(14 days)
The ICEfx™ 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. This System is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures.
The ICEfx 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
- . 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 ICEfx™ Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The ICEfx System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by the use of Galil Medical CX technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
The provided document is a 510(k) Premarket Notification summary for the ICEfx Cryoablation System. It focuses on demonstrating substantial equivalence to a predicate device, the Visual-ICE Cryoablation System (K113860), rather than proving independent effectiveness through a clinical study with detailed acceptance criteria and performance metrics typically associated with AI/ML device submissions.
Therefore, the information required to populate the requested table and answer the detailed questions about acceptance criteria, study design (sample size, data provenance, ground truth establishment, expert adjudication, MRMC studies, training set details), and specific performance metrics is not present in this document.
This submission is for a medical device that achieves its therapeutic effect through the application of extremely cold temperatures via a physical system (Joule-Thomson effect with argon gas), not through an AI/ML algorithm that predicts or diagnoses based on data. The "performance data" mentioned in the summary refers to engineering and verification/validation testing of the physical system, electrical components, and software, ensuring it functions as intended and meets safety standards, rather than evaluating interpretive accuracy (like an AI model).
Here's what can be extracted and why the rest cannot be answered:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit): The document states that "A full battery of verification and validation testing was conducted... to ensure that the design, functionality, and performance met all the specified requirements." These "specified requirements" are the implicit acceptance criteria, but no specific quantitative metrics (e.g., "Cryoprobe reaches -X degrees Celsius within Y seconds" or "Iceball diameter of Z mm after T minutes") are provided in this summary.
- Reported Device Performance: The document generally states: "Test results demonstrated that the ICEfx Cryoablation System meets defined specifications..." It lists types of testing performed (system, electrical, mechanical, labeling, software, usability) but does not provide specific performance outcomes or values against defined criteria.
| Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|
| System Functionality Requirements | Met defined specifications. |
| Electrical Safety Requirements | Met defined specifications. |
| Mechanical Safety Requirements | Met defined specifications. |
| Labeling Accuracy | Met defined specifications. |
| Software Functionality and Safety | Met defined specifications. |
| Usability | Met defined specifications. |
2. Sample sized used for the test set and the data provenance:
- Not applicable/Not provided. The "test set" here refers to the physical device undergoing engineering tests, not a dataset for an algorithm. There is no mention of "data provenance" in the context of clinical data for algorithmic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is relevant for AI/ML devices where human expert consensus often establishes ground truth for image interpretation or diagnosis. For a cryoablation system, "ground truth" would be related to physical properties (e.g., temperature attained, iceball size), established by instrumentation and calibration, not human interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. Adjudication is used for expert disagreements in clinical ground truth establishment, which isn't the focus of this device's testing.
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:
- No. This is a physical cryoablation system, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. There is no "algorithm only" performance reported as this device is a physical cryosurgical tool. Its software controls the system, but it doesn't provide diagnostic outputs or interpretations that would be evaluated in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for the "test set" as it relates to performance; however, for a cryoablation system, ground truth for its physical performance would be based on instrumentation readings and measurements (e.g., temperature probes confirming freezing, imaging to measure iceball dimensions against known physical properties of ice formation).
8. The sample size for the training set:
- Not applicable/Not provided. This device does not use an AI model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. Since there's no training set for an AI model, this question is not relevant.
In summary: The provided 510(k) summary is for a traditional medical device (cryoablation system) that demonstrates substantial equivalence through engineering verification and validation testing, not through a statistical evaluation of an AI algorithm's performance on clinical data or comparative effectiveness studies with human readers. Therefore, many of the questions asked, which are highly relevant to AI/ML device submissions, do not apply to this document.
§ 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.