(73 days)
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is used primarily to provide a vacuum source for oral, nasal and pulmonary aspiration. The device is used on the order of a physician.
The DeVilbiss Model 6305D Heavy Duty AC Aspirator is an AC powered vacuum pump assembly designed to be used in conjunction with a collection canister to meet the requirements for oral, nasal and pulmonary aspiration.
Here's a breakdown of the acceptance criteria and the study details for the DeVilbiss Model 6305D Heavy Duty AC Aspirator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (DeVilbiss Model 6305D) |
|---|---|
| Maximum Deadhead Vacuum Pressure | 22.0 in. Hg |
| Minimum Free Flow Rate (Air) at STP | 25.0 LPM |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information about a "test set" in the context of a typical AI/software device evaluation. The evaluation is focused on the physical performance of the aspirator, not a diagnostic or AI-driven assessment of patient data. Therefore, the concepts of data provenance (country of origin, retrospective/prospective) are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation is not based on expert-established ground truths for a test set of data. The ground truth for performance is based on direct physical measurements of the device's vacuum pressure and flow rate.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as points 2 and 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it relevant to this type of device. This evaluation pertains to the physical performance of a medical device (an aspirator), not the diagnostic accuracy or human-in-the-loop performance with an AI system. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study was implicitly done, but not in the context of an "algorithm." The device itself (the aspirator) was tested in a standalone manner to measure its physical performance (vacuum pressure and flow rate) against established criteria. This is an "algorithm only" in the most rudimentary sense of the device operating on its own.
7. Type of Ground Truth Used
The ground truth used for this evaluation was direct physical measurements of the device's performance characteristics (maximum deadhead vacuum pressure and minimum free flow rate). These are objective, quantifiable physical properties.
8. Sample Size for the Training Set
There is no concept of a "training set" for this device evaluation. The device is a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
§ 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.