(155 days)
The VigorMist Compressor is intended to be used with a compatible pneumatic nebulizer (specifically the W estMed V ixOne) t o c onvert c ertain inhalable drugs into an aerosol form for inhalation by a patient for the treatment of asthma, COPD, and other respiratory ailments. The device is intended for the home care market. It is intended for use with a single adult, pediatric, or infant patient.
The VigorMist™ Compressor is a small air compressor designed to provide sufficient air pressure and flow to power a hand held nebulizer. It measures 11 7/8" x 7 1/8" x 4 1/2" and weights 4.6 lbs.
The device has a thermal protector that will automatically shut off the device when overheated. The operating components are located internally. The compressor, some minor wiring and exhaust/intake tubing are located inside .. External components include a switch, filter with housing, AC cord and cover or accessories compartment. The accessories coming with the compressor include a nebulizer, Air tube and mouthpiece.
The provided information for the VigorMist Compressor Nebulizer (K031413) primarily focuses on its intended use, description, and regulatory details for a 510(k) submission. It does not include detailed studies or data proving specific acceptance criteria in the way a modern AI/software device submission would.
Based on the provided text, I can infer some general acceptance criteria for a medical device like this (e.g., performance specifications, biocompatibility, standards conformity), but the document does not present quantitative metrics or specific study designs to demonstrate these.
Here's an attempt to structure the information based on your request, highlighting what is present and what is conspicuously absent:
Acceptance Criteria and Device Performance for VigorMist Compressor Nebulizer (K031413)
The provided 510(k) summary for the VigorMist Compressor Nebulizer (K031413) indicates that the device underwent testing to ensure it met performance specifications and regulatory requirements. However, the document does not present specific quantitative acceptance criteria or detailed results of a study designed to demonstrate performance against those criteria in a format typical for complex AI or diagnostic devices.
Instead, the submission states that "The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications." This indicates that some form of internal validation was conducted, likely against engineering and safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Specifications (e.g., air pressure, flow rate, aerosol conversion efficiency) | "The VigorMist™ successfully completed testing and demonstrates that the product fulfills performance specifications." (No specific numerical values or ranges are provided in this document.) |
| Biocompatibility | Successfully completed. (No details on tests or results.) |
| Standards Conformity | Successfully completed. (No specific standards listed as evidence within this document, though general conformity to medical device regulations is implied by the 510(k) clearance.) |
| Safety (Thermal Protection) | "The device has a thermal protector that will automatically shut off the device when overheated." (This is a design feature, not a direct performance metric with acceptance criteria.) |
Regarding the Study That Proves the Device Meets Acceptance Criteria:
The document refers to "Performance Testing" but does not describe a clinical study or a detailed technical study with the characteristics requested (sample size, ground truth, expert adjudication, etc.). This submission is for a Compressor Nebulizer, a relatively simple electro-mechanical device, and the regulatory pathway in 2003 for such devices generally relied on demonstrating substantial equivalence to predicates through engineering testing and adherence to recognized standards, rather than large-scale clinical trials or AI-specific validation studies.
Here's what can be inferred or explicitly stated from the document in response to your specific questions:
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of what is provided. The document refers to "testing," but it's likely referring to bench testing, engineering validation, and standards conformity for the device hardware itself, not a test set of data like one would use for an AI algorithm.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not relevant to the type of testing described for this device.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance
- MRMC Study: No. This type of study is not relevant for a compressor nebulizer.
- Effect Size of AI Improvement: Not applicable, as there is no AI component mentioned.
6. If a Standalone (Algorithm Only) Performance Study Was Done
- Standalone Study: No. This device is a hardware compressor; it does not contain an algorithm in the sense of a software-based diagnostic or analytical tool.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a compressor nebulizer, "ground truth" would relate to engineering specifications (e.g., precise measurements of air pressure, flow rate, aerosol particle size distribution determined by calibrated instruments, and compliance with safety standards). The document states testing was completed for "biocompatibility, standards conformity," and "performance specifications," indicating these were the basis for demonstrating quality and safety.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
Conclusion:
The provided 510(k) summary for the VigorMist Compressor Nebulizer (K031413) serves as a regulatory document demonstrating substantial equivalence to predicate devices, focusing on the device's design, intended use, and a general statement of successful completion of performance, biocompatibility, and standards conformity testing. It does not contain the detailed study descriptions, quantitative acceptance criteria, or ground truth methodologies that would be expected for a modern AI-powered diagnostic device submission, as it is a mechanical device.
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.