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The VACLOK™ Syringe Kit is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The VACLOK™ Syringe Kit can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

The VACLOK™ Syringe is a polycarbonate piston syringe modified to include tins on the plunger and a stopping pin in the barrel. The plunger can be pulled back and turned to lock the fins back with the barrel pin.

This 510(k) premarket notification for the VACLOK™ Syringe Kit does not contain the detailed information required to fulfill the request. This document is a summary of safety and effectiveness that primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study reports with acceptance criteria and performance data.

Here's why the requested information cannot be extracted from the provided text:

• Type of Device: The VACLOK™ Syringe Kit is a physical medical device (piston syringe) used for aspiration and delivery of fluids, not an AI/Software as a Medical Device (SaMD). The concepts typically associated with AI/SaMD performance evaluation, such as acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance, are generally not applicable or reported in the same way for traditional hardware devices in a 510(k) submission focused on substantial equivalence.
• Focus of 510(k): The core of this 510(k) submission is to demonstrate that the VACLOK™ Syringe is "substantially equivalent" to already legally marketed predicate devices (Bone Graft Syringe K023088 and Merit Control Syringe K994253) in terms of design features, materials, and intended use. This approach relies on the predicate devices having already established their safety and effectiveness through their own clearance or premarket approval, or by being "grandfathered" devices (marketed before May 28, 1976).
• Lack of Specific Study Data: The document explicitly states: "The safety and effectiveness of the VACLOK™ Syringe is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." It does not present a new clinical study or performance study with defined acceptance criteria and statistical results typical for demonstrating the performance of a novel or significantly modified device, especially not an AI/SaMD.

Therefore, I cannot provide the requested table and study details. The provided text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details of a study that would use such.
3. Information on experts, ground truth establishment, or adjudication methods.
4. MRMC comparative effectiveness study data or effect sizes.
5. Standalone performance data (as it's a hardware device not an algorithm).
6. Types of ground truth.
7. Training set sample size or how ground truth was established for a training set.

The submission relies on a comparison to predicate devices, implying that their established safety and effectiveness data (which are not detailed here) are sufficient for the VACLOK™ Syringe.

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The VACLOK Syringe is intended to be used by a cardiologist or radiologist during angiographic or radiologic procedures.

The Merit Vaclok Syringe is a polycarbonate piston syringe modified for the use in applications requiring vacuum.

The provided text is related to a 510(k) premarket notification for the "VACLOK Syringe." This document focuses on the substantial equivalence of the VACLOK Syringe to a previously cleared device (Merit Coronary Control Syringe) for its intended use, rather than presenting a study with acceptance criteria and measured device performance in the way clinical studies for diagnostic accuracy or performance efficacy would.

Therefore, the provided document does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria.

Here's why and what's missing:

• No Acceptance Criteria: The document explicitly states: "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." This means there were no predefined quantitative criteria (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.) that the device needed to meet.
• No Performance Study Results: The document summarizes a substantial equivalence argument, which typically involves comparing the new device's design, materials, and intended use to a predicate device. It does not present results from a clinical or laboratory performance study that would measure specific metrics against acceptance criteria.
• No Information on Sample Size, Ground Truth, Experts, etc.: Because no performance study is described, there's no mention of sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.

In summary, the provided text describes a regulatory submission for a Class II medical device based on substantial equivalence, not a performance study designed to demonstrate meeting specific acceptance criteria.

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