Search Results

The AngioDynamics Uniblate System is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures, such ar martial or complete ablation of non-resectable liver lesions, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode that provides an adjustable ablation zone of 1 cm-3 cm. The device has an attached electrical cable and infusion tubing set which connects the it directly to the RTA Medical 1500X RF generator and the IntelliFlow peristaltic pump. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal salive through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.

The provided text is a 510(k) summary for the AngioDynamics Uniblate Electrosurgical Device (K080451). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, study data, or performance metrics that would typically be found in a detailed device validation study report.

The 510(k) summary primarily focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, not on a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not present in this type of regulatory submission summary.

The document lacks the information to answer all your specific points. This 510(k) submission is a declaration of intent to market and a comparison to predicate devices, not a detailed performance study report.

Ask a specific question about this device

The RITA Medical Systems UniBlate Electrosurgical Device is intended to coagulate tissue during percutaneous, laparoscopic, and intraoperative surgical procedures.

The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode. The instrument has an attached electrical cable and infusion tubing set which connects the device directly to the RITA Medical 1500X RF generator and the IntelliFlow peristaltic pump respectively. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal saline through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.

The provided text describes a 510(k) summary for the UniBlate Electrosurgical Device. This regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing, rather than establishing clinical efficacy through a detailed study with specific acceptance criteria as one might find for a novel therapeutic device.

Therefore, the requested information regarding "acceptance criteria" based on a study of clinical performance, "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "sample size for the training set" is not explicitly available within the provided text.

The document indicates that "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications." However, it does not detail these design specifications as specific quantitative acceptance criteria or report device performance against them in a table format. The primary goal of this 510(k) submission is to show that the device is "substantially equivalent to the predicate device, and meets safety and effectiveness criteria" through these performance tests, which are not described in detail.

Here's what can be extracted and inferred from the text:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly provided in the document. The text states: "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria." This implies that internal acceptance criteria were met, but they are not listed, nor are specific performance metrics reported against them. The focus is on substantial equivalence to predicate devices (StarBurst XLi and Cool-Tip RF System) in terms of principles of operation, construction, and intended use.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly provided in the document. The text mentions "Performance testing" but does not detail the nature, sample size, or provenance (country of origin, retrospective/prospective) of any clinical or technical test sets used for evaluating the device against its "design specifications."

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable/provided. The document describes performance testing for device functionality and design specifications, not a study requiring expert-established ground truth for clinical outcomes or diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable/provided. No information on an adjudication method is discussed, as the document focuses on technical performance and substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention an MRMC comparative effectiveness study. The context is a device for tissue coagulation, not a diagnostic imaging device where such studies are common.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The UniBlate device is an electrosurgical device, not an algorithm. The concept of "standalone performance" in this context would relate to the device operating as designed, independent of human intervention in its function, which is implicitly what "Performance testing was done to ensure that the UniBlate Device functions as intended and meets design specifications" refers to. However, this is not detailed as a separate study.

7. Type of Ground Truth Used

Device-specific test parameters/design specifications, implicitly. For an electrosurgical device, "ground truth" for performance testing would typically refer to established engineering and safety standards, as well as the ability to achieve defined tissue coagulation parameters (e.g., lesion size, temperature profiles) in a controlled environment, demonstrating it functions "as intended." However, these specific "ground truths" (e.g., measurements of coagulation zone, power output, temperature feedback accuracy) are not detailed in the summary. The overarching "ground truth" for the 510(k) is substantial equivalence to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable/provided. This device is hardware and does not involve AI or machine learning that would require a "training set."

9. How Ground Truth for the Training Set Was Established

Not applicable. As above, no training set is discussed or implied.

Ask a specific question about this device