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The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use or for use in the neurovasculature.

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 1.5 mm J Tip.

Long Taper Guide Wires:
The Long Taper Guide Wires incorporate an extended core wire taper length providing enhanced flexibility.

The provided FDA 510(k) clearance letter and summary for the Splashwire Hydrophilic Guide Wire (K251181) outlines the regulatory approval process and demonstrates substantial equivalence to a predicate device (K201595). However, it does not contain the specific information required to address your request regarding acceptance criteria and the detailed study that proves the device meets those criteria, particularly for an AI-enabled medical device.

The document describes a traditional medical device (a guide wire) and the non-clinical bench testing performed to ensure its safety and performance. This typically involves physical and mechanical property tests. It does not refer to AI/ML software, algorithms, or any studies involving human readers or ground truth expert consensus in the way you've outlined.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI-enabled device, nor details on sample sizes, expert ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.

Based on the provided document, the device is a physical medical device (a guide wire), not an AI-enabled one. The acceptance criteria and "study" described are standard bench tests for physical properties, not performance metrics for an AI algorithm.

Here's a breakdown of what can be inferred from the document regarding the device's performance, but it does not align with the parameters of an AI/ML study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing was conducted on the subject Splashwire Hydrophilic Guide Wire in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." And "All test results were comparable to the predicate Splashwire Hydrophilic Guide Wire and the subject Splashwire Hydrophilic Guide Wire met the predetermined acceptance criteria."

While specific numerical acceptance criteria and performance data are not provided in this summary, the document indicates that the following categories of non-clinical bench tests were successfully completed and met their predetermined acceptance criteria:

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

This information is not available in the provided document. For a physical medical device, "test set" would refer to the number of units tested for each characteristic. The provenance of the data is not applicable in the context of clinical images or patient data; it would refer to the samples of the manufactured guide wire used for the bench tests. These are likely internal lab tests.

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

This information is not applicable to this type of device and study. "Ground truth" in this context would be derived from the physical properties of the device measured by laboratory instruments, not expert human interpretation of data.

4. Adjudication Method for the Test Set:

This information is not applicable as there are no human interpretations or adjudications involved in the physical bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

This information is not applicable. MRMC studies are relevant for software that aids human interpretation (e.g., AI for radiology). This device is a physical guide wire.

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

This information is not applicable. This describes the performance of a physical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on measurements of its physical and mechanical properties according to established industry standards and FDA guidance for guide wires (e.g., ISO standards, FDA guidance on guidewire performance). It's not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set:

This information is not applicable. This device is not an AI/ML algorithm that requires a training set. The "design controls" mentioned refer to the engineering and manufacturing process, not data training.

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

This information is not applicable as there is no training set for a physical device.

In summary, the provided document details the 510(k) clearance for a physical medical device (Premarket Notification: K251181) and its substantial equivalence based on standard bench testing. It does not provide information relevant to the assessment of an AI-enabled medical device.

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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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