(17 days)
The SurgRx EnSeal system includes bipolar electrosurgical instruments and an accessory adapter for use with standard electrosurgical generators. It is intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, colorectal, urologic procedures, Nissen fundoplication, hysterectomies, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection in the same instrument can be used on tissue of any amount that will fit in the jaws of the instruments.
The SurgRx EnSeal Vessel Sealing & Hemostasis System has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
EnSeal™ Vessel Sealing and Hemostasis System. The functionality and components of the System are the same as the Predicate Device.
The provided text is a 510(k) summary for the SurgRx EnSeal Vessel Sealing & Hemostasis System. It states that the device is a modification of a previously cleared device (K031133) and does not require additional performance testing because the modification does not affect the system's performance. Therefore, typical acceptance criteria and a study demonstrating performance against those criteria, as one might find for a novel device, are not detailed in this document.
However, based on the information provided, we can deduce some aspects and limitations regarding "acceptance criteria" and "study."
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The submission states: "This modification does not affect performance of the System. Additional performance testing not required." This implies that the device is expected to meet the same performance criteria as its predicate device (K031133), but those specific criteria are not listed here.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. As "additional performance testing not required," there would likely not have been a new test set for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided.
4. Adjudication Method for the Test Set
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC study was not performed or mentioned in this document. The submission focuses on substantial equivalence based on the predicate device's performance, not comparative effectiveness with or without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the device is an electrosurgical system, not an AI algorithm.
7. Type of Ground Truth Used
Not explicitly stated for this submission. For the original predicate device, performance would typically be evaluated against established biological, surgical, or engineering outcomes relevant to vessel sealing and hemostasis (e.g., burst pressure, thermal spread, tissue effect).
8. Sample Size for the Training Set
Not applicable as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary derived from the document:
The core "acceptance criterion" for this specific 510(k) submission (K050671) is substantial equivalence to the predicate device (K031133). The "study" that proves the device meets this "acceptance criterion" is the design validation that demonstrated the modification did not alter the existing system's performance.
From the text:
- Acceptance Criterion: Substantial equivalence to the predicate device (EnSeal™ Vessel Sealing and Hemostasis System # K031133), based on the functionality and components remaining the same. The implicit performance criteria are those established for the original predicate device.
- Study Proving Acceptance: "Results of design validation." The document explicitly states: "This modification does not affect performance of the System. Additional performance testing not required." This implies that the design validation assessed that the changes did not negatively impact the previously established performance of the predicate device.
The document is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive new performance studies if the changes are minor or do not impact core functionality.
§ 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.