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

The Steripath® Flow™ Blood Collection System 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 reduce the frequency 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®).

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

The Steripath® Micro Blood Collection System 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 reduce the frequency of blood culture contamination when contaminants are present in the initial blood cultures drawn with standard procedure without manual diversion.

Additionally, components of the system may be used for infusion following sample collection after discomection of the Initial Specimen Diversion Device® (ISDD®).

The device, Steripath® Micro Blood Collection System, is a system to draw blood for in vitro diagnostic testing. The purpose of this submission is to expand the product line to include inlet components with the BD Venipuncture® UltraTouch™ Push Button Needle, outlet components with a transfer adapter, and universal models with no inlet component.

The Steripath® Micro Blood Collection System 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 reduce the frequency of blood culture contamination when contaminants are present in the initial blood sample compared to blood cultures drawn with standard procedure without manual diversion.

The device sequesters and diverts 0.5 - 1.0 mL of the initial specimen of blood (potentially contaminated) into a diversion chamber. Once diversion is complete, a subsequent blood sample flows through a second pathway within the device and 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. Additionally, components of the system may be used for infusion after disconnection of the Initial Specimen Diversion Device® (ISDD®).

The Steripath® Micro Blood Collection System, needle configurations, for the subject device are manufactured using non-sterile BD UltraTouch® needles, which are equivalent to the commercially available BD UltraTouch® Push Button™ Blood Collection Set (K212724), except for the sterilization step. The Steripath® Micro Blood Collection System and UltraTouch® needles have the same intended use. Incorporation of the needle with the ISDD® functions on the same technological characteristics and principles of operation with the difference that the subject device leverages the Initial Specimen Diversion Technology® (ISDT) and mechanically sequesters the initial specimen of blood. Inclusion of this technology does not raise any added questions of safety or effectiveness.

The different configurations of the Steripath® Micro Blood Collection System are made available by using different combinations of the inlet and outlet accessories. Proposed configurations are listed in Table 5.1.

The provided text describes a medical device, the Steripath® Micro Blood Collection System, and its 510(k) premarket notification for substantial equivalence to a predicate device. The information details the device's characteristics and various types of testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample sizes used for the individual performance tests (sequestration, vacuum, diversion volume, etc.). It describes the types of tests performed (e.g., Sterilization, Aging/Shelf-Life, Biocompatibility, Packaging Integrity, and Performance Testing) and states that "all design verification and validation activities were performed."

The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective data. The testing appears to be primarily laboratory-based engineering and performance verification testing rather than large-scale clinical studies.

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

This information is not provided in the text. The type of testing described (e.g., sterilization, biocompatibility, mechanical performance) typically relies on established standards and laboratory protocols rather than human expert interpretation for "ground truth" in the way a diagnostic imaging study would.

4. Adjudication Method for the Test Set

This information is not applicable or not provided. Since the testing focuses on objective mechanical and biological properties against established standards, an adjudication method for conflicting expert opinions is not relevant in the context of the described tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on device characteristics and performance verification for substantial equivalence, not comparative effectiveness of human readers with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this device is a physical medical device (blood collection system), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.

7. The Type of Ground Truth Used

The ground truth used for the device's performance is based on established industry standards and engineering specifications for medical devices. For example:

• Sterilization: Standards like ISO 11137-1.
• Aging/Shelf-Life: Standards like ASTM F1980-16.
• Biocompatibility: Standards like ISO 10993-1.
• Packaging: Standards like ASTM D4169-16.
• Functional requirements (e.g., diversion volume, vacuum performance) are based on the device's design specifications.

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a training set. Therefore, this information is not applicable.

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

This device is not an AI/ML algorithm. Therefore, this information is not applicable.

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

The Steripath® Micro Blood Collection System 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 reduce the frequency 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®).

The Steripath® Micro 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 into a syringe that is used to inoculate culture bottles. Upon removal of the Initial Specimen Diversion Device®, ISDD®, components of the system can be used for infusion per the included manufacturer's instructions for use.

The subject device incorporates multiple syringe oulet accessory configurations that include and three sizes of syringes that are previously cleared as referenced below. The Steripath® Micro Blood Collection System are available:

The provided document is a 510(k) summary for the Steripath® Micro Blood Collection System (K200661). It details the device's indications for use, technology, comparison to a predicate device, and performance testing. However, it does not contain specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy, or contamination rates), sample sizes for test sets, data provenance, information about expert ground truth, adjudication methods, MRMC study details, or standalone performance metrics for the aspects related to the "acceptance criteria and study that proves the device meets the acceptance criteria" as requested in the prompt.

The "Summary of Performance Testing" section lists some requirements and states "PASS" for each, but this is a high-level summary and doesn't provide the detailed numbers, methodologies, or study specifics that would typically characterize a study proving device performance against acceptance criteria. It primarily focuses on comparing the new device to its predicate and ensuring it meets safety and functionality standards.

Therefore, many aspects of your request cannot be fulfilled by the provided document.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions several requirements and functional tests:

• Sequestration
• Minimum Vacuum performance
• Maximum Vacuum performance
• Diversion Volume
• Positive Pressure Maximum

For each of these, the "Verification Test Result" is reported as "PASS". However, the actual acceptance criteria (e.g., minimum percentage of sequestration, specific vacuum pressure ranges, specific diversion volume ranges) are not detailed in this document. The "PASS" result indicates the device met unstated criteria.

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

• Sample Size: Not specified for the listed performance tests.
• Data Provenance: Not specified.

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

• Not applicable/Not provided. The performance tests described (e.g., sequestration, vacuum performance) are technical/engineering tests, not clinical evaluations requiring expert interpretation of ground truth in the context of diagnostic accuracy.

4. Adjudication method for the test set:

• Not applicable/Not provided. These are technical tests, not diagnostic interpretations.

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 device is a blood collection system, not an AI diagnostic device that assists human readers.

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

• Not applicable. This device is a mechanical blood collection system, not an algorithm.

7. The type of ground truth used:

• For the listed performance tests (Sequestration, Vacuum performance, Diversion Volume, Positive Pressure Maximum), the "ground truth" would be established by the physical and functional specifications of the device, measured by engineering testing methods. It is not expert consensus, pathology, or outcomes data in a clinical diagnostic sense. The document states "all design verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met."

8. The sample size for the training set:

• Not applicable. This is a mechanical device, not an AI/machine learning model that requires a training set.

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

• Not applicable.

In summary, the provided document focuses on substantiating equivalency to a predicate device through general functional and safety testing, rather than presenting detailed clinical performance study results against specific, quantitatively defined acceptance criteria for diagnostic accuracy or contamination rates with detailed study methodologies. The "PASS" results for functional requirements confirm the device meets its design specifications but lacks the granular data requested in your prompt.

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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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