(16 days)
The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.
The Medical Depot Nebulizer Device is the same as our Power Neb II except with a membrane rather than a piston compressor. It is also the same as the Graham - Field Mini-Mist II which was originally cleared by John Bunn Company and has the same compressor as this device.
The provided document is a 510(k) premarket notification summary for the Medical Depot Power Neb I, a nebulizer. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria, performance studies with specific metrics, or information on AI/ML models.
Based on the provided text, the device is a compressor for medical nebulization and does not appear to be an AI/ML-enabled device. Therefore, the questions related to AI/ML model evaluation, such as sample sizes for test and training sets, ground truth establishment methods, expert involvement, and MRMC studies, are not applicable in this context.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative acceptance criteria or detailed device performance metrics in the format of a table. The device's performance is implicitly evaluated through its substantial equivalence to predicate devices. The key performance aspect described is its ability to "provide a source of compressed air for medical purposes" and, "in conjunction with a pneumatic nebulizer, to produce a fine aerosol mist of medication for respiratory therapy."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This device is a mechanical compressor, not a diagnostic or AI/ML device that would require test sets with patient data.
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. Ground truth establishment with experts is not relevant for this type of medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-enabled device and no MRMC study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
Summary based on the 510(k) document:
The Medical Depot Power Neb I is a nebulizer compressor. The "study" proving its acceptance criteria is the comparison to predicate devices (Medical Depot Power Neb II and John Bunn Model 510 Medication Compressor, along with the Graham-Field Mini-Mist II). The "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to these legally marketed devices, sharing similar technology (a membrane compressor, which is also present in one of the predicate devices) and intended use. The 510(k) clearance process focuses on demonstrating this equivalence rather than performing extensive novel clinical trials or performance studies with specific, quantifiable acceptance metrics as would be seen for new drugs or high-risk devices.
§ 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).