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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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