(60 days)
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a device used to remove fluids from airway or respiratory support system and infectious materials from wounds.
The VEGA Medical Suction Equipment, model SU-01/SU-DC01 is a portable AC powered suction pump. It consists of a pump unit, collection bottle, relief valve, vacuum gage, bacteria filter, and suction tube. The device is designed and manufactured to comply with IEC 60601-1. IEC 60601-1-2, and ISO 10079-1.
The provided text describes the 510(k) premarket notification for the "VEGA Medical Suction Equipment, model SU-01/SU-DC01." However, it does not include information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for AI/algorithm-based devices with performance metrics like sensitivity, specificity, etc.
Instead, this submission is for a medical suction pump, which is a hardware device. The "acceptance criteria" and "study" described are about demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards for such hardware.
Here's a breakdown based on the provided text, addressing your points where applicable for this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria for performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, acceptance criteria are inferred from the compliance with international standards and comparison to the predicate device.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Compliance with ISO 10079-1 (Performance) | Manufacturer-conducted Performance Compliance Test according to ISO 10079-1 |
| Compliance with IEC 60601-1 (Electrical Safety) | Accredited laboratory-conducted Electrical Compliance Test according to IEC 60601-1 |
| Compliance with IEC 60601-1-2 (EMC) | Accredited laboratory-conducted EMC Compliance Test according to IEC 60601-1-2 |
| Substantial equivalence in intended use and technological characteristics to predicate device (DeVilbiss Suction Unit K982304) | The device has the same intended use. Differences in operational specifications, power consumption, outlook, dimensions, weight, and mode of operation "do not affect the intended use or alter the fundamental scientific technology." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) submission for a medical suction pump. The "tests" mentioned are compliance tests against engineering standards, not performance evaluations on a patient "test set" with data in the way AI/software devices are evaluated.
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 information is not applicable. Ground truth, as typically discussed for medical AI/imaging, is not relevant for the compliance testing of a hardware medical suction pump. Compliance is against defined engineering standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used in scenarios where human interpretation or consensus is required to establish ground truth from complex medical data (e.g., images, clinical records). This is not the case for a hardware device's compliance testing.
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 information is not applicable. This type of study investigates the impact of AI on human reader performance, which is not relevant for a standalone medical suction device. The submission explicitly states: "No particular Clinical Test was conducted for VEGA Medical Suction Equipment."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical medical suction equipment, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The "truth" for this device's evaluation is compliance with established engineering and safety standards (ISO 10079-1, IEC 60601-1, IEC 60601-1-2) and demonstration of substantial equivalence to a predicate device based on its design and specifications.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth to establish 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.