(128 days)
The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.
The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1.
The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.
The provided text describes a Medical Air Compressor and its regulatory clearance, not an AI/ML device. Therefore, many of the requested criteria related to AI/ML device evaluation (such as expert adjudication, MRMC studies, standalone performance, and training/test set details) are not applicable to this document.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a quantitative "acceptance criteria" table in the way one might expect for an AI/ML device that generates specific performance metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with voluntary and international standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| 1. Substantial Equivalence to Predicate Device (Drager Inc. Medical Air Compressor, Model 98, K982789) | - Intended Use: "The intended use of the Independence™ Medical Air Compressor is the same as that for standard, currently marketed medical air compressors." |
- Materials and Design: "The materials and design of this device are similar to those of the predicate device (Drager Inc. Medical Air Compressor, Model 98, K982789)."
- Technical Characteristics: "The technical characteristics of the Independence™ Medical Air Compressor do not introduce new questions regarding safety or effectiveness."
- Labeling: "the labeling associated with the Independence™ Medical Air Compressor provides similar information as the predicate device." |
| 2. Safety and Effectiveness | - Performance Testing: "Performance testing was conducted per internal, company requirements." - Environmental and EMC Testing: "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
- Compliance with Standards: "The Independence™ Compressor device is also compliant with various voluntary and international standards including: IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."
- Overall Conclusion: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." and "In summary eVent Medical Ltd. has demonstrated the Independence™ Medical Air Compressor to be safe and effective." |
| 3. Regulatory Classification | - Classification: Class II per 21 CFR 868.6250, Portable Air Compressor. (Matches predicate and regulatory requirements). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a medical air compressor, "test set" would likely refer to engineering validation and verification tests, not a clinical data set.
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)
This is not applicable as the device is a medical air compressor, not an AI/ML diagnostic tool requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
This is not applicable. The device is an air compressor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a medical air compressor, "ground truth" would be related to engineering specifications and performance metrics. The document states:
- "Performance testing was conducted per internal, company requirements."
- "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
- Compliance with "IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."
Therefore, the "ground truth" or reference standards are the engineering specifications, regulatory guidance documents, and international voluntary standards.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML product that learns from training data.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML product.
§ 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.