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The Medline Vacu-line Suction Aspirator is a portable, AC-powered device to be used on general patient population excluding neonatal due to pressure range, to supply a vacuum source adequate within the stated operating vacuum range, to aspirate fluids from respiratory airway. Intended use in home care or hospital environments.

Medline Vacu-line Suction Aspirator is an AC powered medical suction aspirator that is intended to remove saliva, thick mucus and other secretions from the patient's airway or respiratory system. The device is intended to be used by healthcare facilities and in homecare. The device is small in size, lightweight and easy to carry allowing it to be portable. The main structure of the suction device includes vacuum pump, vacuum gauge, pressure regulating valve, and is to be used in conjunction with accessories like suction tubing, air filters, and canisters (these accessories are outside the scope of this submission). The Medline Vacu-line Suction Aspirator is a non-sterile device and can be used on multiple patients when following the proper cleaning techniques detailed in the instruction for use, but the accessories are all single patient use and should be disposed of properly and in accordance with their respective instructions for use. The device is a high vacuum/low flow with a vacuum gauge of minimum vacuum range 21.15 ± 4.86 kPa to maximum vacuum range 82.84 ± 1.84 kPa, 2.5 grade and a flow rate of ≥14L/min. The power supply for the device is AC 120 voltage (60Hz) and can be used continuously for up to 30 minutes. The device has a sound level of 66.81 ± 1.37 dB in an open atmosphere and 68.42 ± 0.93 dB in a closed atmosphere. The canister bottles are 850cc, single patient use and disposable. This devices uses an Inline Hydrophobic filter that has a pore size of 0.45 microns; the filter blocks bacteria from entering the vacuum and it will prevent liquid from entering the vacuum pump and tubing.

The document provided describes the Medline Vacu-line Suction Aspirator, a medical device, and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a table format with corresponding results for some parameters, but it provides performance specifications of the proposed device as part of the "Summary of Non-Clinical Testing" and "Summary of Technological Characteristics." I will present these as the de facto acceptance criteria and reported performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size (number of devices tested) for the performance bench testing (Air Flow Rate, Pressure Test, Working Current, Noise Level) or the cleaning validation. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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 section is not applicable as this document relates to the regulatory submission for a medical device (suction aspirator) and the testing performed is non-clinical bench testing, not a study involving human subjects or expert assessment of clinical data to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the same reasons as point 3.

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 section is not applicable. The device is an AC-powered suction aspirator, not an AI-powered diagnostic or imaging device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable, as the device is not an algorithm or AI system. The testing performed was standalone bench testing of the physical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical performance and safety testing, the "ground truth" or reference standards would be:

• Physical measurements: Calibrated instruments and established engineering standards for flow rate, pressure, current, and noise level.
• Observed effect: For cleaning validation, the "ground truth" was the observed lack of degradation in performance or appearance after repeated cleaning cycles.

8. The sample size for the training set

This section is not applicable as there is no mention of a training set. This is a medical device, not an AI/ML model that requires training.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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