(73 days)
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, lesions, and warts.
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, 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, 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.
The provided document is a 510(k) summary for the Visual-ICE™ Cryoablation System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results proving a device meets acceptance criteria, or information on AI/standalone performance. It primarily focuses on the device's technical specifications and intended clinical applications.
Therefore, I cannot provide the requested information about acceptance criteria and detailed study results from the provided text. The document states a "full battery of verification and validation testing was conducted" and that "Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications," but it does not explicitly list those specifications or provide the data from those tests.
Here's a breakdown of what can and cannot be extracted based directly on your request:
1. A table of acceptance criteria and the reported device performance
- Cannot provide. The document states that testing demonstrated the system "meets defined specifications" but does not enumerate these specifications or the exact performance results against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot provide concrete details. The document mentions "animal cadaver testing" but does not specify the sample size, type of animals, or provenance. It does not mention any human data or the specifics of other testing (system, electrical, mechanical, etc.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Cannot provide. The document does not describe the establishment of a "ground truth" for a test set in the context of diagnostic or AI performance evaluation. This device is a cryoablation system, a therapeutic device, not a diagnostic one.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Cannot provide. No mention of an adjudication process for a test set is made, as this is not a diagnostic device involving expert review of results.
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, not applicable. The document describes a cryoablation system, which is a therapeutic device rather than an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not applicable. This is a hardware cryoablation system, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. See points 3 and 4. The "ground truth" for a therapeutic device's performance would typically relate to its physical functionality (e.g., cooling efficacy, temperature control, mechanical reliability), not diagnostic interpretation.
8. The sample size for the training set
- Not applicable. No mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No mention of a "training set" or its ground truth.
Summary of what the document does state regarding testing:
- Testing Conducted: A "full battery of verification and validation testing" including system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing, design and usability testing, and animal cadaver testing.
- Outcome: "Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness."
- Predicate Device: Galil Medical's Presice Cryoablation System (K060390). The Visual-ICE System is stated to use "the same technology and has the same intended use and indications for use as the predicate."
In essence, the document confirms that testing was done to ensure the device met its requirements and was substantially equivalent, but it does not provide the granular details of those tests, specific acceptance criteria, or the results in a quantifiable manner as you've requested.
§ 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.