Search Results

Depending on the cryogen used, the following are indications for use:

Liquid Nitrogen:
For use as a cryosurgical tool for destruction of unwanted tissue in the fields of dermatology, general surgery, neurosurgery, thoracic surgery, urology, proctology, oncology, gynecology and ENT.

• May be used to ablate prostatic tissue.
• May be used for the ablation of prostatic tissue in cases of prostate cancer and benign prostatic hyperplasia.
• May be used for ablation of cancerous or malignant tissue.
• May be used for ablation of benign tumors.
• May be used for palliative intervention.
• May be used for ablation or freezing of skin cancers and other cutaneous disorders.
• May be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
• May be used for ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid and canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, and fissures, peri-anal condylomata, pilonidal cysts. actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
• May be used for the destruction of warts or lesions.
• May be used for the palliation of tumors of the oral cavity, rectum, and skin.
• May be used for ablation of arrhythmic cardiac tissue.
• May be used for the ablation of benign or malignant growths of the anus and rectum.
• May be used for the ablation of hemorrhoids.

Nitrous Oxide:
For use as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, general surgery, urology, and veterinary medicine.

Carbon Dioxide:
For used as a tool in the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Argon and Krypton:
For use as a cryosurgical tool in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue including liver metastass, skin lesions, warts and prostate tissue.

The CMS Blizzard 700 Series Models 730, 740, 750, 760, 770, 780 & 790 are made up of two components: 1) a console which holds up to two cryogen packets of varving sizes and 2) depending on the model, can employ from three to nine individually controlled cryoprobes. The consoles includes a power switch, individually controlled cryogen flow switches, thermocouple temperature displays and, depending on the model between three and nine cryoprobe ports. The devices are used to destroy unwanted tissue by the application of cold to the selected site. The cryogen is forced through the cryoprobe under pressure. The cryoprobe, having been placed in the appropriate position, then becomes cold and freezes the tissue.

The provided text is a 510(k) summary for the CMS Blizzard 700 Series cryosurgical units. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary is a regulatory document used to demonstrate substantial equivalence to a legally marketed predicate device, primarily focusing on similarities in intended use, technology, and safety/effectiveness. It is not a clinical study report or a detailed performance validation report.

Therefore, for your request, I must report that the requested information is not present in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on comparing features with predicate devices, not on quantitative performance metrics or acceptance criteria for those metrics.
2. Sample size used for the test set and the data provenance: Not present. No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. There is no mention of ground truth establishment.
4. Adjudication method for the test set: Not present.
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: Not present. This document describes a cryosurgical unit, not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

Ask a specific question about this device