(83 days)
The MEI is a laparoscopic and endoscopic, bipolar, electrosurgical device intended for grasping, dissecting, coagulating and transecting tissue in laparoscopic and open procedures.
The types of surgery indicated are:
General surgery Laparoscopic procedures Endoscopic procedures Laryngeal coagulation Orthopedic coagulation Thorascopic coagulation Neurosurgical coagulation Gynecological coagulation, (except for use in female sterilization) Ear, Nose and Throat coagulation
The Multifunction Endoscopic Instrument is a single patient use device, which is a combination scissors and bipolar coagulator-grasper. It is intended for use in canjunction with presently employed 5-10mm trocar cannulae. The instrument grasping and cutting functions are operated easily using one hand. The device is indicated for use in a variety of open and minimally invasive procedures. It is designed to facilitate grasping, mobilization, dissection, coagulation and transection of tissue.
The grasping and cutting functions of the distal end are accomplished by employing three elements.
- A central stationary member serves as both a scissors blade and a forceps jaw.
- A separate scissors blade and a forceps jaw are attached to the some that they can be independently pivoted to open and close thereby performing the cutting and grasping functions.
- The pivoting scissors blade and forceps jaw are connected to the handle and actuated via linkages.
The provided 510(k) summary for the "Multifunction Endoscopic Instrument" (K012033) does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures. This document is a premarket notification for substantial equivalence, not a clinical study report.
Here's a breakdown of what is and is not present in the document based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Not present. The document does not define specific acceptance criteria (e.g., minimum accuracy of 90%) or report quantitative device performance metrics (e.g., "The device achieved 95% accuracy in cutting"). The performance testing section mentions compliance with voluntary standards (ANSI/AAMI HF18-1993, IEC 60601-1-2, IEC 601-2-18, IEC 60601-2-2), which are safety and electrical performance standards, not clinical effectiveness or accuracy metrics.
2. Sample Size Used for the Test Set and the Data Provenance
- Not present. As there's no clinical performance study described, there is no mention of a test set sample size or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not present. This information would only be relevant if a clinical performance study involving expert assessment was conducted, which is not described.
4. Adjudication Method for the Test Set
- Not present. No clinical study or test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve With AI vs Without AI Assistance
- Not present. This is not relevant here as the device is a surgical instrument, not an AI or diagnostic imaging system. There is no mention of AI assistance or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not present. This is not relevant. The Multifunction Endoscopic Instrument is a human-operated surgical tool, not an algorithm.
7. The Type of Ground Truth Used
- Not present. Since there are no performance metrics or clinical studies discussed, there is no ground truth established or used. The "performance testing" refers to compliance with industry safety standards.
8. The Sample Size for the Training Set
- Not present. There is no mention of a "training set" for this device, which implies there was no machine learning or AI component to its development as described in this summary.
9. How the Ground Truth for the Training Set Was Established
- Not present. Similar to point 8, this is not applicable.
Summary of what the document does describe:
The 510(k) summary primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Intended Use: Grasping, dissecting, coagulating, and transecting tissue in various surgical procedures.
- Technological Characteristics: Being a single-patient-use, combination scissors and bipolar coagulator-grasper, using bipolar electrical energy for coagulation, and sharp objects for cutting. It connects to electrosurgical generators.
- Compliance with Voluntary Standards: Mention of adherence to ANSI/AAMI HF18-1993, IEC 60601-1-2, IEC 601-2-18, and IEC 60601-2-2, which are related to electrical safety and general requirements for medical electrical equipment.
This document is a regulatory submission for market clearance, not a detailed report of clinical performance studies with specific quantitative acceptance criteria.
§ 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.