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The Freezpoint device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses an 8g or 16g cartridge of nitrous oxide. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N20 (-89ºC).

AI/ML Overview

The Freezpoint device is a cryosurgical unit that uses liquid nitrous oxide to destroy tissue by applying cryogenic gases at extremely low temperatures. The following information outlines the acceptance criteria and the study conducted to prove the device meets these criteria, as derived from the provided 510(k) summary.

I. Acceptance Criteria and Reported Device Performance

The primary acceptance criteria for the Freezpoint device, based on its comparison to the predicate device CryOmega, revolved around demonstrating equivalent performance in key functional aspects: the amount of cryogen dispensed and the temperature achieved.

Acceptance Criteria	Reported Device Performance (Freezpoint)	Predicate Device Performance (CryOmega)
Amount of gas dispensed per unit of time	Calculated as <0.01g different from the predicate device during a 5-second spray. (Considered negligible difference).	Calculated as <0.01g different from the Freezpoint device during a 5-second spray.
Temperature attained at the treatment site	All replicate measurements of gas sprayed onto a thermocouple were less than -89°C. This substantiates the low boiling point of nitrous oxide (-89°C).	All replicate measurements of gas sprayed onto a thermocouple were less than -89°C, aligning with the expected low boiling point of nitrous oxide (-89°C).
Compliance with ASTM standards for devices	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.	Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments.

II. Sample Size and Data Provenance for the Test Set

Sample Size: The document refers to "replicate sprays" for both the Freezpoint and CryOmega devices for both weighing and temperature measurements. The exact number of replicates is not specified.
Data Provenance: The data was generated through bench testing conducted by the device manufacturer (Bovie Medical Corp./CryoConcepts LP). The country of origin is not explicitly stated but can be inferred to be the United States, given the FDA submission. The nature of the testing is prospective as it involves new measurements of the Freezpoint device and direct comparison to the predicate.

III. Number of Experts and Qualifications for Ground Truth

This type of bench testing for a cryosurgical device does not typically involve human experts to establish "ground truth" in the same way clinical trials for diagnostic devices would. The performance metrics (gas dispensed and temperature) are objectively measured using scientific instruments.
The qualifications of the individuals who performed the bench testing and analyzed the data are not detailed in the provided summary. However, it's implied that they possess the necessary technical expertise to conduct such measurements.

IV. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) was used as this was a bench testing study, not a study involving human interpretation or clinical outcomes that would require such a process. The measurements are objective and quantitative.

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

No MRMC comparative effectiveness study was done. This device is a cryosurgical tool, not an imaging or diagnostic device that requires human interpretation. The study focused on the physical performance characteristics of the device.

VI. Standalone Performance Study

Yes, a standalone performance study was done. The bench testing focused on the intrinsic performance of the Freezpoint device itself (amount of gas dispensed, temperature attained) and compared it directly to the predicate device. This was an "algorithm only" equivalent for a physical device, establishing its performance parameters without human interaction influencing the core function being measured.

VII. Type of Ground Truth Used

The "ground truth" used for this study was based on objective physical measurements rather than expert consensus, pathology, or outcomes data.
- For the amount dispensed criterion, the ground truth was the accurate weight measurement of the dispensed gas.
- For the temperature criterion, the ground truth was the temperature reading from a thermocouple.
- The comparison was against the established performance of a legally marketed predicate device (CryOmega) and the known physical properties of nitrous oxide (-89°C boiling point).

VIII. Sample Size for the Training Set

This device is a physical cryosurgical unit, not an AI or machine learning algorithm. Therefore, the concept of a "training set" is not applicable. The device's manufacturing and design are based on established engineering principles for cryosurgical units.

IX. How the Ground Truth for the Training Set was Established

As there is no "training set" for this type of physical medical device, this question is not applicable. The device's functionality is determined by its mechanical design and the physical properties of the cryogen.

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