(72 days)
The Presice system is intended for cryogenic destruction of tissue during surgical procedures. The Presice is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Presice system has the following specific indications:
- Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
- Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention)
- Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses. cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
- Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
- General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas)
- ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)
- Thoracic surgery (abla no cardiat tissue cancerous lesions)
- Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
The Presice System may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
Presice is a cryosurgical unit with argon-cooled probes. The principle changes between the Presice and the predicate SeedNet Family System include: Addition of new Electrical Thaw capability (i-Thaw™), enabling a choice between two thaw operating modes, Electrical or Helium Thaw. The new Electrical Thaw mode is supported by the use of new IceRod and SeedNet Cryo Needles, the IceSeed™ i-Thaw™ and the IceRod™ i-Thaw™ comprised of a new electrical thaw mechanism in addition to the Helium based thaw mechanism used in the cleared SeedNet Family Needles. Addition of a Multi-Thermal Sensor (MTS). Addition of touch screen user interface, thermal printer, USB port and frame grabber. Change of the software programming language from LabView to C++ and C#, while implementing the changes required to support the new electrical thaw feature and improving the user interface. In addition, the company has updated the operating system to Windows XP Pro, developers environment to .NET Framework and added certain off-the-shelf software (including drivers for the touch screen, thermal printer, USB port and frame grabber) for improved system functionality. Addition of a new name, the Presice™.
The provided text describes the Presice™ cryosurgical unit and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance.
Instead, the document focuses on:
- Regulatory details: Applicant information, device classification, predicate devices, and FDA approval.
- Intended Use: Broad applications of the cryosurgical unit across various medical fields.
- Performance Data & Substantial Equivalence: This section explains the changes made to the Presice system compared to its predicate (e.g., electrical thaw, multi-thermal sensor, software updates, new UI). It then states that the device was subjected to comprehensive testing to verify its safety and performance and demonstrate equivalency. However, it does not detail specific acceptance criteria, test methodologies, or results for metrics typically associated with AI/ML systems (e.g., accuracy, sensitivity, specificity, AUC). The "performance testing" mentioned is general and likely refers to engineering and functional performance, not clinical performance metrics for an AI-driven diagnosis or prediction.
- FDA Correspondence: Official letters confirming substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided text.
The closest information related to "performance" is the general statement: "Test results demonstrated that the Presice system meets its specifications and does not raise any new safety and/or effectiveness issues." This implies internal functional and safety specifications were met, but these are not the "acceptance criteria" you're inquiring about for an AI/ML product.
§ 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.