(79 days)
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, ENT, gynecology, oncology, 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 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
- · 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, 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 the rectum, hemorrhoids, 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: Ablation of arrhythmic cardiac tissue cancerous lesions
- · Proctology: Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids
The Visual-ICE Cryoablation System is a mobile console 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 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, by the use of Galil Medical i-Thaw® technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
This Special 510(k) is being submitted to modify the software with a variety of changes to enhance usability of the system. The functions of the system that users use to deliver the cryoablation treatment remain unchanged.
The provided text is a 510(k) Summary for the Visual-ICE® Cryoablation System, Software Revision 1.3.1. It describes a medical device and its intended use, but it does not contain information about acceptance criteria, device performance metrics, sample sizes for test or training sets, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).
The document is a regulatory submission demonstrating substantial equivalence to a predicate device, focusing on software changes and their impact on safety and effectiveness. It states that "Software Revision 1.3.1 passed all verification and validation testing," implying that it met internal development and regulatory requirements, but it does not detail those specific acceptance criteria or the study data that proves the device meets them in terms of clinical performance.
Therefore, many of the requested elements cannot be extracted from this document.
Here's what can be inferred and what is explicitly not present:
1. Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics or thresholds. The document implies an acceptance criterion of "passed all verification and validation testing" for the software changes, but no numerical or qualitative performance targets are provided.
- Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics. The document states "no new unacceptable risks were identified" and "no changes were made to the Visual-ICE System hardware," focusing on the safety and functional integrity of the software update rather than clinical performance data.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. "Complete software verification and validation testing" was performed, but the size or nature of the test set (e.g., number of test cases, simulated procedures, or patient data if applicable) is not detailed.
- Data Provenance: Not specified. Given it's a software update for an existing device, testing likely involved internal simulations, unit tests, integration tests, and system-level tests. There is no mention of patient data (retrospective or prospective, or country of origin) being used for this specific software revision's validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The document describes software verification and validation, which typically involves engineering and quality assurance personnel, not clinical experts establishing ground truth for diagnostic or therapeutic accuracy in the same way an AI model for image interpretation would require.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication is relevant when multiple experts interpret data to establish a consensus ground truth. This type of process is not described for software verification and validation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic or therapeutic device that would involve human readers. The device is a cryoablation system, and this submission relates to a software update for its control system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a cryoablation system, which is inherently a human-in-the-loop interventional device. The software update affects its control and usability. Standalone algorithm performance is not applicable in this context.
7. The type of ground truth used:
- Not explicitly defined in the context of clinical ground truth (e.g., pathology, outcomes data). For software verification, the "ground truth" would be the expected behavior/output as defined by the software requirements and design specifications. For example, if a timer should display "X" seconds, the ground truth is "X" seconds, and the test verifies that it does.
8. The sample size for the training set:
- Not applicable/Not mentioned. This is not a machine learning or AI device that requires a training set in the conventional sense. The software was developed and verified, not "trained."
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned, as there is no training set for this type of device.
In summary: The provided document is a regulatory statement for a software update to a cryoablation system. It confirms that the software passed internal verification and validation, thus maintaining substantial equivalence to previously cleared devices. However, it does not include the detailed performance study information typically associated with AI/ML-based diagnostic or therapeutic devices such as acceptance criteria based on accuracy/sensitivity/specificity, clinical test sets, expert ground truth establishment, or comparative effectiveness studies.
§ 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.