(319 days)
The Harvard Library is intended to provide a vehicle to create and download a library of drug names and parameters to the Harvard 2 Syringe Pump. It is designed to lessen the likelihood of operator errors when entering drug information into the Harvard 2 Syringe Pump.
The Harvard Library is a computer program which runs on MSDOS based personal computers under Microsoft Windows V3.1 or higher.
This document refers to the Harvard Library computer program, designed to create and download drug libraries to the Harvard 2 Syringe Pump to reduce operator errors. The document is a 510(k) summary, which typically does not include detailed study results or acceptance criteria in the format requested. Therefore, much of the requested information cannot be extracted directly from the provided text.
Based on the provided text, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria or provide specific performance metrics in a table format. The intended use focuses on "lessen[ing] the likelihood of operator errors," implying that the performance would be measured by a reduction in such errors. However, there are no reported numbers for this.
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 provided in the 510(k) summary.
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 provided in the 510(k) summary. As it's a software for drug library management, "experts" in the context of ground truth would likely be pharmacists or clinicians knowledgeable in drug administration and error prevention.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the 510(k) summary.
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 is not applicable as the Harvard Library is not an AI-assisted diagnostic tool involving human readers or interpretation of medical images. It's a software for reducing data entry errors. There is no mention of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "computer program" that "creates and downloads" data. Its intended function is to work with a human operator using the syringe pump to reduce errors during data entry. Therefore, a purely standalone performance without any human interaction would likely not be the primary focus for evaluating its intended use. Any evaluation would inherently involve the human-in-the-loop interacting with the software to demonstrate its ability to reduce errors. However, the document does not specify any study design.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not specify the type of ground truth used. For a device intended to reduce operator errors during drug information entry, ground truth would likely involve:
- Correct drug names and parameters for a given set of drugs.
- Correctly entered data into the Harvard 2 Syringe Pump by operators, compared against the intended drug information.
- Assessment of whether the "Library" effectively prevented common types of data entry errors.
8. The sample size for the training set:
This information is not provided in the 510(k) summary.
9. How the ground truth for the training set was established:
This information is not provided in the 510(k) summary.
Summary of Device and Regulatory Status:
- Device Name: Harvard Library
- Common Name: Computer Program
- Classification Name: Infusion Pump (though the device itself is software for an infusion pump)
- Intended Use: To create and download a library of drug names and parameters to the Harvard 2 Syringe Pump, designed to lessen the likelihood of operator errors when entering drug information.
- Technological Characteristics: Computer program running on MS-DOS based personal computers under Microsoft Windows V3.1 or higher.
- Predicate Devices: Shasta Logic - Clinicalc, A Mixed Bag Corp - Infusion Calculator, Harvard Apparatus - Harvard 2 Syringe Pump.
- Regulatory Status: The FDA determined the device to be substantially equivalent to predicate devices, allowing it to be marketed under general controls provisions.
The provided document is primarily a regulatory notification (510(k) summary) for market clearance, focusing on substantial equivalence and intended use. Detailed study designs, acceptance criteria with specific performance metrics, and in-depth clinical validation data are typically not fully elaborated in these summary documents, but would have been part of the full 510(k) submission.
§ 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).