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For the treatment of verruca (warts) including plantar warts, sehorrheic keratosis, achrochorodon, molluscum, contagiosum, age spots, dermatofibroma, small keltoids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chrondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyrogenic granualpma.

The Subject Device is used in the practice of dermatology in the treatment of skin lessons using a cryogen spray system. This methodology is an accepted practice used by physicians for decades using accepted procedures and techniques. It utilizes a cryogen composition profile to freeze common skin lessons that is has a lower global warming potential then the predicate device and is safe and provide equivalent performance.

The chemical composition is a blend of HFC-32 and HFO-1234ze. HFC-32, difluoromethane, is a colorless gas typically used as a refrigerant. HFO-1234ze, trans-1,3,3,3-tetrafluoroprop-1-ene, is a colorless gas and a new generation hydrofluoroolefin developed for its low global warming potential.

This document is a 510(k) summary for the CryoDose V50/50, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device, the Nuance Freeze Spray System (K130995). The primary difference highlighted is the cryogen composition, with the new device using a blend of HFC-32 and HFO-1234ze, which has a significantly lower Global Warming Potential (GWP) than the predicate's HFC blend (R-404a).

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of a clinical study, but rather a "Comparison of Technological Characteristics" that serves as the basis for demonstrating substantial equivalence. The "acceptance criteria" here are implied to be performance characteristics that are "similar" or "identical" to the predicate device, ensuring equivalent safety and effectiveness.

Here's a table based on the provided comparison, indicating the "acceptance criteria" (which are performance targets based on the predicate) and the "reported device performance":

The document states: "Technically, the Subject Device has similar mechanical properties to the predicate as well as its performance. The same patient population and use indications applies between the devices. Identical cannister components and applicators are used with both devices. The main differences between the Subject Device and predicate is that the global warning potential is significantly less with the Subject Device. The differences in the Subject Device does not impact safety, effectiveness, or performance."

Study Information

This 510(k) submission does not concern a clinical study involving human patients or complex AI algorithms necessitating large test sets, expert readers, or MRMC studies. Instead, it focuses on demonstrating substantial equivalence of a medical device (a cryosurgical unit) through non-clinical performance testing and comparison of technical specifications to a previously cleared predicate device.

Therefore, many of the requested points regarding sample size, data provenance, expert ground truth, adjudication, and MRMC studies are not applicable to this type of device submission.

Here's the information that is applicable based on the document:

2. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated as a "test set" in the context of a clinical trial. The testing involved parameters like temperature, spray rate, pressure, flammability/ignition, and visual freezing. The sample size for these specific engineering/performance tests is not provided in this summary.
   • Data Provenance: The tests were "performed" on the subject device. The origin (e.g., country) of these performance test results is not specified, but it's presumed to be from the manufacturer's internal testing or a contracted lab. The data is from non-clinical, benchtop performance testing. It is not prospective or retrospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This submission relies on objective physical measurements (temperature, pressure, etc.) and comparison to a predicate device's established performance, rather than subjective expert interpretation of data points that would require "ground truth" establishment in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There was no human "adjudication" in the sense of resolving discrepancies in expert interpretation, as this was not a clinical or image-based diagnostic study.

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 device is a cryosurgical unit, not an AI-powered diagnostic tool. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth," if one can use the term loosely here, for this type of submission is the established performance characteristics of the legally marketed predicate device and accepted engineering/physical standards for the measured parameters. The goal is to show that the subject device's performance metrics are "similar" or "equivalent" to those of the predicate device, implying comparable safety and effectiveness.

8. The sample size for the training set:

   • Not applicable. This is a hardware device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable. See point 8.

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