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510(k) Data Aggregation
(170 days)
The Aprima Smartesis™ Centesis Pump is a motorized pump to be used in conjunction with the appropriate disposable Aprima Smartesis TM Centesis Collection Tray for paracentesis drainage procedures.
The Aprima Smartesis "11 Centesis Pump is a portable, reusable peristaltic suction pump designed for paracentesis procedure in a manner that is both rapid and convenient. The Aprima Pump is comprised of one pump, one power cord, and operating instructions. The Aprima Pump employs peristaltic pump technology to provide displacement of fluid through the centesis tubing set, a component of the Aprima Smartesis Centesis Trav. Operation of the Aprima Pump is initiated with a control knob on the front panel. The Aprima Pump is equipped with a variable speed control of the rollers, thus allowing the operator to control the rate at which the fluid is withdrawn from the patient.
The Aprima Pump is to be used with the Aprima Smartesis Collection Tray only, which includes the needle for access to the abdominal cavity and the connecting tube with attached drainage bags for removal of the fluid during treatment. The Aprima Smartesis™ Centesis Collection Tray and Bags are not included with the Aprima Pump and are packaged and sold individually. No tools are required to load or to remove the tubing and drainage bags.
The provided document is a 510(k) premarket notification for the Aprima Smartesis Centesis Pump, a medical device. This type of document is primarily focused on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI device would.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (sensitivity, specificity, reader improvement, etc.) is not present for this device. The document focuses on engineering and performance testing to ensure safety and functionality compared to a predicate, not diagnostic accuracy or effectiveness in direct patient outcomes.
However, I can extract information related to the engineering and performance tests that were conducted and their acceptance criteria, as well as the design inputs for the device.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes several tests conducted to ensure reliable design and performance, and for each, it states that "The predetermined acceptance criterion was met." However, the specific quantitative acceptance criteria themselves are generally not detailed beyond these statements.
| Test Category | Specific Test | Acceptance Criteria (Stated in Document) | Reported Device Performance (Stated in Document) |
|---|---|---|---|
| Electrical Safety | IEC 60101-1 (General requirements for basic safety and essential performance) tests | Compliance with IEC 60101-1 (includes Leakage Currents, Dielectric Strength, Creepage Distances, Spillage, Push, Impact, Drop, Grip/handle Strength, Movable Guards, Audible Acoustic Energy, Maximum Temperature during Normal Use, Instability, Firmware Verification). | "The UL certificate shows that the Aprima Pump complies with the requirements of IEC 60101-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance." (Tests covered by UL certificate include: Leakage Currents Test, Dielectric Strength Test, Creepage Distances Test, Spillage Test, Push Test, Impact Test, Drop Test, Grip/handle Strength Test, Movable Guards Test, Audible Acoustic Energy Test, Maximum Temperature Test during Normal Use, Instability Test, Firmware Verification) |
| EMC | IEC 60101-1-2 (Electromagnetic disturbances - Requirements and tests) tests | Conformance to IEC 60101-1-2 (includes Harmonic Current Emission, Voltage Fluctuations and Flicker, Power Line Conducted Emissions and Radiated Emissions, Electrostatic Discharge Immunity, Electrical Field Radiated Immunity, Electrical Fast Transient/Burst Immunity, Surge Immunity, Conducted Immunity, Magnetic Field Immunity, Voltage Dips, Short Interruptions and Voltage Variations Immunity). | "Electromagnetic Compatibility Testing was performed to show the device conforms to the requirements of IEC 60101-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests." (Includes: Harmonic Current Emission, Voltage Fluctuations and Flicker, Power Line Conducted Emissions and Radiated Emissions, Electrostatic Discharge Immunity, Electrical Field Radiated Immunity, Electrical Fast Transient/Burst Immunity, Surge Immunity, Conducted Immunity, Magnetic Field Immunity, Voltage Dips, Short Interruptions and Voltage Variations Immunity) |
| Performance Testing | Simulated Use | "Predetermined acceptance criteria for this study were met." (Implied: users could successfully perform the centesis procedure in accordance with intended use). | "All users were able to use provided components to successfully perform the centesis procedure in accordance with the intended use statement and the predetermined acceptance criteria for this study were met." |
| Characterization of Flowrate and Pressure at Different Speed Settings | (Not explicitly stated, but implied to be comparable to predicate or within design spec). | "Testing was performed to characterize the flowrate and pressure for the proposed pump and the predicate pump." (No specific results or comparison values provided in the summary). | |
| Life Cycle Cleaning Test | "Did not exhibit degradation of electrical safety after the simulation of 1 year life cycle of cleaning." | "The predetermined acceptance criterion was met." | |
| Wipe Test of Various Labels | "Pump labeling shall be legible after the required number of cleaning cycles." | "The predetermined acceptance criterion was met." | |
| Aprima Smartesis™ Centesis Pump Distribution Testing | "Pump functions correctly without visible damage before and after distribution cycle testing in packaging." | "The predetermined acceptance criterion was met." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided summary for any of the performance tests (e.g., number of users for simulated use, number of cleaning cycles for life cycle test, number of distribution tests).
- Data Provenance: The tests were conducted internally by Cook Incorporated or by a certified third party (UL certificate implies a third-party evaluation). The data is from prospective testing of the device, not from a retrospective clinical dataset. Country of origin of the data is not explicitly stated beyond Cook Incorporated being located in Indiana, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable to this device's testing. The "ground truth" for these engineering and performance tests is compliance with international standards (IEC) and functional specifications, not clinical diagnostic accuracy requiring expert interpretation. For the "Simulated Use" test, it states "All users were able to use provided components to successfully perform the centesis procedure," implying user feedback rather than expert ground truth establishment for a diagnostic output.
4. Adjudication method
Not applicable. This device is a pump, not an AI diagnostic tool requiring adjudication of results from multiple readers.
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
Not applicable. This document is for a medical device (a pump), not an AI diagnostic algorithm or an AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical pump, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's testing is primarily compliance with established international safety and performance standards (IEC 60101-1, IEC 60101-1-2) and design specifications (e.g., proper function after cleaning, legibility of labels, integrity after distribution, and ability to perform the intended procedure in simulated use).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set in the context of AI/ML.
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