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The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomitous or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.

The device uses conventional technology to provide medical suction. The mechanical portion of the aspirator consists of an electrically driven pump to provide suction, a gauge to indicate the suction level and a regulator to control the suction level.

Here's an analysis of the provided text regarding the acceptance criteria and study for the care-e-vac 3 device:

Based on the provided information, the care-e-vac 3 is a medical suction device, and its 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Care-E-Vac II) rather than presenting a detailed clinical study with specific performance metrics against an acceptance criterion in the way a diagnostic device might.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted as they are not applicable to this type of submission.

Here's what can be inferred and stated based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

   • Not Applicable. The submission describes a "Test Summary" indicating compliance with voluntary standards, but it does not mention a clinical study with a test set of patient data. The evaluation appears to be based on technical performance and comparison to a predicate device, likely through engineering testing rather than clinical data.

2. 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)

   • Not Applicable. No ground truth for a clinical test set is mentioned, as there is no described clinical study in this context.

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

   • Not Applicable. No clinical test set or adjudication method is described.

4. 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

   • No such study was done. This device is a mechanical medical suction device, not an AI-powered diagnostic or assistive technology for human readers.

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

   • Not Applicable. This is a mechanical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not Applicable. For this type of device and submission, the "ground truth" for performance would be adherence to engineering specifications and equivalence to the predicate device's established performance, rather than clinical outcomes or diagnostic accuracy.

7. The sample size for the training set

   • Not Applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

   • Not Applicable. There is no mention of a training set.

Summary of the nature of the study presented:

The information primarily describes a 510(k) submission for a Class II medical device (portable aspirator) that uses substantial equivalence as its regulatory pathway. The "study" mentioned is a "Test Summary" indicating that the device "complies with the voluntary standards" and that "The results of these measurements demonstrated that the care-e-vac 3 is as safe, as effective, and performs as well as the predicate device." This suggests engineering and performance testing against agreed-upon standards and direct comparison with the predicate device, rather than a clinical trial involving patient data and statistical metrics typically used for diagnostic or therapeutic efficacy claims.

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