(27 days)
The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.
The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment 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 wireless remote control provides alternative timer control from a distance in the treatment room. 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 kit:
There are no proposed changes to the disposable spray kit. There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use.
This document describes the 510(k) premarket notification for the truFreeze® System. The information provided heavily focuses on the mechanical modifications and testing rather than clinical performance for diagnostic or prognostic purposes, which the requested questions seem to imply.
Based on the provided text, the device is a cryosurgical unit, not an AI-based diagnostic tool. Therefore, many of the requested elements (like MRMC studies, training sets, ground truth establishment by experts, etc.) are not applicable or described in this type of submission.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not present or not relevant to this type of device and submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No leaking observed | No leaking observed for all tested samples |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 4 samples of the Transfer Interface Assembly (2 at the low end of the depth specification, 2 at the high end of the depth specification). Each sample was subjected to 6 fill cycles for a total of 24 trials.
- Data Provenance: Not specified, but implied to be internal verification testing conducted by CSA Medical. No country of origin or retrospective/prospective nature is mentioned, but it's part of device verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The ground truth here is a physical characteristic (absence of leaking) observable during mechanical testing, not a clinical diagnosis or interpretation requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically for subjective assessments (e.g., image interpretation), whereas this test is for a directly observable physical failure (leaking).
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 applicable. This is a cryosurgical unit, not an AI-assisted diagnostic device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a cryosurgical unit, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this engineering test was the direct observation of "no leaking" during multiple fill cycles, which is a physical performance characteristic of the device's redesigned components.
8. The sample size for the training set
- Not applicable. This is a mechanical device, not an AI model that requires a training set. The descriptions are for modifications to existing hardware components.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI model is described.
§ 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.