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The sheath is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The sheath curve can be visualized when used with impedance-based electroanatomical mapping systems.

The proposed SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath subject devices are non-pyrogenic, single use devices that are supplied sterile to the UD Steerable Sheath families are comprised of the following components that are packaged together:

• . One Steerable Sheath
• . One Transseptal Dilator
• . One J-tip Mechanical Guidewire

The SureFlex and VersaCross HD Steerable Sheaths are intended for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The sheath curve can be visualized when used with separately cleared impedancebased electroanatomical mapping (EAM) systems. The steerable sheath component used in conjunction with a compatible transseptal dilator can facilitate transseptal puncture using separately cleared compatible needle or wire-based puncture devices. The steerable sheath component is connected to the impedance-based EAM system via a compatible legally marketed accessory cable. The subject device is used in a sterile environment where facilities are appropriately equipped and staffed to perform transseptal procedures.

The steerable sheath component is 8.5 Fr with a 63 cm or 73 cm useable length and is available in three curve options (small, medium, large). It is flexible and bi-directionally deflectable at the distal end (180 degrees clockwise and counterclockwise). The radiopaque tip (containing a platinum/iridium marker band) maximizes visualization of the sheath during manipulation. The sheath contains 4 electrodes equi-spaced along the shaft to enable shaft visualization. The sheath has two distal sideports and the proximal end includes a hemostasis valve and a 3-way stopcock to facilitate the injection or fluids. A silicone lubricant is applied to the outer surface of the shaft for smoother device manipulation. The sheath handle allows the user to control the deflection of the sheath tip through rotation of the knob in the direction of desired distal deflection.

The compatible dilator component is 8.5F with a 95cm usable length and is comprised of HDPE material with a tungsten radiopaque marker coil at the tip for visualization. The dilator has a tapered distal tip that provides support for the sheath. The compatible mechanical guidewire (0.032″ or 0.035″) component is J-tipped, 180 cm in length and is comprised of a stainless-steel core mandrel with a PTFE coating.

The provided document is a 510(k) Premarket Notification for medical devices, specifically steerable sheaths (SureFlex HD Steerable Sheath and VersaCross HD Steerable Sheath). It details the substantial equivalence determination made by the FDA.

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product. The medical devices in question are physical catheters/sheaths, and the performance testing summarized refers to mechanical, electrical, biocompatibility, sterilization, pyrogen, and packaging testing, as well as a simulated-use animal study. These are typical validation activities for a physical medical device.

The only mention of "visualization" or "mapping systems" is in the context of the sheath's curve being visualized when used with impedance-based electroanatomical mapping systems, and the predicate device's compatibility with CARTO® 3 EP Navigation Systems. This refers to the ability of the physical sheath to be seen on separate, compatible systems, not an AI or SaMD performing a diagnostic or therapeutic function itself.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving a device meets acceptance criteria for an AI/Software as a Medical Device (SaMD) product based on the provided text, as this information is not present. The document focuses on the substantial equivalence of a physical medical device.

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The Epicardial Access System is intended to access the epicardial surface of the heart via a subxiphoid approach.

The subject Epicardial Access System represents device modifications made to the Epicardial Steerable Guiding Sheath and Epicardial Introducer and Stylet components of the legally marketed Epicardial Access System (K191546). The Epicardial Access Needle component remains unchanged. The System is comprised of the following devices, which are single-use and supplied sterile to the user:

• Epicardial Access Needle
• Epicardial Steerable Guiding Sheath containing:
  • Steerable Sheath
  • Dilator
  • J-tip Guidewire
• Epicardial Introducer and Stylet
  The subject device is designed to provide access to the epicardial surface of the heart via a subxiphoid approach. It is used in percutaneous access procedures primarily by Electrophysiologists and Interventional Cardiologists trained in the subxiphoid approach. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy under sterile technique.

The provided document is a 510(k) premarket notification for a medical device (Epicardial Access System), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new product validation with acceptance criteria based on clinical outcomes or performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/ML-based devices.

Therefore, the supplied text does not contain the information requested for acceptance criteria and a study proving a device meets those criteria, specifically concerning data provenance, clinical performance metrics, expert adjudication, or MRMC studies. The document primarily details non-clinical performance testing (mechanical, general physical, biocompatibility, sterilization, pyrogen, and packaging verification) to show the modified device performs similarly to its predicate.

It describes hardware modifications to an existing system, not the development or validation of an AI/ML algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

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

   • Does not exist in the document. The document describes various non-clinical tests performed (mechanical, physical, biocompatibility, etc.) but does not list pre-defined quantitative acceptance criteria (e.g., success rates, tolerance levels, specific metric thresholds) for these tests, nor does it provide the reported performance values from these tests beyond a general statement that "Epicardial Access System met all test requirements."
   • This type of detailed performance data and acceptance criteria would typically be found in internal test reports, not in an FDA 510(k) summary focused on substantial equivalence.

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

   • Not applicable/Not present. The performance testing described is primarily non-clinical (benchtop mechanical, physical, etc.). There is no "test set" in the sense of a clinical dataset with patient data.
   • There is no mention of "data provenance" (country of origin, retrospective/prospective) because no clinical data or clinical test sets are used or described for device acceptance.

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

   • Not applicable/Not present. Since there is no clinical test set requiring human expert ground truth establishment, this information is not provided.

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

   • Not applicable/Not present. No clinical 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 present. This document discusses a physical medical device (catheter introducer system), not an AI/ML device. Therefore, no MRMC study or AI assistance evaluation was performed.

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

   • Not applicable/Not present. Not an AI/ML algorithm.

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

   • Not applicable/Not present. The "ground truth" for the non-clinical tests would be defined by engineering specifications and established test methods, not clinical outcomes or expert consensus.

8. The sample size for the training set:

   • Not applicable/Not present. This is not an AI/ML device; therefore, there is no training set mentioned.

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

   • Not applicable/Not present. No training set.

In summary, the provided FDA document pertains to a hardware medical device (Epicardial Access System) undergoing modifications and seeking 510(k) clearance by demonstrating substantial equivalence through non-clinical performance and engineering tests, not a software/AI device validated with clinical performance metrics against ground truth data.

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