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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.

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The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use.

Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.

This is a 510(k) premarket notification for a medical device, which means the FDA has determined it is "substantially equivalent" to an existing legally marketed device (the predicate device). In this context, "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and testing performed to demonstrate that the new device is as safe and effective as the predicate, despite minor differences.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance for clinical efficacy. Instead, the "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating compliance with regulatory standards and comparable performance to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for specific tests. For the thermal effects test, it mentions "ex vivo animal tissues," but the number of samples is not provided. Other tests refer to compliance with standards rather than specific sample sizes of device units tested.
• Data Provenance: The tests are "non-clinical." This implies laboratory or bench testing. The origin of the animal tissues for the thermal effects test is not specified (e.g., country of origin). All tests were conducted by the manufacturer, Hygea Medical Technology Co., Ltd.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this submission. This is a 510(k) for a hardware device (Microwave Ablation Device and Probe) and the non-clinical tests described are primarily engineering and performance tests, not clinical evaluations requiring human expert interpretation of diagnostic images or outcomes. Therefore, there is no "ground truth" established by experts in the context of clinical data for this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used in clinical studies involving human readers and interpretations (e.g., radiologists reviewing images) to establish a consensus ground truth. The tests described are engineering and biochemical in nature and would not involve such adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This device is a microwave ablation system, not an AI-powered diagnostic or assistive tool, and the submission does not include any clinical studies, MRMC studies, or AI components.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical ablation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" is generally defined by:

• Established engineering and performance standards: e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6, ISO 11607-1, ISO 11135-1, ISO 10993-1.
• Physical measurements and observations in bench testing (e.g., temperature stability within ±3% tolerance, confirmation of thermal effects in ex vivo tissues, successful completion of stability tests).
• Successful software validation against established FDA guidance.

There is no "expert consensus, pathology, or outcomes data" mentioned as ground truth in this non-clinical submission.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The non-clinical tests are validating the device's physical and electrical performance.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set.

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