(19 days)
The SurgRx EnSeal system includes bipolar electrosurgical instruments and a radiofrequency generator. 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, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as 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.
The SurgRx EnSeal devices are intended for use during open or laparoscopic general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue and/or seal vessels during surgery. 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.
The EnSeal electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.
The information provided is extremely limited regarding the acceptance criteria and study details. This 510(k) summary (K062949) for the SurgRx EnSeal Vessel Sealing & Hemostasis System states its substantial equivalence to a predicate device (K061526) based on design validation and preclinical laboratory (bench) and performance tests. However, it does not include any specific acceptance criteria or detailed study results.
Therefore, I cannot provide a table of acceptance criteria and reported performance, nor can I answer many of your specific questions as the information is simply not present in the provided text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or reported device performance are detailed in the provided documents. The submission only states: "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided.
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)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. Furthermore, this device is an electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is not an algorithm; it is a physical electrosurgical instrument. The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The submission mentions "Preclinical laboratory (bench) and performance tests." For an electrosurgical instrument, ground truth would typically be established through direct measurement of physical parameters (e.g., seal strength, burst pressure, thermal spread, cutting efficacy, tissue impedance) against engineering specifications and comparison to predicate devices, often using ex vivo or in vivo animal models. However, the specific type of ground truth and the metrics used are not detailed in this summary.
8. The sample size for the training set
This information is not provided. As this is an electrosurgical instrument, the concept of a "training set" in the context of machine learning is not directly applicable. If it refers to data used for initial design and optimization, those details are not given.
9. How the ground truth for the training set was established
This information is not provided, and the concept of a "training set" for ground truth establishment, typically associated with AI/ML, isn't directly relevant to this type of device.
Summary of what we can glean from the provided text:
- Device Type: Electrosurgical Vessel Sealing & Hemostasis System.
- Purpose of Submission: Demonstrate substantial equivalence to a predicate device (K061526).
- Evaluation Method: Preclinical laboratory (bench) and performance tests.
- Conclusion: The device is considered safe, effective, and substantially equivalent to the predicate based on "design validation."
- Key Detail Gap: The submission lacks specifics on acceptance criteria, test methodologies, sample sizes, and detailed performance data, which are typically found in the full 510(k) submission, but not in this summary.
§ 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.