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A single use, disposable, blood administration set with pressure pump and blood filter used to deliver blood/blood products rapidly through use of the pressure pump and/or gravity flow.

The Blood Hand Pump Administration Set is a single use, disposable, gravity blood set with a blood filter and hand pressure pump. The addition of the hand pressure pump provides the capability for delivering blood/blood products more rapidly by compressing the pump by hand.

The provided document is a 510(k) summary for a medical device (Blood Hand Pump Set) and is not a study. Therefore, it does not contain detailed information about acceptance criteria, specific performance metrics, sample sizes, or ground truth establishment typically found in a scientific study.

The document indicates that the device's substantial equivalence was determined based on its "technological characteristics" and "performance data" indicating it "meets specified requirements." However, it does not specify what those requirements are or how the performance data was generated beyond a general statement.

Here's an analysis based on the information available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The flow rate for hand pump compression administration "may be as much as twice that of gravity flow." (This is a characteristic, not a performance metric against a specific criterion). |

Missing Information:

• Specific quantitative acceptance criteria (e.g., minimum flow rate, pressure limits, material biocompatibility, sterility) are not provided.
• Actual measured performance values against these criteria are not given.

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

Missing Information:

• Sample Size: Not reported. The document does not describe any specific "test set" of data or how it was generated.
• Data Provenance: Not reported. It's unclear if any testing involved human subjects or was entirely bench testing, and if so, where it took place (country of origin). The document refers to "performance data" generally.
• Retrospective/Prospective: Not specified.

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

Missing Information:

• Not applicable. This type of device (blood administration set) does not typically involve "ground truth" derived from expert image interpretation or clinical diagnosis in the way an AI diagnostic device would. Its performance is assessed through engineering and biocompatibility testing. The "ground truth" for a device like this would be engineering specifications and safety standards.

4. Adjudication Method for the Test Set

Missing Information:

• Not applicable for this type of device and submission.

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

Missing Information:

• Not applicable. This is a medical device for fluid administration, not an AI-assisted diagnostic tool for human readers. No human interpretation is involved.

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

Missing Information:

• Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical design and materials.

7. Type of Ground Truth Used

Missing Information:

• The document implies that the ground truth/basis for evaluation was adherence to engineering specifications, safety standards, and equivalence to predicate devices. It does not mention pathology, outcomes data, or expert consensus in a clinical sense for performance evaluation.

8. Sample Size for the Training Set

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Missing Information:

• Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.

In summary: The provided 510(k) summary is a regulatory document demonstrating substantial equivalence, not a detailed scientific study. It focuses on comparing the new device's technological characteristics and overall performance to already cleared predicate devices rather than presenting detailed raw data, specific acceptance criteria values, sample sizes, or methodologies of internal validation tests. For medical devices like this, performance data typically refers to results from bench testing (e.g., flow rate tests, pressure resistance, sterility testing, material compatibility) and not clinical trial data involving "ground truth" from experts for diagnostic purposes.

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