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510(k) Data Aggregation
(74 days)
To destroy tissue during surgical procedures by applying extreme cold.
The Accurett® is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas, carbon dioxide (CO2). The device design is based on direct application of carbon dioxide in the liquid phase to the selected area. The CO2 gas is delivered to the treatment site at -79°C to effect cellular destruction. The hand-held device is shaped like a pencil to afford maximum user comfort. Prior to use, a commercially available 16g CO2 gas cylinder cartridge is loaded into the Accurett® device. The flow of gas is controlled by a trigger on the unit. Mode of operation: Joule-Thompson Principle to cool the gas.
The provided text describes a 510(k) premarket notification for the Accurett® cryosurgical unit and accessories. It focuses on demonstrating substantial equivalence to a predicate device (CryoProbe™). The information primarily outlines the device, its intended use, and the comparison to the predicate, with a specific mention of performance testing to address the change in cryogen.
Based on the provided text, here is a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that performance testing was conducted to assure the use of CO2 gas was "appropriate, safe and effective." However, it does not explicitly state specific acceptance criteria or quantitative performance results for attributes like freezing rate, tissue destruction depth, or any other performance metric. It only states the output temperature for CO2.
| Performance Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Output Temperature (CO2) | Not explicitly stated | -79°C |
| Output Temperature (N2O) | Not explicitly stated (for predicate) | -89°C (for predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "design verification testing was performed" but does not specify the sample size used for this testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth as this is a device submission for substantial equivalence based on performance testing related to a change in cryogen, not a diagnostic AI study.
4. Adjudication Method for the Test Set
This is not applicable as the document describes performance testing for a cryosurgical device, not a diagnostic study requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done, as this document pertains to a medical device submission, not an AI-assisted diagnostic system.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was not done as this document refers to a cryosurgical device, not an AI algorithm.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology, expert consensus) is not directly applicable here. The "proof" focuses on demonstrating the safety and effectiveness of the device with the new cryogen, likely through engineering and functional testing rather than clinical ground truth as defined in diagnostic studies. The document states "design verification testing was performed to assure the use of the CO2 gas was appropriate, safe and effective for the intended use."
8. Sample Size for the Training Set
There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned in the document.
Summary of the Study Proving Device Meets Acceptance Criteria (as described in the document):
The study referenced is "performance testing" conducted as part of "design verification testing." The motivation for this testing was a "Risk Analysis ... according to ISO 14971:2012" to assess the impact of changing the cryogenic gas from N2O to CO2. The objective of this testing was "to assure the use of the CO2 gas was appropriate, safe and effective for the intended use."
The document states that "The result of use of the different gas is the output temperature: for the CO2 it is -79ºC while for the N2O it is -89°C." This implies that the temperature achieved by the new cryogen (CO2 at -79°C) was considered acceptable for "destroying tissue during surgical procedures by applying extreme cold," which is the stated indication for use.
In essence, the "study" was a series of design verification tests, including measuring output temperature, to ensure the modified device (Accurett® with CO2) performed as intended and was safe and effective, thereby demonstrating substantial equivalence to the predicate device (CryoProbe™ with N2O). Specific quantitative acceptance criteria or detailed test results are not provided in this summary document.
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