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The Nipro Surefuser Ambulatory Balloon Infuser is intended for continuous and accurate infusion of medications at a predetermined flow rate. Routes of administration include intra-arterial, intravenous, percutaneous, subcutaneous, and epidural. An elastomeric reservoir is used eliminating the need for electrical power. The device is designed for single use in hospital, outpatient, and home care settings.

The subject device can be classified as a balloon (elastomeric) infusion pump as described in 21 CFR 880.5725. The following models are included: 50, 100, and 250 ml.

The provided text describes a 510(k) premarket notification for the Nipro Surefuser Ambulatory Balloon Infuser. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI.

Therefore, the information requested about acceptance criteria, specific device performance numbers, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details are not available in the provided text because this type of information is typically part of a detailed clinical or performance study, not a 510(k) summary for a substantially equivalent device like a balloon infusion pump.

The 510(k) summary states generalized findings. Here's what can be extracted based on the document's content:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not specified. The document refers to "Performance (functional), biocompatibility, and appearance tests" but does not detail the methodologies, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective nature) of these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" concept does not apply to the type of device and testing described in this 510(k) summary, which is focused on demonstrating mechanical and biocompatibility functionality and substantial equivalence.

4. Adjudication method for the test set: Not applicable. No clinical study requiring adjudication of expert opinions is described.

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 an AI/imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/imaging device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" concept doesn't align with the tests described. The "truth" would be the device meeting pre-defined engineering and safety specifications.

8. The sample size for the training set: Not applicable. This is not an AI/imaging device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/imaging device.

Study Summarized:

The study referenced in the document is the 510(k) premarket notification (K051828) for the Nipro Surefuser Ambulatory Balloon Infuser. This is not a traditional clinical study but rather a regulatory submission demonstrating substantial equivalence to a predicate device.

• Purpose: To demonstrate that the Nipro Surefuser Ambulatory Balloon Infuser is as safe and effective as a legally marketed predicate device (Infusor LV, K011317).
• Methodology (as described in the summary): Comparison of technical characteristics (materials, design, technological characteristics), and unspecified "Performance (functional), biocompatibility, and appearance tests."
• Conclusion: The tests demonstrated the subject devices perform as intended, are safe and suitable for human use, and are substantially equivalent to similar legally marketed devices. The FDA concurred with this assessment.

In essence, the "study" is the entirety of the 510(k) submission process, which includes testing and comparison documentation to satisfy regulatory requirements for market clearance, not an in-depth clinical trial with measurable performance statistics against a clinical gold standard.

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