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The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:

J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 3.0 mm J Tip.

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The InQwire Super Stiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Super Stiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature.

The Merit InQwire Super Stiff guide wire consists of 0.032" and 0.035" outer diameter (OD) guidewire configurations with guidewire lengths of 80cm, 100cm, 150cm, 180cm and 260cm. The guidewire is provided in straight and J3mm with a range of flexible properties.

The Merit InQwire Super Stiff guide wire is composed of a stainless-steel core wire and a PTFE coated stainless steel coil. The guidewire is welded at the distal and proximal tip with each tip having a polished weld finish. The stainless-steel construction provides radiopacity. The guidewire is supplied sterile, non-pyrogenic and is intended for single patient use only.

The Merit InQwire Super Stiff guide wire is placed through a vascular access device and advanced under fluoroscopy to the desired location according to the planned procedure by the clinician. It is used to facilitate the placement of devices during diagnostic and interventional procedures within the peripheral vasculature and central circulatory system, excluding the coronary arteries and cerebral vasculature.

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The Merit analog inflation syringe is used to inflate and deflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.

The Merit analog inflation syringe is a single use disposable device capable of generating and monitoring pressure in angioplasty or other similar interventional devices. It is fitted with a threaded plunger assembly with lock/release bar, flexible high pressure extension tube. It is provided with a 510(k)-cleared three way medium pressure stopcock.

The provided text describes a 510(k) premarket notification for the Merit Medical Systems, Inc. Analog Inflation Syringe (BasixCOMPAK). This device is intended to inflate and deflate angioplasty balloons and measure pressure. The submission asserts substantial equivalence to a predicate device, the Merit Monarch COMPAK Inflation Syringe & Universal Fluid Dispensing Device (K083523). The primary difference noted is the display type: analog for the subject device versus digital for the predicate.

The document lists various tests performed to demonstrate safety and efficacy, drawing upon industry standards and guidance. However, it does not provide detailed acceptance criteria values or specific performance data for each test. Instead, it broadly states that "the device met the acceptance criteria necessary to demonstrate the safety and efficacy of the device."

Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The provided document states generally that the device "met the acceptance criteria necessary to demonstrate the safety and efficacy of the device" for all listed tests. However, it does not provide the specific quantitative acceptance criteria values (e.g., "pressure must be accurate within +/- X mmHg") nor the specific reported performance values (e.g., "the device demonstrated accuracy of +/- Y mmHg"). The document lists the types of tests performed and the standards they were based on, implying that the specific criteria and results are in the full test reports, which are not included here.

Regarding the other requested information, the document unfortunately does not contain details for points 2 through 9:

• 2. Sample size used for the test set and the data provenance: Not mentioned. The document lists tests but not the number of units tested.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a mechanical instrument, and its performance is evaluated against engineering specifications and industry standards, not subjective expert assessment of data like in an AI diagnostic device.
• 4. Adjudication method for the test set: Not applicable. Performance is measured objectively.
• 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 is a standalone medical device, not an AI-assisted diagnostic tool involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, by definition, the safety and performance tests described were for the standalone device. However, the term "algorithm only" is more typically associated with software-based devices, which this is not.
• 7. The type of ground truth used: For this device, the "ground truth" would be established engineering specifications, calibrated measurement standards, and requirements outlined in the referenced ISO and ASTM standards. For example, a "gauge accuracy" test would compare the device's reading to a known, highly accurate reference pressure gauge.
• 8. The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
• 9. How the ground truth for the training set was established: Not applicable.

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