarket notification for a medical device called the "PK Needle." It's a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to existing legally marketed devices, and it primarily focuses on device safety and performance characteristics for regulatory approval rather than clinical study results establishing diagnostic or therapeutic accuracy against ground truth.
Therefore, many of the requested categories are not applicable to this type of document because it details the physical and functional characteristics of an electrosurgical device, not a diagnostic AI or image analysis system.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document describes several performance tests, but it does not specify explicit "acceptance criteria" in a quantitative, tabular format as one might expect for a diagnostic device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted and the device performed "substantially equivalent" to its predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Dimensional measurements within specifications | Passed: Dimensional Measurements conducted. |
| Cutting equivalency to predicate device | Passed: Cutting equivalency to predicate demonstrated. |
| Withstand expected forces | Passed: Expected forces on devices tested. |
| Proper design feature activation (button) | Passed: Design feature testing (button activation) conducted. |
| Maintain sterility and functionality over shelf life | Passed: Shelf Life and Sterilization tests conducted. Shelf life of three (3) years confirmed. |
| Biocompatibility with patient contact materials | Passed: Biocompatibility testing carried out with passing results for new flouropolymer sheath and new ink. |
| Compliance with relevant voluntary standards (ISO, ANSI/AAMI, IEC) | Passed: Device design complies with listed standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for tests like "cutting equivalency" or "expected forces." The tests appear to be bench tests of the device itself rather than studies involving human subjects or clinical data sets on a large scale. Data provenance is not applicable as these are engineering and materials tests, not clinical data studies. The tests are prospective in the sense that they are performed on the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This device is an electrosurgical instrument, not a diagnostic device where "ground truth" would be established by experts interpreting medical images or pathology. The "truth" here relates to engineering specifications and performance characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for bench testing of device functionality.
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-assisted diagnostic or image interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical electrosurgical instrument for direct surgical use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on engineering specifications, material science standards (e.g., biocompatibility), and functional tests designed to mimic its intended use (e.g., cutting equivalency). It's not based on clinical "outcomes data" or "pathology" in the context of diagnostic accuracy.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the machine learning sense.
9. 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.