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The Nordica PV Cryo Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures (i.e., recording and stimulation only). The Nordica PV Cryo Mapping Catheter is designed to obtain electrograms in the atrial regions of the heart.

The Nordica PV Cryo Mapping Catheter is a 3F sterile, single use, multi-electrode, diagnostic catheter designed to map cardiac signals during ablation procedures. The catheter is provided with a fixed loop diameter of 15mm or 20mm with either 5 or 4 evenly spaced, radiopaque pairs of electrodes. The proximal end of the catheter contains an electrical connection for the EP electrical cable that integrates with electrophysiology lab recording systems. Once deployed in the vasculature through the central lumen of a catheter, a circular or spiral shape is established such that the electrodes contact the endocardial surface. This allows for recording, pacing, and interrogation of electrical conduction between the left atrium and the pulmonary veins.

The provided text describes the submission for a 510(k) premarket notification for the "Nordica PV Cryo Mapping Catheter" and focuses on demonstrating substantial equivalence to a predicate device.

Crucially, this document focuses on the safety and performance of a medical device (a catheter) through various engineering, sterilization, biocompatibility, and animal studies. It explicitly states: "This section is not applicable as the subject and predicate devices do not contain any software components or utilize software for their intended use." and "Human Clinical Performance Testing: Clinical testing was not required to demonstrate substantial equivalence to the predicate device."

Therefore, the request for acceptance criteria and a study proving a device meets the acceptance criteria in the context of AI/software performance, human readers, ground truth, and training/test sets is not applicable to this document.

The document details the following types of testing for the physical medical device:

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

The document provides a "Table 1: Comparison of Technological Characteristics with the Predicate Device" which implicitly serves as a comparison of the subject device's features against the predicate's known characteristics, thereby establishing the "acceptance criteria" through equivalence. The "reported device performance" is then demonstrated through various specific tests.

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

• Test set for Biocompatibility: "All tested subject devices met the acceptance criteria for each biological endpoint test". The exact number of devices tested for each biological endpoint (e.g., ISO MEM Elution, Hemolysis, etc.) is not specified, but it implies a sufficient sample size was used for each test to provide robust results.
• Test set for Benchtop Studies: "The results of benchtop testing demonstrated the design outputs of the subject device met the design input acceptance criteria required to demonstrate substantial equivalence with the predicate device." Similarly, exact sample sizes for each benchtop test (e.g., buckle force, catheter deflection, etc.) are not provided.
• Pre-Clinical GLP Animal Study: A "chronic GLP animal study" was performed on a "canine animal model". The exact sample size (number of animals) is not specified.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, beyond stating it was a "chronic GLP animal study" which implies a prospective, controlled study in a laboratory setting. All testing appears to be internal (Synaptic Medical Corporation) or contracted to ISO/ASTM compliant labs.

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

This is not applicable as the studies are engineering, biological, and animal model evaluations, not human-read AI evaluations.

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

Not applicable.

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.

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

Not applicable. The device has no software components or AI.

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

For the various tests, the "ground truth" is defined by the established scientific and engineering standards and methods:

• Biocompatibility: Defined by the acceptance criteria of ISO 10993 series standards (e.g., no cytotoxicity, no hemolysis, no sensitization, no pyrogenicity, etc.).
• Sterilization: Defined by ISO 11135:2014+A1:2019 (achieving SAL of 10^-6 or better) and EN ISO 10993-7:2008 + A1:2022 (residual limits).
• Shelf-Life: Defined by ASTM F1980-21 for accelerated aging and specific packaging integrity tests (ASTM F2096-11(2019), ASTM F88/F88M-21).
• Benchtop Performance: Defined by ISO 10555-1:2013/AMD 1:2017 and internal "design input acceptance criteria" for various physical properties (e.g., buckle force, tensile strength, electrical continuity).
• Pre-Clinical GLP Animal Study: Evaluation of "chronic safety, performance, and usability" in a canine model, presumably against pre-defined physiological endpoints and observational criteria.

8. The sample size for the training set

Not applicable, as this device does not involve AI/machine learning.

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

Not applicable, as this device does not involve AI/machine learning.

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The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is intended to introduce various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit consists of a 1) Steerable Sheath, 2) Dilator and 3) Guidewire, and is indicated for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. When the left side of the heart is accessed, the device is used with a compatible Transseptal Needle to puncture the interatrial septum for transseptal catheterization procedures. The NaviGo 12F Steerable Intracardiac Catheter Introducer Kit is a sterile, single use device, with asymmetrical bi-directional steerable introducer with usable length of 65cm. The Steerable Sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The handle is equipped with a rotating collar to deflect the Steerable Sheath tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text describes the NaviGo 12F Steerable Intracardiac Catheter Introducer Kit and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes various performance tests conducted, but it does not explicitly list quantitative acceptance criteria for each test in a table format with corresponding reported performance values. Instead, it generally states that the device "met the acceptance criteria" or "demonstrated robust biocompatibility."

However, based on the descriptions, we can infer some general criteria and outcomes:

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

• Sterilization Testing: Not explicitly stated, but bioburden testing, LAL testing, and EO/ECH residual testing were performed on "the subject device."
• Shelf-Life Testing: Not explicitly stated, but accelerated aging studies and various package integrity tests were performed on "the subject device."
• Biocompatibility Testing: Not explicitly stated, but various in-vitro and in-vivo tests were conducted. The "In-Vivo Thrombogenicity Evaluation [GLP Animal Study]" refers to the animal study below. Materials were from the device itself.
• Benchtop Studies: Not explicitly stated, but various devices would have been tested for each category.
• Pre-Clinical (GLP Animal Study):
  • Sample Size: Six (6) healthy canines.
  • Data Provenance: Prospective animal study conducted in a GLP (Good Laboratory Practice) environment. The location/country of the GLP lab is not specified but it's an animal model, not human data.

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

• Pre-Clinical (GLP Animal Study):
  • Number of Experts: Two (2)
  • Qualifications: "Board Certified Electrophysiologists specializing in ablation of pulmonary veins in the management of atrial fibrillation."

4. Adjudication Method for the Test Set

• For the Pre-Clinical (GLP Animal Study), the two electrophysiologists "performed the procedures and rated the overall performance and usability of the subject device." The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states "predominant rating of Acceptable and Above Average," suggesting a consensus or combined assessment was reached, but the process is not detailed.
• For other tests (benchtop, sterilization, biocompatibility), the ground truth is based on standard test methods and established scientific criteria, not expert adjudication in the same sense.

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

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter introducer kit), not an AI/software device that would typically involve human readers interpreting images with or without AI assistance. The study described is a pre-clinical animal study to assess safety, performance, and usability of the physical device.

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

No, a standalone algorithm performance study was not done. This is not an AI/software device.

7. The Type of Ground Truth Used

• Sterilization: Regulatory standards (ISO, ANSI/AAMI, EN ISO) for sterilization efficacy, bioburden levels, endotoxin levels, and residual limits.
• Shelf-Life: Regulatory standards (ASTM F1980-21, ASTM F2096-11(2019), ASTM F88/F88M-21) and product V&V testing.
• Biocompatibility: Regulatory standards (ISO 10993-1:2018, ISO 10993-4, -5, -7, -10, -11, -23) and FDA guidance for biological evaluation endpoints.
• Benchtop Studies: Design input acceptance criteria based on engineering specifications and industry standards relevant to catheter function (e.g., buckle force, deflection, kink resistance, leakage, bond strength).
• Pre-Clinical (GLP Animal Study): Direct observation, clinical assessment, and expert rating by Board Certified Electrophysiologists in a canine model for safety, performance, and usability. This includes observations for adverse events, device maneuverability, and overall handling, as well as thrombogenicity assessment.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The "training set" concept is typically relevant to AI/machine learning models.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

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The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.

The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.

The provided text is a 510(k) summary for a medical device called the "RithmID-SD Steerable Diagnostic Electrophysiology Catheter". This document focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility testing, and comparisons of technical characteristics.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria for each test in a separate column. Instead, for most tests, it states "All test samples met the acceptance criteria," indicating that the criteria were satisfied. The performance results are qualitative; for a few tests, comparative statements are made relative to the reference device.

Here's a compilation of the tests and their reported performance:

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