(99 days)
The ENDOPATH Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
The Endopath® Electrosurgery Probe Plus II device (product codes beginning with EPH and EPS) work with a standard monopolar unit and has applications for minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve. The subject device system offers one handle (EPH02) and seven shafts (EPS01-EPS07) which allow for a variety of configurations to best meet the surgeon's needs. Shafts EPS01 through EPS07 are for use through a 5 mm diameter surgical trocar or a larger trocar with a 5 mm reducer.
This document describes the Ethicon Endo-Surgery, LLC Endopath Electrosurgery Probe Plus II (K160128), an electrosurgical cutting and coagulation device. The provided text primarily focuses on establishing substantial equivalence to a predicate device through bench testing and laboratory evaluations. It does not present a study involving AI or specific AI performance metrics. Therefore, several sections of your request related to AI-specific study details (e.g., MRMC study, human readers improving with AI, standalone algorithm performance, training set details, training set ground truth) cannot be addressed from this document.
Here's an analysis of the provided information based on your request, focusing on the device's performance as presented:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Data generated from these tests met the predetermined acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria for each test or the exact performance values observed for the Endopath Electrosurgery Probe Plus II. It only states that the device "performed as intended" and met the criteria.
| Acceptance Criterion (Category) | Reported Device Performance |
|---|---|
| Sterilization | Sterilized via gamma radiation to the same sterility assurance level as the predicate device. |
| Biocompatibility | Passed all biocompatibility ISO testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity) in accordance with ISO 10993:2009 and FDA Blue Book Memorandum #G95-1. |
| Electrical Safety & EMC | Complies with IEC 60601-1-2:2007 (EMC) and IEC 60601-1:2005 (electrical safety). |
| Bench Testing (Flow rate, Impedance, Force) | Data for flow rate of suction and irrigation, impedance, minimum distal retraction force, and sheath extension force met predetermined acceptance criteria. (Specific criteria and values not provided). |
| Acute Study (Tissue Effects) | Demonstrated the ability to create tissue planes, dissect tissue, and provide hemostasis in different tissue types, with tissue effects not different than the predicate device. (Specific metrics not provided). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test within the "Bench" and "Acute" studies.
- Bench Testing: The phrase "Flow rate of suction and irrigation, impedance, minimum distal retraction force and sheath extension force were evaluated for the ENDOPATH Electrosurgery Probe Plus II" implies multiple measurements for each.
- Acute Study: "Testing was performed in an acute study... to demonstrate that the tissue effects were not different than the predicate device." This suggests a comparative study in an animal model, but no sample size (e.g., number of animals, number of tissue samples) or details on data provenance (e.g., country of origin) are provided.
Data Provenance:
- Bench Testing: Not explicitly stated, but typically conducted in-house at the manufacturer's facility.
- Acute Study: "Testing was performed in an acute study with the ENDOPATH Electrosurgery Probe Plus II vs. the currently marketed predicate device to demonstrate that the tissue effects were not different than the predicate device." This indicates a prospective animal study comparing the subject device to the predicate. The location of the animal study is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Bench Testing: Ground truth is established by engineering specifications and measurements. No human experts are mentioned as establishing ground truth for these quantitative physical tests.
- Acute Study: The document states "study demonstrated the ability of the subject device to create tissue planes, dissect tissue, and provide hemostasis in different tissue types." This implies observation and assessment by skilled personnel (e.g., veterinary surgeons, pathologists). However, the number and qualifications of these experts are not specified.
4. Adjudication Method for the Test Set
Not applicable/not specified. For bench tests, results are typically objective measurements. For the acute animal study, if multiple observers were involved, an adjudication method would be relevant, but none is 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
No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described in this document. This device is an electrosurgical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this refers to an electrosurgical device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. The type of ground truth used
- Bench Testing: The ground truth for electrical safety, EMC, sterilization, and physical parameters (flow rate, impedance, force) is based on established industry standards and engineering specifications.
- Biocompatibility: Ground truth is established by adherence to ISO standards for biological evaluation of medical devices.
- Acute Study: The ground truth for tissue effects (ability to create tissue planes, dissect, coagulate efficiently) is based on expert observation and assessment by clinicians or researchers in an animal model, likely with histological confirmation as implied by "tissue effects." This is a form of expert consensus/observation, potentially backed by pathology if tissue samples were analyzed.
8. The sample size for the training set
Not applicable. This document describes a traditional medical device, not an AI/machine learning system, so there is no training set in the context of AI.
9. How the ground truth for the training set was established
Not applicable. As there is no AI training set, this question is not relevant to the provided document.
§ 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.