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The Sanarus Visica™ Treatment System is intended for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition, the system is intended for use in the following indications:

General Surgery

• Ablation of breast fibroadenoma
• Localization of breast lesions

Gynecology

• Ablation of malignant neoplasia or benign dysplasia of the female genitalia

Oncology

• Ablation of cancerous or malignant tissue
• Ablation of benign tumors
• Palliative intervention

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe (Visica™ Treatment Device). The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates off standard 110/230 VAC wall power and is controlled by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself. A remote foot-pedal can be used to start and stop the system.

The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only to the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control two independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics. It primarily focuses on regulatory approval (510(k)) and establishing substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, ground truth, or sample sizes for testing or training sets.

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are present.
2. Sample size used for the test set and the data provenance: No test set or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about ground truth establishment or experts.
4. Adjudication method: Not mentioned.
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: No MRMC study or AI component is discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance is discussed.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: No training set or algorithm is discussed.
9. How the ground truth for the training set was established: Not applicable as no training set is mentioned.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria for this specific submission. It states that the "Visica™ Treatment System has comparable technological characteristics and performance specifications to the predicate devices," but doesn't elaborate on what those specifications are or how they were met for this current submission.

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