Search Results

To destroy tissue during surgical procedures by applying extreme cold.

The CRYOSUCCESS is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying cold gas (nitrous oxide, N₂O). The device is based on direct application of nitrous oxide in the liquid phase to the selected treatment area. The N₂0 gas is delivered to the treatment site at -89° C to effect cellular destruction (necrosis). CRYOSUCCES functions by means of heat evaporation upon phase transition, where liquid nitrous oxide (N₂O, laughing gas) is applied to the treatment area by means of a capillary tube at a constant temperature of -89°C (cold performance) followed by evaporation. The treatment may be invasive.

The provided text describes a 510(k) summary for the device CRYOSUCCESS, a cryosurgery unit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.

However, I can extract information related to the acceptance criteria and the study that proves the device meets them based on the submission's structure:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was evaluated against:

• Standard: ASTM F 882-84 (2002) - Standard for Biocompatibility of Materials Used in Medical Devices (Note: The provided text identifies the standard as F 882-84, which typically refers to biocompatibility. However, the context of the device (cryosurgery unit) and the stated 'requirements' suggest it's likely referring to a broader set of performance/safety standards, or specific aspects of this standard were applied. Without further details on the specific requirements within this standard that were tested, a detailed performance table cannot be generated.)
• Additional requirements: "additional requirements specified by the manufacturer." These are not detailed in the provided text.

The reported device performance is a general statement: "The device has fulfilled the requirements detailed above." No specific numerical performance metrics are provided in this summary.

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

The document refers to "bench testing" and "V&V Plan & Report CRYOSUCCESS enclosed." However, the 510(k) summary itself does not provide details on:

• The sample size used for the test set.
• The data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Their Qualifications for Establishing Ground Truth:

The provided text does not contain any information about experts used to establish ground truth or their qualifications. This summary relies on technical characteristics and performance against specified standards rather than clinical data requiring expert review for ground truth.

4. Adjudication Method:

The provided text does not contain any information about an adjudication method. This type of method is typically used in clinical studies with human interpretation, which is not described here.

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

The provided text does not describe or mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

The provided text does not mention or describe any standalone (algorithm-only) performance, as the device is a physical cryosurgery unit, not an algorithm or software.

7. Type of Ground Truth Used:

For this device (a cryosurgery unit), the "ground truth" would likely be based on technical specifications and functional testing results (e.g., temperature achieved, flow rate, material integrity, sterility). The summary highlights that "The relevant requirements set forth in standard ASTM F 882-84 (2002) and the additional requirements specified by the manufacturer are sufficient to assure a safe and effective functioning of the CRYOSUCCESS cryosurgery device." This implies the ground truth for testing came from established engineering and safety standards. No pathology, outcomes data, or expert consensus on clinical outcomes are detailed in this summary.

8. Sample Size for the Training Set:

The provided text does not contain any information about a training set. Training sets are relevant for machine learning algorithms, which is not applicable to this physical medical device.

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

As there is no training set mentioned or implied, this information is not applicable and not provided in the document.

In summary, the 510(k) summary primarily focuses on demonstrating substantial equivalence through a comparison of technical characteristics to a predicate device and adherence to a recognized standard (ASTM F 882-84) and internal manufacturer requirements, rather than presenting a detailed clinical study with performance metrics against specific acceptance criteria for a diagnostic or AI-driven device.

Ask a specific question about this device