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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:

| Steripath®
Micro Kit
Model

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:

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The syringe is intended to inject or withdraw fluids from the body.

The Monoject 60mL Syringe is a standard piston syringe without needle. It consists of 3 parts; a calibrated hollow barrel, with a moveable plunger and an attached gasket. It is available in three nozzle types: Luer lock, luer slip and catheter tip. The barrel is made from polypropylene and is designed with clear graduation for easy use. The luer barrel nozzle has an ISO 594 compliant male luer tip for fitting any female luer taper hub that is also ISO 594 compliant. The plunger is made from polypropylene. The gasket is made from thermoplastic elastomer material. The syringe is individually packaged in a peel blister that ensures the sterility of the device until the package is opened. This is a single use only device. An inner box contains 30 devices, and the master case contains 12 inner boxes. This syringe is sterilized by gamma irradiation.

The provided text describes a 510(k) summary for a medical device, specifically the Monoject 60mL Syringe. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It does not contain information about a study with acceptance criteria and a detailed report of how a device meets those criteria in the context of an AI-powered system or a study involving human readers.

Therefore, most of the requested information (points 1, 2, 3, 4, 5, 6, 7, 8, 9) is not applicable or cannot be extracted from the given text because:

• This is a traditional medical device (syringe), not an AI/ML-powered device. The 510(k) summary details performance tests for a physical product (syringe), not an algorithm's performance.
• The document focuses on non-clinical performance testing for safety and effectiveness, not clinical trials with human subjects or AI-assisted performance.
• The concept of "ground truth," "experts," "adjudication," "training set," and "test set" as typically understood in the context of AI/ML or comparative effectiveness studies of diagnostic algorithms is not relevant here. The "ground truth" for a syringe is its physical specifications and functionality.

However, I can extract information related to the performance testing and conclusions based on the provided text, aligning with the spirit of "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific type of device.

Acceptance Criteria and Device Performance (Interpreted for a Syringe Device)

The "acceptance criteria" for the Monoject 60mL Syringe are implicitly defined by the successful completion of the non-clinical performance tests, proving the device is safe and effective and comparable to predicate devices. The "reported device performance" is that it met these test requirements.

Here's a breakdown of the specific points related to the provided 510(k) summary, acknowledging the context of a traditional medical device:

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

   • See the table above. The acceptance criteria are implicitly met by successful completion of the listed non-clinical tests, and the reported performance is that these tests were passed, leading to the conclusion of safety, effectiveness, and substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Sample Size: The document does not specify the exact sample size for each performance test. It only states that "Performance testing was conducted."
   • Data Provenance: Not specified. This typically refers to the testing done by the manufacturer (Nipro Medical Corporation) or a contracted lab. The country of origin of the data is not mentioned, nor is whether the data is retrospective or prospective, as these terms are less relevant in the context of physical product performance testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. For a physical device like a syringe, "ground truth" is established by adherence to engineering standards, material specifications, and performance requirements. There are no "experts" in the sense of medical reviewers establishing ground truth for diagnostic accuracy, as this is not a diagnostic device. The tests themselves, conducted by qualified engineers/technicians following standardized protocols, serve as the verification.

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

   • Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical trials or expert reviews, especially for diagnostic outputs. For objective performance tests of a physical device, the outcome is measured by instrumentation against defined limits, not adjudicated by human consensus.

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. This is not an AI-powered device, nor is it a diagnostic device that involves human "readers." Therefore, an MRMC study is completely irrelevant here.

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

   • No. This is a physical medical device (syringe), not an algorithm.

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

   • The "ground truth" for this device's performance is objective, defined by established engineering and performance standards for syringes (e.g., ISO 594 compliance, specified limits for force, leakage, etc.) and the material properties required for biocompatibility.

8. The sample size for the training set:

   • Not applicable. This term relates to machine learning (AI), which is not involved in the development or testing presented for this syringe.

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

   • Not applicable. As above, this is an AI/ML concept and does not apply to this traditional medical device submission.

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