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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 XCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).

The xCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The xCAT™ can measure distances and thickness on two dimensional images. Images produced by the xCAT can be exported via Ethernet or onto optical media or a memory stick. The building blocks of the xCAT are a motorized scanning arm carrying an Xray source and image detector, and a computer running the xCAT software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.

The provided 510(k) summary for the Xoran xCAT™ does not contain information regarding specific acceptance criteria, a study proving device performance against such criteria, or details typically found in a clinical or performance study report. The document focuses on establishing substantial equivalence to predicate devices rather than proving performance against defined metrics.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the text:

1. A table of acceptance criteria and the reported device performance:

• Not provided. The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, resolution, noise levels) or report specific performance metrics for the xCAT™ beyond its intended imaging capabilities and reconstruction process.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. No test set, sample size, or data provenance are mentioned, as a formal performance study against detailed acceptance criteria is not described.

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 provided. Ground truth establishment is not discussed, as there is no described test set or performance evaluation.

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

• Not provided. Adjudication methods are not applicable as no test set or ground truth establishment process is described.

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 provided. An MRMC study is not mentioned. The xCAT™ is described as an imaging device that produces images for human viewing and measurement, without explicit mention of AI assistance or human reader performance improvement studies.

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

• Not provided. The document describes the device as producing images for viewing and measurement by a user, implying human intervention. There is no mention of a standalone algorithm performance evaluation without human-in-the-loop.

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

• Not provided. As no performance study is detailed, the type of ground truth used is not specified.

8. The sample size for the training set:

• Not provided. The document describes the xCAT™ as an imaging device that reconstructs 3D images from X-ray sequences. It does not mention any machine learning or AI components that would require a "training set."

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

• Not provided. This is not applicable, as no training set or AI component requiring ground truth for training is described.

Summary of what the document does provide regarding device evaluation:

The 510(k) submission establishes substantial equivalence to predicate devices (Neurologica's NL 3000 CereTom and Xoran Technologies Inc. MiniCATTM) rather than providing a detailed performance study with specific acceptance criteria. The basis for clearance is that its design, material, functionality, and technology are comparable to these existing, legally marketed devices, and it does not pose new safety or effectiveness issues.

The "study" implicitly referenced is the comparison to predicate devices, which allows the FDA to conclude that the device is substantially equivalent for its intended use. Potential hazards are stated to be controlled by a risk management system, including Hazard Analysis and Software Development and Validation Process, but no details of these processes or their outcomes are provided.

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