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The EXTesia Introducer Sheath Set is intended to be inserted percutaneously into a vessel to facilitate placing the interventional or diagnostic devices into a vein or artery.

The EXTesia Introducer Sheath Set is used to facilitate placing a catheter through the skin into a vein or artery. The set consists of an introducer (a sheath and a dilator) packaged together with an entry needle, guide wire, flushing syringe, and scalpel. The sheath and dilator contain a radiopaque material which makes these devices visible under fluoroscopy. In addition, the sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

EXTesia Introducer Sheath Set is packaged in a Tyvek 1073B pouch, sealed, labelled and EtO sterilized. It is for single use only. The EXTesia Introducer Sheath Set is designed for 3 years shelf life.

This document is a 510(k) summary for the EXTesia Introducer Sheath Set, not a study report that details specific acceptance criteria and device performance in a clinical study with human data. Therefore, many of the requested details about acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets cannot be extracted from this document.

However, based on the provided text, I can infer some information relevant to performance testing and the lack of clinical studies.

1. Table of acceptance criteria and the reported device performance:

The document broadly states that the device "meets the requirements for product specifications" but does not provide specific quantitative acceptance criteria or detailed performance results for each test.

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

• This document does not specify sample sizes for mechanical, functionality, biocompatibility, sterilization, or simulated usability tests.
• Data Provenance: Not specified, but these are typically in-house laboratory and engineering tests, not clinical studies with human data from specific countries. The testing would be prospective (designed and executed for this submission).

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 for performance testing described. The "ground truth" for mechanical and functional tests is typically based on engineering specifications and validated test methods, not expert human assessment in the way clinical studies would require. Simulated usability implies expert observation or evaluation but details on the number or qualifications of "experts" are not provided.

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

• Not applicable for performance testing described. Adjudication methods like 2+1 or 3+1 are used in clinical studies where there's a need to resolve discrepancies in human expert interpretations of ground truth. The performance testing outlined here (biocompatibility, sterilization, mechanical, functionality, simulated usability) would follow pre-defined test protocols with objective pass/fail criteria, not consensus-based adjudication.

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:

• No MRMC comparative effectiveness study was done. The document explicitly states: "No Clinical Testing was required for this product." This makes it clear that there was no study involving human readers/users in a comparative effectiveness setting as described for AI assistance.

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

• Not applicable. The EXTesia Introducer Sheath Set is a physical medical device (catheter introducer), not a software algorithm or AI-powered device. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The performance testing focused on the physical characteristics and function of the device itself.

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

• For the performance testing mentioned (biocompatibility, sterilization, mechanical integrity, functionality, product specifications, simulated usability), the "ground truth" would be established by engineering specifications, international standards, and established laboratory test methods. For example, biomechanical tests would have defined load limits, and sterility tests would have defined microbial reduction rates. Outcomes data, pathology, or expert consensus (in a clinical sense) are not relevant to these types of bench and simulated tests.

8. The sample size for the training set:

• Not applicable. This product is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no training set was used.

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The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.

The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.

The provided document is a 510(k) summary for a medical device (Xcess Guiding Catheter), not an AI/ML-enabled medical device. Therefore, the questions related to AI/ML specific acceptance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e., algorithm only) performance," "sample size for the training set," and "how ground truth for the training set was established," are not applicable.

This document describes the process of demonstrating substantial equivalence for a physical medical device. The acceptance criteria focus on bench testing performance and biocompatibility in comparison to a predicate device.

Here's an analysis of the provided text in the context of the requested information, while acknowledging the non-AI nature of the device:

Device Name: Xcess Guiding Catheter
Device Type: Percutaneous Catheter (Class II)
Predicate Device: VISTA BRITE TIP Guiding Catheter (K962830)

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests confirmed the products met the pre-defined acceptance criteria." However, it does not provide a quantitative table of the specific acceptance criteria (e.g., maximum force for tensile strength, specific values for torquability) or the specific numerical results of the tests. It only lists the types of tests performed.

Specific Performance Tests Conducted (without quantitative criteria/results):

• Visual and dimension inspection
• Coating integrity and particulate evaluation
• Catheter usability
• Catheter shape retention
• Catheter freedom from leakage
• Catheter torque
• Catheter pressure integrity
• Catheter flexibility and kink
• Catheter joints tensile strength
• Corrosion resistance
• Radio-detectability

Specific Biocompatibility Tests Conducted:

• Cytotoxicity
• Sensitization
• Irritation or Intracutaneous Reactivity
• Acute Systemic Toxicity
• Material-Mediated Pyrogenicity
• Hemocompatibility (Hemolysis, Thrombogenicity, and Complement Activation)

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

• Sample Size: The document does not specify the sample sizes used for any of the performance or biocompatibility tests.
• Data Provenance: The document implies the testing was conducted internally by Curatia Medical Co. (Santa Clara, CA, USA) or its designated testing facilities, as it states, "Curatia Medical has determined that the Xcess Guiding Catheters are substantially equivalent." The data is prospective in the sense that the tests were performed specifically for this 510(k) submission, not gathered retrospectively from existing data. The country of origin for the data is implicitly USA (California).

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

• Not Applicable: For a physical medical device like a guiding catheter, "ground truth" as it would be understood for an AI/ML model (e.g., disease diagnosis) is not established by human experts in the same way. The "ground truth" or acceptance criteria for mechanical and biological performance are established by engineering standards (e.g., ISO 10555-1, ISO 10993 series) and risk analysis, not by expert interpretation of images or clinical cases. Testing against these standards determines performance.

4. Adjudication Method for the Test Set

• Not Applicable: As this is verification testing of a physical device against engineering and biological standards, there is no "adjudication method" involving multiple human readers/experts in the way there would be for, say, an AI diagnostic tool. Test results are objective measurements compared against predefined specifications.

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

• Not Applicable: This type of study is relevant for AI/ML-enabled diagnostic or assistive devices where human reader performance is being evaluated. The Xcess Guiding Catheter is a physical interventional device, not an AI or diagnostic tool.

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

• Not Applicable: This question pertains specifically to AI/ML algorithms. The Xcess Guiding Catheter is a physical device, and therefore does not have an "algorithm-only" mode.

7. The Type of Ground Truth Used

• The "ground truth" for the Xcess Guiding Catheter's performance is based on established international standards (ISO 10555-1 for performance, ISO 10993 series for biocompatibility) and the specific design requirements derived from a risk analysis for a percutaneous catheter. This is a scientific/engineering ground truth based on accepted practices for medical device design and testing, rather than an expert consensus on clinical data, pathology, or outcomes data in the context of an AI model.
• The comparison to the predicate device (VISTA BRITE TIP Guiding Catheters) also serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

• Not Applicable: This question applies to AI/ML algorithms where a "training set" of data is used to develop the model. For a physical medical device, there is no training set in this context. Device design and manufacturing processes are developed and refined through engineering iterations, but not via "training" on a data set.

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

• Not Applicable: As there is no "training set" for a physical device, there is no ground truth established for it.

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