(288 days)
The "IDA-2 PLUS" is a self reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.
The "IDA-2 PLUS" is a self reading calibrated burette which measures the volume of fluid flowing from an infusion device into the instrument. Flow rates from 1 to 1000 mL per hour can be administered. This device is designed to be used by manufacturers, biomedical engineering departments in hospitals and third party service organizations to verify the accurate performance of infusion devices that operate in the range stated above. A wide range of infusion devices can be analyzed including: syringe, drop counting, peristaltic, and volumetric types. Non steady flow rate pumps can also be analyzed. The device is designed to operate using water or saline.
Operational modes: The IDA-2 Plus will offer two modes of operation; stand alone and computer control. The computer control mode will allow the user to operate the device from an external program. All possible tests available in the stand alone mode will be available in the computer control mode. The computer control mode allows for a graphical display of data, found to be useful in troubleshooting a faulty drive mechanism in the infusion device under test.
Reading Speed: The device can operate in the Steady Flow Mode, which will give a time to first reading of 6 minutes at 1 mL/hr and 25 seconds at rates above 100ml/hr. In the Non-Steady & High Accuracy Flow Mode it will depend on the time to deliver 1 mL of fluid.
Occlusion Pressure Range: The IDA-2 Plus features a pressure transducer that is operational in the range of 0 to 34.8 psi. It has the ability to display the pressure value in psi or mm Hg. A print out is also available.
Volume Measurement: This feature displays the volume delivered into the IDA-2 Plus. Instantaneous/ Average Flow: This feature displays either the instantaneous or average flows through the device.
External communication links: The device uses a Centronics standard parallel interface that is Epson compatible. The printer can be set to print immediately after determining a rate or at intervals of 5 minutes or 1 hour. The serial RS232 port is used for computer control and is set at 2400 baud, using 8 databits, 1 stop bit and no parity.
Data reduction software: "Graphics Capture Program " This feature of the device allows the user to acquire and continuously graph the flow rate, volume and occlusion pressure from a separate computer. Numerical values for average flow rate, instantaneous flow rate and derived volume can be displayed for any instant along the time axis. The user has the option to erase, print or save the acquired data for future review and statistical evaluation.
The provided text describes a medical device called "IDA-2 Plus", an infusion pump analyzer. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and a study proving device performance.
Here's an analysis of what is available and what is missing:
1. A table of acceptance criteria and the reported device performance
The document mentions that the IDA-2 Plus "was extensively verified and validated to be working per the design and published specifications" and "meets its marketing specifications". It briefly lists some operational ranges and features, which could be interpreted as performance specifications, but it does not provide a formal table of acceptance criteria with corresponding reported performance values from a specific study.
Available Performance-Related Information (interpreted as potential specifications/performance):
| Feature/Specification | Reported Device Performance (Implied) |
|---|---|
| Flow Rate Measurement | 1 to 1000 mL/hr |
| Reading Speed (Steady Flow, 1 mL/hr) | 6 minutes to first reading |
| Reading Speed (Steady Flow, >100 mL/hr) | 25 seconds to first reading |
| Reading Speed (Non-Steady & High Accuracy) | Depends on time to deliver 1 mL of fluid |
| Occlusion Pressure Range | 0 to 34.8 psi |
| Pressure Display | psi or mm Hg |
| Data Output (Printer) | Immediate, 5-minute intervals, or 1-hour intervals |
| Communication (Serial RS232) | 2400 baud, 8 databits, 1 stop bit, no parity |
| Air-in-line detection | Utilized, with error messages (in Non-Steady & Higher Accuracy Mode) |
| Valve blockage detection | Error message displayed and printed if outside range |
Missing: Specific, quantifiable acceptance criteria (e.g., "Accuracy of flow rate measurement shall be +/- X%") and the actual test results demonstrating compliance with these precise criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document states "extensively verified and validated" but provides no details on sample size for testing or data provenance.
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)
Not applicable. This device is an analyzer for infusion pumps, not a diagnostic tool requiring expert interpretation of medical images or patient data. Its "ground truth" would likely be based on calibrated reference instruments and known fluid dynamics, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, this doesn't involve subjective interpretation that would require adjudication.
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 is not a diagnostic AI system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device can operate in "stand alone" mode, which implies it performs its analysis without continuous human intervention during the measurement process. The "computer control mode" would allow external programming, but the core measurement is likely standalone. However, the document does not describe a "standalone study" in the context of an algorithm's performance. It just describes modes of operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Implied: The "ground truth" for verifying this device's performance would be established through calibrated reference standards and known physical principles of fluid flow and pressure. For instance, a known, highly accurate flow generator would be used to supply fluid, and the IDA-2 Plus's measurements would be compared against that known input.
8. The sample size for the training set
Not applicable. This device is an analyzer, not an AI/ML model that requires a training set of data in the typical sense. It operates based on its internal sensing and measurement algorithms.
9. How the ground truth for the training set was established
Not applicable. As above.
In summary, the provided text is a 510(k) summary for a medical device (an infusion pump analyzer). It focuses on the device's description, intended use, operational features, safety considerations, and similarity to predicate devices. It states that verification and validation were performed to meet design specifications, but it completely lacks the specific details of these studies that your questions are asking for, especially regarding acceptance criteria tables, sample sizes, and detailed ground truth establishment methods typical for AI/ML or diagnostic device studies.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).