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The CardioFocus Deflectable Sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.

The HeartLight® Deflectable Sheath is a sterile, disposable device which provides a conduit for catheter introduction into the vasculature and into the chambers of the heart. The Deflectable Sheath is able to move its distal section in one direction in a single plane and is activated by a rotating knob at the front of the device handle. The deflection of the sheath and the torquing of the device allow the distal end of the sheath to be positioned at the ostium of pulmonary veins.

The provided document describes the HeartLight Deflectable Sheath, a medical device, and its comparison to a predicate device for the purpose of a 510(k) premarket notification. The information pertains to engineering testing and biocompatibility rather than the performance of an AI/ML powered device impacting diagnostic accuracy. Therefore, many of the requested elements for an AI/ML study, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable in this context.

However, I can extract the acceptance criteria and performance data as presented for this device.

1. Table of Acceptance Criteria and Reported Device Performance

The document details performance and functional requirements testing for the HeartLight Deflectable Sheath, primarily through a comparison to the predicate device, FlexCath® Advance™ Steerable Sheath (K123591), and a reference device, HeartSpan® Steerable Introducer (K132164). The acceptance criteria are generally implied by stating "Same" or "Similar" to the predicate, with specific values provided where there are differences.

Study Proving Device Meets Acceptance Criteria:

The study involved a series of Design Verification tests and Biocompatibility tests.

The document states: "Design Verification testing were performed for the HeartLight 12F Deflectable Sheath to verify that design outputs meet relevant performance and functional requirements and conforms to the intended use of the device." And "The device specification requirements for functionality, performance specifications, physical characteristics, safety characteristics, labeling, packaging and shipping, shelf life, and sterilization all passed the specific tests and engineering evaluations. The testing demonstrates that the device does not raise questions of safety or effectiveness when compared to the predicate."

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

• Test Set Sample Size: The document does not specify the exact sample size for each performance test (e.g., how many sheaths were tested for deflection, kink resistance, etc.). The testing appears to be bench testing of the device itself rather than human-subject data.
• Data Provenance: The data is generated from bench testing and laboratory biocompatibility studies of the device components. There is no information regarding country of origin of the data as it's not human subject data. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission.

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

• Not Applicable. This is a medical device clearance based on engineering performance and biocompatibility bench testing, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from patient data.

4. Adjudication method for the test set:

• Not Applicable. As above, no human expert adjudication on clinical cases was involved. The evaluation relied on predefined engineering specifications and ISO standards for biocompatibility.

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 not an AI/ML powered device.

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

• Not Applicable. This is not an AI/ML powered device. The "standalone" performance here refers to the device's physical and functional attributes in bench tests.

7. The type of ground truth used:

• Engineering Specifications and ISO Standards: For performance testing (e.g., deflection angle, usable length, hemostasis, kink resistance), the "ground truth" was the predefined engineering specifications and criteria that the device needed to meet, often referenced against the predicate device's characteristics.
• ISO 10993-1 Standards: For biocompatibility, the "ground truth" was compliance with the requirements outlined in ISO 10993-1 for an external communicating device in contact with circulating blood for less than 24 hours. Specific tests included: C3a Complement Activation Assay, SC5b-9 Complement Activation Assay, ASTM Partial Thromboplastin Time, USP Pyrogen Study, ISO Systemic Toxicity Study in Mice, ISO Intracutaneous Study in Rabbits, ASTM Hemolysis Study, Cytotoxicity Study Using the ISO Elution Method, ISO Guinea Pig Maximization Sensitization Test, and Thromboresistance Study in the Sheep (Heparinized Model).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML powered device. The device itself is manufactured; it does not have a "training set" in the AI/ML sense.

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

• Not Applicable. See point 8.

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The FlexCath Select Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart, including the left side of the heart through the interatrial septum. The sheath deflection facilitates catheter positioning.

The FlexCath Select Steerable Sheath is a sterile, single use percutaneous introducer fitted with a valve to allow for introduction, withdrawal and swapping of catheters and wires while preventing air ingress and minimizing blood loss. A side-port with stopcock is integrated to allow continuous drip infusion, injection through the center lumen, flushing, aspiration, blood sampling and pressure monitoring. The FlexCath Select Steerable Sheath can be deflected to provide additional maneuverability to catheters that are advance through the sheath and into the right or left chamber of the heart. The FlexCath Select Steerable Sheath is comprised of two (2) main sections: the shaft and the handle. A dilator is included with each sheath. This application introduces FlexCath Select 10 French (10Fr) FlexCath Select Steerable Sheath (990065), which is a modification of the 12 French (12Fr) FlexCath Advance Sheath (4FC12). Modifications were made to the shaft, cap and strain relief components, hemostasis valve assembly (stopcock, valve, and hub), dilator, new adhesive material and packaging tray cavity.

This document describes a 510(k) premarket notification for the "FlexCath Select Steerable Sheath and Dilator (Model 990065)". The submission aims to establish substantial equivalence to predicate devices, namely the "FlexCath Advance Steerable Sheath & Dilator (Model 4FC12)" and the "HeartSpan Steerable Introducer (Models FST-085-00, FST-085-01, and FST-085-02)". The primary modification and expansion of indications for use revolve around the ability to introduce the catheter into the left side of the heart through the interatrial septum (transseptal puncture).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria and the reported device performance" in a quantitative format with specific values for acceptance and performance. Instead, it describes a substantial equivalence comparison with predicate devices and states that "all testing demonstrated that acceptance criteria were met" and "all testing passed by meeting the established requirements".

However, we can infer some performance characteristics and implicit "acceptance criteria" from the comparative tables and descriptions:

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

The document states: "In-vitro testing was performed to demonstrate substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements." It further mentions "Non-clinical performance testing (bench testing) was performed to support substantial equivalence".

• Sample Size for Test Set: The document does not specify the sample sizes used for the various in-vitro or bench tests. It broadly refers to "all relevant key performance attributes were tested".
• Data Provenance: The data is described as "in-vitro testing" and "non-clinical performance testing (bench testing)". This inherently means the data is retrospective in the sense that it evaluates the manufactured device against pre-defined specifications. There is no mention of human subject data or clinical studies for this 510(k) submission, as it focuses on substantial equivalence through bench testing. The testing was presumably conducted by Medtronic CryoCath LP, which is based in Canada.

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

This section is not applicable as the ground truth for this device's performance was established through bench testing and engineering specifications against predicate devices, not through expert consensus on medical images or clinical outcomes. The "ground truth" here is the performance of the predicate devices and the established engineering requirements for safe and effective function.

4. Adjudication Method for the Test Set

This is not applicable as the evaluations were based on objective engineering and performance testing rather than subjective human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

This is not applicable. The device (FlexCath Select Steerable Sheath and Dilator) is a physical medical device, not an AI or imaging-related product. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is entirely outside the scope of this submission.

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 instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for demonstrating substantial equivalence was primarily based on:

• Performance of Predicate Devices: The established performance characteristics, safety, and effectiveness of the FlexCath Advance Steerable Sheath & Dilator (K123591) and the HeartSpan Steerable Introducer (K132164).
• Engineering Specifications and Bench Testing: The device's ability to meet pre-defined engineering and functional requirements through mechanical and performance verification.
• Risk Assessment: Evaluation of new failure modes, particularly those related to transseptal puncture, against acceptable risk levels, often informed by clinical knowledge of procedures.

8. The Sample Size for the Training Set

This is not applicable. As a physical medical device, there is no "training set" in the context of an AI/machine learning model. The device design and materials were developed based on engineering principles and knowledge gained from previous device designs (e.g., FlexCath Advance and HeartSpan).

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

This is not applicable for the same reasons as point 8. The "ground truth" for the device's design and functionality was established through engineering design processes, material science, and prior experience with similar devices, rather than a data-driven "training set" in the computational sense.

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