(66 days)
To provide a portable compressed air source for the nebulization of drugs to be delivered to a patient via a hand-held nebulizer in the home, nursing home or hospital environments.
The Medic-Aid Porta-Neb is an electrically powered compressor which provides 6-8 Lpm of air flow under a back pressure of 12 psi. It is designed to be connected to a hand-held nebulizer to provide the air source to nebulize drugs to be inhaled by a patient.
The provided document is a 510(k) Non-Confidential Summary of Safety and Effectiveness for the Medic-Aid Porta-Neb Nebulizer Compressor. This type of submission is a premarket notification to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device).
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical or performance study with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it demonstrates substantial equivalence to a predicate device by comparing various attributes. The 'acceptance criteria' in this context are implicitly that the Porta-Neb device's attributes are equivalent to or better than the predicate device, or meet recognized standards, without introducing new questions of safety or effectiveness.
| Attribute | Acceptance Criteria (Implicit: Equivalence to Predicate or Standard) | Reported Device Performance (Porta-Neb) | Predicate Device (DeVilbiss Pulmo-Aide K854520) Performance |
|---|---|---|---|
| Use | |||
| Intended to nebulize drugs | Yes | Yes | Yes |
| Utilized with different nebulizers | Yes | Yes | Yes |
| Serves as an air source to drive nebulizers | Yes | Yes | Yes |
| Portable | Yes | Yes | Yes |
| Used in hospital, nursing home, or home | Yes | Yes | Yes |
| Design | |||
| Small, compact, portable | Yes | Yes | Yes |
| Operates on 110 Volt | Yes | Yes | Yes |
| Nebulizer flow rates | Comparable to predicate | 6-8 Lpm | 5-7 Lpm |
| Has air outlet to connect to air delivery tubing | Yes | Yes | Yes |
| Is used with nebulizer, mask, or mouthpiece | Yes | Yes | Yes |
| Materials | |||
| No materials related to this device are in contact with the patient | Yes | Yes | Yes |
| Packaging | |||
| Provided clean | Yes | Yes | Yes |
| Performance Standards / Specifications | |||
| None applicable under Section 514 | Yes | Yes | Yes |
| Meets design, safety and performance requirements of EN 60601, UL 2601, IEC 601-1, CAN / CSA C22.2 No.60 1.1 | Yes (Meeting these standards is the implicit criterion) | Yes | Not known, but assumed Yes (for predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes a submission for substantial equivalence to a predicate device, not a clinical study involving a test set of patient data or specific samples for performance evaluation in the usual sense. Therefore, there is no traditional "test set" sample size as would be used for evaluating diagnostic accuracy or clinical outcomes. The evaluation is based on comparing the device's technical specifications and intended use against a known predicate device and recognized standards.
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)
Since there is no traditional "test set" or clinical study described in the document, no experts were used to establish ground truth in the context of a clinical validation study. The ground truth for this submission is based on established engineering and safety standards, and the known characteristics of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no clinical "test set" and no human interpretation of data being evaluated, no adjudication method was used. The comparison is based on objective device specifications and regulatory standards.
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 MRMC comparative effectiveness study was done. This document pertains to a medical device (nebulizer compressor) that is not an AI/software device requiring such studies to evaluate a human reader's performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Medic-Aid Porta-Neb is a hardware device (nebulizer compressor), not an algorithm or software requiring standalone performance testing in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance and safety characteristics of the predicate device (DeVilbiss Pulmo-Aide K854520) and compliance with recognized electrical/medical device safety standards (e.g., EN 60601, UL 2601, IEC 601-1, CAN / CSA C22.2 No.60 1.1).
8. The sample size for the training set
Not applicable. This is a hardware device submission, not an AI/ML model needing a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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).