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510(k) Data Aggregation
(220 days)
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS
Hudson RCI® AquaPak® Prefilled Nebulizer adds sterile water or saline solution in aerosol form to a patient's breathing gases. It may be used with pediatric (ages 2 years and above) and adult patients.
Hudson RCI® AquaPak® Prefilled Nebulizers provide sterile water or sterile saline for inhalation therapy. Nebulizers generate aerosol, a fine mist of liquid water (or sodium chloride solution) that is suspended in the gas to be inhaled by the patient.
The Hudson RCI® AquaPak® Prefilled Nebulizers are designed to aerosolize and provide a fine mist of sterile water or saline solution to inspired gas during aerosol therapy.
Prefilled sterile reservoirs for AquaPak® Nebulizers come in three sizes; 440ml, 760ml and 1070ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides nebulizer functionality.
Adaptor types available for the Hudson RCI® AquaPak® Prefilled Nebulizers include the 028 and the 033 Nebulizer Adaptors. Both the standard model with the yellow collar (type 028) and the quiet model with the blue collar (type 033) feature an adjustable air entrainment window, which provides a specific oxygen concentration by entraining room air into the oxygen stream.
The provided document is a 510(k) summary for the Hudson RCI® AquaPak® Prefilled Nebulizer. It outlines the device's characteristics, intended use, and compares it to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study that uses a device to meet acceptance criteria in the way typically expected for AI/CADe devices described in the prompt's requirements.
Instead, this document describes non-clinical comparative performance testing to demonstrate substantial equivalence for a medical device (a nebulizer), not to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity with a test set. This is a crucial distinction.
Therefore, I cannot fulfill most of your requested points as they are designed for studies evaluating the performance of AI/CADe systems or diagnostic devices against a defined ground truth.
Here's what I can extract and infer based on the provided text, while explicitly stating what information is not available:
Acceptance Criteria and Study for Hudson RCI® AquaPak® Prefilled Nebulizers
This document describes a 510(k) premarket notification for a medical device, the Hudson RCI® AquaPak® Prefilled Nebulizer. The "study" described is primarily non-clinical bench testing to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical trial or performance study against specific, quantified acceptance criteria for an AI/CADe system.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for accuracy, sensitivity, or specificity. Instead, it describes "comparative characteristics" to a predicate device and "non-clinical comparative performance testing" to demonstrate substantial equivalence. The "performance" is implicitly deemed acceptable if it is substantially equivalent to the predicate.
| Comparative Characteristic / Test Performed | Proposed Device: Hudson RCI® AquaPak® Prefilled Nebulizer | Predicate Device: Smiths Medical Portex™ Thera-Mist® Large Volume Nebulizer | Outcome (Implicit "Acceptance") |
|---|---|---|---|
| Indications for Use | Adds sterile water or saline solution in aerosol form to a patient's breathing gases. | Delivers particulate humidity in the 3 to 5 micron range for chronic secretion patients. | Substantially Equivalent |
| Principle of Operation | Jet nebulizer with adjustable air entrainment | Jet nebulizer with adjustable air entrainment | Substantially Equivalent |
| Gas source | 50 Psi oxygen regulated via a flow meter | 50 Psi oxygen regulated via a flow meter | Substantially Equivalent |
| Flow rate and FiO2 Control Capabilities | 028 Model: 28% at 5 LPM, 35% at 8 LPM, 40%-98% at 10 LPM. 033 Model: 28%-35% at 8 LPM, 40%-98% at 10 LPM. | Normal Flow LVN: 28%-60%. High Flow LVN: 36%-95% at 14-15 LPM. | Substantially Equivalent |
| Aerosol Particle Size Delivery | 1.5 to 3 micron range | 3 to 5 micron range | Acknowledged difference, noted as minor and raising no new safety/efficacy issues. |
| Sterilization | Adaptors - Non-sterile; Sterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill. | Adaptors - Non-sterile; Sterile Water/Saline Reservoirs - Reverse osmosis, distillation, and aseptic fill. | Substantially Equivalent |
| Single Use | Yes | Yes | Substantially Equivalent |
| Shelf Life | Adaptors - N/A; Sterile Water/Saline – 2 years from date of manufacture. | Adaptors - N/A; Sterile Water/Saline – 2 years from date of manufacture. | Substantially Equivalent |
| Lift Pressure (Test) | Not explicitly reported in numbers, but "performed." | Not explicitly reported in numbers, but "performed." | Demonstrated Substantial Equivalence |
| Oxygen Entrainment (Test) | Not explicitly reported in numbers, but "performed." | Not explicitly reported in numbers, but "performed." | Demonstrated Substantial Equivalence |
| Nebulization Rate (Test) | Not explicitly reported in numbers, but "performed." | Not explicitly reported in numbers, but "performed." | Demonstrated Substantial Equivalence |
| Particle Size Distribution (Test) | Not explicitly reported in numbers, but "performed." (Note: Range already listed in comparison table) | Not explicitly reported in numbers, but "performed." (Note: Range already listed in comparison table) | Demonstrated Substantial Equivalence |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench testing" but does not provide the number of units tested.
- Data Provenance: Not applicable in the context of typical AI/CADe data. The testing is non-clinical bench testing of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable here. Ground truth is not established by experts for this type of non-clinical device testing. Instead, the performance is measured against engineering specifications or compared directly to a predicate device.
4. Adjudication method for the test set
- Not applicable. There is no expert adjudication for this type of non-clinical bench testing.
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. This is not an AI/CADe device, and no MRMC study was performed or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/CADe sense. For bench testing, the "ground truth" would be established by validated measurement equipment and adherence to engineering specifications for device function (e.g., flow rates, particle size, lift pressure). The primary "ground truth" for regulatory submission is substantial equivalence to the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device, and no training set was used.
Summary of Device and Evidence:
The Teleflex Medical Hudson RCI® AquaPak® Prefilled Nebulizer sought 510(k) clearance by demonstrating "substantial equivalence" to the Smiths Medical Portex™ Thera-Mist® Large Volume Nebulizer. This was achieved through a comparison of "comparative characteristics" and "non-clinical comparative performance testing." The tests performed included Lift Pressure, Oxygen Entrainment, Nebulization Rate, and Particle Size Distribution. The document states that the differences between the proposed device and the predicate are "minor and raise no new issues of safety and efficacy." The detailed numerical results of these bench tests are not provided in this summary, only that they were performed to verify the performance and substantial equivalence.
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