(25 days)
The VascuClear Precision Bipolar is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of vessels.
The VascuClear Precision Bipolar is a sterile, bipolar electrosurgical instrument with features to dissect, coagulate, and transect (cut) tissue with an integral knife blade. The device is compatible with a 5mm trocar and utilizes bipolar energy from standard bipolar generators. The instrument consists of three main parts as follows: 1. A handle with two sliding buttons. One button opens and closes the jaw of the device for grasping and clamping. The other button moves the integral knife blade back and forth. A standard pigtail cord is attached to the handle. 2. A shaft that connects the handle to the working end. The shaft is approximately 0.2 inches (5mm) in diameter and 16.5 inches (42cm) long from the handle to the tip of the instrument. 3. The working end of the instrument that consists of jaws, electrode surfaces and an integral knife with a dissecting tip.
The provided text describes a 510(k) submission for a medical device, the VascuClear Precision Bipolar. This submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove that the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) is not applicable or cannot be extracted from this type of regulatory document.
However, I can extract information related to the non-clinical performance and the basis for the substantial equivalence claim.
Acceptance Criteria and Device Performance
A formal table of acceptance criteria and reported device performance in the context of an AI/software study is not provided, as this document is for a physical electrosurgical instrument seeking 510(k) clearance based on substantial equivalence.
The document states that the acceptance criteria for the non-clinical testing were to confirm that:
- "the modifications function as intended"
- "did not adversely affect the operation of the instrument"
- "Electrical safety and biocompatibility testing were also performed to confirm the safety and effectiveness of the VascuClear Precision Bipolar."
The reported device performance indicates that the tests performed met these criteria, leading to the conclusion that the modified device's technological characteristics and principles of operation are the same as the predicate device.
Study Information (Non-Clinical Testing)
The document refers to "NON-CLINICAL PERFORMANCE DATA" for the VascuClear Precision Bipolar.
- Sample size used for the test set and the data provenance: Not applicable. This refers to non-clinical testing (e.g., bench testing for function, electrical safety, biocompatibility), not a test set of data. The provenance of the data would be internal laboratory testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be adherence to engineering specifications and safety standards, not expert interpretation of data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to non-clinical testing, not a clinical data review process.
- 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 is a physical medical device, not an AI/software product, and therefore no MRMC study was conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an AI/software product.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance data, the ground truth would be established by engineering specifications, international safety standards (e.g., for electrical safety), and biocompatibility standards.
- The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of the document's relevance to your request:
The provided text from a 510(k) summary focuses on demonstrating "substantial equivalence" of a modified electrosurgical instrument to a predicate device. The performance data mentioned relates to non-clinical testing (functional, electrical safety, biocompatibility) to ensure the modifications did not negatively impact the device's operation. It does not contain information about clinical trials, AI/ML performance, or data sets and ground truth as typically described for software-based medical devices.
§ 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.