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nüm is a sterile topical anesthetic spray - 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.

num Vapocoolant is a sterile-fluid-path, single-use, prescription device that delivers a vapocoolant mixture of 95% r254fa (1,1,1,3,3-Pentafluoropropane) and 5% 134a (1,1,1,2-Tetrafluoroethane). The vapocoolant is stored in a sealed canister within the Main Body of the device. When dispensed from the canister, this mixture self-propels itself from the delivery system using its vapor pressure as propellant leaving the device exits through the Nozzle which is engineered to produce a mist spray. When the vapocoolant reaches the skin, cooling achieved through rapid evaporation of the non-medicated volatile products, and through the cooling capacity of the low-temperature evaporating vapocoolant. Device sterility is achieved through electron beam sterilization and maintained through protective Tyvek lidstock on the top of the nozzle, and a Cap in the base of the Main Body.

The provided text describes the 510(k) premarket notification for the "num Vapocoolant™" device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance "acceptance criteria" and a "study" in the traditional sense of a clinical trial proving performance against those criteria. In 510(k) submissions for devices like this vapocoolant, the "acceptance criteria" are implicitly met by demonstrating equivalence to a legally marketed predicate device, especially for unclassified devices.

The "study" here is a series of non-clinical tests and comparisons to establish this substantial equivalence. There is no information about an AI/ML component, human readers, expert consensus for ground truth on patient data, MRMC studies, or training/test sets as these concepts typically apply to AI/ML device evaluations.

Therefore, the response below will interpret "acceptance criteria" in the context of a 510(k) submission for a non-AI/ML device seeking substantial equivalence, and the "study" as the set of non-clinical tests and comparisons performed.

Acceptance Criteria and Device Performance for num Vapocoolant™

For the num Vapocoolant™ device, the "acceptance criteria" are implicitly met by demonstrating Substantial Equivalence (SE) to a legally marketed predicate device, Gebauer's Skin Refrigerant. The performance criteria for such a device largely revolve around safety, the intended mechanism of action (cooling through rapid evaporation), and equivalence in composition and application compared to the predicate. The "study" proving acceptance is the detailed comparison and non-clinical testing outlined in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Differences and Assessment:

• num is a sterile, single-dose container; predicate is non-sterile, multi-dose.
• Assessment: Sterilization does not alter chemistry of volatiles. The single-dose design of num still produces an equivalent cooling effect when used as per IFU. These differences do not raise new safety or effectiveness questions. |
  | Biocompatibility | Acceptable biological risk for patient contact. | Demonstrated compliance with ISO 10993, including Cytotoxicity and Sensitization testing. This established acceptable biological risk. |
  | Sterilization (if applicable) | Validated sterilization process and maintenance of sterility. | num Vapocoolant™ is sterile (SAL 10⁻⁶) via radiation, validated per ISO 11137 series. This differs from the predicate (non-sterile), but the vapocoolant chemistry is unaltered by sterilization. |
  | Performance Testing (Mechanism & Delivery) | Ensures safety, reliability, and efficacy of product delivery and function, similar to predicate. | Non-clinical performance tests included: Device sterility, Sterile barrier efficacy, Sterile barrier usability, Actuation force, Vapocoolant performance, and Spray Production and Duration. These tests would ensure the device consistently delivers the vapocoolant as intended. |
  | Environmental Compatibility | Non-flammable. | Both devices are Non-Flammable. |

2. Sample Size Used for the Test Set and Data Provenance

This 510(k) submission does not involve a "test set" in the context of an AI/ML device evaluated on patient data. The "tests" here are non-clinical, laboratory-based evaluations of the device's physical and chemical properties and performance characteristics, as well as a direct comparison to a predicate device. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.

3. Number of Experts and Qualifications for Ground Truth

This submission does not mention the use of experts to establish "ground truth" for a test set of patient data, as it is not an AI/ML device evaluating medical images or patient outcomes. The determination of substantial equivalence is made by the FDA based on the submission's evidence, often relying on established standards and testing protocols rather than multi-expert consensus on patient cases.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" of patient cases requiring adjudication by multiple readers or experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a vapocoolant spray and not an AI/ML diagnostic or assistive tool where human reader performance would be measured with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Not applicable, as this device is a physical medical device (vapocoolant spray), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context is established by demonstrated compliance with recognized standards and direct comparison to a legally marketed predicate device.

• Predicate Equivalence: The primary "ground truth" is the established safety and effectiveness of the predicate device (Gebauer's Skin Refrigerant), which the num Vapocoolant™ aims to be substantially equivalent to.
• Non-clinical Test Standards: "Ground truth" for specific parameters (e.g., biocompatibility, sterilization, spray performance) is derived from ISO 10993 (biocompatibility), ISO 11137 series (sterilization), and other implicit engineering and performance standards for medical spray devices.

8. Sample Size for the Training Set

Not applicable. The described device is a physical product, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm.

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