(161 days)
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE™ Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), 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, and skin lesions.
The Visual-ICE Cryoablation 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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy.
• 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal 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, 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 (with the exception of cardiac tissue)
• Proctology Ablation of benign or malignant growths of the anus or rectum
The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE™ System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, using Boston Scientific's i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
The provided document does not describe the acceptance criteria or a study that proves a device meets acceptance criteria in terms of an AI/ML algorithm's performance. Instead, it is a 510(k) summary for a medical device called the "Visual-ICE Cryoablation System," which is a cryosurgical tool.
The document discusses:
- Device Description and Intended Use: The Visual-ICE cryoablation system functions by applying extreme cold temperatures to destroy tissue, indicated for various surgical procedures, including specific indications for prostate tissue ablation, cancerous or malignant tissue ablation, and pain palliation for metastatic bone lesions.
- Non-Clinical Performance Testing: This section outlines verification and validation testing performed on the system itself (mechanical, electrical, software, labeling, packaging, and usability) to ensure it meets specified requirements and is substantially equivalent to a predicate device. This is about the cryoablation device's physical and functional performance, not an AI algorithm.
- Clinical Testing Summary (MOTION Study): This section details a clinical trial (MOTION) that evaluated the safety and effectiveness of the Visual-ICE Cryoablation System for pain palliation of metastatic lesions in bone. This is a clinical study on the efficacy of the medical device in treating a condition, not an AI model's diagnostic or predictive performance.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/ML device meets those criteria because the document describes a traditional medical device, not an AI/ML product.
To answer your specific questions in the context of the provided document, I'd have to reframe them to fit the subject matter, but that would go against the spirit of describing AI/ML device performance.
- No AI/ML algorithm performance study is described.
- No acceptance criteria for an AI/ML algorithm are given.
The "Acceptance criteria for all verification and validation testing" mentioned in the non-clinical section refer to the physical device's specifications (e.g., electrical safety, mechanical robustness), not an AI's diagnostic or predictive metrics. The "performance" in the clinical study refers to the effectiveness of the cryoablation system in achieving pain palliation.
§ 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.