(268 days)
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 OptoMonitor 3 includes the display of ARi/TIARi adjunctive hemodynamic indicators when compared to the approved OptoMonitor 3 with a fully integrated TAVI software update cleared via K213854.
The provided text is a 510(k) summary for the OptoMonitor 3 device. It describes a comparative analysis to a predicate device, focusing on the addition of ARi/TIARi adjunctive hemodynamic indicators. Unfortunately, the document does NOT contain a table of acceptance criteria and reported device performance directly tied to a specific study meeting those criteria. Instead, it describes general claims of meeting acceptance criteria for risk and functionality, and then details two analyses: a retrospective analysis of ARi/TIARi calculations and a clinical annotation study.
Based on the provided text, here's a description of the acceptance criteria (inferred from the studies described) and the study that proves the device meets the acceptance criteria, as much as can be extracted:
Overview of Device Performance and Acceptance Criteria (Inferred)
The document primarily focuses on demonstrating the substantial equivalence of the new OptoMonitor 3 (with ARi/TIARi) to a previously cleared OptoMonitor 3 (predicate). The acceptance criteria are therefore implicitly related to showing that the new features (ARi/TIARi calculation) are accurate and that the device's original functions (pressure measurement) remain robust after the software update.
Inferred Acceptance Criteria & Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| ARi/TIARi Calculation Accuracy: The device's calculation of ARi and TIARi should be statistically equivalent to established mathematical expressions. | Retrospective analysis showed that "manual calculation of regurgitation indices using mathematical formulas given in the literature yields statistically equivalent results to the indices displayed by OpM3 TAVI. The correlation coefficients... as well as the Bland-Altman plots, indicate high levels of agreement for each of the four indices. For additional exploration, the Pearson correlations were found to be higher than 0.99 for all four indices." |
| Pressure Measurement Accuracy (against expert annotation): The device's reported pressure values (Systolic LV, Systolic Ao, Diastolic Ao, Diastolic LV, LVEDP) should show high agreement with expert annotations. | Clinical annotation study: Bland-Altman analysis was performed, showing the following Levels of Agreement (LoA) between OptoMonitor 3 and expert annotations: |
- Systolic LV: Upper 0.22, Lower -0.26
- Systolic Ao: Upper 0.15, Lower -0.17
- Diastolic Ao: Upper 0.23, Lower -0.11
- Diastolic LV: Upper 4.02, Lower -3.45
- LVEDP: Upper 4.77, Lower -2.42 |
| No New Questions of Safety and Effectiveness: The addition of ARi/TIARi should not introduce new safety concerns or compromise existing functionalities. | "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." and "All acceptance criteria were met regarding risks and device functionality." |
Study Information
The document describes two key analyses: a Retrospective Analysis for ARi/TIARi calculation, and an Annotation Study for pressure measurement accuracy.
1. Retrospective Analysis (for ARi/TIARi Calculation)
- Sample size: 30 pressure recordings from 10 unique patients, for a total of 150 beats.
- Data Provenance: Clinically derived data recorded with the OptoMonitor from "existing pre and post market data sources." (Country of origin not specified, retrospective).
- Number of experts used to establish ground truth: Not applicable – ground truth was established by "mathematical expressions given in the literature by Sinning et al. and Bugan and Kumar et al." and manual calculation (Microsoft Excel). No human experts were involved in establishing this specific ground truth.
- Qualifications of experts (for ground truth): Not applicable.
- Adjudication method for the test set: Not applicable, as ground truth was mathematical.
- MRMC Comparative Effectiveness Study: No, this was an algorithmic comparison to mathematical ground truth.
- Standalone Performance: Yes (algorithm's calculation vs. mathematical formula).
- Type of Ground Truth: Mathematical expressions from published literature and manual calculation.
- Sample size for training set: Not specified, implicitly zero for this specific evaluation as it's testing the implementation of known mathematical formulas. The device is a "currently marketed device" and only software changes are discussed, implying any core training would have occurred previously.
- How the ground truth for training set was established: Not applicable for this specific evaluation.
2. Clinical Annotation Study (for Pressure Measurement and Waveform Interpretation)
- Sample size used for the test set: 420 waveforms in 29 patients.
- Data Provenance: Retrospectively conducted annotation study. (Country of origin not specified, retrospective).
- Number of experts used to establish the ground truth for the test set: "Experts panel" (number not specified, but plural implies more than one).
- Qualifications of those experts: "Expert clinicians." Specific qualifications (e.g., years of experience, specialty) are not provided.
- Adjudication method for the test set: Not explicitly stated, but "experts panel annotated" implies a consensus or independent annotation approach. No formal 2+1 or 3+1 method is mentioned.
- MRMC Comparative Effectiveness Study: No, this was a comparison of the device's output to expert annotations, not an MRMC study comparing human readers with and without AI assistance.
- Standalone Performance: Yes (algorithm's interpretation of tracings vs. expert annotation).
- Type of Ground Truth: Expert consensus/annotations. The experts annotated "the systolic Ao, diastolic LV, diastolic Ao, and LVEDP pressures on the pressure tracings."
- Sample size for the training set: Not specified. As with the first study, the device is marketed, suggesting prior development.
- How the ground truth for the training set was established: Not specified.
Additional Considerations from the Document:
- Risk-Based Approach: The document states that the Risk Management File for the predicate device was reviewed, and one new risk ("indices measured under suboptimal conditions") was identified, evaluated as tolerable, and benefits outweigh risks. This implies internal acceptance criteria for risk management were met.
- Verification and Validation Activities: It's stated that "All acceptance criteria were met regarding risks and device functionality" and that "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." While the specific criteria aren't listed, this indicates a broader V&V process was conducted.
§ 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).