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The TELLTALE Electrosurgical Guidewire System is indicated for transcatheter electrosurgical traversal and laceration of native and bioprosthetic tissue in patients at risk of coronary obstruction during TAVR.

The TELLTALE system is comprised of the TELLTALE Guidewire, guide catheters and accessories to aid with the preparation, placement, and use of guidewire.

The TELLTALE system consists of the following elements:

• TELLTALE Guidewire
• TELLTALE Pachyderm Guide catheters (for left coronary cusp and for right coronary cusp)
• TELLTALE System Accessories
  • Spring-loaded cable connector
  • Denuder/Kinker
  • Guidewire grippers
  • Insulation envelope
  • Insulation tube
  • Plastic torquers
  • 6F Peel-away introducer
  • Guidewire introducer

The TELLTALE Guidewire has an outer diameter of 0.014" and a working length of 310cm. It is composed of a stainless-steel guidewire covered with an outer insulative polymer layer. The distal tip and proximal end of the guidewire are uninsulated. The TELLTALE Guidewire mid-shaft is provided to the user fully insulated to protect the operator from RF energy when the uninsulated guidewire tip is used for electrosurgical leaflet traversal inside the patient.

The proximal end of the TELLTALE Guidewire, which has no patient contact, is uninsulated and gold-plated to allow for connection to an electrosurgery generator to facilitate the delivery of monopolar RF energy to the cutting surfaces of the guidewire.

The TELLTALE Guidewire is to be used with RF generators that provide continuous wave, monopolar PURE CUT mode energy with power settings of 10 to 50 W (into a rated load of 300 ohms with maximum voltage of 900 V peak or less).

There are two cutting surfaces of the TELLTALE Guidewire:

1. the distal tip for leaflet traversal
2. a mid-shaft cutting location for aortic leaflet laceration.

The mid-shaft of the TELLTALE guidewire is identified by a 10mm gold marker band which is radiopaque. The mid-shaft cutting surface is created by the user by removing the insulative coating after the distal tip is used to traverse through tissue.

There are seven guide catheters specifically shaped to aid in leaflet traversal by allowing physicians to select the traversal location and providing support for TELLTALE Guidewire leaflet traversal. The TELLTALE System is supplied with three boxes; all guide catheters will be in separate shelf cartons, within one box. All seven guide catheters have a usable length of 100cm and an outer diameter of 6.4F.

There are multiple accessories provided to aid with the procedure:

• Guidewire gripper: The guidewire gripper attaches to a standard Y-adaptor and clamps onto the TELLTALE Guidewire to assist with guidewire traction during the procedure.

• Insulation envelope: Insulation envelope is provided for the physician to place the end of the guidewire during the traversal procedure to contain the backend of the guidewire and provide additional insulative protection

• Insulation Tube: An insulation tube is provided for the physician to place on the proximal end of the gooseneck snare during traversal (puncture) of the leaflet to provide insulation. It is also place by the physician on the end of the snared tip of the guidewire during the leaflet laceration procedure to provide insulation to the tip of the guidewire.

• Spring Loaded Connector: A detachable spring-loaded connector cable that plugs into the monopolar receptacle of a compatible RF generator that is used in conjunction with a compatible patient return electrode and allows for a secure insulative connection between the TELLTALE Guidewire and the generator. The detachable connector allows for exchange of catheters over the TELLTALE Guidewire as needed during the procedure.

• Denuder/Kinker: The Denuder/Kinker is provided to (1) create a reproducible denuded or uninsulated, area at the mid-shaft location of the TELLTALE Guidewire for laceration and (2) kink the TELLTALE Guidewire at the lacerating surface to produce the required angle for the leaflet laceration procedure.

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ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.

The ShortCut is a transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to transfemoral aortic valve replacement (TAVR), to reduce the risk of coronary ostium obstruction and coronary access compromise and enable a valve-in-valve procedure for patients at risk of coronary obstruction. Splitting of a leaflet creates a triangular opening in the leaflet that allows blood flow into the adjacent coronary artery.

The ShortCut is a sterile, single use, 16 Fr device which is inserted through the femoral artery over a guidewire into the left ventricle using standard catheter placement techniques. The ShortCut is comprised of the following parts:

• a. Distal Unit (DU) Distal end of the catheter which contacts the valve leaflets and splits them (Figure 1). It is comprised of the Splitting Element (SE) and the Positioning Arm (PA). The Splitting Element penetrates the leaflet from the ventricular side at the bottom of the leaflet and performs the cut. The Positioning Arm is positioned on the aortic aspect of the leaflet and acts as a protective stabilizer for the activated SE. The DU is delivered in a sheathed 16 Fr configuration that is opened upon reaching the target site.
• b. Delivery System (DS) The catheter shafts connect the Handle to the DU and delivers the required movements from the Handle to the DU. The DS is compatible with a 16 Fr introducer sheath and is delivered over a 0.035" Guide Wire (GW). The outer shaft of the DS (Sheathing Tube) is used to sheathe the DU during introduction and removal from the body. The inner shafts of the DS. together with its pig-tailed tip, enable flexing and positioning of the DU at the valve.
• c. Handle The user interface, designed to control the DS and the DU and to enable correct positioning of the DU on the valve (Figure 2).

The provided document describes the acceptance criteria and the study that proves the ShortCut device meets these criteria. The device is a percutaneous catheter system intended to split bioprosthetic aortic valve leaflets prior to transcatheter aortic valve replacement (TAVR) to reduce the risk of coronary obstruction in valve-in-valve (ViV) procedures.

Here's an organized summary of the requested information:

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

The acceptance criteria are implicitly derived from the success rates of the primary effectiveness and safety endpoints, as well as the composite technical success endpoint.

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

• Test Set (Clinical Study):
  • Sample Size: 60 enrolled subjects initiated the index procedure with ShortCut.
  • Data Provenance: Prospective, international, multi-center study.
    • Countries of Origin: 13 sites in the US, 8 in EU (Europe), and 2 in Israel.
    • Nature of Data: Prospective clinical trial data.

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

The document doesn't explicitly state the exact number or detailed qualifications of experts used to establish the ground truth for the clinical test set in terms of "expert consensus." However, it mentions several points related to external review and assessment:

• Primary Effectiveness Endpoint: Assessed intraprocedurally by echocardiography or angiography. This would typically be interpreted by the interventional cardiologists performing the procedure or specialized imaging physicians (e.g., echocardiographers).
• Primary Safety and Secondary Endpoints (Adverse Events): Adjudicated by a Clinical Events Committee (CEC). The qualifications of the CEC members are not specified, but such committees are typically composed of independent medical professionals with relevant expertise (e.g., cardiologists, neurologists) who review reported events.

4. Adjudication method for the test set:

• Adjudication Method: A Clinical Events Committee (CEC) adjudicated adverse events (SAEs and AEs), including primary safety endpoints (mortality and stroke) and secondary safety endpoints.
• The document mentions that 23 AEs determined by the site as non-serious and not related were not adjudicated by the CEC, indicating a protocol-defined scope for CEC review.

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, an MRMC comparative effectiveness study was not done. This device is a mechanical catheter for a surgical procedure, not an AI/imaging diagnostic tool that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The study focuses on the device's direct performance in a procedural setting.

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

• No, a standalone (algorithm-only) performance study was not done. As mentioned, this is a mechanical device, not an algorithm. Its performance is intrinsically linked to its use by qualified physicians ("human-in-the-loop").

7. The type of ground truth used:

The ground truth for the clinical study was based on:

• Intraprocedural Assessments:
  • "Evidence of a split": Visualized by intraprocedural Transesophageal Echocardiography (TEE) immediately post-ShortCut procedure and prior to TAVR, OR increase in aortic regurgitation from pre to post leaflet split, assessed by intraprocedural TEE or angiography. This relies on direct observation and established clinical imaging markers.
• Clinical Outcomes/Events:
  • Safety Endpoints: Adjudicated clinical events (mortality, stroke, coronary obstruction, etc.) based on patient follow-up and CEC review.
• Procedural Metrics: Direct observations and measurements during the procedure (e.g., successful access, delivery, retrieval, device integrity).

8. The sample size for the training set:

• The document refers to "bench studies" and "animal studies" as nonclinical performance testing.
  • Animal Training/Validation: One acute GLP animal study was conducted with 5 pigs to evaluate acute safety and functionality. This serves as a critical pre-clinical validation step but is not a "training set" in the machine learning sense.
  • There is no mention of a "training set" in the context of machine learning, as this is a medical device, not an AI algorithm. The rigorous bench and animal testing, along with the compassionate use cases, serve as pre-clinical and early human experience data that inform the device's design and refine its use before the pivotal clinical trial.

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

• Given that this is not an AI/ML device, the concept of a "training set" with established ground truth in that specific sense is not applicable.
• For the bench studies, ground truth was established through engineering specifications, validated test methods (e.g., ISO, ASTM standards), and predefined acceptance criteria for physical and functional performance.
• For the animal study, ground truth was established through:
  • Visual inspection for thrombus formation.
  • Gross pathology and histopathology examination of explanted organs to assess tissue damage, leaflet split, and potential emboli.
  • Direct observation of leaflet splitting and device usability during the procedure. These observations were then compared against the expected device function.

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