(55 days)
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 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).
The device is a non-sterile, non-patient contact device.
The provided text describes the 510(k) submission for the OptoMonitor 3 device, which is a pressure monitor used with OptoWire™ pressure guidewires to measure pressure in blood vessels. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (OptoMonitor 3 cleared via K193620).
Crucially, this document does not describe a study involving an AI/Machine Learning algorithm for diagnostic purposes, nor does it present acceptance criteria and performance data in the context of an AI-based system. Instead, it concerns a medical device that measures physiological pressure. The "performance data" section specifically refers to electrical safety, electromagnetic compatibility (EMC), and wireless coexistence testing, not diagnostic accuracy or efficacy.
Therefore, many of the requested points related to AI/ML (e.g., ground truth, expert consensus, MRMC study, training data) are not applicable to the content of this document.
However, I can extract the relevant information regarding acceptance criteria and performance testing for this specific device.
Device Type: Medical Device - Catheter Tip Pressure Transducer (OptoMonitor 3)
Intended Use: To measure pressure in blood vessels (coronary and peripheral) during diagnostic angiography and/or interventional procedures, providing hemodynamic information such as fractional flow reserve for diagnosis and treatment of blood vessel disease.
Here's an attempt to answer the prompt based only on the provided text, recognizing that it's for a traditional medical device, not an AI product:
Acceptance Criteria and Device Performance Study for OptoMonitor 3
The OptoMonitor 3 is a pressure monitoring device, and the provided document is a 510(k) submission seeking substantial equivalence to a predicate device. The "study" described here is primarily a series of verification and validation (V&V) tests to confirm that changes in the new device version do not introduce new questions of safety and effectiveness, and that its performance remains comparable to the predicate. It is not a clinical study assessing diagnostic accuracy in the way an AI algorithm would be evaluated.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal "acceptance criteria" table with numerical targets in the same format as for an AI/ML diagnostic. Instead, it focuses on demonstrating that the performance characteristics of the new OptoMonitor 3 are "essentially the same" or "equivalent" to the predicate OptoMonitor 3 (K193620). The changes are primarily related to communication methods (Bluetooth) and display unit options, along with minor software updates. The "performance data" section details compliance with various electrical safety, EMC, and wireless coexistence standards.
The table below summarizes the key performance characteristics compared to the predicate, implying that the acceptance criterion is "same" or "equivalent performance" to the legally marketed and cleared predicate device.
| Characteristic | Predicate Device (K193620) Performance | Subject Device (K202943) Performance | Differences (and Implied Acceptance: "Same/Equivalent") |
|---|---|---|---|
| Intended Use | To measure pressure in blood vessels... for diagnosis and treatment of blood vessel disease. | To measure pressure in blood vessels... for diagnosis and treatment of blood vessel disease. | Same |
| General Indication for Use | Diagnostic computer... to compute and display various physiological parameters. | Diagnostic computer... to compute and display various physiological parameters. | Same |
| FFR Capability | Yes | Yes | Same |
| Basis for FFR Determination | Ratio of whole heartbeats of Pd and Pa | Ratio of whole heartbeats of Pd and Pa | Same |
| Operating Temperature | 15°C to 30°C | 15°C to 30°C | Same |
| Operating Relative Humidity | 10% to 85% non-condensing | 10% to 85% non-condensing | Same |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa | Same |
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg | Same |
| Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading (-30 to 50 mmHg) or +/- 3% of reading (50 to 300 mmHg) | +/- 1 mmHg plus +/- 1% of reading (-30 to 50 mmHg) or +/- 3% of reading (50 to 300 mmHg) | Same |
| Zero Drift |
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).