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The CRYOTRON 2 ® Cryotherapy Device is for use when cold therapy is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

The CRYOTRON 2 ® Cryotherapy Device delivers a topical spray of compressed medical-grade carbon dioxide. The patented technology of the CRYOTRON 2 ® Cryotherapy Device uses the natural expansion of liquid CO₂ to create a cold spray of micro- crystals delivered under pressure. Using a gradual sweeping motion, the user applies the spray to the treatment site for 30-60 seconds at a distance of 3-5 inches. Rapid cooling (thermal shock) occurs when the spray sublimates (passes directly from solid (ice) phase to gas phase) as it contacts the skin.
The CRYOTRON 2 ® Cryotherapy Device consists of four components that are housed in a mobile cart:
A pistol-grip hand-piece that delivers the carbon dioxide spray.
An electronic console/control panel that provides operational information to the user.
A rechargeable battery.
A cylinder of compressed medical-grade carbon dioxide gas (sold separately).
An infrared temperature measurement system continuously monitors the temperature of the skin surface. The skin surface temperature is displayed on the electronic console, and a red LED on the pistol-grip hand-piece flashes when the skin surface temperature falls to 4°C. An optional laser pointer within the pistol-grip hand-piece provides a visual indication of the zone where the skin temperature is measured.

The provided text is a 510(k) summary for the CRYOTRON 2 Cryotherapy Device. It describes the device, its intended use, and its predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation.

This document is from 2003, well before the widespread adoption of AI/ML in medical devices, and the device described is a physical cryotherapy device, not an AI/ML-driven diagnostic or therapeutic tool. Therefore, the requested information elements related to AI/ML device testing are not applicable and not present in the provided text.

Based on the provided text, I cannot complete the table or answer the questions as they pertain to AI/ML device performance and testing.

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Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) Topical Anesthetic: a vapocoolant (skin refrigerant) intended for topical application to control pain associated with minor surgical procedures (such as lancing boils, incisions and drainage of small abscesses), injections (venipuncture, IV starts) and the temporary relief of minor sports injuries. The Medium Spray is also intended for the treatment of restricted motion associated with myofascial pain caused by trigger points.

Gebauer's Skin Refrigerant (Mist and Medium Spray) Topical Anesthetic is a prescription device designed to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device delivery system submitted in this application is specifically designed to deliver a medium and mist spray of the Gebauer's Skin Refrigerant (Mist Spray and Stream Spray) mixture. The medium and mist is an appropriate mode of application when users follow the labeled directions for use, cooling skin through rapid evaporation of the non-medicated volatile propellants.

The provided text describes Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) and its substantial equivalence to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The document, primarily a 510(k) summary, focuses on establishing substantial equivalence based on:

• Identical formulation and delivery system to Gebauer's Instant ICE (K021726).
• Identical indications for use to Gebauer's Ethyl Chloride (K991514), with additional clarification for pre-injection anesthesia examples.

The only "performance" mentioned is a reference to: "The temperature equivalency data previously submitted in 510(k) K021726, shows that Gebauer's Instant Ice 110 Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time." However, details of this study are not provided in the current document, and it pertains to a predicate device's equivalency, not specific acceptance criteria for the new device itself.

Therefore, I cannot populate the requested table and answer the study-related questions from the provided text.

Summary of missing information:

• Acceptance Criteria for Gebauer's Skin Refrigerant (Mist Spray and Medium Spray): Not stated.
• Reported Device Performance for Gebauer's Skin Refrigerant (Mist Spray and Medium Spray): Not stated.
• Details of the temperature equivalency study (K021726): Not provided in this document, only a high-level summary of its outcome. This study was for a predicate device.

To address your request, information specifically outlining performance acceptance criteria and a study design/results for the Gebauer's Skin Refrigerant (Mist Spray and Medium Spray) would be needed.

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