(187 days)
The Celsio Flexible Cryocatheter System is intended for cryoadhesion applications during interventional procedures such as the removal of tissue, foreign bodies, mucous plugs, blood clots, necrotic tissue, tumors and tissue biopsies, and for palliative devitalization (destruction) of tissue by the application of extreme cold.
The Celsio Flexible Cryocatheter System is a cryosurgical device with a disposable carbon dioxide (CO2) cartridge that is used with commercially available endoscopes with a minimum working channel diameter of 2mm and maximum working length of 1052 mm, in interventional endoscopic procedures. The Celsio Flexible Cryocatheter System is comprised of a Flexible Cryocatheter (sterile, single use), a CO2 Refrigerant Cartridge (non-sterile, single use) and a Refrigerant Dispenser (nonsterile, single use). The flexible cryocatheter is typically delivered using a compatible endoscope to the target location. Once the refrigerant dispenser is activated, pressurized refrigerant fluid is delivered to the catheter tip where it undergoes expansion to its lower temperature (the Joule-Thomson effect), causing surrounding tissue in contact with the catheter tip to freeze and adhere.
The provided text is a 510(k) summary for a medical device (Celsio Flexible Cryocatheter System). It details the device's intended use, comparison to a predicate device, and general performance data, but does not contain specific details about acceptance criteria or a study proving that an AI/Software device meets acceptance criteria.
The document discusses "performance data" and "Design Verification and Validation testing" for the cryocatheter system itself, including thermal characteristics (ice ball dimensions, temperature, cooling/thawing rates) and pre-clinical testing (ex-vivo, in-vivo, post-mortem). However, these are standard tests for a physical medical device and do not involve AI or software performance as would be relevant to the questions posed about AI acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance.
Therefore, I cannot provide the requested information from the given text as it pertains to a physical medical device clearance, not an AI/software device clearance. The prompt explicitly asks for details related to a "device" meeting acceptance criteria, and then queries a series of points that are specifically relevant to AI/Software performance studies (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance). Since the provided document is for a physical cryosurgical unit, it does not contain the information necessary to answer those specific questions.
§ 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.