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The Aspire Aspirator G is a piston syringe to inject fluids into, or aspirate fluids from, the body.

The Subject Device is a single-use, hand-held, and general-purpose aspirator configured with a barrel, plunger, and handles. The front handle is pivotally connected the back handle and distally connected to the barrel. The back handle is pivotally connected to the front handle and distally connected to the plunger. Squeezing the handles creates a mechanical advantage to move the plunger inside the barrel. The handle design also prevents the plunger from being pulled completely out of the barrel during use. The main difference between the Subject Device and the Predicate is the addition of a basic off-the-shelf pressure gauge and change from a one-piece to two-piece button between the handles.

Here's a breakdown of the acceptance criteria and study information for the Aspire Mechanical Aspirator G based on the provided FDA 510(k) summary:

The document describes non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study of AI performance. Therefore, many of the requested categories related to AI performance, human readers, and ground truth establishment (which are typically relevant for AI/ML device submissions) are not applicable here.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by confirming the Subject Device performs the same as the Predicate device across various bench tests. The reported performance is that the Subject Device confirms to these tests.

Study Details (Non-Clinical Bench Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided document. The tests listed are standard for medical devices of this type and would typically involve a statistically relevant number of units, but the specific quantity is not given.
   • Data Provenance: Not applicable as this is bench testing of physical device performance, not data-driven AI. The tests confirm manufacturing standards and device functionality.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. This is a physical device, and performance is measured against established engineering standards (e.g., ISO, ASTM, MIL-STD) and predicate device performance, not expert human interpretation.

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

   • Not applicable. This is objective bench testing against measurable standards, not subjective human assessment requiring adjudication.

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. This is a mechanical aspirator, a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical device; there is no algorithm or AI component. The "standalone" performance here refers to the device itself operating according to its design specifications.

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

   • The "ground truth" for this type of device is defined by engineering specifications and recognized industry standards (e.g., ISO, ASTM, MIL-STD) for performance characteristics like leakage, force, and sterilization efficacy. The predicate device's established performance also serves as a benchmark for equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device requiring a training set.

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

   • Not applicable, as there is no training set for an AI/ML model.

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