(89 days)
Mist Spray:
CryoDose TA OTC is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Stream Spray:
CryoDose TA OTC is used like ice for muscle spasm and for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions and minor sports injuries.
Nuance Medical's CryoDose TAOTC (subject device) is an over-the-counter (OTC) device designed to deliver a standard mixture 245fa (1,1,1,3,3-Pentafluoropropane) and 134a (1,1,2-Tetrafluoroethane), which is being offered in two delivery configurations, Mist Spray (Model No. 1815) and Stream Spray (Model No. 1821). This mixture self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device's delivery system controls the amount of the CryoDose TA TTC mixture that is dispensed, the Mist Spray configuration produces very fine droplets that create cooling at the points of contact. The Stream Spray configuration produces a pinpoint stream that contacts the skin surface at a specific single location. Both configurations contain the same standard mixture thus there is not safety or effectiveness concerns between configuration. The skin is cooled through rapid evaporation of the non-medicated propellants.
This document is a 510(k) Summary for the CryoDose TA OTC (Mist Spray and Stream Spray) device, which is a vapocoolant for temporary pain relief. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with acceptance criteria and performance metrics for a novel AI/software device. Therefore, many of the requested categories related to AI/software performance studies (like sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.
However, I can extract information related to the device's characteristics and the types of tests performed to support its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for substantial equivalence based on a physical medical device (vapocoolant spray) and not an AI/software product, the "acceptance criteria" are related to demonstrating similarity to a predicate device rather than numerical performance thresholds for diagnostic accuracy. The "reported device performance" is essentially that the device was found to be "substantially equivalent" and met the requirements outlined for physical and chemical characteristics.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet acceptance requirements of ISO 10993-5:2009 (Cytotoxicity), ISO 10993-10:2010 (Sensitization), and ISO 10993-10:2010 (Irritation) for a surface-contacting/breached or compromised surface with limited contact duration (≤ 24 hours). | "Biocompatibility testing met each evaluation's acceptance requirements, which demonstrated the material's safety." (Reference device's results utilized as identical to subject device.) |
| Chemical Composition | Identical aerosol profile: 245fa (1,1,1,3,3-Pentafluoropropane) at 95% and 134a (1,1,2-Tetrafluoroethane) at 5%. | "The subject device and predicate are composed of identical aerosols profiles... The subject device's aerosol is checked and verified upon receipt from the aerosol supplier to ensure the same chemical profile as the predicate." (Identical chemical composition confirmed.) |
| Structural & Parts Composition | Canisters, valves, and caps equivalent to the predicate device. | "Engineering verification measurements were taken and visual inspections were made to determine the canisters, valves, and caps were equivalent to the predicate." (Reference device's results utilized as identical to subject device.) |
| Directions for Use (DFU) | Key elements including indication for use, intended use, precaution, warning, and contraindication statements, and treatment regimen equivalent to the predicate. | "All key elements of the Directions for Use (DFU) between the predicate and the subject device are equivalent... No substantial differences exist between the predicate and subject device's Directions for Use." |
| Temperature & Output Bench Testing | Equivalent temperature output at the application surface and volume dispensed per actuation/total compared to the predicate/reference device. | "Comparative performance testing was conducted as it related to temperature output at the application surface and volume dispensed per actuation/total and equivalent results were demonstrated." (Reference device's results utilized as identical to subject device.) |
| Stability & Shelf Life | Identity, strength, quality, and purity maintained throughout labeled dating period under controlled and accelerated conditions. | "All requirements were confirmed to meet established acceptance criteria." |
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study involving a "test set" of medical images or patient data for an AI/software device. The testing involved laboratory and bench testing of the physical properties and chemical composition of the device, utilizing data from an identical reference device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study assessing diagnostic performance against a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 vapocoolant spray, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a vapocoolant spray.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility tests, the "ground truth" was the established standards and acceptance criteria of ISO 10993. For chemical and structural composition, the "ground truth" was the known composition and structure of the predicate device. For performance characteristics, the "ground truth" was the expected performance and temperature/volume output of the predicate/reference device.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable.
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