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The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.

The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.

The provided text describes the regulatory clearance for the Fortress Introducer Sheath System (7F and 8F sizes) and does not contain information about an AI/ML powered medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML capabilities, or details about a study evaluating such a device, cannot be extracted from this document.

The document discusses the substantial equivalence of the Fortress Introducer Sheath System (7F and 8F) to a predicate device (6F Fortress Introducer Sheath System, K153197). The performance data presented are for non-clinical tests related to the mechanical properties, biocompatibility, sterilization, and shelf-life of the physical device.

Here's an analysis of what can be extracted from the document, recognizing that it doesn't pertain to an AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance (as non-AI/ML)

Since this is a non-AI/ML device, "acceptance criteria" here refers to specific tests and relevant standards the device must meet. The "reported device performance" is that the device met these criteria, demonstrating substantial equivalence to the predicate.

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

• Test Set Sample Size: Not explicitly stated for each test, but it is implied that sufficient samples were tested to meet the requirements of the standards listed. These are physical device tests, not data-driven AI/ML tests.
• Data Provenance: The tests are non-clinical (laboratory-based) and conducted to international and internal standards. Provenance is therefore the testing conducted by the manufacturer and/or external laboratories. The country of origin for the device manufacturer is Germany.

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

• This information is not applicable as the document describes physical device testing, not an AI/ML product requiring expert ground truth for image or data analysis. Usability evaluation (IEC 62366-1:2015) would involve human users, but the number and qualifications of those users are not specified, nor are they "experts establishing ground truth" in the AI/ML sense.

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

• This is not applicable as the document describes physical device testing. The results are determined by compliance with specified test methods and acceptance criteria rather than expert 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:

• This is not applicable as the device is a physical medical introducer sheath system, not an AI/ML product intended to assist human readers.

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

• This is not applicable as the device is a physical medical introducer sheath system, not an AI/ML algorithm.

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

• This is not applicable as the document describes physical device testing. The "ground truth" or reference for evaluating performance against is defined by the technical specifications outlined in the referenced international standards and internal requirements.

8. The sample size for the training set:

• This is not applicable as the device is a physical medical introducer sheath system and does not involve AI/ML requiring a training set.

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

• This is not applicable as the device is a physical medical introducer sheath system and does not involve AI/ML requiring a training set.

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The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.

The Fortress Introducer Sheath System is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.

The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath (5F and 6F sizes) has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.

The System consists of the following components:

• A One Introducer Sheath with hemostasis valve
• A Two dilators: 5F and 6F 100cm version
• A One dilator: 5F and 6F 45cm version

This document is a 510(k) Premarket Notification from the FDA regarding the Fortress Introducer Sheath System. It details the device's indications for use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly stated as "Passed," indicating that the device met the pre-defined requirements for each test. The actual numerical or descriptive criteria for "passing" are not explicitly listed in this summary, but the "Test Result" column confirms that all tests were successfully completed according to their respective acceptance criteria.

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

The document does not explicitly state the sample sizes used for each of the tests. The tests performed are primarily performance and safety tests on the device itself (e.g., mechanical testing, material compatibility, sterilization), not clinical studies with human subjects. Therefore, typical data provenance details like "country of origin" or "retrospective/prospective" are not applicable in the way they would be for a clinical trial. The testing appears to be laboratory-based verification and validation.

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

Not applicable. The tests performed are laboratory-based engineering and biological compatibility tests, not evaluations requiring expert consensus on clinical imagery or patient data. The "ground truth" for these tests would be established by the industry standards and methodologies followed (e.g., ISO standards, ASTM standards, FDA guidance documents) by qualified laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements and evaluations against pre-defined engineering and safety specifications, not subjective assessments requiring adjudication among multiple observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical performance and safety testing. The device is an introducer sheath system, which is a physical medical device, not an AI software or imaging diagnostic tool that would typically undergo MRMC studies.

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

Not applicable. The Fortress Introducer Sheath System is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering principles, material science, biological compatibility standards, and regulatory guidance documents. For instance:

• Mechanical tests: "Ground truth" is defined by the device's design specifications and performance limits (e.g., strength, kink resistance, insertion force) derived from engineering analysis and comparison to predicate devices, verified through physical measurements.
• Biological tests (Cytotoxicity, LAL, Sterilization): "Ground truth" is defined by accepted biological safety standards and validated testing protocols to ensure the device is non-toxic, non-pyrogenic, and sterile.
• Visibility under X-ray: "Ground truth" is the device's observable radiopacity under X-ray imaging.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of data-driven model development.

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

Not applicable, as there is no "training set" for this type of device.

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The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures.

The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and Luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The Fortress Introducer Sheath System consists of the following components: - One: introducer sheath - Two: dilators

The provided text is a 510(k) summary for the Fortress Introducer Sheath System. It focuses on establishing substantial equivalence to predicate devices and does not detail specific acceptance criteria or a study proving its performance against such criteria in the way described in the request. The document describes the device, its intended use, and its technological characteristics but lacks information related to clinical performance studies, ground truth establishment, or expert evaluation for decision-making regarding device efficacy.

Therefore, for each requested point:

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

   • Not provided. The document does not list specific performance acceptance criteria or report performance against them. It relies on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics.

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

   • Not provided. No information about a specific test set, its sample size, or data provenance is mentioned as this is not a clinical study report.

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/Not provided. Since no specific test set requiring ground truth establishment is described, this information is not present.

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

   • Not applicable/Not provided. There is no mention of an adjudication process for a test set.

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/Not provided. This device is an introducer sheath system, a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is irrelevant and not mentioned.

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

   • Not applicable/Not provided. As stated above, this is a physical medical device, not an algorithm.

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

   • Not applicable/Not provided. No clinical ground truth is established or discussed in this document. The "ground truth" for this 510(k) submission is the pre-existing safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

   • Not applicable/Not provided. This is not an AI or machine learning device, so there is no concept of a training set.

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

   • Not applicable/Not provided. As there is no training set, this information is not relevant or present.

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