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510(k) Data Aggregation
(268 days)
OptoMonitor 3
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.
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(55 days)
OptoMonitor 3
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 |
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(175 days)
OptoMonitor 3
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.
| Performance Parameter | Acceptance Criteria (Implied: Same as Predicate) | Reported Device Performance (OptoMonitor 3) |
|---|---|---|
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg |
| Pressure Accuracy | +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) | +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) |
| Thermal Zero Shift |
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