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To destroy tissue during surgical procedures by applying extreme cold.

The CryoProbe™ is a hand-held cryosurgical instrument for destroying tissue during surgical procedures by applying extreme cold gas (N2O). The device is based on direct application of nitrous oxide in the liquid phase to the selected area. The N2O gas is delivered to the treatment site at -89° C to effect cellular destruction.

The hand-held device is shaped like a pencil to afford maximum user control and comfort. An N2O gas cylinder, commercially available, is held within the pencil body. The gas cylinder is punctured at its intended nozzle by the CryoProbe™ gas guidance tube and retained by the safety valve (handle) until treatment begins. The gas flow is controlled by the microapplicators, high or low flow. This flow rate is selectable when a gas cylinder is installed by selecting the appropriate microapplicator for the assembly.

The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported.

This document describes the CryoProbe™, a hand-held cryosurgical instrument. The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on detailed performance studies with acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets them based on the provided text.

Here's why and what's missing:

• Acceptance Criteria: Acceptance criteria are specific, measurable thresholds that a device must meet to be considered safe and effective. These are typically defined before testing. The document states "The CryoProbe™ is designed for safety, performance, and convenience for the user. The design is confirmed by Risk Analysis and actual market usage in the European market. Over 3,000 units are in distribution and use with no adverse effects reported." This is a general statement about design intent and post-market experience, not a set of measurable acceptance criteria.
• Study Details: The document mentions "Risk Analysis and actual market usage," but these are not described as formal studies with methodologies, sample sizes, ground truth establishment, or specific performance metrics that would allow for a table of acceptance criteria vs. reported performance.

To provide the information you've requested (table, sample size, ground truth, MRMC, etc.), there would need to be a detailed report on specific performance testing (e.g., consistency of temperature, cryolesion size, safety mechanisms, etc.) with pre-defined success/failure thresholds. This level of detail is typically found in design verification and validation documents, which are usually not part of a public 510(k) summary in this format.

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