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HQS Introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.

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This document is an FDA 510(k) clearance letter for a medical device called the "HQS Introducer (Model 2064-HQS)". It does not describe any acceptance criteria or studies related to AI/algorithm performance. Therefore, I cannot extract the requested information from the provided text.

The document is a regulatory communication stating that the device is substantially equivalent to legally marketed predicate devices, allowing its commercialization. It discusses administrative details, regulatory compliance, and indications for use of the catheter introducer, but it does not contain information about an AI or algorithm-based device, its performance, or studies demonstrating its effectiveness.

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XCath (model 2064-XC) is intended to be inserted into the HQS Introducer (model 2064-HQS) to establish multiple and simultaneous conduits through the same vascular access (previously established by the HQS introducer).

The whole XCath / HQS allows insertion of several endovascular devices at the same time while minimizing blood loss associated with such insertions.

The XCath (model 2064-XC) consists of a multiple ways access (2, 3 or 4 ways) adapted to the HQS Introducer (K113849) to optimize the sealing when several vascular tools up to 9,3F need to be introduced through the same vascular access.

The device features include (1) a flexible multilumen body, with 2, 3 or 4 channels compatible with the open valve of HQS Introducer; (2) a base with 2, 3 or 4 valves, (3) Extension line for each valve with stopcock and Luer Lock connection.

Once the XCath is connected to the HQS Introducer, the device can accommodate vascular tools up to 9,3 French (3,1mm). The XCath (accessory) is fixed in proximal position of the HQS introducer body and allows the simultaneous insertion of several vascular tools.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes for each non-clinical performance test. It notes that "The following in vitro testing was performed on the XCath ... to assure reliable design and performance." The data provenance is "in vitro" testing performed by ALSEAL, the manufacturer, in France.

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

This information is not applicable. The device is a medical instrument (catheter introducer accessory), and its performance is evaluated through engineering and biocompatibility bench testing, not through expert review of data like in an AI/diagnostic device study.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human interpretation of data, not for bench testing of a medical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret medical data, often with and without AI assistance. The XCath is a hardware device tested for its physical and functional performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

No, a standalone study in the context of an algorithm's performance was not done. This device is a physical medical instrument, not an algorithm. Its "standalone" performance refers to its ability to meet engineering specifications through bench testing.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by engineering specifications, ISO standards (specifically ISO 11070: 1999 for intravascular catheters introducers), and internal procedures. For biocompatibility, the ground truth is defined by ISO 10993-1 standards.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device is not an AI/machine learning algorithm. The engineering tests are to verify the final product's performance against predefined criteria.

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

This information is not applicable, as there is no training set for this type of device.

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The HQS introducer (Model 2064-HQS) is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions

The High Quality Sealing (HQS) Introducer comprises 4 elements, a radio- opaque introducer sheath equipped with a haemostasis valve, a radio- opaque dilator, a centering wire device and an extension line with 3 ways stopcock. The range of HQS introducer (18F, 20F, 22F, 24F, 26F) permits the insertion, preserving sealing, of large caliber tools, from OF, up to the nominal size of-the-introducer-sheath.. The introducer and its adjustable valve are easily handled with one hand. The distal tip is designed to perform an efficient introduction of the HQS introducer with the dilator in the vessel. The centering device permits to introduce a guidewire through the valve and to keep a perfect sealing. The extension line is connected to the lateral port of the introducer for the injection during the procedure.

The provided text is a 510(k) summary for a medical device called the "HQS Introducer (Model 2064-HQS)". It describes the device, its intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness for substantial equivalence. It does not describe an AI medical device.

Therefore, the requested information about acceptance criteria and studies (particularly those related to AI performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies) cannot be extracted from this document as it pertains to a physical medical device.

The study described is a series of in-vitro and biocompatibility tests to ensure the physical device meets established standards for safety and performance, not a study to prove AI performance.

Here's what can be extracted about the general acceptance criteria and studies for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the device is in compliance with ISO 11070:1999 for "Sterile, single use intravascular catheter introducers" and ISO 10993-1:2009 for biocompatibility. The specific acceptance criteria for each test (e.g., tensile strength, overpressure resistance, useful dimensions) are not quantitatively reported in this summary, but the general statement is that the results demonstrate that the device is in compliance and meets the requirements.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to physical product testing, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 for a physical device, not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical device, not an AI.
7. The type of ground truth used: For the physical device, the "ground truth" is defined by the performance standards outlined in ISO 11070:1999 and ISO 10993-1:2009, which specify acceptable physical and biological characteristics.
8. The sample size for the training set: Not applicable. This is a physical device, not an AI.
9. How the ground truth for the training set was established: Not applicable. This is a physical device, not an AI.

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