(5 days)
BREG's Pain Care 3200 has the same intended use as BREG's Pain Care 3000. Both units are intended to provide continuous infusion of a local anesthetic into an intra-operative site for the post-operative management of pain.
The purpose of BREG's Pain Care 3000 and 3200 is to provide a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).
Not Found
Here is an analysis of the provided text regarding the Pain Care 3200 device, focusing on acceptance criteria and a study to prove its performance:
Based on the provided FDA 510(k) clearance letter (K013928) for the Breg Pain Care 3200, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The FDA letter is a substantial equivalence determination, meaning the device (Pain Care 3200) was deemed substantially equivalent to a legally marketed predicate device (Pain Care 3000) for its stated intended use. This type of clearance typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often without requiring new standalone clinical studies against specific performance metrics outlined in your request.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance, not a detailed technical study report.
To directly answer your prompt based on the absence of this information in the provided text:
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A table of acceptance criteria and the reported device performance:
- Not Available: The provided document does not specify quantitative acceptance criteria or report performance metrics from a study for the Pain Care 3200. The clearance is based on substantial equivalence to the Pain Care 3000.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Available: The document does not describe a test set, sample size, or data provenance for performance evaluation.
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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 Available: No ground truth establishment is described in relation to performance testing in this document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Available: No test set or adjudication method is described.
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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 device is an infusion pump, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI would not be relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Available/Not Applicable: The Pain Care 3200 is an infusion pump, a medical device with mechanical and electronic components; it is not an algorithm, so standalone algorithm performance is not relevant. The substantial equivalence determination implies that its performance is equivalent to the predicate without requiring a new "standalone" study in the sense of an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available: As no performance study with a test set is described, no ground truth type is mentioned.
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The sample size for the training set:
- Not Applicable: This is an infusion pump, not a machine learning model, so there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable: There is no training set for this device.
In summary, the provided FDA communication is a regulatory clearance document. While it indicates that the device has been cleared for market based on substantial equivalence, it does not include the detailed technical study information that your questions are looking for regarding acceptance criteria and performance studies. Such information would typically be found in a separate design validation report or a clinical investigation report, which are not part of this 510(k) summary letter.
§ 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).