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Hospira infusion sets are intended for the delivery of fluids, including but not limited to, blood and blood products, from a container to a patient's vascular system.

The Hospira PVC Infusion Blood Sets with/without the Manual blood pump consists of Non-DEHP PVC tubing and components previously cleared in Hospira 510k's. The change addressed in this submission, is the material used to construct the cylindrical blood pump. The modified design incorporates a ball check valve previously used in the bulb style manual blood pump. Other changes include minor dimensional and geometric changes.

The document is a 510(k) summary for the Hospira Infusion Blood Sets. It details the device's characteristics, intended use, and substantial equivalence to previously marketed devices. The study conducted to prove the device meets acceptance criteria is a series of non-clinical, bench performance tests.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document indicates "Pass" for all tests, implying that "Pass" is the acceptance criterion for each individual test.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each individual performance test (e.g., number of devices tested for biocompatibility, sterility, etc.). It only mentions that the "Hospira Blood administration sets... passed all specified test requirements."

The data provenance is retrospective, as these are bench tests conducted to demonstrate compliance with standards and substantial equivalence for a 510(k) submission. The country of origin of the data is not specified, but the submitter information lists Hospira Incorporated in Lake Forest, Illinois, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a medical device (infusion blood set), and the ground truth for its performance is established through internationally recognized engineering and scientific standards (ISO standards) and internal quality control testing, not through expert consensus on diagnostic images or other subjective assessments. The results are objective measurements against predefined criteria.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance is assessed against objective engineering and scientific standards, not through a process requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic tools to assess how AI assistance impacts human reader performance. The Hospira Infusion Blood Set is a physical medical device, not a diagnostic algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical medical device, not an algorithm. Its performance is inherent to the device's physical and material properties.

7. Type of Ground Truth Used

The ground truth used for this study is based on objective measurements and assessments against established international and industry standards. For example, biocompatibility is evaluated against ISO 10993 series, sterility against ISO 11137-2, and connection compatibility against ISO 594-2. The "ground truth" is that the device physically meets these engineering and safety specifications.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The "study" here refers to non-clinical bench testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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