FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE

• K Number: K030303
• Device Name: FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
• Manufacturer: CRYOCATH TECHNOLOGIES, INC.
• Date Cleared: 2003-04-29 ( 90 days)
• Product Code: GEH
• Regulation Number: 878.4350
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Not Found

AI/ML Overview

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study for the device associated with K030303, which was converted to P020045/S5 and approved in 2004.

Here's why:

• P020045/S5 is a very old PMA (Pre-Market Approval) amendment/supplement. The level of detail you're asking for, especially regarding specific study design elements like ground truth establishment for training sets, multi-reader multi-case studies, and specific sample sizes for training/test sets, was rarely reported in such granular detail in public summaries for devices approved nearly two decades ago.
• Public Summaries Limitations: While PMA approval documents do contain clinical study information, the publicly available "Summary of Safety and Effectiveness Data" (SSED) often provides a high-level overview rather than the deep dive into methodology you're seeking. The actual statistical analysis plan, raw data, and detailed clinical report are proprietary and not publicly accessible.
• Evolution of Reporting Standards: Reporting standards for AI/ML-based medical devices, especially concerning detailed validation methodologies, were not established or consistently applied in 2004, as AI in medical imaging was nascent compared to today.

To answer your question accurately, I would need access to the full, detailed clinical study report submitted to the FDA for P020045/S5, which is not publicly available.

If you are interested in a hypothetical example of how such information would be presented for a modern AI-powered medical device, I could construct one for you. However, I cannot generate specific details for this particular legacy approval.

Summary

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K030303 has been converted to P020045/S5, approved on June 10, 2004.

Regulation Number and Section

§ 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.