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510(k) Data Aggregation
(78 days)
The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum
- · Skin Tags
- · Actinic Keratosis
- Lentigo
- · Verruca Plana
- · Verruca Vulgaris
- Verruca Plantaris
- · Genital Lesions
- · Seborrheic Keratosis
The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CryOmega Flexx device:
The document is a 510(k) premarket notification summary for the CryOmega Flexx, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device (CryOmega-K102006) rather than defining and proving new acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are essentially the performance characteristics of the predicate device, which the new device must meet or be substantially equivalent to.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device Performance) | Reported CryOmega Flexx Performance |
|---|---|
| Cryogen Temperature at Treatment Site: -89°C | "replicate measurements of gas sprayed onto a thermocouple from each device were all less than -90°C" (This indicates it meets or exceeds the predicate's reported temperature.) |
| Amount of Gas Dispensed: (Implied by predicate) | "replicate sprays of each device were performed, weighing the devices before and after a 5 second spray. The amount dispensed for the CryOmega Flexx and CryOmega were calculated and found to be <1.0% different. The difference in amount dispensed was therefore negligible." (This demonstrates equivalency in gas dispensed.) |
| Cellular Destruction Efficacy: (Implied by predicate's mechanism of action) | "the spray of liquid nitrous oxide was previously shown to destroy red blood cells immobilized in agar. A spray of the device was able to reach a depth of approximate 1.0 mm after a 5 second spray." (This relies on prior validation of the predicate's mechanism, and confirms the new device achieves a similar physical effect (spray depth) which is linked to efficacy.) It's important to note this isn't a direct measure of efficacy for the listed lesions, but rather a physical proxy. |
| Safety: Complies with ASTM F882-84 (96) | "Complies with ASTM: F882-84 (96) for Cryosurgical Medical Instruments" (Declared compliance with the same standard as the predicate.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a precise sample size for the "replicate sprays" or "replicate measurements." It uses the term "replicate," implying multiple measurements were taken, but the exact number is not stated.
- Data Provenance: The study was a bench testing study conducted by the manufacturer, CryoConcepts LP. The data is prospective (generated specifically for this submission) and conducted in a controlled lab environment. There is no mention of country of origin for the data itself, but the manufacturer is based in Bethlehem, Pennsylvania, USA.
The study is essentially comparing the new device (CryOmega Flexx) directly against the predicate device (CryOmega-K102006) in terms of physical performance rather than against a clinical dataset of patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this study. The "ground truth" for this bench test study is objective physical measurements (temperature, mass, spray depth) taken by technical instruments, not expert human interpretation.
4. Adjudication Method for the Test Set
This is not applicable to this study as it involves objective physical measurements, not subjective human assessments requiring adjudication.
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
This is not applicable. This document describes a bench testing study for a cryosurgical device, not an AI-powered diagnostic system or a study involving human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. This device is a cryosurgical tool, not an algorithm. Performance is assessed through physical bench tests.
7. The Type of Ground Truth Used
The ground truth used in this study is based on objective physical measurements obtained from bench testing instruments (thermocouple for temperature, scale for mass, and a visual assessment of spray depth in agar for the cellular destruction proxy).
8. The Sample Size for the Training Set
This is not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set.
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