(89 days)
The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196℃ requiring either active or passive venting during surgical procedures.
The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade and/or low grade dysplasia) and malignant lesions.
The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets them in the context of an Artificial Intelligence (AI) or machine learning (ML) device. The document describes a 510(k) premarket notification for the "truFreeze® System," which is a cryosurgical tool.
The document discusses:
- The indications for use for the truFreeze system, including the addition of Barrett's Esophagus with low-grade dysplasia.
- A clinical study conducted to support the effectiveness and safety of the truFreeze system for ablating Barrett's Esophagus with low-grade dysplasia. This is a study of a physical medical device, not an AI/ML algorithm.
- Data on the safety and effectiveness of the device, focusing on patient response (complete eradication of dysplasia - CE-D) and adverse events.
- Comparison to predicate and reference devices to establish substantial equivalence.
Therefore, I cannot extract the information required for the requested table and study details related to an AI/ML device's acceptance criteria and performance as the provided document does not pertain to such a device.
§ 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.