(88 days)
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. 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. In addition, the system is intended for use in the following indications:
Urology
- Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia .
Oncology - . Ablation of cancerous or malignant lissue
- Ablation of benign tumors .
- . Palliative intervention
Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders .
Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
General Surgery - Destruction of warts or lesions .
- Palliation of tumors of the oral cavity, rectum and skin .
- Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell . tumors of the eyelid or canthus arca, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
Thoracic Surgery - Ablation of arrhythmic cardiac tissue .
- Ablation of cancerous lesions .
Prociology - Ablation of benign or malignant growths of the anus or rectum ●
- Ablation of hemorrhoids ●
The ENDOcare CRYOcare™ Cryosuryical System consists of a console which can control one to eight single-use, disposable CR YOprobes™ and one to eight independent inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.
The system is available in 1, 4 and 8-CRYOprobetM configurations. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (c.g., 1-8) and the size of the outer casc.
This appears to be a 510(k) premarket notification for a medical device (ENDOcare CRYOcare™ Cryosurgical System) and not a study validating an AI/ML device. Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not present in this document.
The document primarily focuses on:
- Device Description: What the ENDOcare CRYOcare™ Cryosurgical System is and its configurations.
- Indications for Use: The specific medical conditions and procedures for which the device is intended (e.g., ablation of prostate tissue, cancerous tissue, skin lesions).
- Substantial Equivalence: Comparing the device to previously approved predicate devices to demonstrate it is as safe and effective.
- Sterilization Methodology: How the single-use CRYOprobes™ are sterilized.
- FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence and allowing the device to be marketed.
Therefore, I cannot provide the requested information as it is not contained within the provided text. This document describes a traditional medical device, not an AI/ML system that would undergo the type of rigorous statistical performance evaluation outlined in your request.
§ 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.