(22 days)
The EnSeal™ PTC Tissue Sealing Device of the EnSeal™ Vessel Sealing and Hemostasis system is a bipolar electrosurgical instrument for use with 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.
EnSeal™ PTC Tissue Sealing Device. The functionality of the device is the same as the predicate device. The EnSeal™ electrosurgical instruments are the same as the predicate devices utilizing RF powered bipolar distal ends.
The provided text describes a 510(k) premarket notification for the EnSeal™ PTC Tissue Sealing Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive de novo clinical study data with acceptance criteria and detailed performance metrics as would be found in a PMA.
Therefore, the input does not contain the kind of detailed information about acceptance criteria and a study proving those criteria that your request anticipates for a medical device with an AI component or complex performance claims requiring extensive clinical validation. The document states "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." and "The EnSeal™ PTC Tissue Sealing Device is equivalent to the predicate device based on results of design validation." This suggests that the studies performed were primarily bench testing and design validation to show the new device operates similarly to the predicate, not a clinical trial with specific performance targets against a ground truth.
Given the available information, I cannot complete most of the requested fields. Here's what I can extract and what is missing:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the format of a table with specific thresholds (e.g., sensitivity > X%, specificity > Y%). It broadly states that "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications." This implies that the acceptance criteria were likely related to engineering specifications and functional equivalence to the predicate device, but these are not enumerated. The reported performance is a general statement of "design validation" demonstrating equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. Likely related to meeting design specifications and functional equivalence to predicate device. | "designs function as intended and meet design specifications." |
| "equivalent to the predicate device based on results of design validation." |
2. Sample size used for the test set and the data provenance
The document mentions "Preclinical laboratory (bench) and performance tests" but does not specify the sample size for these tests. There's no mention of a "test set" in the context of patient data, data provenance (country of origin), or whether the data was retrospective or prospective, as this device uses bench testing for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The clearance is based on bench testing and design validation against engineering specifications and predicate device performance, not clinical interpretation against a ground truth established by experts.
4. Adjudication method for the test set
Not applicable. There's no mention of a "test set" requiring adjudication in the context of this 510(k) submission.
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 device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm; it's a physical surgical tool.
7. The type of ground truth used
The "ground truth" for this submission would be defined by engineering standards, functional specifications, and the performance characteristics of the predicate device, demonstrated through bench testing. It does not involve expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there's no training set, there's no ground truth to establish for it in this context.
§ 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.