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The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The LiquID .051 LP Guide Catheter Extension device is a guide catheter extension that is substantially equivalent to the currently marketed devices with the distinction of having a smaller intraluminal diameter. Guide catheter extensions (GCE) are designed to facilitate the placement of interventional devices. During common clinical practice, a GCE is advanced over a guidewire from within the interior lumen and beyond the distal tip of a conventional guide catheter. These devices allow physicians to achieve deeper vascular intubation providing enhanced placement and support. The device is currently available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The LiquID .051 LP Guide Catheter Extension fits within a 6F conventional guide catheter. The 150cm device has a stainless-steel shaft connected to a 15cm single lumen tube. The 15cm single lumen tube catheter body contains a coil for kink resistance and radiopacity. The single lumen tube catheter body is also silicone coated for lubricity. The device has two proximal positioning marks located at 95cm and 105cm from the distal tip. The device handle is color coded to match the standard guide catheter color code.

This document is an FDA 510(k) clearance letter for a medical device, the LiquID .051 LP Guide Catheter Extension. It primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance criteria through a traditional clinical study with human subjects.

Therefore, many of the typical elements associated with acceptance criteria and study design for diagnostics or AI-driven devices (like sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth for training/test sets) are not applicable here. This document describes engineering and bench testing to ensure the new device functions similarly and safely to the predicate, even with a smaller internal diameter.

Here's a breakdown of the information that can be extracted, and where the requested AI/diagnostic specific information is not present:

Acceptance Criteria and Reported Device Performance

The document doesn't present specific quantitative acceptance criteria with corresponding performance numbers in a table format as would be typical for a diagnostic or AI device. Instead, it lists the types of performance tests conducted to verify the device's functionality compared to the predicate. The "acceptance criteria" here are implied to be that the device performs adequately and safely, comparable to the predicate, across these tests.

Note: The document only states that these tests were "verified" or that the device "has been shown to be substantially equivalent." It does not provide numerical results or detailed pass/fail thresholds for each test, as is common in a 510(k) summary focused on substantial equivalence based on bench testing.

Study Specifics (as applicable to a medical device 510(k) for substantial equivalence)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. For bench testing of physical devices, the "sample size" refers to the number of devices tested for each parameter. This is typically determined by established engineering standards and statistical justification, but the specific numbers are not disclosed in this summary.
   • Data Provenance: Not applicable in the context of patient data. The "study" here refers to bench (laboratory) testing of the physical medical device. The tests were conducted internally by Seigla Medical, Inc. (device manufacturer).

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

   • Not applicable. "Ground truth" in this context is established by engineering specifications and measurements (e.g., measuring dimensions, force required to kink, etc.), not by expert human interpretation of medical data.

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

   • Not applicable. This concept is for clinical data adjudication, not for physical device bench testing.

4. 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 not a diagnostic device, and no AI component is mentioned.

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

   • Not applicable. This is a physical medical device, not a diagnostic algorithm.

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

   • The "ground truth" for this device's performance testing is based on engineering specifications, direct physical measurements, and functional performance criteria relative to the predicate device and intended use. For example, the ground truth for "Distal Device ID" is the measured internal diameter compared to the design specification of 0.051".

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

   • Not applicable for the same reason as above.

Summary regarding the device and its testing:

The LiquID .051 LP Guide Catheter Extension is a re-engineered version of an existing device (LiquID 061 and 071 Guide Catheter Extensions) with a smaller intraluminal diameter. The 510(k) clearance process required the manufacturer to demonstrate that this new device is substantially equivalent to its predicate. This was achieved through:

• Bench (laboratory) testing: The listed tests (Distal Device ID, Stent Catheter Delivery, Contrast Injection, Distal Device OD, Distal Tensile, Kink Resistance, Trackability) are all physical performance tests.
• Comparison of characteristics: The table on page 6 directly compares key characteristics like product class, intended use, sterilization method, radiopacity, and working length, showing them to be identical or appropriately modified (like the tip ID).

The core of this 510(k) summary is to confirm that the change in the internal diameter does not introduce new questions of safety or effectiveness and that the modified device performs as expected for its stated indications for use, similar to its predicate.

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The LiquID Guide Catheter Extension is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The LiquID device is a guide catheter extension that is substantially equivalent to currently marketed devices with the distinction of having a larger intraluminal diameter. The device is available in two models: Liquid 061 and LiquID 071 which are designed to fit within 6F and 7F conventional guide catheters, respectively. The device has a 150 cm working length and a 0.018" diameter proximal stainless-steel shaft connected to a 15cm single lumen distal shaft (exchange length).

The LiquID device distal shaft includes an internal PTFE liner, a MP35N coil internally clad with a tantalum core for support and radiopacity, and an exterior nylon-based encapsulation layer. The rounded and atraumatic distal tip includes PTFE and Pebax that is monolithically attached (no joints) to the distal shaft. The distal shaft exterior is wiped with silicone fluid for lubricity.

The transition between the single lumen distal shaft and proximal shaft includes a stainless collar that is welded to the proximal shaft, positioned over the PTFE liner, and encapsulated in polymer. This construction provides a smooth transition and structural integrity.

The LiquID device has proximal positioning marks (laser created oxide marks) that are approximately 95cm and 105cm from the distal tip and has a colored proximal handle that follows the coronary guide catheter size color code. The proximal shaft is not coated.

The LiguID device is packaged in a HDPE hoop within a Tyvek poly sealed pouch. The pouch is contained in an SBS shelf box. Twenty-five (25) shelf boxes are contained within a shipping container. The shipping containers are used for transporting the devices between the manufacturer, the ethylene oxide (EO) sterilization contractor, and the distribution locations.

The document provided is a 510(k) premarket notification for a medical device (guide catheter extension). It does not describe a study involving an AI algorithm or software. Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, pertaining to AI-related aspects like sample size, ground truth, expert adjudication, or MRMC studies, cannot be extracted from this document.

The document focuses on the physical and functional performance of the medical device itself, establishing its substantial equivalence to predicate devices. It lists verification tests, biocompatibility tests, and sterilization validation:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The listed tests are likely laboratory bench tests and material characterization, not studies involving human or animal data sets in the context of AI.

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. This document does not describe studies involving human interpretation or ground truth establishment by experts for data sets.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device submission.

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 physical medical instrument, not an AI software/algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document is for a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's performance would be engineering specifications, material properties, and established biological safety standards, not medical diagnostic ground truth.

8. The sample size for the training set:
Not applicable. There is no AI algorithm being trained.

9. How the ground truth for the training set was established:
Not applicable. There is no AI algorithm being trained.

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