(202 days)
Gebauer's Instant Ice TM (Mist Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.
Gebauer's Instant Ice TM (Stream Spray): Use like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries and muscle spasms.
Gebauer's Instant Ice ™ (Mist Spray and Stream Spray) is an over-the-counter device to deliver 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,1,2-Tetrafluoroethane) in a stream or mist spray. This mixture self-propels itself from the delivery system without the need for a propellant, because of the mixtures high vapor pressure. This form of delivery is an appropriate mode of application when the consumer follows the labeled directions for use, cooling skin through rapid evaporation of non-medicated volatile propellants.
Here's a breakdown of the acceptance criteria and study information based on the provided document for Gebauer's Instant Ice ™:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Primary Acceptance Criteria (Substantial Equivalence) | The device is demonstrated to be substantially equivalent to predicate devices (Gebauer's Ethyl Chloride® and Mueller® Coolant Cold Spray/Cramer® Cold Spray) in: |
- Basic product design and technology
- Indications for use
- Target population
- Risk factors |
| Temperature Equivalency (Gebauer's Instant Ice™ Stream vs. Gebauer's Ethyl Chloride® Medium) | Gebauer's Instant Ice™ Stream is equivalent to Gebauer's Ethyl Chloride® Medium (± 5.0° C) at the 95% confidence interval 80% of the time. |
| Temperature Range (Gebauer's Instant Ice™ Mist/Stream vs. Mueller® Coolant Cold Spray & Cramer® Cold Spray) | The temperature range of Gebauer's Instant Ice™ Mist Spray and Gebauer's Instant Ice™ Stream Spray are contained within the range of two currently marketed over-the-counter products (Mueller® Coolant Cold Spray and Cramer® Cold Spray).
Detail: The 95% confidence intervals for average temperatures of Gebauer's Instant Ice™ Stream and Mist Spray products, Mueller® Coolant Cold Spray, and Cramer® Cold Spray were calculated, and the temperature interval between the Mueller® and Cramer® products was determined. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific "sample size" in terms of number of data points or subjects used for the temperature equivalency testing. It refers to "temperature equivalency data" and "95% confidence intervals for average temperatures."
- Sample Size: Not explicitly stated as a number of measurements or subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It appears to be data collected specifically for the 510(k) submission, likely prospective measurements conducted by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing involves physical measurements (temperature), not subjective interpretations by experts.
4. Adjudication Method for the Test Set
This information is not applicable. Ground truth was established through direct physical measurement (temperature), not through expert review needing adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This device is a cold spray, and its effectiveness is determined by its cooling properties, not by human reader interpretation of images or data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was done in a sense that the device's performance (temperature equivalency) was assessed directly without human input influencing the measurement. The cooling action and temperature output were measured inherent to the device itself.
7. Type of Ground Truth Used
The ground truth used was physical measurement / direct observation of temperature. The claim is that the device produces a certain temperature profile, and this was directly measured and compared against predicate devices.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. This is a physical product (a cold spray), not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
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