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510(k) Data Aggregation
(268 days)
Opsens Inc.
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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(57 days)
Opsens Inc.
The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.
Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.
The provided text is a 510(k) summary for the PacePro Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device (SavvyWire) and does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study. The device is a medical guidewire with temporary pacing capabilities, not an AI-powered diagnostic device.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/human reader studies, as this information is not present in the provided document.
However, I can extract information related to the device's performance testing as described in the summary, which serves a similar purpose of demonstrating the device meets its design requirements and is safe and effective.
Here's what can be extracted based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device submission focused on substantial equivalence:
1. Table of Acceptance Criteria (or Performance Tests) and Reported Device Performance
The document details performance tests conducted to show the PacePro Wire's equivalence to its predicate. While not explicitly "acceptance criteria" for an AI algorithm's performance, these are the criteria for the device's physical and functional performance.
| Category | Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Sterilization | Adherence to ISO 11135-1 (Ethylene Oxide sterilization). | "The following standards are utilized to show equivalence of Sterilization...ISO 11135-1 (2014)..." (Implies successful adherence) |
| Packaging | Adherence to ISO 11607-1 (Packaging for terminally sterilized medical devices). | "The following standards are utilized to show equivalence of...Packaging...ISO 11607-1 (2019) – Amendment 1:2023..." (Implies successful adherence) |
| Shelf-life | No specific standard mentioned, but testing was performed. | "The following standards are utilized to show equivalence of...Shelf life:" (Implies successful outcome). |
| Biocompatibility | Adherence to FDA Guidance ISO 10993-1, categorized as "External communicating device – circulating blood," limited exposure up to 24h. | "Biocompatibility evaluation was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1..." Testing completed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, SC5b-9 complement. (Implies successful testing for all listed) |
| Design Verification | Adherence to FDA Guidance "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling Guidance for Industry and Food and Drug Administration Staff October 2019." | "All Design Requirements were successfully verified for the PacePro Wire device." |
| Mechanical Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Particulate Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Rapid Pacing Testing | Included as part of Design Verification. | Part of "All Design Requirements were successfully verified." |
| Safety and Effectiveness | No new questions of safety and effectiveness identified after Verification and Validation. | "No new questions of safety and effectiveness were identified during execution of Verification and Validation activities." |
| Pacing Capabilities | Equivalent to predicate device. | "The pacing capabilities of the PacePro Wire is tested to be equivalent to that of the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes typically refer to the number of devices tested for each characteristic (e.g., tensile strength, flexibility, etc.). This detail is not provided in a summary document like a 510(k).
- Data Provenance: The tests are conducted by the manufacturer, Opsens Inc. The data provenance would be internal laboratory testing and third-party lab testing as required for standards like ISO 10993. It's prospective testing conducted specifically for this submission. Country of origin for data is likely Canada (where Opsens Inc. is located) or certified testing labs they utilize elsewhere.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The device is a physical guidewire, not a diagnostic AI system requiring expert human interpretation as ground truth. The "ground truth" for this device's performance is established by objective engineering and biological tests against established standards.
4. Adjudication method for the test set
Not applicable, as it's not an AI/human reader study.
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
Not applicable. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
The "ground truth" for this medical device is based on:
- Compliance with established international and national standards (e.g., ISO 11135-1, ISO 11607-1, ISO 10993-1, FDA Guidance documents for guidewires).
- Engineering specifications and functional requirements of the device.
- Biocompatibility testing results for material safety.
8. The sample size for the training set
Not applicable. This is not an AI-powered device with a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-powered device with a training set.
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(278 days)
Opsens Inc.
The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
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 SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.
The provided text describes the performance data and substantial equivalence arguments for the SavvyWire™ and OptoMonitor 3 with TAVI, rather than detailing specific acceptance criteria and the results of a study designed to prove the device meets those criteria in a quantitative table. The document focuses on demonstrating substantial equivalence to existing predicate devices through various tests and studies.
Based on the provided text, a direct table of acceptance criteria and reported device performance with specific quantitative thresholds and met/not met status cannot be fully constructed as this information is not presented in that format. However, I can infer the general nature of the acceptance criteria from the tests conducted and the stated conclusions.
Here's a breakdown of the requested information based on the document, with inferred acceptance criteria where explicit quantitative values are not given:
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Test Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Equivalence (Overall System) | The SavvyWire™ and OptoMonitor 3 with TAVI are shown to perform in a manner equivalent to the predicate devices with the same intended use. All substantial equivalence requirements were met. |
| Safety and Effectiveness (Risk Management) | "All acceptance criteria were met regarding risks and device functionality." "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." "The risks related to all applicable hazards which were identified for the SavvyWire™ have been reduced to the acceptable level by mitigation...all residual risks post-mitigation have been deemed acceptable for this design." The device is shown to be at least as safe and effective as the predicate device. |
| Sterilization, Packaging, Shelf-life | Equivalence to specified ISO and ASTM standards (ISO 11135-1, ISO 11607-1, ASTM F1980-07) was utilized. Devices subjected to accelerated aging equivalent to 2 years ("TO" = no aging) were tested. (Specific results are not detailed, but adherence to standards implies meeting criteria). |
| Biocompatibility | Evaluation conducted in accordance with FDA guidance Use of International Standard ISO 10993-1. All listed tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, SC5b-9 complement) were completed. (Specific results are not detailed, but completion implies meeting criteria for classification as "External communicating device – circulating blood" with "limited exposure"). |
| Electrical Safety & EMC | The OptoMonitor 3 with TAVI Software complies with applicable requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-34 when used with SavvyWire™. Certain applicable portions of ISO 14708 are also applied. (Compliance implies meeting criteria). |
| Mechanical Performance (e.g., Guide Wire Properties) | Design Verification was conducted based on FDA Guidance Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling. All Design Requirements were verified. "Verification testing includes: Rapid Pacing Testing, Mechanical Testing, Functional Testing, FOIC Testing." "Design Specification Verification and ISO 11070 Compliance were completed by documentation check." (Meeting design requirements and compliance implies success). |
| Pacing Functionality (Equivalence to Bipolar Pacing Catheters) | The pacing of the SavvyWire™ (unipolar) was "tested to be equivalent to that of the reference device, Pacel™ Bipolar Pacing Catheters in an animal study comparing the two devices and clinical performance is also confirmed via a clinical study." (Successful equivalence demonstration). Animal performance testing "validated device functionality and to provide comparison data to the predicate devices." Clinical study demonstrated "use of the SavvyWire™ guidewire in the LV for rapid ventricular pacing...is substantially equivalent to other marketed devices." |
| Pressure Measurement Performance (Accuracy, Range, Drift, etc. for OptoMonitor 3) | Pressure Range: -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). Thermal Zero Shift: |
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(55 days)
Opsens Inc.
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)
Opsens Inc.
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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(170 days)
Opsens Inc.
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
The proposed OptoWire III is a new version of the OptoWire Deux that includes changes to strengthen the robustness of the product. Additional changes have been made to improve manufacturability. Changes include a reduction in tip length and coil gap, changes in the tube inner and outer configuration, and a minor material change in the PTFE coating.
The Opsens OptoWire III is used in conjunction with the Opsens OptoMonitor and Accessories, the "OptoMonitor System" consisting of an electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and hemodynamic information, such as fractional flow reserve (FFR) values, and various connection cables.
The OptoWire III consists of the following items:
- OptoWire assembly (quidewire) including the pressure sensor sub-assembly
- Fiber Optic Interface Cable (FOIC)
- Packaging including tray, Torque Device, pouch and box
- Labelling including labels and printed IFU
The provided text describes a 510(k) premarket notification for the OptoWire III. This document focuses on demonstrating substantial equivalence to a predicate device (OptoWire Deux) rather than proving the device meets acceptance criteria from a clinical study with specific performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.
Therefore, much of the requested information regarding acceptance criteria for a diagnostic study, sample sizes for training/test sets, expert qualifications, and adjudication methods is not present in this regulatory submission. The document emphasizes engineering and bench testing to demonstrate that changes made to the OptoWire III do not raise new questions of safety or effectiveness compared to its predicate.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria (e.g., target sensitivity, specificity) with corresponding reported device performance for a diagnostic task. Instead, it compares the technological characteristics and performance of the proposed device (OptoWire III) to its predicate device (OptoWire Deux) to demonstrate substantial equivalence.
The "Performance Data" section describes various design verification tests, biocompatibility tests, and animal studies to ensure the OptoWire III functions as intended and is safe. Key performance aspects like Pressure Accuracy and Thermal Zero Shift for the pressure sensor are explicitly stated and are identical to the predicate:
| Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) |
|---|---|
| +/- 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) |
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(106 days)
Opsens Inc
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 vessels.
The proposed OptoMonitor is a software upgrade that includes software modifications allowing for the calculation of dPR index, and revised labeling relevant to this change. This device and its components are considered accessories to catheter pressure transducers and are intended for use with leqally marketed catheters. The OptoMonitor with the new dPR calculation is an upgraded version of the software embedded in the previously cleared OptoMonitor's Display Unit. The OptoMonitor comprises the exact same hardware as cleared version with most of the software remaining unchanged, except for the display unit software which in addition to the current calculation of Fractional Flow Reserve (FFR), the upgraded version will also calculate the diastolic pressure ratio (dPR). dPR is a resting index which consists in calculating the ratio of Pd and Pa over the diastolic portion of the heart beat cycle. dPR is a resting index for the diagnostic of the severity of stenosis equivalent to iFR (instantaneous wave-Free Ratio). IFR calculates the ratio of Pd and Pa over 75% of the diastolic portion. The OptoMonitor is composed of 3 parts: The Hybrid Cable Unit (HCU), the Signal Conditioner Unit (SCU) and the Display Unit (DU). There are no changes to the device hardware (HCU and SCU) from device system cleared under K142598. The device is a non-sterile, non-patient contact device.
Here's a breakdown of the acceptance criteria and study information for the OptoMonitor with dPR software upgrade, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the dPR software update itself. Instead, it compares the dPR's diagnostic performance against iFR (the reference standard and reference device) and FFR. The "reported device performance" are the accuracy, specificity, and sensitivity of dPR.
| Metric | Acceptance Criteria (Implied by equivalence to iFR) | Reported Device Performance (dPR) | Notes |
|---|---|---|---|
| Accuracy | Equivalent to iFR | 97.1% [95.7%, 98.1% @95% CI] | Compared to iFR as a reference standard, using a cut-off of 0.89. |
| Specificity | Equivalent to iFR | 95.9% [93.6%, 97.5% @95% CI] | Compared to iFR as a reference standard, using a cut-off of 0.89. |
| Sensitivity | Equivalent to iFR | 98.4% [96.6%, 99.3% @95% CI] | Compared to iFR as a reference standard, using a cut-off of 0.89. |
| Diagnostic Performance vs. FFR | Not statistically different from iFR vs. FFR | Not statistically different from diagnostic performance of iFR vs. FFR, with 95% confidence interval significantly overlapping. | This assesses if dPR (cut-off=0.89) vs FFR (cut-off=0.80) performs similarly to iFR (cut-off=0.89) vs FFR (cut-off=0.80). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The performance metrics (accuracy, specificity, sensitivity) were "calculated from both CONTRAST² and VERIFY ²² studies." The exact number of patients or cases from these studies used for the dPR analysis is not provided.
- The document implies that the data is retrospective, as it is based on re-analysis of existing study data (CONTRAST and VERIFY). The country of origin for these studies is not specified in this document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The ground truth for the dPR analysis appears to be the iFR itself (as a "reference standard") and FFR. The qualifications of the original investigators/experts who conducted the CONTRAST and VERIFY studies and established FFR/iFR values are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. The analysis appears to be a direct comparison of calculated dPR values against iFR and FFR values from existing studies, rather than a new adjudication process involving human reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? No. The document explicitly states: "No animal studies or clinical investigations are included with this submission."
- Effect Size of Human Readers with/without AI assistance: Not applicable, as no human reader study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The reported accuracy, specificity, and sensitivity for dPR (97.1%, 95.9%, and 98.4% respectively) are results of the algorithm's performance in calculating dPR and comparing it to iFR from existing studies. The dPR calculation is an automated software function on the OptoMonitor.
7. Type of Ground Truth Used
The ground truth used for evaluating dPR's performance was:
- Instantaneous wave-Free Ratio (iFR): Explicitly stated as the "reference standard."
- Fractional Flow Reserve (FFR): Used as a comparative measure to assess the diagnostic performance of dPR vs FFR and iFR vs FFR.
8. Sample Size for the Training Set
This information is not provided in the document. The document describes a "software upgrade" to calculate dPR, indicating that the algorithm was likely developed and validated on internal datasets, but the size of any training data is not mentioned.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Given that the dPR calculation is a derivation from existing physiological measurements (Pd and Pa pressures), the "training" might involve tuning the algorithm to accurately replicate known iFR values or align with FFR correlations from existing clinical data. The exact method of establishing ground truth for any potential training set is not detailed.
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(131 days)
Opsens Inc
The OptoMonitor 2 is a system intended for use in all blood vessels, including coronary and peripheral vasculature, to measure intravascular pressure during angiography and/or interventional procedures.
Pressure measurements are obtained to provide hemodynamic information, such as FFR, for the diagnosis and treatment of blood vessel diseases. Pressure measurements are also obtained to provide intra-catheter or intravascular pressure, such as within occlusion perfusion catheter, for the diagnosis and treatment within the vasculature.
The proposed OptoMonitor II is a new version of the OptoMonitor System that includes software modifications and new labeling to allow for the expanded indications of intravascular pressure monitoring during interventional procedures, such as with the occlusion perfusion catheter, for diagnosis and treatment within the vasculature. This device and its components are considered accessories to catheter pressure transducers and are intended for use with legally marketed catheters.
The OptoMonitor II is intended to measure pressure using specifically devoted optical pressure sensing devices. The OptoMonitor II comprises two modes of operation:
- FFR mode using an OptoWire (The FFR mode is exactly the same as the predicate device, there are no changes to FFR mode included in this submission.)
- Pressure mode using an Optical Pressure Catheter (The Pressure mode is a new modality and the subject of this submission)
The OptoMonitor II automatically switches to the proper operational mode upon connecting the device. This information is contained within the EEPROM contained in every device that connect to the OptoMonitor II.
Both modes are nearly the same with the following differences:
- The FFR mode includes the calculation and display of Pd/Pa and FFR values.
- The FFR mode includes the equalization of distal pressure against aortic pressure.
- The pressure mode includes atm (atmosphere) as pressure unit.
- The pressure mode does not allow re-zeroing the distal pressure of more than 50 mmHg when in mmHg, and of more than 300mmHg when in atm unit.
- The pressure is not output on the distal output interface when unit ATM (instead of mmHg).
The proposed OptoMonitor-II includes the Optical Unit (OU), the Display Unit (DU), The Handle Unit (HU) and accessories (cables, power supply, etc). These hardware components are exactly the same as the cleared device hardware (K142598 cleared on 06/12/2015), software and labeling (to indicate updated software) is updated with this submission.
OptoMonitor-II is compatible with the cleared Occlusion Perfusion Catheter(OPC) devices as described in the FDA submissions K130525, K154554 & K153488. The OPC catheters are legally marketed devices that are not altered by Opsens. All sizes of Occlusion Perfusion Catheters are compatible with the OptoMonitor II device since the catheters are all within the specified pressure range and the connectors are compliant to Optomonitor requirements.
The device is a non-sterile, non-patient contact device.
The provided document is a 510(k) premarket notification for the OptoMonitor II device. The document states that the OptoMonitor II is an updated version of the OptoMonitor system, primarily involving software modifications and new labeling to expand its indications to include intravascular pressure monitoring during interventional procedures, such as with an occlusion perfusion catheter.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" against which a study directly proves the device meets. Instead, it compares the technological characteristics and performance specifications of the proposed OptoMonitor II with its predicate device (OptoMonitor K142598) to establish substantial equivalence. The overall "acceptance criterion" is implicitly that the OptoMonitor II performs comparably to the predicate device and does not raise new questions of safety or effectiveness.
Here's a table based on the "Substantial Equivalence Table" provided, highlighting key performance specifications:
| Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (OptoMonitor II) |
|---|---|---|
| Operating Temperature | 15°C to 30°C | 15°C to 30°C |
| Transport Temperature | -25°C to 60°C | -25°C to 60°C |
| Operating Relative Humidity | 10% to 85% non-condensing | 10% to 85% non-condensing |
| Storage Temperature | Room Temperature | Room Temperature |
| Operating Pressure | 70 to 106 kPa | 70 to 106 kPa |
| Pressure Range | -30 to 300 mmHg | -30 to 300 mmHg FFR and catheter low pressure range. Distal high pressure range between -1 (-760 mmHg) atm and 20 atm (152000 mmHg) in high pressure mode. |
| 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). The high pressure range shall have an accuracy of 4% of reading or 1% of the full scale range whichever is greater. |
| Thermal Zero Shift |
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(270 days)
Opsens, Inc.
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
The OptoWire and OptoMonitor System includes a pressure sensing guidewire (OptoWire), electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. The OptoWire and OptoWire cable are sterile, single-use devices; the remaining system components are reusable.
Here's a breakdown of the acceptance criteria and study information for the OptoWire and OptoMonitor System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance tests (bench and animal) but does not explicitly list specific acceptance criteria values alongside the reported device performance in a single section. Instead, it states that "All internal design criteria were successfully met" and the device "compared favorably to predicate devices tested" for the OptoWire mechanical/functional verification.
However, a detailed comparison table with predicate devices (Volcano Corp. PrimeWire Prestige Plus Pressure Guide Wire and ComboMap Pressure and Flow System) does provide specific performance metrics for the OptoWire and OptoMonitor System that can be inferred as criteria for substantial equivalence.
Inferred Acceptance Criteria & Reported Device Performance (from "Substantial Equivalence Comparison" table):
| Feature/Parameter | Acceptance Criteria (Inferred from Predicate/Target) | OptoWire and OptoMonitor System Performance (Reported) | Met Acceptance Criteria? |
|---|---|---|---|
| OptoWire | |||
| Guidewire OD | 0.014" (Predicate: PrimeWire Prestige Plus) | 0.014" | Yes |
| Guidewire Length | Ranges (e.g., 185 cm, 300 cm for predicate) | 175 cm | Favorable Comparison |
| Guidewire Shaft Material | Stainless Steel; Nitinol (Predicate: PrimeWire) | Stainless Steel; Nitinol | Yes |
| Guidewire Coating | Teflon; GlyDx Hydrophilic (Predicate: PrimeWire) | Teflon; Silicone | Favorable Comparison |
| Guidewire Tip Configuration | Straight, pre-shaped "J" (Predicate: PrimeWire) | Straight | Favorable Comparison |
| Guidewire Tip Length | 3.0 cm (Predicate: PrimeWire) | 3.5 cm | Favorable Comparison |
| Radiopaque Tip? | Yes (Predicate: PrimeWire) | Yes | Yes |
| Pressure Sensor Location | 3.0 cm from distal tip (Predicate: PrimeWire) | 3.5 cm from distal tip | Favorable Comparison |
| Pressure Sensing & Signal Trans | Hard wired strain gauge (Predicate: PrimeWire) | Fiberoptic sensor & fiber bundle | Favorable Comparison |
| OptoMonitor | |||
| Operating Temperature (Monitor) | 16°C to 32°C (Predicate: ComboMap) | 15°C to 30°C | Yes |
| Transport Temperature (Monitor) | -20°C to 60°C (Predicate: ComboMap) | -25°C to 60°C | Yes |
| Operating Relative Humidity | 30% to 75% (Predicate: ComboMap) | 10% to 85% non-condensing | Yes |
| Storage Temperature (Monitor) | -20°C to 60°C (Predicate: ComboMap) | Room Temperature | Favorable Comparison |
| Operating Pressure | 50 to 106 kPa (Predicate: ComboMap) | 70 to 106 kPa | Yes |
| Pressure Range | -30 to 300 mmHg (Predicate: PrimeWire/ComboMap) | -30 to 300 mmHg | Yes |
| Pressure Accuracy | +/- 1 mmHg + 1% (-30 to 50 mmHg), +/- 3% (50-300 mmHg) (Predicate: ComboMap) | +/- 1 mmHg + 1% (-30 to 50 mmHg), +/- 3% (50-300 mmHg) | Yes |
| Thermal Zero Shift |
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