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The Medi-Pump 1615 aspirator is intended to be used to remove bodily fluids from a patient's airway or respiratory system. The aspirator is a prescription device intended for use in the home by professional home healthcare providers and non-professional caregivers.

Device Description

The Medi-Pump is a portable AC powered home use suction pump. The device has been designed, tested and certified to UL 1431. The primary device components include a plastic enclosure, a piston style vacuum pump, a vacuum regulator and gauge, a 1000cc plastic collection jar with overflow valve, an in-line hydrophobic bacterial filter, and a 6' PVC patient tube.

AI/ML Overview

The provided text primarily focuses on the 510(k) summary for the "Medi-Pump Model 1615 Aspirator," a medical device. This document is a regulatory submission to the FDA, and as such, it outlines the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than detailed study results or acceptance criteria in the manner one might find for a diagnostic or AI-driven device.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully answered from this specific document. The information available pertains to the device's performance characteristics as they relate to regulatory standards (UL 1431 and substantial equivalence to a predicate).

Here's an analysis based on the provided text, addressing what can be answered and indicating where information is not available:

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the device's clinical performance, as would be expected for a diagnostic tool. Instead, it focuses on the device's adherence to regulatory and safety standards and its functional characteristics.

Acceptance Criteria Category	Specific Criteria (Implicit from document)	Reported Device Performance
Safety Standard Compliance	Device must meet UL 1431 - Standard for Safety: Personal Hygiene and Health Care Appliances.	"The device has been designed, tested and certified to UL 1431."
"Both models [1615 and predicate 1210] have been tested and certified to UL 1431."
Functional Equivalence	Must function as a portable AC powered home use suction pump for removing bodily fluids from airway/respiratory system.	The Medi-Pump 1615 aspirator is intended for this use.
"In terms of construction, function, safety and effectiveness the Model 1615 is substantially equivalent to the model 1210 which is also a portable AC powered home use suction pump."
Vacuum Performance	(Implicit: Must provide adequate vacuum for aspiration, comparable to predicate).	"the device incorporates a slightly different style vacuum pump which provides a slightly higher vacuum" (This indicates it meets or exceeds the predicate's vacuum performance).
Overload Protection	Must have overload protection.	"is equipped with a single use (fuse) overload protector"
Power Plug Type	(Implicit: Type of power plug, likely for safety and compatibility).	"has a non-polarized power plug"
Design/Appearance	(Implicit: Modern, appealing appearance if design changes are made).	"the housing has been modified to provide a more updated, appealing appearance"
Component Specification	Must include specific components: plastic enclosure, piston style vacuum pump, vacuum regulator/gauge, collection jar, filter, patient tube.	The device description lists all these primary components.

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 available in the provided document. A 510(k) for this type of device typically relies on engineering testing and comparison to a predicate, not clinical trial data with test sets of patients as would be for a diagnostic tool or AI. The "testing" mentioned refers to engineering and safety standard compliance (e.g., UL 1431).

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/available for this type of device and submission. "Ground truth" in the context of clinical expert consensus is not relevant to demonstrating substantial equivalence for a powered suction pump based on engineering tests.

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

This information is not applicable/available for this type of device and submission. Adjudication methods are typically used in clinical studies with human readers/interpreters, which is not the case here.

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/available. This is not an AI-assisted device, and no MRMC comparative effectiveness study is mentioned or relevant to this submission.

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

This information is not applicable/available. This is not an algorithmic or AI device.

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

The concept of "ground truth" as typically applied in diagnostic or AI studies is not directly applicable here. For this device, "ground truth" would be related to meeting established engineering and safety standards (e.g., UL 1431 requirements for vacuum, flow, electrical safety, etc.) and demonstrating functional equivalence to the predicate device. These are objective engineering measurements and comparisons, not clinical "ground truth" derived from patient data.

8. The sample size for the training set

This information is not available and not applicable, as this is not an AI or machine learning device that requires a training set.

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

This information is not available and not applicable, as this is not an AI or machine learning device.

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K Number

K965059

Device Name

CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243)

Manufacturer

THOMAS INDUSTRIES