Search Results

The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open. minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate 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 also intended for use in the following indications:

General Surgery

• · Destruction of warts or lesions.
• · Palliation of tumors of the oral cavity, rectum, and skin.
• · Ablation of breast fibroadenomas.
• Ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.

Urology
· Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia.

Gynecology

• · Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
  Oncology
• · Ablation of cancerous or malignant tissue.
• · Ablation of benign tumors.
• · Palliative intervention.
• Neurology
• · Freezing of nerve tissue in pain management/cryoanalgesia.

Dermatology
· Ablation or freezing of skin cancers and other cutaneous disorders.

Proctology

• · Ablation of benign or malignant growths of the anus and rectum.
• · Ablation of hemorrhoids.

Thoracic Surgery

• · Ablation of cancerous lesions.

The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency.

Main components: Co-Ablation System, Sterile Co-Ablation Probe. Accessory: Sterile Temperature Probe.

The Co-Ablation System is a mobile medical equipment. The Co-Ablation System consists a host of Co-Ablation System including liquid nitrogen storage tank (referred to as cryotank), cryo-valve, warm working medium storage tank (referred to as warmtank), warm-valve, waste bottle,insulated pipe and control/display system, etc. The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U.

The Sterile Co-Ablation Probe is a single-use sterile product, consisting of a handle, quick release connector, probe tip and probe shaft. It must be used in conjunction with the Co-Ablation System. During treatment, the Sterile Co-Ablation Probe is inserted into the lesion to be ablated. The freezing channel is opened, and the freeze working medium (liquid nitrogen) rapidly flows to the probe and evaporates to absorb heat, rapidly freezing and destroying tissue near the probe tip. When the system is switched from the freeze mode to warm mode, high temperature steam passes to the tip of the Sterile Co-Ablation Probe, rapidly heating the tip portion of the Sterile Co-Ablation Probe so that the frozen tissue around the Sterile Co-Ablation Probe is quickly melted, and the Sterile Co-Ablation Probe is easily pulled out. The Sterile Co-Ablation Probe consists of right-angle and straight configurations with model number Elite, and comprises 20 specifications as listed below:

The Sterile Temperature Probe is designed for use with the Co-Ablation System to monitor temperatures in the surrounding tissue. The Sterile Temperature Probe with model number Ease, and comprises 4 specifications: TSS08, TSL08, TMS15 and TML15.

The provided text is a 510(k) Summary for the Hygea Medical Technology Co., Ltd.'s Co-Ablation System with Sterile Co-Ablation Probe. It details comparisons to predicate devices and lists non-clinical performance data.

However, there is no information presented regarding acceptance criteria, reported device performance against those criteria, or a specific study proving the device meets those criteria in the context of an AI/algorithm's diagnostic performance. The document focuses on the substantial equivalence of the cryoablation system as a medical device based on its design, function, and non-clinical safety/effectiveness tests (electrical safety, EMC, usability, software, sterilization, biocompatibility, shelf life, ex-vivo, and animal testing).

Specifically, the document states:

• "No clinical data was necessary to determine the substantial equivalence of this device." This directly indicates that no clinical study, which would typically contain acceptance criteria and performance metrics for a diagnostic device, was conducted or submitted for this 510(k) clearance.
• The "Software Testing" section mentions "the software verification/validation met the acceptance criteria," but these acceptance criteria are related to general software development standards (IEC 62304, FDA guidance for software and cybersecurity) and not to the diagnostic performance of an AI/algorithm.

Therefore, I cannot provide the requested table and information because the provided text does not contain data related to:

1. A table of acceptance criteria and reported device performance for an AI/algorithm's diagnostic capability.
2. Sample size and data provenance for a test set for AI/algorithm performance.
3. Number and qualifications of experts for ground truth establishment for AI/algorithm performance.
4. Adjudication method for an AI/algorithm test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI/algorithm performance.
8. Sample size for the training set of an AI algorithm.
9. How the ground truth for an AI training set was established.

This 510(k) summary is for a cryoablation system, which is a therapeutic device, not an AI-powered diagnostic device. The performance data presented refers to the physical and software functionalities of the system in performing cryoablation, not to the diagnostic accuracy of an AI.

Ask a specific question about this device