(127 days)
The intended use of the AG PLUS is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.
The AG PLUS compressor is to be used only with specific 510(k) cleared nebulizer whose input specifications may be met by the pressure and flow characteristics of the AG PLUS compressor. The initial nebulizer distributed with the AG PLUS compressor will be the Medel Jet Pro, the performance of which is contained in this 510(k) notification.
The AG PLUS is transportable equipment intended for home health care use. The AG PLUS is not intended as a life sustaining or life support device.
Not Found
This document is a 510(k) clearance letter for a medical device called "AG PLUS", a nebulizer. It indicates that the device has been found substantially equivalent to a legally marketed predicate device. However, this letter does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed study proving performance against defined acceptance criteria in the manner typically seen for AI/ML device clearances.
Therefore, based only on the provided text, I cannot extract the requested information.
Here's why and what kind of document would typically contain this information:
- Acceptance Criteria & Device Performance: This information is usually found in the performance testing sections of the 510(k) submission, specifically detailing studies conducted to characterize the device's technical specifications (e.g., aerosol particle size, drug delivery rate, compressor flow/pressure). These studies would compare the new device's performance to the predicate or to established standards.
- Study Details (Sample Size, Data Provenance, Ground Truth, Experts, MRMC, Standalone): These are details specific to the design and execution of clinical or performance studies. If this were an AI/ML device, these points would be critical. However, for a nebulizer, the "studies" typically focus on engineering performance (e.g., aerosol characterization, compressor output) rather than diagnostic accuracy studies with human readers or pathology.
- Training Set Information: This is entirely relevant to AI/ML devices. A nebulizer is a mechanical device, so it doesn't have a "training set" in the context of machine learning.
What to look for if this were an AI/ML device (which it isn't):
If this document were for an AI/ML device, I would expect to find the requested information in sections detailing:
- Clinical Performance Study: This is where the results of the device's diagnostic accuracy, sensitivity, specificity, etc., would be presented, often against a ground truth.
- Reader Study / Multi-Reader Multi-Case (MRMC) Study: If human-in-the-loop performance or comparison to human readers was evaluated.
- Validation Study: Detailing the test set characteristics, ground truth establishment, and standalone performance metrics.
- Algorithm Development / Training Details: Describing the training data and how its ground truth was established.
In summary, the provided document is a regulatory clearance letter, not a technical report or clinical study summary. It confirms market authorization based on substantial equivalence but does not contain the detailed performance study information requested.
§ 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).