(89 days)
EZ-Sprayer is intended to apply topically by spray or atomizing an oil or water base solution to either the nose and / or throat, for example, topical anesthetics solutions of lidocaine or xylocaine.
The device will not be supplied with water or oil base solutions.
The disposable, air or gas powered venturi sprayer / atomizer with reservoir and spring loaded flow control button, with an adjustable spray nozzle.
A disposable, nose or throat atomizer for either oil or water base solutions.
The provided text describes the "EZ Spray" powered atomizer and its substantial equivalence to a predicate device, the DeVilbiss Atomizer Model 5005. It does not contain information about a study proving the device meets acceptance criteria in the manner typically associated with AI/ML device evaluations (i.e., performance metrics, sample sizes, ground truth establishment, or expert reviews).
The document is a 510(k) submission summary for a medical device (EZ Spray) and focuses on demonstrating substantial equivalence to a pre-amendment predicate device, the DeVilbiss Atomizer Model 5005. The "acceptance criteria" here refer to design and performance specifications intended to show that the EZ Spray functions similarly to the predicate, and these are compared directly against the predicate device's characteristics rather than against a predefined set of independent performance benchmarks with associated statistical studies for standalone or human-assisted AI.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of medical device submission.
Here's the relevant information that can be extracted, framed within the requested structure where possible, and noting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the characteristics of the predicate device. The "reported device performance" is the EZ Spray's characteristics, which are claimed to be equivalent.
| Attribute/Acceptance Criteria (based on Predicate) | Reported Device Performance (EZ Spray) |
|---|---|
| Use | |
| Intended for lavaging nose and throat | Yes |
| Atomizing oil and water base solutions | Yes |
| Environment of use - Hospital, OR, anesthesia, ICU, physician office | Yes |
| Disposable | Yes |
| Design / Theory of Operation | |
| Venturi design for atomizing solution | Yes |
| Utilizes air or oxygen to atomize solutions | Yes |
| Adjustable tip to direct spray up or down | Yes |
| Available to adjust flow / output | Yes |
| Method of adjusting flow (Spring loaded button) | Yes |
| Reservoir bottle | Yes |
| Connection port for air source | Yes |
| Materials | |
| Bottle (Polycarbonate) | Polycarbonate |
| Nozzle assembly (ABS) | ABS |
| Performance Standards / Specifications | |
| Gas or air source is dry, compressed air or oxygen | Yes |
| Plume geometry generally concial | Yes |
| Operating pressure and flow (10 Lpm @ 50 psi) | Yes |
| Delivers a volume of liquid at full flow in 60 seconds (approx. 2 oz) | 1.9 oz |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable. This is not an AI/ML device. The "test set" in this context refers to the device itself being compared against a predicate, not a dataset for performance evaluation.
- Data Provenance: Not applicable. The comparison is based on the functional and material characteristics of the EZ Spray and the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the comparison is the established characteristics and performance of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no need for adjudication as the comparison was made against the known properties of the predicate device.
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
- MRMC Study: No. This is not an AI-assisted device. Therefore, no MRMC study or effect size calculation for human readers with/without AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a mechanical atomizer, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" used for this submission is the established characteristics, materials, and performance specifications of the predicate device (DeVilbiss Atomizer Model 5005), which was pre-amendment and legally marketed. The submission asserts that the EZ Spray is substantially equivalent to this predicate based on these established attributes.
8. The sample size for the training set
- Training Set Size: Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. There is no training set for this type of device.
§ 868.5640 Medicinal nonventilatory nebulizer (atomizer).
(a)
Identification. A medicinal nonventilatory nebulizer (atomizer) is a device that is intended to spray liquid medication in aerosol form into the air that a patient will breathe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.