(144 days)
The IMPACT® Model 323 Aspirator is a self-contained suction apparatus designed for use in removing debris from a patient's airway or respiratory system, secretions, blood, vomitus, surgical fluids, tissue (including bone), bodily fluids and infectious materials from wounds, either during surgery or at the patient's bedside. It is suitable for use in pre-hospital, hospital, mass casualty and transport environments. The Model 323 is only for use by or on the order of a physician.
The IMPACT® Model 323 Aspirator is a completely self-contained suction source. It is lightweight, compact, easy to use and is easy to clean. It features a vacuum gauge, integral mounting hardware, power switch, rechargeable batteries, adjustable vacuum regulator, 800 cc collection container, integral carry handle, and convenient stowage of the container holders. The device is housed within an injection molded plastic case.
The provided text describes a 510(k) submission for the IMPACT® Model 323 Aspirator, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with AI components or human-in-the-loop performance measurement. Therefore, much of the requested information regarding acceptance criteria derived from AI performance metrics, sample sizes for AI training/test sets, expert adjudication methods, and MRMC studies, is not applicable to this document.
However, the document does specify performance criteria related to the device's functional integrity and safety.
Here's a breakdown of the information available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conforms to IEC 60601-1 (3rd Edition - Corrigendum 2) | Conforms to IEC 60601-1 (3rd Edition - Corrigendum 2) |
| EMC Requirements | Conforms to IEC 60601-1-2:2007 | Conforms to IEC 60601-1-2:2007 |
| General Performance | Conforms to FDA's Guidance - "Guidance Document for Powered Suction Pump 510(k)s" (September 30, 1998) | Conforms to FDA's Guidance - "Guidance Document for Powered Suction Pump 510(k)s" (September 30, 1998) |
| Specific Performance | Conforms to EN ISO 10079-1:2009 | Conforms to EN ISO 10079-1:2009 |
| Human Factors/Usability | Conforms to FDA's Guidance on Human Factors and Usability Engineering | Conforms to FDA's Guidance on Human Factors and Usability Engineering |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission details the premarket notification for a physical medical device, not a software or AI-driven diagnostic/prognostic tool. The "test set" in this context refers to bench testing performed on the device itself, not a dataset of patient information for AI evaluation. The document does not specify the number of units tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth in the context of AI models (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by its compliance with international standards and FDA guidance through bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically for resolving discrepancies in human expert labeling for AI training/testing, which is not relevant to this device's evaluation.
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. MRMC studies are used to evaluate diagnostic imaging systems, particularly in the context of AI assistance for human readers. This document is for a suction aspirator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for the device's performance is compliance with established international and national technical standards and regulatory guidance documents (e.g., IEC 60601-1, IEC 60601-1-2:2007, EN ISO 10079-1:2009, FDA Guidance for Powered Suction Pump 510(k)s, FDA Guidance on Human Factors and Usability Engineering). This compliance is typically verified through various forms of engineering and functional bench testing.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning product and therefore does not have 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 it.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.