(26 days)
The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and measure physiological parameters in the coronary and peripheral blood vessels.
Comet™ II is a coronary and peripheral quidewire with a pressure sensor mounted approximately 3 cm proximally to the distal end of the straight tip. The optical pressure sensor is integrated within the distal region of a 0.014" quidewire to measure blood pressure gradient changes across coronary and peripheral lesions during endovascular procedures. The tip is radiopaque to help with guidewire placement and shapeable by the user. The guidewire is attached to an optical cable through a detachable connector. The optical cable has a connector on the proximal end for interface with an ancillary Boston Scientific signal processing module. When connected to the signal-processing module, a Boston Scientific iLab Polaris™ Multi-Modality Guidance System displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure. A torque device is preloaded onto the proximal end of the wire. The pressure guidewire, optical cable, and torque device are all connected in the single use sterilized packaging. The intended use of Comet II remains within the scope of the predicate intended use.
The provided text describes a 510(k) premarket notification for the Comet™ II Pressure Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report for a new device's performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of an AI/human-in-the-loop study, is not present in the provided text.
Specifically, the text states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." This indicates that a comprehensive clinical trial with human subjects to prove the device meets specific acceptance criteria typical of an AI-driven medical device (like those involving multi-reader multi-case studies, expert consensus on ground truth, or analysis of human reader improvement with AI assistance) was not performed or not required for this 510(k) clearance.
The study described is primarily non-clinical performance bench testing.
Here's a breakdown of the requested information based only on the provided text, with clear indications where the information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Performance criteria includes dimensional requirements, pressure gradient measurement (sensor) requirements, and interface with compatible devices." However, specific numerical acceptance criteria (e.g., accuracy +/- X mmHg) and the corresponding reported performance values from these bench tests are not detailed in the provided text.
| Performance Criterion | Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| Dimensional Requirements | Not specified (e.g., within X mm) | Stated that "Bench testing was performed to evaluate physical integrity, functionality, and performance" |
| Pressure Gradient Measurement (Sensor) Requirements | Not specified (e.g., accuracy +/- X mmHg, drift within Y%) | Stated that "Bench testing was performed to evaluate physical integrity, functionality, and performance" |
| Interface with Compatible Devices | Not specified (e.g., successful connection X% of time) | Stated that "Bench testing was performed to evaluate physical integrity, functionality, and performance" |
| Overall Performance | "Shown to be appropriate for its intended use" and "substantially equivalent to the Comet Pressure Guidewire, K151610." | "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench testing" which would involve a sample size of devices, but the number is not provided.
- Data Provenance: Not specified. As it's bench testing, country of origin related to patient data is not applicable. The data would be newly generated from the bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The ground truth for bench testing of a pressure guidewire would be established by calibrated instruments and established engineering standards, not by human experts interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Ground truth for bench testing is objectively measured by instruments, not subject to human interpretation or adjudication methods.
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, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the Comet II." This type of study would be relevant for devices involving AI assistance to human readers, which this guidewire is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an AI algorithm. This device is a physical pressure guidewire that measures physiological parameters. Its "performance" is its ability to accurately measure pressure and direct a catheter, relying on its internal sensor and physical properties, not a standalone AI algorithm. The text states it interfaces with a "Boston Scientific iLab Polaris™ Multi-Modality Guidance System" which "displays various physiological parameters including aortic pressure, distal pressure and a fractional flow reserve (FFR) value calculated from the ratio of distal pressure over aortic pressure." While this system performs calculations, it's not described as a standalone AI algorithm whose performance needs to be evaluated independently of the device's physical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "pressure gradient measurement (sensor) requirements," the ground truth would typically be established by reference standard measurements from highly accurate and calibrated pressure transducers used in a controlled laboratory setting (bench testing).
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning or AI models. Its performance is based on its physical design, manufacturing, and calibration, not learned from data.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" for this device.
§ 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).