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The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.

The provided text describes the performance data and substantial equivalence arguments for the SavvyWire™ and OptoMonitor 3 with TAVI, rather than detailing specific acceptance criteria and the results of a study designed to prove the device meets those criteria in a quantitative table. The document focuses on demonstrating substantial equivalence to existing predicate devices through various tests and studies.

Based on the provided text, a direct table of acceptance criteria and reported device performance with specific quantitative thresholds and met/not met status cannot be fully constructed as this information is not presented in that format. However, I can infer the general nature of the acceptance criteria from the tests conducted and the stated conclusions.

Here's a breakdown of the requested information based on the document, with inferred acceptance criteria where explicit quantitative values are not given:

Inferred Acceptance Criteria and Reported Device Performance

Here's the rest of the requested information:

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

• Clinical Study (Test Set for Clinical Performance):

  • Sample Size: 20 patients. Twenty-one (21) devices were used (one per patient except the first patient needed two).
  • Data Provenance: Single-arm, two-center, prospective study. The document does not specify the country of origin for the clinical study data, but it is an FDA submission, implying compliance with US regulatory standards for clinical data. Given the context of the company (Opsens Inc. in Quebec, Canada) and a US consultant, the study might be multicenter, potentially including sites in the US or Canada.

• Animal Studies:

  • Sample Size: Not specified quantitatively.
  • Data Provenance: Animal performance testing (prospective).

• Design Verification (Mechanical, Electrical, etc.):

  • Sample Size: Not specified quantitatively, but tests were conducted. "Design Specification Verification and ISO 11070 Compliance were completed by documentation check and therefore did not use any SavvyWire™ product." implying some tests were document-based, while others (mechanical, functional, FOIC, rapid pacing) involved physical devices.
  • Data Provenance: Laboratory testing.

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

• The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical or animal studies.
• For a clinical study involving TAVR procedures, it is implied that the procedures were performed and outcomes assessed by qualified interventional cardiologists or cardiac surgeons. The "ground truth" for success in TAVR procedures and pacing would typically be established by established clinical protocols and expert medical judgment.

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

• The document does not specify any formal adjudication method (e.g., 2+1, 3+1 for imaging or clinical endpoints) for the clinical study. It describes a single-arm clinical study for TAVR procedures.

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 MRMC or AI-assisted human reader study was conducted or described. This device is a physical medical device (guidewire and monitor), not an AI-powered diagnostic imaging tool that would typically involve human-in-the-loop performance studies.

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

• The device is a physical guidewire with pressure sensing and pacing capabilities, used with a monitor. The "performance" described is the device's functional and safety performance, not an algorithmic diagnostic output. Therefore, the concept of "standalone (algorithm only)" doesn't directly apply here in the typical sense of AI/software performance. However, aspects like "Pressure Accuracy," "Thermal Zero Shift," and "Zero Drift" for the OptoMonitor 3 are standalone device performance metrics, independent of human interpretation.

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

• Clinical Study: The ground truth for the clinical performance (e.g., successful pacing, successful THV advancement/positioning) was established by clinical observation and outcomes during actual TAVR procedures in patients. This falls under outcomes data and clinical observation/judgment by the treating physicians.
• Animal Study: Ground truth was based on direct observation of device functionality in animal models, comparison to predicate devices, and findings from necropsy and histopathology.
• Design Verification: Ground truth for mechanical, electrical, and biocompatibility tests derived from engineering specifications, established medical device standards (ISO, ASTM, IEC), and laboratory test results.

8. The sample size for the training set:

• This device is not an AI/machine learning model, so there is no "training set" in the sense of data used to train an algorithm. The development of such a device involves engineering design, prototyping, and testing, rather than data-driven machine learning.

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

• As above, there is no "training set" in the context of an AI/ML model for this device. Ground truth for the underlying engineering design values would be based on established physics, biomedical engineering principles, and performance requirements derived from clinical needs and predicate device capabilities.

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