Search Results

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (eg. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

The truFreeze System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart. Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable Spray Kits:
Currently, there are 2 types of spray kits available. One kit is available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting Cryo Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

CryoDecrompression Tube (CDT):
Proposed changes involve the CryoDecrompression Tube (CDT) only. The CDT is a necessary part of the truFreeze Active Venting Kit to suction gas out of the patient when liquid nitrogen is sprayed.

The document provided describes modifications to the truFreeze System, specifically to the CryoDecompression Tube (CDT). The purpose of these modifications is to address user annoyance related to tube kinking and an orange indicator display during use, without changing the intended use or indications for use of the device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes for each test mentioned (e.g., number of CDTs tested for bend, kink resistance, or flow rate). It generally uses terms like "All samples."

The data provenance is not specified. However, given it's a 510(k) submission for device modifications, these tests would typically be conducted internally by CSA Medical, Inc. in a lab setting rather than involving patient data. This is a technical performance verification, not a clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. The document describes engineering and performance verification tests for a medical device modification. There is no "ground truth" in the clinical sense established by human experts, but rather against predefined engineering specifications.

4. Adjudication Method for the Test Set

This is not applicable. The tests are objective engineering measurements and performance evaluations against predefined specifications, not subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This is a modification to a cryosurgical device, not an imaging diagnostic AI device where such studies are common. The changes are technical and related to the form factor and material of a tube, not to diagnostic accuracy.

6. Standalone Performance Study

Yes, a standalone performance study in the form of design verification and engineering tests was done. The "Summary of Testing" section (page 6-7) explicitly states that "The requirements specified have been successfully met, the proposed modifications have completed design verification in accordance with the specifications." These tests evaluate the device's technical performance against a set of engineering specifications, independently of human interaction for the measured parameters.

7. Type of Ground Truth Used

The "ground truth" for these tests is based on predefined engineering specifications and performance requirements. For example, the maximum OD, resistance to kinking, and gas egress flow rate are quantitative measures compared against a set threshold or standard.

8. Sample Size for the Training Set

This information is not applicable. The truFreeze System is a physical medical device (cryosurgical tool) with modifications to a specific component (CDT). This is not an AI/ML device where a "training set" would be used for algorithm development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above. There is no AI/ML training set or algorithm in the context of these device modifications.

Ask a specific question about this device