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The Steripath® Gen2 Blood Collection System is a system to draw blood for in vitro diagnostic testing.

The Steripath® Gen2 Blood Collection is indicated for use as a blood collection system that diverts and sequesters the initial specimen prior to collection of a subsequent test sample to requency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

Additionally, components of the system may be used for infusion following sample collection after disconnection of the Initial Specimen Diversion Device® (ISDD®). Venipuncture needles are indicated for short term infusion (less than 2 hours).

The Steripath® Gen2 Blood Collection System diverts and sequesters the initial portion of the blood specimen (potentially contaminated blood) in the diversion reservoir. When diversion is complete, a subsequent blood sample flows through a second pathway within the device. The subsequent blood sample is collected either directly into a culture bottle (not provided by Magnolia Medical Technologies), or into a syringe that is used to inoculate culture bottles. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs). The subject device incorporates multiple configurations that include various inlet and outlet accessories that are previously cleared as referenced below.

The Steripath® Gen2 Blood Collection System is a single use, sterile, mechanical device that diverts and sequesters the initial 1.5mL to 2.0mL of blood from the patient. The system consists of an Initial Specimen Diversion Device® (ISDD®) made of injection molded, medical grade plastics. Off-the-Shelf (OTS) components provide the interface to the patient vasculature, and to the culture bottle or syringe for subsequent sample collection. Upon removal of the ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use (note: infusion with butterfly needles is limited to less than 2hrs).

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device's performance, structured as requested.

The provided document describes a 510(k) premarket notification for the "Steripath® Gen2 Blood Collection System." This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving enhanced effectiveness through a primary clinical endpoint study as might be required for a PMA. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are geared towards showing functional equivalence, safety, and a reasonable expectation of effectiveness, rather than a direct clinical performance study against a defined clinical endpoint for de novo approval.

The primary claim of effectiveness for the Steripath® Gen2 is its ability to reduce the frequency of blood culture contamination. While clinical studies are summarized, the core of the FDA's acceptance for a 510(k) clearance hinges on functional and performance testing, and the demonstration that the new feature (initial specimen diversion) does not raise new questions of safety or effectiveness.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for the device are largely derived from its functional requirements and safety standards. The reported device performance indicates that the device passed all these verification tests.

1. Table of Acceptance Criteria and the Reported Device Performance:

Study Proving the Device Meets Acceptance Criteria:

The document describes "Functional and Performance Testing" which includes the "Key Functional and Performance Requirements" listed in the table above. It states: "The system meets its functional requirements for safe and effective performance as noted below." All listed verification test results are "PASS."

Additionally, the submission references clinical testing to support the device's efficacy claim regarding contamination reduction, although the document does not explicitly state these clinical results as "acceptance criteria" for the 510(k) clearance itself, but rather as supportive evidence for the indication for use related to contamination reduction. These are presented as summaries of human studies:

No details are given on specific statistical acceptance criteria for these clinical studies within this summary document (e.g., minimum percentage reduction or hypothesis testing results), as the primary focus for a 510(k) is often substantial equivalence based on safety and functional performance.

Additional Information for the Study

The request includes several points typically associated with AI/ML model validation studies. The provided document concerns a mechanical blood collection device and not an AI/ML system. Therefore, many of these points are not applicable or directly addressed in the provided FDA 510(k) summary for a non-AI device. I will address them to the extent possible, noting when a point is not applicable.

2. Sample size used for the test set and the data provenance:

• Functional/Performance Testing (Test Set): The document states "The Steripath® Gen2 Blood Collection System has been found to conform to its System, Labeling, Controls, Interfaces, Accessory, Functional, Physical, Biological Safety and Packaging requirements." and "functional requirements for safe and effective performance." The specific number of devices tested for each functional requirement (e.g., for "Unidirectional movement" or "Actuation force") is not specified in this summary document.
• Clinical Testing (Test Set):
  • Rupp Study: 1,808 total samples, 904 collected using Steripath®.
  • Bell Study: 41,685 total samples, 6,293 collected using Steripath®.
• Data Provenance:
  • Functional/Performance: Implied to be internal testing by Magnolia Medical Technologies, Inc.
  • Clinical: Retrospective or prospective status is not explicitly stated in this summary, but the studies were conducted at U. of Nebraska Medical Center (UNMC) and Lee Health (USA, implicitly, as it's an FDA submission). The Rupp study is identified as a "company sponsored study."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable (N/A) for this device. This pertains typically to AI/ML image analysis, where ground truth often requires expert annotation. For a mechanical blood collection device, "ground truth" for contamination would typically be laboratory culture results, not expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• N/A. Again, this is typically for AI/ML studies involving human reader review. The clinical studies here involve laboratory results (blood culture contamination rates), which inherently establish their 'truth' through a standardized, objective process.

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:

• No, an MRMC study was not done. This is a mechanical device, not an AI assistance tool for human readers. The clinical studies compared the device's performance against standard procedure without manual diversion, effectively comparing a new collection method to an older one, not human reader performance with or without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• N/A. This device does not have an "algorithm only" mode; it is a physical medical device used for blood collection.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For the functional/performance requirements, the "ground truth" is adherence to engineering specifications and relevant standards.
• For the clinical studies, the "ground truth" for contamination reduction would be laboratory blood culture results (positive for contaminants vs. negative), which constitutes clinical outcome data relevant to the device's intended use.

8. The sample size for the training set:

• N/A. As a physical device, there is no "training set" in the context of machine learning. The device design and manufacturing process are developed through engineering and design controls, not data training.

9. How the ground truth for the training set was established:

• N/A. Same reason as above.

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