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To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or any interventional procedures.

Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel desease.

The proposed OptoMonitor 3 is a new version of the OptoMonitor System. This device and its components are considered accessories to Opsens OptoWire™ pressure guidewires and are intended for use with legally marketed pressure guidewires.

The proposed OptoMonitor 3 includes an Optical Unit (OU), a Display Unit (DU), a Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components and device functionalities are equivalent to that of the previous generation OptoMonitor (K192340 (cleared on 12/12/2019).

The device is a non-sterile, non-patient contact device.

The provided text describes a 510(k) premarket notification for the OptoMonitor 3 device, which is an updated version of the OptoMonitor System. The submission aims to establish substantial equivalence to a predicate device (K192340).

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison table between the proposed OptoMonitor 3 and its predicate device, OptoMonitor (K192340), rather than explicitly listing acceptance criteria with reported performance for a new study. However, the "Technological Characteristics" section of the table effectively serves as a list of performance parameters with implied acceptance criteria being "Same" as the predicate device.

2. Sample Size for Test Set and Data Provenance

The document states: "No animal studies or clinical investigations are included with this submission." and "Results from these tests mentioned above demonstrate that the technological and performance characteristics of the proposed OptoMonitor 3 is comparable to the predicate device". This implies that the substantial equivalence determination for performance was primarily based on bench testing and verification/validation activities of the device's hardware and software changes, rather than a clinical trial with a "test set" of patients.

Therefore:

• Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated through technical testing.
• Data Provenance: Not applicable for clinical data. The data provenance would be internal laboratory testing.

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

Since no clinical studies or human-in-the-loop evaluations were performed as part of this submission, there were no experts used to establish ground truth for a clinical test set. The validation focused on engineering and software verification.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or cited in this submission. The device is a pressure monitoring system, not an imaging interpretation or diagnostic aid that typically requires such studies.

6. Standalone (Algorithm Only) Performance Study

The document focuses on the entire OptoMonitor 3 system. While it mentions that "algorithms used for the FFR calculation remained unchanged from the predicate OptoMonitor," it does not detail a standalone performance study solely on the FFR algorithm. The performance data presented (pressure range, accuracy, etc.) relates to the entire device's ability to measure pressure.

7. Type of Ground Truth Used

For the engineering and software verification/validation, the ground truth would be established by:

• Reference standards and calibrated instruments: For pressure measurements, the device's output would be compared against known, highly accurate reference pressure sources.
• Pre-defined specifications and requirements: The software and hardware performance were validated against their design specifications.

8. Sample Size for the Training Set

Not applicable. This device is a measurement instrument, not an AI/ML model that undergoes a training phase with a "training set" of data in the typical sense.

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

Not applicable, as there was no training set for an AI/ML model.

Summary of Device Changes and Performance Rationale:

The OptoMonitor 3 is an updated version of the predicate OptoMonitor. The key changes are related to:

• Optical Unit: New casing, CPU, PCBs, validated software (algorithms for FFR calculation unchanged), addition of capability to receive aortic pressure signal from Cathlab Hemodynamic system, addition of low-level signal input, redesigned handle unit.
• Display Unit: Use of commercially available all-in-one PC, new software to support additional hardware options, addition of possibility to connect to hospital DICOM system.
• Aortic Input: Change from High Level (100 mmHg/V) to Low Level (5μV/V/mmHg) for the aortic input.
• AUX Input: Addition of a High Level (100 mmHg/V) AUX input, which was not present on the predicate.

The manufacturer argues substantial equivalence because:

• Indications for Use are the same.
• Technological characteristics are "essentially the same."
• The "Substantial Equivalence Table" shows identical specifications for crucial performance parameters like pressure range, accuracy, thermal zero shift, and zero drift.
• Software verification and validation testing were conducted.
• Electrical safety and EMC testing confirmed compliance with relevant standards.
• Risk Management processes evaluated the changes, and "no new questions of safety and effectiveness were identified."
• The algorithms for FFR calculation remained unchanged.

Therefore, the study supporting the device's acceptance criteria primarily involved bench testing and verification/validation activities against established engineering specifications and comparison to the predicate device's performance characteristics, without the need for animal or clinical studies.

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