(470 days)
The EZ-Mister is indicated for use in atomizing topical anesthetics to the oropharynx and upper airway regions.
The EZ-Mister consists of a plastic atomizer used to deliver topical anesthetic solutions. The device includes a receptacle intended to contain a single container of topical anesthetic; the atomizer housing has a plastic tube that extends into the anesthetic solution. The device uses oxygen flow to achieve atomization.
The E-Z Mister device is a topical anesthetic atomizer. The study performed to demonstrate its performance focused on particle size testing. However, the document does not include a table of acceptance criteria, the specific results of the particle size testing, or the other requested details regarding the study methodology.
Based on the provided information, I can answer some of the points:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided document. It's only mentioned that "Performance data provided in this submission consists of particle size testing." Without specific thresholds or target ranges for particle size, it's impossible to create this table.
- Reported Device Performance: Not explicitly provided in the document. The document only states that particle size testing was performed, but the results of this testing are not given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the particle size testing.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable as the study involved particle size testing, not a clinical assessment requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the study involved particle size testing, not a clinical assessment requiring adjudication.
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
- No, a multi-reader multi-case comparative effectiveness study was not done. The study was focused on the physical characteristics (particle size) of the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This question is not applicable as the study involved particle size testing through laboratory measurements, not a clinical assessment requiring ground truth established by experts or pathology.
8. The sample size for the training set
- This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable as the device is a physical medical device, not an algorithm or AI system that requires a training set.
§ 868.5170 Laryngotracheal topical anesthesia applicator.
(a)
Identification. A laryngotracheal topical anesthesia applicator is a device used to apply topical anesthetics to a patient's laryngotracheal area.(b)
Classification. Class II (performance standards).