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VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).

The VacLok™ AT Vacuum Syringe is a general piston syringe constructed using a barrel, plunger, piston seal, and locking mechanism. It is designed to lock in any position along the length of the barrel with the capability of holding a vacuum when the cam locking mechanism is engaged.

The provided text is a 510(k) summary for the Merit VacLok™ AT Vacuum Syringe, a medical device. This document focuses on demonstrating the device's substantial equivalence to predicate devices, primarily through performance bench testing against recognized international standards and biocompatibility testing. It does not describe an AI/ML-based device or a study involving human readers or expert consensus for establishing ground truth in an AI/ML context.

Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device (e.g., sample size for test set with data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the acceptance criteria and performance testing that was conducted for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device complies with FDA-recognized consensus standards ISO 7886-1 and ISO 594-2, and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." Specific acceptance criteria values are not explicitly listed in a table, but the areas of testing and the general statement of compliance serve as the "reported device performance."

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

The document does not specify the exact sample sizes (e.g., number of syringes) used for each bench test. The data provenance is also not detailed beyond the statement that testing was performed by the manufacturer against international standards. It's inherent to this type of device submission that testing is done in a controlled laboratory setting (prospective testing of manufactured devices), rather than using clinical patient data. The country of origin for the data (testing lab location) is not specified.

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

This question is not applicable as this is a medical device (syringe) performance evaluation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical records. The "ground truth" for the device's performance is established by the specifications and acceptance criteria of the referenced ISO standards.

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

This question is not applicable as there is no human interpretation or subjective assessment being adjudicated. Device performance is measured objectively against predefined standards.

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

This question is not applicable as the device is a physical syringe, not an AI system.

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

This question is not applicable as the device is a physical syringe, not an algorithm. Bench testing evaluates the device's performance standalone relative to engineering standards.

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

The "ground truth" for this device's performance is based on the objective technical specifications and acceptance criteria outlined in recognized international consensus standards (e.g., ISO 7886-1, ISO 594-2) and the FDA's guidance documents for biocompatibility and sterilization.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of a physical medical device. Manufacturing processes are subject to quality controls and design validation, but not a data-driven "training" as in AI/ML.

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

This question is not applicable for the reasons stated above.

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The DyeVert™ NG Contrast Modulation System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

The DyeVert™ NG Contrast Modulation System is to be used for the controlled infusion and contrast volume reduction of radiopaque contrast media for angiographic procedures with the following agents: Iodixanol 270 or 320 mgI/mL, Iohexol 300 or 350 mgI/mL and Iopamidol 370 mgI/mL.

The Osprey Medical DyeVert™ NG Contrast Modulation System (DyeVert System) is a compatible device to manual contrast injections and provides fluid pathway resistance modulation such that excess contrast volume (i.e. contrast that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast agent volume reduction occurs; while maintaining adequate image quality.

The DyeVert System consists of a disposable, single-use sterile device including a Reservoir and Diversion Valve. The device is positioned between a manual injection control syringe and an injection manifold via the DyeVert stopcock. The diversion valve responds to the contrast injection pressure administered by the physician manually and modulates the amount of contrast diverted to the reservoir.

The DyeVert System has been designed for use with standard injection syringes and manifolds with Luer fittings that have been demonstrated to comply with ISO 594 "Conical fittings with a 6% luer taper for syringes, needles and certain other medical equipment". The DyeVert System is designed for use with contrast media and catheter configurations as listed in the Instructions for Use.

The document provided is a 510(k) premarket notification for the DyeVert NG Contrast Modulation System. It describes the device, its intended use, and compares it to a predicate device. This is a submission for a modified device, and the review explicitly states "No clinical testing was performed to support this Special 510(k) Premarket Notification." This means that the device was approved based on its similarity to a previously cleared device (predicate device) and extensive bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in human subjects.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them (especially in a clinical context with human readers, ground truth, and sample sizes) cannot be fully provided from this document as no clinical study was conducted.

However, I can extract the information related to bench testing and how its results demonstrated the device met pre-established acceptance criteria, even though those specific criteria aren't enumerated in detail.

Here's the breakdown of the available information:

No clinical study was performed for the DyeVert NG Contrast Modulation System.

The device's substantial equivalence was established through a comparison to a predicate device and extensive non-clinical (bench) testing. Therefore, many of the requested categories related to clinical study design and outcomes are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:

• "Device performance testing was performed and leveraged for flow rate, peak pressure reduction, contrast diversion, mechanical cycle testing and visual verification to design specifications for specific contrasts and catheter configurations."
• "Confirmation testing was conducted for priming, high pressure simulation, leak testing, reservoir capacity and tensile strength."
• "All testing passed and demonstrated product performance met all prior established acceptance criteria."
• "Biocompatible testing was leveraged from the predicate in accordance with ISO 10993-1:2009... All testing passed and meet prior established acceptance criteria."
• "Shelf-life, shipping and distribution testing... All testing passed and demonstrated product performance met all prior established acceptance criteria."

Specific Acceptance Criteria (Not explicitly detailed in the document):

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

• Test Set Sample Size: Not specified in the document for the non-clinical tests.
• Data Provenance: Non-clinical (bench) testing performed by Osprey Medical. The country of origin for this bench testing data is not specified, but the company is based in Minnetonka, Minnesota, USA. The testing is retrospective in the sense that it's performed on the finalized device design.

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

• Not applicable. No clinical study was performed that would require expert-established ground truth for a test set. Bench testing relies on objective measurements against pre-defined engineering and material specifications.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study involving human assessment was performed.

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

• No. No MRMC study was performed. The device is for contrast modulation, not for diagnostic interpretation by human readers.

6. Standalone Performance Study (Algorithm Only):

• Not applicable. This is a mechanical device, not an AI or algorithm-driven system. Its "performance" is mechanical and fluid dynamic, evaluated through bench tests.

7. Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" was the established design specifications, engineering standards (e.g., ISO, ASTM), and chemical/biological safety standards (e.g., ISO 10993). For instance, a flow rate measurement would be compared to a target flow rate specification.

8. Sample Size for the Training Set:

• Not applicable. This refers to a supervised learning algorithm context, which is not relevant for this device.

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

• Not applicable.

In summary, the K161505 submission for the DyeVert NG Contrast Modulation System is a "Special 510(k)" for a modified device. Approval was based on demonstrating substantial equivalence to a predicate device and comprehensive bench testing, which confirmed the device met all prior established performance, material, and safety acceptance criteria. No new clinical trials were conducted to support this specific submission.

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