(90 days)
This product is an ultrasonic nebulizer that is used to provide acrosolized broncho dialator medication to persons with asthma and emphysema. The device creates acrosolized particles of the prescribed medication via ultrasound that is forced via a vacuum or draw into disposable tubing. The aerosolized medication travels up the lubing and into either a nasal or oral mask. The patient then inhales the medication as per his/her physician's orders.
This product contains the exact same technological characteristics of similar devices currently on the market. The product functions exactly as these similar devices. The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe. The components found within this product are common items. The product consists of a thermally protected, simplistic circuit board, a piczcoelectric ceramic, a medicine cup, an ABS plastic case, a switch, an electrical cord.
This is a 510(k) premarket notification for a medical device called ULTRANEB ULTRASONIC, an ultrasonic nebulizer. The provided documents are primarily an FDA clearance letter and an "Indications for Use Statement." These documents do not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states that "The product is designed with similar performance characteristics as devices currently on the market. The performance of the device allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe." However, it does not detail specific quantitative acceptance criteria (e.g., aerosol particle size, nebulization rate) or the reported performance data against those criteria. This information would typically be in a more comprehensive testing report or a summary thereof, which is not included here.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. The documents do not describe any specific test set or clinical study conducted for this 510(k) submission, nor do they specify sample sizes or data provenance. The 510(k) process for this device appears to rely on substantial equivalence to existing devices rather than new clinical trials demonstrating performance against specific criteria.
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)
- Not applicable / Cannot be provided. Since no specific test set or clinical study with ground truth establishment is described in these documents, this information is not available.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. As no test set with expert adjudication is described, this information is not available.
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 an ultrasonic nebulizer, not an AI-assisted diagnostic or imaging device used by human "readers." Therefore, an MRMC study or AI assistance is not relevant to its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical nebulizer; there is no "algorithm" in the sense of AI or image processing that would have standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Cannot be provided. As no specific data or ground truth establishment is described, this information is not available. The submission likely relied on engineering and performance data to demonstrate equivalence, not clinical ground truth in the context of diagnostic accuracy.
8. The sample size for the training set
- Not applicable / Cannot be provided. This device is not an AI/ML-based device that would require a training set.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided. This device is not an AI/ML-based device that would require a training set.
Summary of available information:
The provided documents indicate that the ULTRANEB ULTRASONIC device received 510(k) clearance from the FDA based on its substantial equivalence to devices already marketed in interstate commerce.
- Device Description: An ultrasonic nebulizer that creates aerosolized particles of prescribed bronchodilator medication (for asthma and emphysema) via ultrasound, forced through disposable tubing into a nasal or oral mask for patient inhalation.
- Technological Characteristics: The manufacturer states that the product "contains the exact same technological characteristics of similar devices currently on the market" and "functions exactly as these similar devices."
- Performance Characteristics: The product "is designed with similar performance characteristics as devices currently on the market" and its "performance... allows it to be used in conjunction with various nasal and oral masks that are currently in distribution in the United States and Europe."
- Components: Described as "common items" including a thermally protected circuit board, a piezoelectric ceramic, a medicine cup, an ABS plastic case, a switch, and an electrical cord.
The FDA's finding of substantial equivalence means that the device is as safe and effective as a legally marketed predicate device, typically without requiring new clinical trials or detailed performance studies in the same way a novel device might. The "performance characteristics" and "technological characteristics" being "similar" to predicate devices served as the basis for clearance, but the specific metrics used for this comparison are not elaborated in these documents.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).