(70 days)
The 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
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Ablation of breast fibroadenoma .
Gynecology -
Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Oncology -
Ablation of cancerous or malignant tissue ●
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Ablation of benign tumors ●
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. Palliative intervention
The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe. 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 overates on the Joule-Thompson principle and the refrigerative canacity 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 2 independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.
The provided text describes the Sanarus Visica™ Treatment System but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a cryosurgical unit, and it primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided text.
Here's a breakdown of why I cannot answer each point based on the given information:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on the intended use and technological characteristics rather than specific performance metrics against pre-defined acceptance criteria.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical study data is provided in the document.
- 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): No ground truth establishment or expert involvement for a test set is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
- 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 assistance is mentioned. This device is a cryosurgical system, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for tissue ablation, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no study data is presented, no ground truth type is specified.
- The sample size for the training set: No training set is mentioned as there's no machine learning or AI component to this device.
- How the ground truth for the training set was established: Not applicable for the same reason as above.
The document's purpose is to demonstrate that the "new" Sanarus Visica™ Treatment System is substantially equivalent to a previously cleared Sanarus Visica™ Treatment System (K020605). This type of submission relies on showing that the new device has "the same technological characteristics and performance specifications as the predicate device" rather than presenting new clinical study data against defined acceptance criteria.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.