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The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.

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The provided text is a Food and Drug Administration (FDA) letter regarding the 510(k) premarket notification for the "GOPump Rapid Recovery System, Disposable Infusion Pump Kit." This document is a regulatory approval letter and does not contain the acceptance criteria or the study details that would demonstrate the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on the regulatory classification and approval process, not on the technical performance studies of the device.

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The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.

The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate. The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.

The provided text describes a 510(k) summary for a Disposable Infusion Pump Kit and does not contain information about an AI/ML-based device. Therefore, I cannot extract the specific details related to acceptance criteria and studies that prove an AI device meets these criteria.

However, I can provide a summary of the device's characteristics and the changes that were submitted for 510(k) clearance, as an example of acceptance criteria and device performance for a traditional medical device:

Device Acceptance Criteria and Performance (Based on Modified Device Information)

The acceptance criteria for the modified Disposable Infusion Pump Kit and its reported performance are primarily based on equivalence to the predicate device K051474, with specific changes outlined below.

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The "acceptance criteria" here are largely defined by the predicate device's established performance and the demonstration that the modified device either maintains that performance for unchanged features or achieves acceptable new performance for modified features within a recognized safety and effectiveness profile.

The study proving the device meets the acceptance criteria is implicitly the 510(k) submission process itself, where Symbios Medical Products, LLC provided data to the FDA to demonstrate substantial equivalence to the predicate device. For the mechanical and material aspects, this would involve engineering testing and verification.

The other points of your request are not applicable as the provided document does not describe an AI/ML-based medical device. There is no information on:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a proset rate for post-operative pain management.

The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and a bandage. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate.
The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification for a "Disposable Infusion Pump Kit," which includes information about its classification, description, and intended use, along with FDA correspondence confirming substantial equivalence to predicate devices.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (like sample size, data provenance, ground truth establishment, expert involvement, or adjudication methods).
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.

The document primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study with quantifiable acceptance criteria.

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